1. Physiological sleep metrics (recorded with ear EEG in subsample of 60 patients).
2. Self-reported sleep quality.
3. Quality of life.
4. Physical and mental health.
5. Thoughts and beliefs about sleep and pain. conditions: Chronic Pain conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Digital CBT-I name: Digital Sleep hygiene education measure: Insomnia severity measure: Average pain intensity during the last 7 days measure: The trajectory of ISI severity scores measure: 30% ISI responders measure: 50% ISI responders measure: Weekly pain intensity score trajectory measure: 30% pain intensity responders measure: 50% pain intensity responders measure: Global Perceived Effect (GPE) for sleep measure: Global Perceived Effect (GPE) for pain measure: Sleep Quality measure: Physical and Mental Health measure: Sleep diary measure: Thoughts about sleep and pain measure: Thoughts about sleep measure: Treatment compliance measure: Health-related quality of life - mobility measure: Health-related quality of life - self care measure: Health-related quality of life - usual activities measure: Health-related quality of life - pain/discomfort measure: Health-related quality of life - anxiety/depression measure: Health-related quality of life - global measure: Age measure: Sex measure: Chronic pain measure: Ethnicity measure: Height measure: Weight measure: Marital status measure: Level of education measure: Pain distribution measure: Medical history and concomitant illnesses measure: Concomitant medication measure: Health-related quality of life - mobility measure: Health-related quality of life - self care measure: Health-related quality of life - usual activities measure: Health-related quality of life - pain/discomfort measure: Health-related quality of life - anxiety/depression measure: Health-related quality of life - global measure: Insomnia Severity measure: Average pain intensity during the last 7 days measure: Medication use measure: Economical evaluation measure: Time from sleep onset until final awakening (TST) from Ear EEG in subgroup of 60 patients measure: Sleep efficiency (SE) from Ear EEG in subgroup of 60 patients measure: Sleep onset latency (SOL) from Ear EEG in subgroup of 60 patients measure: Wake after sleep onset (WASO) from Ear EEG in subgroup of 60 patients measure: REM sleep latency from Ear EEG in subgroup of 60 patients measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG measure: Number of awakenings within TST from Ear EEG measure: Arousal index which is number of arousals per hour from Ear EEG measure: Ease-of-use and Comfort with ear EEG measure: Ear EEG adverse device effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense status: RECRUITING city: Odense zip: 5000 country: Denmark name: Henrik B Vaegter, PhD role: CONTACT phone: 004565413869 email: hbv@rsyd.dk name: Louise S Olsen, MSc role: CONTACT phone: 004565413869 email: Maria.Louise.Stage.Olsen@rsyd.dk name: Henrik B Vægter, PhD role: PRINCIPAL_INVESTIGATOR name: Louise S Olsen, MSc role: SUB_INVESTIGATOR lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06361901 id: 2023GR0452 briefTitle: Comparison of Therapeutic Effect Between Speech Rehabilitation Program and Speech Therapy in Stroke Patients With Aphasia overallStatus: RECRUITING date: 2023-11-17 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: Korea University Guro Hospital class: OTHER briefSummary: Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group.

Clinical evaluation tools will be performed before and after the treatment for all patients

* K-Western Aphasia Battery for aphasia assessment tools
* Cerebral blood flow changes with near-infrared spectroscopy conditions: Stroke conditions: Aphasia conditions: Speech Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Zenicog;language rehabilitation program name: Conventional language rehabilitation measure: Aphasic quatient measure: Change of cerebral blood flow sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Medicine, Korea University Guro Hospital status: RECRUITING city: Seoul zip: 08308 country: Korea, Republic of name: Seung Nam Yang, MD, PhD role: CONTACT phone: 82-2-2626-1500 email: snamyang@korea.ac.kr lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06361888 id: 2023-012-00CH1 briefTitle: A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2027-08-31 date: 2027-08-31 date: 2024-04-12 date: 2024-04-12 name: Hutchmed class: INDUSTRY briefSummary: To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer conditions: Metastatic Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 482 type: ESTIMATED name: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine name: Nab-paclitaxel Plus Gemcitabine name: Surufatinib with Nab-paclitaxel, and Gemcitabine measure: Overall Survival (OS) measure: Progression-free Survival (PFS) (RECIST1.1) measure: Objective response rate (ORR)(RECIST1.1) measure: Duration of response (DoR)(RECIST1.1) measure: Disease control rate (DCR)(RECIST1.1) measure: Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) measure: Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Tianyinshan Hospital city: Nanjing state: Jiang Su zip: 210000 country: China name: Shukui Qin, Prof. role: CONTACT lat: 32.06167 lon: 118.77778 facility: Tianjin Cancer Hospital city: Tianjin state: Tianjin zip: 300000 country: China name: Jihui Hao, Prof. role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06361875 id: VAV00045 id: U1111-1295-2852 type: REGISTRY domain: ICTRP briefTitle: A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above overallStatus: RECRUITING date: 2024-04-01 date: 2025-05-22 date: 2025-05-22 date: 2024-04-12 date: 2024-04-12 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) compared to an active control (QIV- standard dose (SD), QIV- high dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older. conditions: Influenza Immunization studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel with dose escalation for sentinel cohort primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Modified double-blind (Participants; Sites except for those preparing/administering study intervention; Sponsor's except Sponsor unblinded internal safety review committee) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1002 type: ESTIMATED name: Quadrivalent Influenza mRNA Vaccine MRT5421 name: Quadrivalent Influenza mRNA Vaccine MRT5424 name: Quadrivalent Influenza mRNA Vaccine MRT5429 name: Quadrivalent Influenza Standard Dose Vaccine name: Quadrivalent Influenza High-Dose Vaccine name: Quadrivalent Recombinant Influenza Vaccine measure: Number of participants with immediate unsolicited systemic adverse events (AEs) measure: Number of participants with solicited injection site reactions measure: Number of participants with solicited systemic reactions measure: Number of participants with unsolicited AEs measure: Number of participants with medically attended adverse events (MAAEs) measure: Number of participants with serious adverse events (SAEs) measure: AESIs reported throughout the study measure: Number of participants with adverse events of special interests (AESIs) measure: Number of participants with out-of-range biological test results measure: Geometric Mean Titer (GMT) measure: Geometric Mean of individual Titer Ratio (GMTR) measure: Seroconversion measure: HAI Ab titer ≥ 40 (1/dil) measure: Neutralizing Ab titers at D01 and D29 measure: Individual neutralizing antibodies titer ratio measure: 2-fold and 4-fold increase in neutralizing titers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research Site Number : 8400048 status: RECRUITING city: La Mesa state: California zip: 91942 country: United States lat: 32.76783 lon: -117.02308 facility: California Research Foundation Site Number : 8400038 status: RECRUITING city: San Diego state: California zip: 92123-1881 country: United States lat: 32.71533 lon: -117.15726 facility: Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400001 status: RECRUITING city: DeLand state: Florida zip: 32720-0834 country: United States lat: 29.02832 lon: -81.30312 facility: Indago Research and Health Center Site Number : 8400032 status: RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Research Centers of America Site Number : 8400037 status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Suncoast Research Group, LLC Site Number : 8400015 status: RECRUITING city: Miami state: Florida zip: 33135 country: United States lat: 25.77427 lon: -80.19366 facility: Brengle Family Medicine Site Number : 8400045 status: RECRUITING city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 facility: AMR Lexington Site Number : 8400042 status: RECRUITING city: Lexington state: Kentucky zip: 40509 country: United States lat: 37.98869 lon: -84.47772 facility: Velocity Clinical Research Site Number : 8400053 status: RECRUITING city: Metairie state: Louisiana zip: 70006 country: United States lat: 29.98409 lon: -90.15285 facility: Optimal Research, LLC Rockville Site Number : 8400025 status: RECRUITING city: Rockville state: Maryland zip: 20850 country: United States lat: 39.084 lon: -77.15276 facility: The Alliance for Multispecialty Research - KCM, LLC Site Number : 8400034 status: RECRUITING city: Kansas City state: Missouri zip: 64114 country: United States lat: 39.09973 lon: -94.57857 facility: Velocity Clinical Research Norfolk Site Number : 8400046 status: RECRUITING city: Norfolk state: Nebraska zip: 68701 country: United States lat: 42.02834 lon: -97.417 facility: Velocity Clinical Research, Omaha Site Number : 8400008 status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States lat: 41.25626 lon: -95.94043 facility: Rochester Clinical Research. Inc. Site Number : 8400005 status: RECRUITING city: Rochester state: New York zip: 14609 country: United States lat: 43.15478 lon: -77.61556 facility: Aventiv Research Columbus Site Number : 8400020 status: RECRUITING city: Columbus state: Ohio zip: 43213 country: United States lat: 39.96118 lon: -82.99879 facility: Coastal Carolina Research Center Site Number : 8400014 status: RECRUITING city: North Charleston state: South Carolina zip: 29405 country: United States lat: 32.85462 lon: -79.97481 facility: AMR Knoxville Site Number : 8400043 status: RECRUITING city: Knoxville state: Tennessee zip: 37909 country: United States lat: 35.96064 lon: -83.92074 facility: Clinical Trials of Texas, Inc. - PPDS Site Number : 8400029 status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 facility: DM Clinical Research/Pediatric Healthcare of Northwest Houston Site Number : 8400056 status: RECRUITING city: Tomball state: Texas zip: 77375 country: United States lat: 30.09716 lon: -95.61605 facility: JBR Clinical Research Site Number : 8400051 status: RECRUITING city: Salt Lake City state: Utah zip: 84107 country: United States lat: 40.76078 lon: -111.89105 facility: Investigational Site Number : 6300002 status: RECRUITING city: Barrio Sabana zip: 00694 country: Puerto Rico hasResults: False

 nctId: NCT06361862 id: WARD - Overtreatment briefTitle: Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients? acronym: WARD-OT overallStatus: RECRUITING date: 2024-01-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-12 date: 2024-04-12 name: Rigshospitalet, Denmark class: OTHER name: Bispebjerg Hospital briefSummary: This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group. conditions: Cancer conditions: Chronic Obstructive Pulmonary Disease conditions: Surgery-Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 700 type: ESTIMATED name: Active alarms from WARD software measure: Frequency of patients having at least one of the following tests/treatments: measure: The frequency of individual treatments and diagnostics: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eske Kvanner Aasvang status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Eske K Aasvang, M.D., DMSci role: CONTACT phone: +4526232076 email: eske.kvanner.aasvang.01@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06361849 id: 55013 briefTitle: TauTona Pneumoperitoneum Assist Device (TPAD) acronym: TPAD overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-12-31 date: 2025-06-01 date: 2024-04-12 date: 2024-04-24 name: Stanford University class: OTHER name: TauTona Group briefSummary: The purpose of this study is to assess the safety and ease of use of a trocar placement access device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery. conditions: Laparoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Trocar Placement Assist Device (TPAD) measure: Surgeon satisfaction survey measure: Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford Hospital & Clinics city: Palo Alto state: California zip: 94305 country: United States lat: 37.44188 lon: -122.14302 hasResults: False

 nctId: NCT06361836 id: SBT777101-02 briefTitle: Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa overallStatus: RECRUITING date: 2024-05 date: 2026-06 date: 2026-06 date: 2024-04-12 date: 2024-04-12 name: Sonoma Biotherapeutics, Inc. class: INDUSTRY briefSummary: This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown. conditions: Hidradenitis Suppurativa studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Sequential escalating dose cohorts primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: SBT777101 measure: Incidence, nature, and severity of adverse events [Safety and Tolerability] measure: Incidence and nature of Dose Limiting Toxicities [DLTs] sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Oliva Gabriel role: CONTACT phone: 617-525-8250 email: ogabriel@bwh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06361823 id: IIH-Semaglutide briefTitle: Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-01 date: 2025-01-01 date: 2024-04-12 date: 2024-04-12 name: Capital Medical University class: OTHER briefSummary: This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension. conditions: Idiopathic Intracranial Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The researchers are tasked with adhering to the protocol requirements when selecting participants, and consistently enrolling eligible patients who are then randomly assigned to either the experimental or control group in a 1:1 ratio. The randomization process is overseen by expert statisticians and executed by specialized clinical researchers in an independent manner. primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: Semaglutide name: Low calorie diet measure: Intracranial pressure measure: Adverse reactions measure: Headache severity measure: Degree of papilledema measure: Perimetric mean deviation measure: Optic nerve sheath diameter measure: Body mass index sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06361810 id: IRB00430008 briefTitle: PSMA Therapy and Immunotherapy in Kidney Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2030-07 date: 2031-07 date: 2024-04-12 date: 2024-04-12 name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins class: OTHER name: Merck Sharp & Dohme LLC name: Lantheus Medical Imaging briefSummary: This is a multi-center, single arm open label phase 1b/2 study of pembrolizumab in combination with 177Lu-PNT2002 (also known as 177Lu-PSMA I\&T) radiopharmaceutical therapy in patients with metastatic clear cell renal cell carcinoma (RCC) who have progressed after prior treatment with anti-programmed cell death protein 1 (PD1) or PD-L1 immune-checkpoint inhibitors (ICIs). The study comprises 2 phases: an open-label Phase 1b dose escalation portion followed by a Phase 2 dose expansion portion. Investigators hypothesize that pembrolizumab in combination with 177Lu-PNT2002 in in patients with metastatic clear cell RCC at a biologically active dose will result in tolerable safety profile and it will lead to improved radiological objective responses in patients who have progressed after prior treatment with standard anti-PD1 or anti- Programmed Cell Death Ligand 1 (PDL1) immune-checkpoint inhibitor containing regimen when compared to historic controls. Patients in both phases will have prostate-specific membrane antigen (PSMA), positron emission tomography (PET) imaging with the radiotracer (F-18)-DCFPyl, to help detect any spread of the cancer. conditions: Metastatic Renal Cell Carcinoma conditions: Metastatic Clear Cell Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Pembrolizumab name: 177Lu-PNT2002 name: (F-18)-DCFPyL measure: Safety assessed by the incidence of dose limiting toxicities. measure: Objective response rate by RECIST 1.1 criteria measure: Progression free survival measure: Safety as assessed by number of participants experiencing adverse events measure: Disease control rates measure: Duration of response to study therapy measure: Overall survival rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06361797 id: IRB00415412 briefTitle: Varying Bone Marrow-Derived Mesenchymal Stem Cells Concentrations' Impact on Rotator Cuff Repair Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2027-10 date: 2024-04-12 date: 2024-04-12 name: Johns Hopkins University class: OTHER name: ON Foundation briefSummary: Randomized controlled trial comparing benefits of varying amounts of proximal humerus-derived bone marrow aspirate and bone marrow concentrate in rotator cuff repair. conditions: Rotator Cuff Tears studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is designed as a parallel group 1:1:1 randomized controlled trial. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients and research assistants collecting data will be unaware of assigned treatment until study completion. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Rotator cuff repair augmented with whole bone marrow name: Rotator cuff repair augmented with concentrated bone marrow measure: Number of Rotator cuff re-tears as assessed by magnetic resonance imaging measure: American Shoulder and Elbow Surgeons Score measure: Visual Analogue Pain Score measure: Subjective Shoulder Value score measure: Comprehensive Shoulder Assessment measure: Revision surgery rate measure: Rate of oral and/or intra-articular corticosteroid required sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Howard County General Hospital city: Columbia state: Maryland zip: 21230 country: United States name: Study Director role: CONTACT name: Principal Investigator role: CONTACT lat: 39.24038 lon: -76.83942 facility: Johns Hopkins Medicine - Green Spring Station city: Lutherville state: Maryland zip: 21093 country: United States name: Matthew J Best, MD role: CONTACT phone: 443-997-2663 email: mbest8@jh.edu name: Uma Srikumaran, MD, MBA, MPH role: CONTACT phone: 410-546-1550 email: us@jhmi.edu lat: 39.42122 lon: -76.62608 hasResults: False

 nctId: NCT06361784 id: INT216-23 id: MFAG27480 type: OTHER_GRANT domain: AIRC Foundation for Cancer Research in Italy briefTitle: Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters. (LOCATION MATTERS) acronym: LM overallStatus: RECRUITING date: 2024-03-29 date: 2029-03-29 date: 2029-03-29 date: 2024-04-12 date: 2024-04-15 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER name: Politecnico di Milano briefSummary: The prospective study LOCATION MATTERS aims to investigate the radiation-induced damage to the heart and the cardiovascular system in patients treated with thoracic radiotherapy. Patients enrolled in the study will complete a set of extensive measures at the baseline, end of RT, and 9 months after treatment. Ultrasound exams, CT scans, pulmonary tests and wearable devices will assess functional and morphological parameters and the association with their variation and the dose delivered to the heart substructures and to the normal lung. conditions: Locally Advanced Lung Non-Small Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Variation in eco-cardio and eco-vascular parameters after thoracic radiotherapy measure: Major adverse cardiac events post-RT measure: Increase in cardiac calcification after RT measure: Longitudinal variation of cardiopulmonary functional parameters measure: Texture variation in the heart substructures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori status: RECRUITING city: Milan zip: 20133 country: Italy name: Alessandro Cicchetti, PhD role: CONTACT phone: 0223903858 email: alessandro.cicchetti@istitutotumori.mi.it name: Chiara Casati role: CONTACT email: chiara.casati@istitutotumori.mi.it name: Alessandro Cicchetti, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06361771 id: 29BRC24.0079 - PRICELESS briefTitle: Evaluation of Invisible Preparation Behaviors of Middle and High School Students in Sports Facilities (PRICELESS) acronym: PRICELESS overallStatus: RECRUITING date: 2024-01-08 date: 2024-12-20 date: 2024-12-20 date: 2024-04-12 date: 2024-04-18 name: University Hospital, Brest class: OTHER briefSummary: The investigators define the Invisible Preparation (IP) as the set of health behaviors that young athletes implement, on their own, to optimize their health and performances. This includes sleep, nutrition and hydration, physical well-being (injuries prevention) and mental well-being. If some studies have reported a lack of compliance in young athletes regarding sleep and hydration recommendations, the literature is poor in this field.

The CMS (Brest Metropolitan Area Sports Medicine Centre, France) aims at preserving the health of young athletes. Prior to their medical examination, the patients will be asked, all along the year 2024, to fill out a form that question them about their health behaviors in the four areas of the IP.

Under the direction of the Brest University Hospital, PRICELESS (Invisible Preparation of Middle and High School Students in Sports Institutions) study will try, based on their answers, to estimate the proportion of young athletes who declare adopting the health behaviors recommended in the IP. conditions: Sports Injury conditions: Prevention conditions: Training conditions: Hydration conditions: Nutrition conditions: Sleep conditions: Mental Health conditions: Physical Well-Being studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1500 type: ESTIMATED measure: The proportion of teenagers who declare adopting the health behaviors recommended in the four areas of the Invisible Preparation. measure: The proportion of girls who declare adopting these behaviors, compared to the proportion in boys. measure: The proportion of Middle School students who declare adopting these behaviors, compared to the proportion in High School students. measure: The proportion of young athletes practicing an intensive sporting activity (10 hours or more per week), compared to the proportion in young athletes practicing a non-intensive sporting activity (less than 10 hours per week). measure: The proportion of young athletes with disabilities who declare adopting these behaviors, compared to the proportion in young athletes without disabilities. sex: ALL minimumAge: 9 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Chu Brest status: RECRUITING city: Brest zip: 29609 country: France name: Marie-Agnès GIROUX-METGES, PhD role: CONTACT phone: 0298347366 phoneExt: +33 email: marie-agnes.metges@chu-brest.fr name: Florent GUIMARD, Resident role: CONTACT phone: 02 98 33 53 40 phoneExt: +33 email: florent.guimard@chu-brest.fr lat: 48.3903 lon: -4.48628 hasResults: False

 nctId: NCT06361758 id: B2023-326(2) briefTitle: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-05-31 date: 2027-05-31 date: 2024-04-12 date: 2024-04-16 name: Shanghai Zhongshan Hospital class: OTHER name: Sun Yat-sen University name: Eastern Hepatobiliary Surgery Hospital briefSummary: This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cadonilimab+Lenvatinib measure: Objective Response Rate (ORR) per RECIST v1.1 measure: Objective Response Rate (ORR) per mRECIST measure: Disease control Rate (DCR) measure: Duration of response (DoR) measure: Progression-Free-Survival (PFS) measure: Overall survival Overall survival (OS) measure: Incidence of Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 facility: Sun Yat-sen University Cancer Center) city: Guangzhou country: China name: Li Xu role: CONTACT name: Li Xu role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Eastern Hepatobiliary Surgery Hospital city: Shanghai country: China name: Kui Wang role: CONTACT name: Jun Xue role: CONTACT name: Kui Wang role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06361745 id: PG-005-6 briefTitle: Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases overallStatus: RECRUITING date: 2024-04-02 date: 2024-12-01 date: 2025-03-01 date: 2024-04-12 date: 2024-04-15 name: PersonGen BioTherapeutics (Suzhou) Co., Ltd. class: INDUSTRY briefSummary: Main purpose:

To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).

Secondary purpose:

To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.

To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID.

To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects.

To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects. conditions: Systemic Lupus Erythematosus conditions: Idiopathic Inflammatory Myopathies conditions: Systemic Sclerosis conditions: IgG4 Related Disease conditions: Primary Sjögren Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: UTAA09 injection primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: T cell injection targeting CD19 chimeric antigen receptor measure: AE measure: Cmax measure: CD19-positive cells measure: Disease remission/response/improvement rates measure: anti-CAR antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PersonGen.Anke Cellular Therapeutice Co., Ltd status: RECRUITING city: Hefei country: China name: Huimin Meng, Doctor role: CONTACT phone: +86-18015580390 email: huimin.meng@persongen.com lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06361732 id: ILBS-liver Transplant-03 briefTitle: Prevalence of CYP3A5 Polymorphisms in the Donors and ABCB1 Polymorphisms in the Recipients Undergoing Pediatric Liver Transplant and Their Influence on Tacrolimus Levels and Graft Function. overallStatus: RECRUITING date: 2022-12-17 date: 2024-10-30 date: 2024-10-30 date: 2024-04-12 date: 2024-04-12 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: It is known that Immunosuppression post-Liver transplant is central to achieving optimal outcomes in liver transplant recipients. It is required to maintain an adequate balance between reducing rejection and toxicities. Mainstay drugs for maintenance therapy are Calcinuerin inhibitors - Tacrolimus versus cyclosporine. Tacrolimus is preferred, as it has less rejection and better graft survival. However, there is risk of renal and metabolic toxicities. Tacrolimus is bound mainly to alpha1-acid-glycoprotein (encoded by the ABCB1gene) expressed on various epithelial and endothelial cells and lymphocytes. Elimination occurs by metabolizing enzymes of cytochrome P450 system, with biliary excretion (95%) of metabolites (majority) with minority through urine (2.4%). Demethylation and hydroxylation of tacrolimus occurs by hepatic and intestinal CYP3A isoforms (CYP3A4 and CYP3A5). Among the factors that play an important role in the pharmacokinetics of tacrolimus, thus affecting the tacrolimus trough levels in the body and in turn influencing the dosing of the drug required to maintain an adequate balance between reducing rejection and toxicities, genetics plays an important role. Increased expression of CYP3A5 causes more metabolism of tacrolimus and hence affecting the tacrolimus concentration/weight-adjusted dose (C/W-D) ratio in the body. The wild type (CYP3A5\*3) are slow metabolizers and mutant ones (CYP3A5 \*1/\*1 and CYP3A5 \*1/\*3) are fast metabolizers. Fast

metabolizers have a low C/W-D ratio and require higher Tacrolimus dosing and are thus susceptible to renal and metabolic toxicities, EBV viremia and post transplant lymphoproliferative disorder. Polymorphisms in ABCB1 (c.3435C\>T) are also known to influence tacrolimus dosage in the first week of transplant (C/D ratio was lower in ABCB1 3435CC in comparison to CT and TT). There is no such data in pediatric liver transplant setting from Indian subcontinent. The aim of the study is to study the prevalence of CYP3A5 polymorphisms in the donors and ABCB1 polymorphisms in the recipients undergoing Paediatric liver transplant and their influence on Tacrolimus levels and graft function. conditions: Pediatric Liver Transplant studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 80 type: ESTIMATED name: No intervention measure: Time (in days) to achieve transaminases within 1.5 times ULN (60 IU/L) in the pediatric Liver transplant recipients with grafts from slow metabolizer (CYP3A5*3/3 allele) versus fast metabolizer (CYP3A5*1/3 and 1/1 alleles) donors. measure: Prevalence of CYP3A5 alleles in the donors of pediatric liver transplant recipients. measure: Influence of donor CYP3A5 alleles (slow versus fast metabolizers) on tacrolimus concentration-weight adjusted dose ratio at 1 week, 4 weeks, 3 months & 6 months and 1 year after liver transplantation. measure: Prevalence of ABCB1 3435 C/T alleles in the recipients of pediatric liver transplant. measure: Influence of recipient ABCB1 3435 C/T on tacrolimus concentration-weight adjusted dose ratio at 1 week, 4 weeks, 3 months and 6 months and 1 year after liver transplantation. measure: Comparison of the Number of Rejection episodes 1 year from LT. measure: Comparison of proportion of patients who were withdrawn from Mycophenolate or required addition of Mycophenolate 1 year from LT. measure: Comparison of proportion of patients with renal toxicity 1 year from LT. measure: Comparison of proportion of patients with Neurological toxicity 1 year from LT. measure: Comparison of e-GFRand cystatin-C levels in the two cohorts of pediatric liver transplant recipients with grafts from slow metabolizer (CYP3A5*3/3 allele) versus fast metabolizer (CYP3A5*1/3 and 1/1 alleles) donors. sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Institute of Liver and Biliary Sciences status: RECRUITING city: New Delhi zip: 110070 country: India name: Dr Snigdha Verma, MD role: CONTACT phone: 01146300000 email: dr.snigdha1@gmail.com name: Dr Rajeev Khanna, MD role: CONTACT phone: 01146300000 email: drrajeev_khanna@rediffmail.com lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06361719 id: 2312INF briefTitle: Efficacy of Two HMOs in Chinese Infants overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-11 date: 2027-06 date: 2024-04-12 date: 2024-04-12 name: Société des Produits Nestlé (SPN) class: INDUSTRY briefSummary: This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group. conditions: Healthy Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 262 type: ESTIMATED name: Experimental Group (EG) name: Control Group (CG) measure: Bifidobacteria abundance in fecal samples measure: Gut microbiota composition measure: Fecal metabolism measure: Fecal metabolism measure: Fecal markers of intestinal immune health measure: Fecal markers of gut barrier function measure: Fecal markers of gut barrier function measure: Fecal markers of gut barrier function measure: Fecal markers of inflammation measure: Fecal markers of inflammation measure: Fecal markers of inflammation measure: Stool patterns measure: Stool patterns measure: GI symptoms and behaviors measure: Immune competence measure: Infant sleep duration and night-time wakings per 24 hours measure: Infant Health Related Quality of Life measure: Growth measure: Growth measure: Growth measure: Growth measure: Growth measure: Physical Examination measure: Infant Illness measure: Infant illness, infections and medication usage measure: Medication use (type and duration) measure: Formula feeding measure: Breastfeeding measure: Infant dietary pattern sex: ALL minimumAge: 3 Days maximumAge: 14 Days stdAges: CHILD hasResults: False

 nctId: NCT06361706 id: 24/047-P briefTitle: VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study acronym: REDOCVR overallStatus: RECRUITING date: 2023-12-04 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-26 name: Badalona Serveis Assistencials class: OTHER name: Department of Health, Generalitat de Catalunya briefSummary: This pilot study aims to evaluate the integration of virtual reality (VR) with a psychoeducational program for individuals experiencing chronic pain and central sensitization. Chronic pain significantly hampers daily life, and the condition of central sensitization intensifies this challenge by making the pain more acute. Our research is grounded in the hypothesis that VR, when used to complement conventional psychoeducational methods, can enhance engagement and understanding of pain management strategies, thus potentially improving patient outcomes.

Key objectives and related measured variables include:

Usability and Feasibility: Evaluated through the System Usability Scale (SUS) responses from both participants and healthcare professionals, assessing the ease of use and integration of VR into the psychoeducational program.

Participant Engagement and Program Adherence: Determined by participants\&#39; satisfaction with the VR system, using Likert scale questionnaires, and tracked through session attendance and program completion rates.

Impact on Chronic Pain Management and Emotional Well-being: Assessed through changes in the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), and the Hospital Anxiety and Depression Scale (HADS) collected at baseline, post-intervention, and 4-8 weeks follow-up Self-management of Chronic Pain: Monitored through the Central Sensitization Inventory (CSI) and changes in patient functionality and mobility using the EuroQol-5D-5L scale, measured at baseline, post-intervention, and 4-8 weeks follow-up.

Healthcare Professionals\&#39; Perceptions: Investigated using SUS scores and qualitative feedback on the applicability and benefits of VR in clinical practice for chronic pain management.

Participants will complete eight 90-minute sessions, engaging with VR to supplement the program\&#39;s content. This approach aims to provide immersive experiences that deepen the understanding and management of chronic pain. Participant feedback on the VR experience, alongside observed changes in pain management and overall well-being, will be critically examined.

By targeting individuals suffering from chronic pain, this research aims to offer healthcare professionals an innovative tool for enhancing pain management strategies. Integrating VR into psychoeducational content, the study seeks to promote more engaging and effective learning experiences, potentially leading to improved outcomes in chronic pain management. conditions: Chronic Pain conditions: Central Sensitization studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The REDOCVR study utilizes a Single-Group Interventional Model, where all participants receive the same VR-enhanced psychoeducational intervention for chronic pain management. This model facilitates a focused evaluation of VR's effectiveness and usability within a structured psychoeducational framework, allowing for direct assessment of participant experiences and outcomes. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: The statisticians and researchers involved in data analysis will be masked to the identity of participants, using a random code for each participant. count: 60 type: ESTIMATED name: VR-Enhanced Psychoeducational Program for Chronic Pain measure: Participant Satisfaction with the VR-enhanced Psychoeducational Program as measured by the Participants Satisfaction Questionnaire measure: Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants measure: Professionals System Usability as measured by the SUS for Professionals measure: Mental Well-being as assessed by the WEMWBS-7 measure: Anxiety and Depression Severity as measured by the HADS measure: Central Sensitization as measured by the CSI measure: Changes in Functionality and Mobility as assessed by the EuroQol-5D-5L Scale measure: Adherence to the VR-enhanced Psychoeducational Program as indicated by session attendance and program completion rates measure: Participant Feedback as recorded on the Participant Comment Sheet sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Primary Care Progrès-Raval status: RECRUITING city: Badalona state: Barcelona zip: 08912 country: Spain name: Jose Ferrer Costa, MD role: CONTACT phone: 0034933951779 email: jfcosta@bsa.cat name: Elena Villabona López, MSc role: CONTACT phone: 0034933890695 email: evlopez@bsa.cat name: Elena Villabona Lopez, MSc role: SUB_INVESTIGATOR name: Jose Ferrer Costa, MD role: PRINCIPAL_INVESTIGATOR name: Melanie Rodriguez Belloso, BSc role: SUB_INVESTIGATOR lat: 41.45004 lon: 2.24741 facility: Primary Care Center Apenins-Montigalà status: RECRUITING city: Badalona state: Barcelona zip: 08917 country: Spain name: José Ferrer Costa, MD role: CONTACT phone: 0034933951779 email: jfcosta@bsa.cat name: Christian Torrecillas Camacho, BSc role: CONTACT phone: 0034933951779 email: ctcamacho@bsa.cat name: José Ferrer Costa, MD role: PRINCIPAL_INVESTIGATOR name: Christian Torrecillas Camacho, BSc role: SUB_INVESTIGATOR name: Alexandra Fernandez Brusco, BSc role: SUB_INVESTIGATOR lat: 41.45004 lon: 2.24741 facility: Primary Care Center Morera-Pomar status: RECRUITING city: Badalona state: Barcelona country: Spain name: Nuria Moran Blanco, MD role: CONTACT phone: 0034934655200 email: nmoran15@bsa.cat name: Laura Villares Urgell, MSc role: CONTACT phone: 0034934655200 email: lvurgell@bsa.cat name: Jose Ferrer Costa, MD role: PRINCIPAL_INVESTIGATOR name: Nuria Moran Blanco, MD role: SUB_INVESTIGATOR name: Laura Villare Urgel, MSc role: SUB_INVESTIGATOR lat: 41.45004 lon: 2.24741 hasResults: False

 nctId: NCT06361693 id: APHP240147 id: 2024-A00143-44 type: OTHER domain: France : Ministry of Health briefTitle: Descriptive Observational Study of Patient-performed Pre-oxygenation acronym: ApréOx overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-12 date: 2024-04-12 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient).

This is the concept of "self-preoxygenation". conditions: Anesthesia conditions: Anxiety conditions: ASA Physical Status I conditions: ASA Physical Status II studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Auto-preoxygenation name: APAIS scale name: Visual analog anxiety scale (VAS-A) name: Visual analog comfort scale (VAS-C) measure: FeO2>90% measure: APAIS anxiety score measure: Visual analog anxiety scale (VAS-A) score measure: Visual analog anxiety scale (VAS-A) score measure: Visual analog comfort scale (VAS-C) score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP city: Paris state: Ile De France zip: 75014 country: France name: Sophie TOUSSAINT, Nurse anesthetist role: CONTACT phone: 00 33 1 58 41 45 17 email: sophie.toussaint@aphp.fr name: Claude LE STANG, Nurse anesthetist role: CONTACT email: cch.grouperecherche@gmail.com name: Christophe BAILLARD, PUPH role: SUB_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06361680 id: Coenzyme Q10 on diabetic child briefTitle: Effect of Coenzyme Q10 on Diabetic Children overallStatus: NOT_YET_RECRUITING date: 2024-10-30 date: 2025-10-30 date: 2025-11-30 date: 2024-04-12 date: 2024-04-12 name: Assiut University class: OTHER briefSummary: Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin conditions: Type 1 Diabetes Mellitus studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets measure: Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus measure: Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus . sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06361667 id: 1/02.02.2024 briefTitle: Culture and Well-being: Art as Prescription Therapy ("Art on Prescription") acronym: AoP overallStatus: RECRUITING date: 2024-03-20 date: 2024-12-15 date: 2025-01-15 date: 2024-04-12 date: 2024-04-12 name: KAVADIA ELENI class: OTHER briefSummary: Cluster randomised controlled trial with two arms: arts intervention (any of the arts interventions, see list), which we call here Active Group (AG) vs waitlist control (WL). conditions: Mental Health Issue conditions: Anxiety Disorders conditions: Depressive Disorder conditions: Emotional Disorder conditions: Schizophrenia conditions: Autism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We will follow standard practice for RCTs and apply an ANCOVA model to estimate the effects of treatment. The formalism is:

y \~ b0 + b1xtreatment_group + b2xtime + b3xtreatment_groupxtime + covariates (1)

Where, y is each outcome, b1-b3 are the regression coefficients and covariates denotes covariates at randomisation (DETERMINE)

The inference of interest for the model concerns b3, the interaction term, as we posit that there will be a difference in slopes between the treatment groups.

The inference is going to happen via an estimation of the t-statistic, defined as follows"

t = b3/SE (2)

Where SE is the standard error for coefficient b3

t \> 1.96 (3)

And 1.96 is the critical value for statistical significance at alpha = 0.05. primaryPurpose: TREATMENT masking: NONE count: 384 type: ESTIMATED name: Arts measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) measure: Generalised Anxiety Disorder Assessment (GAD-7) measure: The Patient Health Questionnaire-9 (PHQ-9) measure: UCLA 3-item Loneliness Scale measure: The Strengths and Difficulties Questionnaire (SDQ) sex: ALL minimumAge: 10 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Eleni Kavadia status: RECRUITING city: Athens country: Greece name: Eleni Kavadia role: CONTACT phone: +30 210 6170804 email: ekavadia@epipsi.gr name: Nikos Stefanis, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.97945 lon: 23.71622 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-10 uploadDate: 2024-03-26T12:19 filename: Prot_000.pdf size: 390364 hasResults: False

 nctId: NCT06361654 id: 2023/0135/OB briefTitle: Effect of Muscular Imbalance Between Flexors and Extensors of the Fingers and Wrist on Upper Limb Injuries in Climbers acronym: CRIMPER overallStatus: RECRUITING date: 2024-03-25 date: 2025-03-25 date: 2025-09-01 date: 2024-04-12 date: 2024-04-15 name: University Hospital, Rouen class: OTHER briefSummary: Climbing is a booming sport with an increasing number of participants. When practicing this sport, there is a muscular imbalance between the flexor and extensor systems (especially in the fingers), with the flexors of the fingers exerting greater force than the extensors. In addition, upper limb injuries, particularly the fingers, are very common.

The study will be carried out on club-licensed climbers, as they are better supervised. They will be recruited through requests sent to various clubs. The measurements will be taken during different climbing sessions, after the warm-up.

The study will include measurements on different climbers. Informed consent and personal data will be collected from the climbers before the measurements are taken. The strength values of the flexors and extensors of the fingers and wrist will be measured using a dynamometer. The climbers will then continue their usual training for 1 year. For 1 year after the measurements, the climbers will be contacted every month by telephone to collect the different injuries they may have suffered in relation to climbing, as well as the number of hours they have spent climbing in the past month. After 1 year, the annual number of hours of climbing and the annual number of injuries can be calculated for each climber. Injury is defined as any medically diagnosed lesion of the musculoskeletal system of the upper limb or pain that prevents the practice of a sport whose aetiology is climbing. These data are used to calculate the "athlete exposure" (A-E), i.e. the incidence of injury per 1000 hours of practice. As the study population is large, this allows for variations in exposure between subjects. conditions: Climber studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 47 type: ESTIMATED name: The strength values of the flexors and extensors of the fingers and wrist will be measured using a dynamometer measure: Athlete exposure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rouen, University Hospital status: RECRUITING city: Rouen state: Normandie zip: 76031 country: France name: timothee gillot, phd role: CONTACT phone: 0232880671 phoneExt: +33 email: timothee.gillot@chu-rouen.fr lat: 49.44313 lon: 1.09932 hasResults: False

 nctId: NCT06361641 id: 49RC23_0259 id: AO2721-44 type: OTHER domain: ANSM briefTitle: Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes acronym: PHEMOP overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-10-19 date: 2027-10-19 date: 2024-04-12 date: 2024-04-12 name: University Hospital, Angers class: OTHER_GOV briefSummary: Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms conditions: Myeloproliferative Neoplasm conditions: Polycythemia Vera conditions: Essential Thrombocythemia conditions: Primary Myelofibrosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Monocytes signatures in myeloproliferative neoplasms at diagnosis measure: WHO 2016 criteria for polycythemia vera, prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis measure: Identify correlation between the monocytic signature and driver mutations (mutation in JAK2, CALR or MPL gene). measure: Identify correlation between the monocytic signature and the grade of fibrosis measure: prognostic value of the monocytic signature using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6 measure: Prognostic value of the monocyte signature for disease worsening according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022 measure: leukemia-free survival measure: myelofibrosis-free survival measure: Monocytes parameters for hematological progression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GOUBAND Agathe city: Angers state: Maine Et Loire zip: 49933 country: France name: Agathe GOUBAND, PharmD role: CONTACT phone: 02 41 35 55 96 phoneExt: 33 email: Agathe.Gouband@chu-angers.fr name: Damien LUQUE PAZ, PharmD role: CONTACT phone: 02 41 35 53 53 phoneExt: 33 email: Damien.LuquePaz@chu-angers.fr lat: 47.46667 lon: -0.55 facility: BESCOND Charles city: Cholet state: Maine Et Loire zip: 49325 country: France name: Charles BESCOND, MD role: CONTACT phone: 0241355880 email: charles.bescond@ch-cholet.fr lat: 47.06667 lon: -0.88333 facility: TRUCHAN-GRACZYK Malgorzata city: Saumur state: Maine Et Loire zip: 49400 country: France lat: 47.26667 lon: -0.08333 hasResults: False

 nctId: NCT06361628 id: RIVER-EU WP4 briefTitle: Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine acronym: RIVER-EU overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-12 date: 2024-04-17 name: University Medical Center Groningen class: OTHER name: Prolepsis Institute for Preventive, Environmental and Occupational Medicine name: University in Zielona Góra name: Pavol Jozef Safarik University briefSummary: The goal of the study is to monitor and evaluate the implementation of interventions that aim to increase HPV \& MMR vaccines among underserved communities across four European countries: Greece, Netherlands, Poland, and Slovakia. The interventions will target identified health systems barriers in an earlier phase of the project. The interventions that will be implemented employ trusted community members as health promotors whom will provide educational sessions on HPV and MMR vaccination to the target groups. In addition, the cost-effectiveness of vaccine uptake strategies for the target groups is being evaluated.

The main research question is: to what extent is the multicomponent tailored intervention effective to increase MMR/HPV intention and vaccine uptake in the target population in Greece, Netherlands, Poland and Slovakia? conditions: Vaccination conditions: Health Systems conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1000 type: ESTIMATED name: multicomponent intervention on vaccination awareness measure: Intention to vaccinate MMR and/or HPV by questionnaire measure: Uptake of MMR and/or HPV vaccinations by questionnaire measure: Knowledge concerning MMR and/or HPV vaccinations in the target group using a questionnaire measure: Communication skills of health care professionals using a questionnaire measure: Satisfaction of the stakeholders as measured by a questionnaire measure: Improved access to vaccinations by addressing identified health system barriers - number of barriers addressed sex: ALL minimumAge: 12 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prolepsis city: Athens state: Athene zip: 151 25 country: Greece name: Pania Karnaki role: CONTACT phone: +30 210 6255700 email: p.karnaki@prolepsis.gr name: Nikole Papaevgeniou, PhD role: CONTACT email: n.papaevgeniou@prolepsis.gr lat: 37.97945 lon: 23.71622 facility: University Medical Center Groningen city: Groningen zip: 9713 GZ country: Netherlands name: Janine de Zeeuw, PhD role: CONTACT phone: +31 6 45552994 email: j.de.zeeuw@umcg.nl lat: 53.21917 lon: 6.56667 facility: University of Zielona Gora city: Zielona Góra state: Lubusz zip: 65 417 country: Poland name: Maria Ganczak, MD PhD role: CONTACT email: m.ganczak@inm.uz.zgora.pl lat: 51.93548 lon: 15.50643 facility: PJ Šafárik University city: Košice state: Košice Region zip: 04180 country: Slovakia name: Daniela Fiľakovská, PhD role: CONTACT phone: +421 55 234 3390 email: daniela.filakovska@upjs.sk lat: 48.71395 lon: 21.25808 hasResults: False

 nctId: NCT06361615 id: CEC_FP_2023042 briefTitle: Effect of a Dual-task Intervention Program on Physical and Cognitive Function overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-08 date: 2024-03-05 date: 2024-04-05 date: 2024-04-12 date: 2024-04-12 name: University of Americas class: OTHER briefSummary: Aim: to compare the effects of single-task (ST) and dual-task (DT) training on physical and cognitive function in institutionalized older adults in 1 month.

Methods: Participants were assigned randomly into two groups, ST (multicomponent physical exercise) and DT training (multicomponent physical exercise + cognitive tasks). Both groups performed the exercise three times per week for 1 month. Short Physical Performance Battery (SPPB), handgrip strength, Barthel Index and Montreal Cognitive Assessment (MoCA) were used to assess physical and cognitive performance, respectively. Variables were measured at the beginning (V1),at the end of the exercise (V2), as well as one month later (V3). Paired Student's t-test and lineal logistic regressions models were used to explore the effect of the exercise interventions. conditions: Functional Movement Disorder conditions: Fragility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Although blinding is not possible for participants in exercise-intervention research, the outcome assessors and data analysts were masked to group assignments. The study was unblinded after the statistical analyses were completed. whoMasked: PARTICIPANT count: 24 type: ACTUAL name: Single-Task name: Dual-Task measure: Short Physical Performance Battery (SPPB) measure: Montreal Cognitive Assessment (MoCA) measure: Barthel Index measure: Isometric Handgrip Strength (IHS) measure: Immobility Syndrome Scale sex: ALL minimumAge: 65 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: Universidad de las Americas city: Santiago de Chile state: Santiago zip: 7750495 country: Chile lat: -33.45694 lon: -70.64827 hasResults: False

 nctId: NCT06361602 id: SYSKY-2023-1015-01 briefTitle: Exploring the Effectiveness and Factors Affecting the Collection of Single Nucleated Cells From Different Volunteers acronym: SYX-AN-01 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-05-01 date: 2024-04-12 date: 2024-04-12 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: 1. 80 cases of healthy donors were subjected to peripheral blood single nucleated cells (PBMC) collection and analyzed the effects of age, body mass index (BMI), blood routine indexes before collection, collection of circulating blood volume, volume of processed blood and the number of circulations, etc., on the PBMC obtained from both men and women, and explored the effects of PBMC collection in different volunteers and the factors affecting the collection. and the influencing factors.
2. The data obtained will provide a reference for the MNC threshold for the subsequent clinical trials of immunocell therapy in hospitals.
3. From the screening of volunteers, PBMC collection and transportation conditions and other specific details of the operation, risk assessment and the establishment of a safe operation standard process, for the hospital to carry out subsequent clinical trials of immune cell therapy to provide an effective reference. conditions: Observational Study studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: inapplicable measure: Exploring the effectiveness and factors affecting the collection of single nucleated cells from different volunteers sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06361589 id: EK2023003-1 briefTitle: Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients overallStatus: RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2028-11-01 date: 2024-04-12 date: 2024-04-12 name: Sichuan Cancer Hospital and Research Institute class: OTHER briefSummary: This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death. Clinical pathology including sex, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from medical records. Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded. Treatment information was obtained from the records, including dose and timing of ALK-TKI therapy and tumor response, number of prior systemic lines of therapy, and local treatment modalities such as radiotherapy and surgery. Quality of life based on the EORTC QLQ C30+LC29 scale (plus the EORTC QLQ BN20 scale in patients with brain/meningeal metastases) was performed at baseline and at each follow-up point. This study will use REDCap platform to collect and manage the study data information of multi-center patients. conditions: ALK-positive Non-small Cell Lung Cancer conditions: Real World Study studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Lorlatinib measure: PFS measure: OS measure: ORR measure: AE measure: PRO1 measure: PRO2 measure: PRO3 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan cancer hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Juan Li, MD role: CONTACT phone: 13880276636 email: dr.lijuan@hotmail.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06361576 id: CA209-1443 briefTitle: Real-World Use of Nivolumab for the Treatment of Patients With Metastatic Upper Gastrointestinal Cancer in Canada overallStatus: COMPLETED date: 2023-09-05 date: 2024-01-25 date: 2024-01-25 date: 2024-04-12 date: 2024-04-12 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this observational study is to describe the demographics, and disease characteristics of participants with metastatic upper gastrointestinal cancer, along with the treatment characteristics of these patients when treated with nivolumab. conditions: Upper Gastrointestinal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 700 type: ACTUAL name: Nivolumab measure: Particpant sociodemographics measure: Participant Eastern Cooperative Oncology Group (ECOG) score measure: Participant HER2 status measure: Participant comorbidities measure: Participant tumour location measure: Participant treatment history measure: Initial nivolumab dosage prescribed to participants measure: Number of nivolumab treatments received by participants measure: Planned combination chemotherapy treatment measure: Nivolumab treatment initiation date measure: Nivolumab dosage modification measure: Participant treatment duration measure: Reason for participant discharge measure: Participant adverse events (AEs) measure: Management of participant adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayshore Specialty Rx Ltd. city: Mississauga state: Ontario zip: L5K 2L3 country: Canada lat: 43.5789 lon: -79.6583 hasResults: False

 nctId: NCT06361563 id: CA209-1442 briefTitle: Real-World Use of Adjuvant Nivolumab in Patients With Upper Gastrointestinal Cancer in Canada overallStatus: COMPLETED date: 2023-09-05 date: 2024-01-25 date: 2024-01-25 date: 2024-04-12 date: 2024-04-12 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this observational study is to describe the patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant nivolumab. conditions: Upper Gastrointestinal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 250 type: ACTUAL name: Nivolumab measure: Participant sociodemographics measure: Participant Eastern Cooperative Oncology Group (ECOG) score measure: Participant histology results measure: Participant comorbidities measure: Participant tumour location measure: Date of tumour resection measure: Participant primary upper gastrointestinal cancer diagnosis measure: Initial nivolumab dosage prescribed to participants measure: Number of nivolumab treatments received measure: Nivolumab dosage modification measure: Nivolumab treatment duration measure: Reason for participant discharge measure: Participant adverse events (AEs) measure: Management of participant adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayshore Specialty Rx Ltd. city: Mississauga state: Ontario zip: L5K 2L3 country: Canada lat: 43.5789 lon: -79.6583 hasResults: False

 nctId: NCT06361550 id: AYTO_SALAMANCA_001 briefTitle: Nutritional Status Assessment and Dietary Recommendations Program (VENREDI) overallStatus: RECRUITING date: 2023-11-02 date: 2025-06-30 date: 2025-12-30 date: 2024-04-12 date: 2024-04-12 name: University of Salamanca class: OTHER name: Ayuntamiento de Salamanca briefSummary: Introduction: The Mediterranean diet has been related to beneficial effects in the prevention of cardiovascular diseases and other chronic pathologies related to diet, including some types of cancer. Specifically in the elderly population, it has been observed that the Mediterranean diet is inversely associated with all causes of mortality and that the greater the adherence to this type of diet, the lower the mortality in elderly adults.

Objective: To evaluate the effect of a multifactorial intervention (seminar on shopping basket and food labeling, workshop on healthy cooking and subsequent tasting of the prepared products) in improving adherence to the Mediterranean diet in older adults.

Methodology: Randomized controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be adults over 60 years of age, retired or pre-retired. A sample size of 200 participants has been estimated, 100 in each group to detect a difference of 0.83 points or more in the MEDAS questionnaire.

All participants will receive an educational talk on healthy nutrition, with an estimated duration of 2 hours. The GI, in addition to this educational workshop, will receive a practical seminar on how to properly carry out the shopping cart. This will take place both in a market and later in a supermarket in Salamanca. In addition, a workshop will be held where participants will prepare a menu consisting of three dishes (starter, main and dessert) and will later taste them.

An initial and post-intervention evaluation will be carried out after 3 months so that both groups can study the change variables related to Adherence to the Mediterranean Diet \[Mediterranean Diet Adherence Questionnaire (MEDAS)\], physical activity \[Short physical performance battery (SPPB)\], sleep quality (ATENAS questionnaire) and assessment of cognitive function (MOCA questionnaire). conditions: Adherence to the Mediterranean Diet studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: VENREDI group name: Health education measure: Adherence to the Mediterranean Diet measure: Physical activity measure: Sleep Quality measure: Cognitive function sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rosario Alonso Domínguez status: RECRUITING city: Salamanca zip: 37007 country: Spain name: Rosario Alonso Domínguez, PhD role: CONTACT phone: 0034923294500 phoneExt: 3280 email: ralonsod@usal.es lat: 40.96882 lon: -5.66388 hasResults: False

 nctId: NCT06361537 id: CONE-02 briefTitle: Phase 3 Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Octapharma class: INDUSTRY briefSummary: Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks conditions: Acute Hereditary Angio Edema studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 124 type: ESTIMATED name: OCTA-C1-INH name: Placebo measure: Time (h) to beginning of unequivocal symptom relief at the defining site in blinded participants. measure: Percentage of participants responding to treatment measure: Time to beginning of unequivocal symptom relief at all sites involved measure: Changes in symptom severity at the defining site by VAS severity rating sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06361524 id: 44967 id: 5F32HL143916 type: NIH link: https://reporter.nih.gov/quickSearch/5F32HL143916 id: 856341 type: OTHER_GRANT domain: American Heart Association briefTitle: Gut Microbiome Profiling in Patients With Chronic Heart Failure overallStatus: ENROLLING_BY_INVITATION date: 2018-08-01 date: 2028-12 date: 2028-12 date: 2024-04-12 date: 2024-04-12 name: Stanford University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) name: American Heart Association briefSummary: The goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. The main questions the study aims to answer are:

1. How does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure?
2. How do these changes relate to heart failure disease severity and complications? conditions: Heart Failure With Reduced Ejection Fraction conditions: Nonischemic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Advanced heart failure-associated microbiome signatures measure: Temporal changes in the gut microbiome community composition in chronic heart failure measure: Comprehensive longitudinal metabolome profile in chronic heart failure measure: Comprehensive longitudinal cytokine profile in chronic heart failure measure: Longitudinal change in New York Heart Association (NYHA) functional class measure: Longitudinal change in the self-reported functional status sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University city: Stanford state: California zip: 94305-5210 country: United States lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06361511 id: 2023H0284 briefTitle: The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2030-05-01 date: 2024-04-12 date: 2024-04-12 name: Ohio State University class: OTHER name: National Institutes of Health (NIH) briefSummary: The proposed research is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in muscle strength, volume, fatigue resistance, and mobility in older adults after daily consumption of 12g of linoleic acid-rich oil. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: High Linoleic Acid Foods name: High Oleic Acid Foods measure: Changes is leg extensor muscle strength measure: Changes in quadriceps muscle volume measure: Change in maximum leg press strength measure: Change in leg fatiguability measure: Change in muscle mitochondria function measure: Changes in cardiolipin species measure: Changes in grip strength measure: Changes in gait speed measure: Changes in chair rise time measure: Changes in stair climb power measure: Change in short physical performance battery score measure: change in blood fatty acids measure: Association of changes in plasma linoleic acid with muscle function measure: Association of changes in plasma linoleic acid with muscle strength measure: Association of changes in plasma linoleic acid with muscle volume measure: Association of changes 4-LA-cardiolipin with muscle function measure: Association of changes 4-LA-cardiolipin with muscle strength measure: Association of changes 4-LA-cardiolipin with muscle volume measure: Association of changes mitochondria function with muscle volume. measure: Association of changes mitochondria function with muscle function measure: Association of changes mitochondria function with muscle strength. sex: ALL minimumAge: 65 Years maximumAge: 80 Years stdAges: OLDER_ADULT facility: The Ohio State University city: Columbus state: Ohio zip: 43210 country: United States lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06361498 id: 23-3115 briefTitle: Ultrasound for Evaluation of Percutaneous G-tube Position overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-12 date: 2024-04-12 name: University of North Carolina, Chapel Hill class: OTHER briefSummary: The goal of this clinical trial is to compare using ultrasound imaging to look at the position of the gastrostomy tube (GT) against fluoroscopic imaging in pediatric patients who had a recent GT tube replacement.

The main questions it aims to answer are:

* If ultrasound is just as accurate as fluoroscopy to assess the GT position.
* If ultrasound takes less time than fluoroscopy to assessing the GT position.

Participants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging. conditions: Gastrostomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Ultrasound Imaging measure: Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location measure: Sensitivity of ultrasound (US) to determine the visualization of GT leakage measure: Specificity of ultrasound (US) to determine the visualization of GT leakage measure: Duration of ultrasound (US) to complete evaluation of GT position sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Hannah P Mignosa-Martin role: CONTACT phone: 919-843-1670 email: hannah_mignosa@med.unc.edu name: Desma Jones role: CONTACT phone: 9198439463 email: desma_jones@med.unc.edu name: William Pryor, MD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06361485 id: 011624 briefTitle: Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain overallStatus: RECRUITING date: 2024-03-25 date: 2027-03-31 date: 2028-04-01 date: 2024-04-11 date: 2024-04-11 name: R3 Stem Cell class: INDUSTRY name: R3 Medical Research briefSummary: This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain. conditions: Low Back Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, open label, non-controlled Pilot study primaryPurpose: TREATMENT masking: NONE maskingDescription: Open Label count: 100 type: ESTIMATED name: Lumbar Injections with 10cc's of Wharton's Jelly Allograft measure: C-reactive protein measure: Erythrocyte sedimentation rate measure: Alanine transaminase (ALT) measure: Aspartate transaminase (AST) measure: Alkaline phosphatase (ALP) measure: Albumin measure: Creatinine measure: Blood Urea Nitrogen (BUN) measure: 36-Item Short Form Survey (SF-36) measure: Numerical Pain Rating Scale (NPRS) measure: Oswestry disability index (ODI) measure: Roland Morris disability questionnaire (RMQ) measure: The Patient-specific functional scale (PSFS) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: R3 Anti Aging Scottsdale status: RECRUITING city: Scottsdale state: Arizona zip: 85262 country: United States name: David Greene, MD, PhD, MBA role: CONTACT phone: 480-306-6256 email: dgreene@r3medicalresearch.com name: Sabrina Solt, NMD role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: R3 Anti Aging Beverly Hills status: RECRUITING city: Beverly Hills state: California zip: 90210 country: United States name: Kathleen Francesca, BA role: CONTACT phone: 424-382-1074 email: kfrancesca@r3stemcell.com name: Neville Campbell, MD role: PRINCIPAL_INVESTIGATOR lat: 34.07362 lon: -118.40036 facility: Scheer Medical Wellness status: RECRUITING city: New York state: New York zip: 10036 country: United States name: Alexandre Scheer, MD role: CONTACT phone: 646-762-9499 email: ascheer911@gmail.com name: Alexandre Scheer, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Dr. Duc (Steve) Le, MD status: RECRUITING city: Cleveland state: Texas zip: 77327 country: United States name: Steve Le, MD role: CONTACT phone: 281-593-1500 email: ducstevele@gmail.com name: Steve Le, MD role: PRINCIPAL_INVESTIGATOR lat: 31.67682 lon: -99.25367 hasResults: False

 nctId: NCT06361472 id: 11695 briefTitle: Contextual Factors-Enriched Standard Care on Mechanical Neck Pain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-08-31 date: 2025-11-30 date: 2024-04-11 date: 2024-04-15 name: Universidad Nacional de la Matanza class: OTHER briefSummary: The primary purpose of this study will be to determine if a CFs-Enriched Standard Care approach is an effective treatment for mechanical neck pain in terms of reducing pain and improving function. We hypothesize that a 4-week CFs-Enriched Standard Care approach will be superior to Standard Care alone in terms of patient-reported disability and pain, with measurements conducted using the Northwick Park Neck Pain Questionnaire and the Numeric Pain Rating Scale, respectively.

This will be an assessor-blinded, 2-group (1:1) randomized clinical trial aiming to enroll 94 participants with neck pain persisting for more than 4 weeks. Both groups will undergo 4 weeks of standard care twice weekly, following established clinical practice guidelines. In the intervention group, CFs will be enhanced, encompassing the physical, psychological, and social elements inherent in the clinical encounter, based on existing evidence.

The primary outcomes will encompass changes in Pain and Disability after 4 weeks of treatment, with a follow-up reassessment at week 12 post-treatment. Secondary outcomes will include changes in Active Range of Motion, Global Rating of Change, and Satisfaction with treatment. The change between groups after treatment and at the 12-week follow-up will be reported for all outcomes, considering the difference from scores recorded at baseline. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The ContextualizAR trial is designed as a two-arm, randomized, controlled, and blinded assessor superiority trial conducted at a single center. Patients will be allocated to one of two groups: a CFs+SC group and the SC group. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the nature of the study, blinding of both therapists and patients will not be feasible. However, to uphold the scientific validity of the study, specific descriptors and methodological details, such as terms like "placebo" or "CFs," have been intentionally excluded from the consent disclosure. To prevent any potential bias in participants' perceptions, information regarding the potential involvement of CFs in outcomes will not be provided. Instead, participants will be informed that the study aims to assess changes resulting from standard treatment for MNP. The person in charge of data statistical analysis (FV) and the evaluators who will assess all participants' pre- and post-intervention assessments (MLL and AR) will be blinded to the allocated intervention. whoMasked: OUTCOMES_ASSESSOR count: 94 type: ESTIMATED name: Standard Care name: Contextual Factors measure: Neck Pain Intensity measure: Neck Disability measure: Active Range of Movement measure: Global Rating of Change measure: Satisfaction with treatment measure: Expectations measure: Credibility sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06361459 id: NL83858.058.12 briefTitle: Stop Smoking in Spine Surgery overallStatus: RECRUITING date: 2023-07-06 date: 2026-06-30 date: 2026-12-31 date: 2024-04-11 date: 2024-04-11 name: Leiden University Medical Center class: OTHER name: Medical Center Haaglanden name: Haga Hospital name: Alrijne Hospital name: Spaarne Gasthuis briefSummary: Patients that are subjected to a medium complex surgical intervention in neck (posterior) or lumbar spine (posterior) with instrumentation are motivated to stop smoking. The outcome data of patients that stop and that continue smoking will be compared. A group of non smokers is evaluated as a control group. Particularly clinical outcome is evaluated, as well as radiological outcome. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: three study groups: group that does not smoke, group that smokes and stops, group that smokes and does not stop primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: Stop smoking measure: ODI or NDI measure: VAS leg or arm pain measure: HADS measure: EuroQol measure: perceived recovery measure: radiological evaluation for fusion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leiden University Medical Centre status: RECRUITING city: Leiden state: Zuid Holland zip: 2300RC country: Netherlands name: carmen vleggeert-lankamp, MD MSc PhD role: CONTACT phone: +31630925428 email: cvleggeert@lumc.nl lat: 52.15833 lon: 4.49306 hasResults: False

 nctId: NCT06361446 id: 023098816 briefTitle: Zonisamide Versus Propranolol in Migraine overallStatus: RECRUITING date: 2024-03-29 date: 2025-03-30 date: 2025-04-20 date: 2024-04-11 date: 2024-04-23 name: Kafrelsheikh University class: OTHER briefSummary: Investigators aim to compare the effect of zonisamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency conditions: Migraine studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We will assess The number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either zonisamide and acetaminophen or propranolol and acetaminophen from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included zonisamide and acetaminophen, and Drug B included propranolol and acetaminophen. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Zonisamide 50 MG name: Propranolol measure: The change in migraine days per 28 days measure: The total number of migraine days after three months of treatment measure: The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency. measure: HIT-6 score absolute change in each group after three months of treatment measure: The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months. sex: ALL minimumAge: 10 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: mohamed_gomaa@med.kfs.edu.eg lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06361433 id: R5-11 briefTitle: Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage acronym: RAINBOW-Hx overallStatus: RECRUITING date: 2023-12-01 date: 2026-02 date: 2026-02 date: 2024-04-11 date: 2024-04-11 name: Hokkaido University Hospital class: OTHER name: Japan Agency for Medical Research and Development briefSummary: The goal of this clinical trial is to test intracerebral transplantation of stem cell product in patient with chronic intracerebral hemorrhage. The main questions aims to answer are:

* The safety of the product
* The efficacy of the product conditions: Intracerebral Hemorrhage studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: HUFF-01 measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 measure: Change in mRS examination measure: Change in NIHSS examination measure: Change in FIM examination measure: Change in Fugl-Myer examination measure: Change in Barthal index examination measure: Change in FDG-PET examination measure: Change in IMZ-SPECT examination sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hokkaido University Hospital status: RECRUITING city: Sapporo state: Hokkaido zip: 0608638 country: Japan name: Masahito Kawabori role: CONTACT phone: +81117065987 email: masahitokawabori@yahoo.co.jp lat: 43.06667 lon: 141.35 hasResults: False

 nctId: NCT06361420 id: 2023YF051-01 briefTitle: Driving Pressure-guided Lung Protective Ventilation acronym: DPV overallStatus: RECRUITING date: 2024-01-26 date: 2024-12-30 date: 2025-03-31 date: 2024-04-11 date: 2024-04-11 name: Yong Lin, PhD class: OTHER briefSummary: The study, named as "The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection: an open-label, randomized control clinical trial", aims to investigate whether driving pressure-guided lung protective ventilation can reduce postoperative oxygenation function in patients who have undergone surgical repair of acute type A aortic dissection. The primary outcomes is the incidence of postoperative hypoxemia (a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93% at any concentration of inspiratory oxygen) within 7 days after the surgery. conditions: Hypoxemia conditions: Ventilator Lung studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: open, randomised control trial primaryPurpose: PREVENTION masking: NONE count: 43 type: ESTIMATED name: Driving pressure-guided positive end expiratory pressure name: Optimal oxygenation-guided positive end expiratory pressure name: Ventilation strategy name: Management of hypoxemia measure: The incidence of postoperative hypoxemia measure: The trend of perioperative oxygenation function measure: Postoperative pulmonary complications except hypoxemia measure: Early/late death measure: Vasoactive-inotropic score at the end of surgery measure: Postoperative adverse cardiovascular events measure: Length of stay in intensive care unit measure: Ventilation assistance time measure: Postoperative extrapulmonary complications sex: ALL minimumAge: 14 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian medical university union hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350001 country: China name: Yong Lin, MD role: CONTACT phone: 13805064575 email: birdman1983@163.com lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06361407 id: 2023-A02464-41 briefTitle: Sensory and Cognitive Predictions, and Their Disruptions in Schizophrenia acronym: SensoSchiz overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2028-02-28 date: 2024-04-11 date: 2024-04-11 name: Centre Psychothérapique de Nancy class: OTHER name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: Disturbances in the sense of self and time could play an important role in the development of psychotic symptoms. Previous work has shown that patients have difficulty preparing to process information on the scale of a second, but are abnormally disturbed by slightly asynchronous information on the millisecond scale. In both cases, the anomalies could explain the patients' unusual experience of time. The hypothesis in neurotypical patients is that small delays or asynchronies asynchronies are treated as irrelevant information and ignored and ignored, whereas in patients suffering from schizophrenia they would disrupt the flow of time. This hypothesis is tested with a new visual illusion. conditions: Schizophrenia conditions: Sensory Processing Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Individuals with schizophrenia will be tested in parallel with neurotypicals primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: The group will be masked at the stage of data analysis. It cannot be masked at the prior stages count: 68 type: ESTIMATED name: Illusion task measure: Effect of a millisecond-level trajectory perturbation measure: Baseline rate of illusion measure: Effect of a rebound (top-down, conscious influence) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06361394 id: CORPFIN0021 briefTitle: The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students overallStatus: RECRUITING date: 2024-02-20 date: 2024-07-25 date: 2025-08-31 date: 2024-04-11 date: 2024-04-11 name: Chang Gung University of Science and Technology class: OTHER briefSummary: The aims of this study are to develop a mindfulness-based course for nursing students. As well as, to verify the effects on psychological well-being (mindfulness, stress, and anxiety) and nursing professional related competences (empathy, clinical practicum stress, nursing competency) among nursing students. conditions: Students studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will enroll in the elective course named "Mindfulness and Happiness," which will consist of 2 hours every week for a continuous period of 18 weeks. The comparison group will not participate in this course. primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: mindfulness course measure: perceived stress at baseline measure: perceived stress at T0 measure: perceived stress at T1 measure: perceived stress at T2 measure: anxiety disorder at baseline measure: anxiety disorder at T0 measure: anxiety disorder at T1 measure: anxiety disorder at T2 measure: mindful attention awareness at baseline measure: mindful attention awareness at T0 measure: mindful attention awareness at T1 measure: mindful attention awareness at T2 measure: empathy at baseline measure: empathy at at T0 measure: empathy at at T1 measure: empathy at at T2 measure: practicum stress at T1 measure: practicum stress at T2 measure: Nursing Competence at T1 measure: Nursing Competence at T2 sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Ya-Chu Hsiao status: RECRUITING city: Taoyuan City state: N/A = Not Applicable zip: 333 03 country: Taiwan name: ya-chu hsiao, EdD role: CONTACT phone: +886939740890 email: yjshiao@mail.cgust.edu.tw lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06361381 id: 24-01-281 briefTitle: The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-12 date: 2024-04-11 date: 2024-04-11 name: University of Hartford class: OTHER briefSummary: Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy subjects. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive modality that modulates the vagus nerve by stimulating its auricular branches. The effects of the combination of TENS and TaVNS on producing an analgesic response have not been studied. Considering that TENS and TaVNS both stimulate similar analgesic pathways but through different means of activation, the investigators can hypothesize that a combination of both methods can produce a more pronounced analgesic response. Therefore, the objective of this study is to assess the hypoalgesic effect of a combination of TENS and TaVNS in pain-free subjects.

The study will be a simple crossover design conducted at the University of Hartford. Subjects will be recruited from the University of Hartford population via oral communication, digital flyers, and posters on campus. Thirty participants will undergo two sessions in a crossover manner with one week in between. During one session, the participants will receive TENS with active TaVNS and the other session will be a placebo procedure (TENS with placebo TaVNS). The order of these sessions will be randomized. Importantly, the pressure pain threshold (PPT) and heat pain threshold (HPT) assessors will be blinded to the treatment category. For active TaVNS, a frequency of 25 Hz will be applied with a pulse duration of 200 µs. For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. High frequency TENS of 100Hz will be applied in both sessions, with a pulse duration of 200 µsec, asymmetrical biphasic square waveform, and intensity of maximal tolerance without pain. TENS and TaVNS will be turned on for 30 minutes after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention and once 15 minutes post-intervention. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) name: Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) name: Transcutaneous Electrical Nerve Stimulation measure: Pressure Pain Threshold measure: Heat Pain Threshold measure: Heart rate measure: Oxygen saturation measure: Blood pressure sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Hartford city: West Hartford state: Connecticut zip: 06117 country: United States lat: 41.76204 lon: -72.74204 hasResults: False

 nctId: NCT06361368 id: NYCU112174AF briefTitle: Efficacy Assessment of Probiotics in Improving Sleep Indices overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-04-11 date: 2024-04-11 name: National Yang Ming University class: OTHER name: Bened Biomedical Co., Ltd. briefSummary: To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions. conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: PS150 name: Placebo measure: Polysomnography (PSG) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Insomnia Severity Index (ISI) measure: Beck Depression Inventory-Second Edition (BDI-II) measure: Beck Anxiety Inventory (BAI) measure: VAS-Sleep measure: Epworth Sleepiness Scale (ESS) measure: Standford Sleepiness Scale (SSS) measure: Visual Analogue Scale for gastrointestinal symptoms (VAS-GI) measure: Saliva Melatonin measure: Saliva Cortisol measure: Saliva IL-6 measure: Saliva Total Antioxidant Capacity (TAC) measure: Saliva Serotonin measure: Saliva GABA measure: Saliva Orexin measure: Urine 6-sulfatoxymelatonin measure: Urine Norepinephrine measure: Actigraphy measure: Sleep Diary sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Institute of Brain Science National Yang Ming Chiao Tung University city: Taipei zip: 112304 country: Taiwan name: Yu En Kuo, Master role: CONTACT phone: +886 975231262 email: iankuo1106@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06361355 id: CMAB807-I-002 briefTitle: Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers overallStatus: RECRUITING date: 2023-11-02 date: 2024-04 date: 2024-06 date: 2024-04-11 date: 2024-04-11 name: Taizhou Mabtech Pharmaceutical Co.,Ltd class: INDUSTRY briefSummary: This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Biological: Post-change CMAB807, Prolia primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Post-change CMAB807 name: Prolia measure: Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time measure: Maximum Concentration of Denosumab measure: Time to Maximum Concentration of Denosumab measure: Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3000 Hours measure: Half-time measure: Clearance Rate measure: Apparent Volume measure: Serum type 1 C-telopeptide (CTX1) measure: anti-drug antibodies(ADA) measure: Neutralization antibodies(Nab) measure: Percentage and Severity of Participants with Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The Second Hospital of Anhui Medical University status: RECRUITING city: Hefei state: Anhui country: China name: Hu Wei, Doctor role: CONTACT phone: 0551-65997164 email: hwgcp@ayefy.com lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06361342 id: 23-003633 briefTitle: Smartphones Aggravating Anxiety Symptoms overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2025-03 date: 2025-03 date: 2024-04-11 date: 2024-04-11 name: Mayo Clinic class: OTHER briefSummary: The goal of this study is to assess if excessive use of smartphone apps of social media can impact a person's mental health. The study is aimed at improving the usage of smartphones which might help improve the mental health of patients. The goal is not to discourage the use of smartphones but instead to utilize smartphones in a way that they do not impact lives. conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: General decrease in smartphone use name: Avoiding Social Media Apps measure: Change in anxiety measure: Change in depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Minnesota city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06361329 id: 20240030C briefTitle: Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL overallStatus: RECRUITING date: 2024-04 date: 2026-03-31 date: 2027-03-31 date: 2024-04-11 date: 2024-04-29 name: First Affiliated Hospital of Zhejiang University class: OTHER briefSummary: ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients. conditions: ETP-ALL studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: Homoharringtonine name: venetoclax name: Cytarabine name: G-CSF name: Vindesine name: Daunorubicin name: cyclophosphamide name: Dexamethasone name: L-ASP measure: 1-year EFS measure: CR/CRi measure: OS measure: MRD measure: Safety of induction therapy sex: ALL minimumAge: 14 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital, College of Medicine, Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310003 country: China name: Jie Jin, PhD&MD role: CONTACT phone: 13705716779 email: jiej0503@163.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06361316 id: CSPC-DEY-PC-JS01 briefTitle: Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer overallStatus: RECRUITING date: 2024-04-08 date: 2025-03-25 date: 2028-07-31 date: 2024-04-11 date: 2024-04-11 name: Kuirong Jiang class: OTHER name: CSPC Ouyi Pharmaceutical Co., Ltd. briefSummary: The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer. conditions: Pancreatic Cancer conditions: Adjuvant Therapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: Irinotecan liposome injection measure: Disease Free Survival, DFS measure: Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE measure: Overall Survival, OS measure: Quality of life, QOL measure: The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy measure: he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FirstNanjingMU status: RECRUITING city: Nanjing state: Jiangsu zip: 025 country: China name: KuiRong Jiang, archiater role: CONTACT phone: 15312995688 email: Jiangkuirong@163.com name: Min Tu, associate doctor role: SUB_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06361303 id: PS230001 id: PS230001 / PSS001 type: OTHER domain: US FDA briefTitle: The Happiest Baby, Inc. SNOO Postmarket Surveillance Study overallStatus: RECRUITING date: 2023-11-29 date: 2025-09 date: 2025-09 date: 2024-04-11 date: 2024-04-11 name: Happiest Baby, Inc. class: INDUSTRY briefSummary: This postmarket surveillance study will evaluate the safety of the SNOO Smart Sleeper Bassinet when used for infants who are at high risk for Sudden Unexpected Infant Death (SUID). This study will survey 1000 caregivers of high-risk infants to examine the frequency of death or serious injury occurring in the SNOO Bassinet. conditions: Infant Death conditions: Serious Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: SNOO Bassinet measure: Serious Injury measure: Infant death measure: Infant age during SNOO use measure: Degree of SNOO use measure: Weaning rationale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Happiest Baby, Inc. status: RECRUITING city: Los Angeles state: California zip: 90064 country: United States name: Christopher Laine, PhD role: CONTACT phone: 310-476-4440 email: christopher@happiestbaby.com name: Sarah Chang, MPH role: CONTACT phone: 310-476-4440 email: schang@happiestbaby.com name: Christopher Laine, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06361290 id: APHP231703 briefTitle: Diaphyseal Reconstruction of Malignant Tumors in Children acronym: RDTM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-04-11 date: 2024-04-11 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Primary malignant bone tumors represent 5% of malignant tumors in children, 90% of which are osteosarcomas or Ewing sarcomas.

The objective of oncological resection is local control of the disease. Excision of the entire tumor should make it possible to maintain good function of the limb, minimizing morbidity, and promoting acceptance by the patient.

Biological reconstructions offer the best long-term functional results. Several possibilities are then available: the Induced Membrane technique, the Vascularized Fibula and Vascularized Fibula associated with an Allograft.

Until today, no reconstruction technique in children has proven its superiority over another and no decision-making algorithm for therapeutic care has been determined based on the importance of the bone resection and the affected segment in diaphyseal tumor reconstruction surgery of the lower limb.

The aim of the present research is to compare the three techniques concerning the consolidation aspect, the reoperation rates, the rates of bone complications, septic, and the functional results by the study of the medical files of approximately 90 patients operated between 1986 and 2017. conditions: Childhood Malignant Tumors of Lower Limbs studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 90 type: ESTIMATED name: Data collection from hospital medical records measure: Duration of bone consolidation period measure: Rate of surgical re-intervention measure: Short- and long-term complication rates measure: Long-term functional results measure: Relationship between radiotherapy and biological reconstruction result sex: ALL maximumAge: 17 Years stdAges: CHILD facility: Hôpital Armand-Trousseau city: Paris zip: 75012 country: France name: Franck Fitoussi, MD-PhD role: CONTACT phone: 679693634 phoneExt: +33 email: franck.fitoussi@trs.aphp.fr lat: 48.85341 lon: 2.3488 facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Edouard Haumont, MD role: CONTACT phone: 486587192 phoneExt: +32 email: edouard.haumont@.aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06361277 id: JW22104 briefTitle: To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers overallStatus: COMPLETED date: 2023-11-03 date: 2023-11-20 date: 2023-11-27 date: 2024-04-11 date: 2024-04-11 name: JW Pharmaceutical class: INDUSTRY briefSummary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 56 type: ACTUAL name: Reference Drug or Test Drug measure: AUCt measure: Cmax sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Clinical Trial Center, Jeonbuk National University Hospital city: Jeonju country: Korea, Republic of lat: 35.82194 lon: 127.14889 hasResults: False

 nctId: NCT06361264 id: Karanahan briefTitle: Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide overallStatus: RECRUITING date: 2018-11-01 date: 2024-12-01 date: 2025-12-01 date: 2024-04-11 date: 2024-04-11 name: KARANAHAN class: OTHER briefSummary: The goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage IV or disease progression). The main question it aims to answer is: Does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days. conditions: Stage IV Breast Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Karanahan measure: The size of tumor foci measure: The quality of life score measure: The immunomodulatory effect sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karanahan Llc status: RECRUITING city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Anastasia Proskurina role: CONTACT email: labmolbiol@mail.ru name: Sergey Sidorov role: PRINCIPAL_INVESTIGATOR lat: 55.0415 lon: 82.9346 hasResults: False

 nctId: NCT06361251 id: CS5_10 briefTitle: Interventional, Monocentric, Double-blind Randomized Category 2b Study Evaluating the Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post -Inflammatory Hyperpigmentation (Pih)) on the Face acronym: CS5_10 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-11 date: 2024-04-17 name: Cryonove Pharma class: INDUSTRY name: Dermatech briefSummary: The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:

* the tolerance of 2 prototypes of cyto-selective cryotherapy treatments
* the performance of 2 prototypes of cyto-selective cryotherapy treatments Participants will be treated for each spots with a definied prototype during 6 treatment visits.

Researchers will compare the tolerance and performance of the 3 prototypes. conditions: Lentigo conditions: Solar Lentigo conditions: Post Inflammatory Hyperpigmentation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Proof of concept study concerning 2 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blind (participant and care provider) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: CRYONOVE (EC14_4osc) name: CRYONOVE (EC05osc) measure: Tolerance measure: Performance (Acquisitions C-cube) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University city: Pretoria country: South Africa lat: -25.74486 lon: 28.18783 hasResults: False

 nctId: NCT06361238 id: 2023-LCYJ-PY-21 briefTitle: Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-03-31 date: 2027-03-31 date: 2024-04-11 date: 2024-04-11 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: This study aims to clarify the preventive effect of perioperative liraglutide application on postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery. conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 260 type: ESTIMATED name: Liraglutide injection name: Placebo injection measure: The incidence of delirium measure: The severity of delirium measure: Cognitive function measure: Anxiety measure: Depression measure: Duration of ICU stay measure: Mechanical ventilation time measure: Duration of hospital stay measure: In-hospital mortality measure: Incidence of adverse events measure: Rate of major cardiovascular adverse events measure: Serum levels of NSE measure: Serum levels of CRP measure: Serum levels of IL-1α measure: Serum levels of TNF-α measure: Serum levels of C3 measure: Serum levels of LDH measure: Serum levels of CK measure: Serum levels of CK-MB measure: Serum levels of AST measure: Serum levels of cTNT measure: Serum levels of BNP measure: Serum levels of C1q measure: Serum levels of IL-1β measure: Serum levels of IL-6 measure: Serum levels of S100β measure: Left Ventricular Posterior Wall Thickness in Diastole (LVPWTd) measure: Left Ventricular End-Diastolic Dimension (LVDd) measure: Left Ventricular End-Systolic Diameter (LVDs) measure: Left Atrial Diameter (LAD) measure: Ejection Fraction (EF) measure: Fractional Shortening (FS) measure: Early Diastolic Velocity/Atrial Diastolic Velocity (E/A) measure: Interventricular Septum Thickness in Diastolic (IVSTd) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06361225 id: 0075-24-MMC briefTitle: Routine Use of RUSH Protocol in the Intensive Care Unit overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08-01 date: 2025-08-01 date: 2024-04-11 date: 2024-04-11 name: Meir Medical Center class: OTHER briefSummary: The RUSH protocol has been used for several years for the rapid evaluation of a patient admitted to the emergency room with shock. Traditionally, its use was especially common in trauma victims, but later its use was extended to patients admitted to the emergency room with shock from any reason. The protocol includes rapid assessment with the guideness of ultrasound of heart contraction, assessment for pleural effusions, assessment of intra-abdominal blood (FAST), diagnosis of venous thrombosis (DVT), and rulling out hydronephrosis. It can also add a pupil size assessment and an evaluation of the gallbladder and bile ducts, as well as the size of the bladder. In intensive care, we use this protocol (or part of it) for the evaluation of a patient who is deteriorating in the ICU for an unknown reason . In some patients we use this protocol as a routine part of the physical examination as part of the daily patient evaluation.

We would like to investigate whether the routine use of the RUSH protocol as part of the daily patient evaluation in the general intensive care unit will lead to any change in the patient's management. conditions: RUSH Protocol studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: evaluation with RUSH protocol measure: Change of patient medical therapy measure: Performing unplanned laboratory tests measure: Performing unplanned image tests measure: Performing unplanned invasive procedure sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Meir Medical Center city: Kfar Saba country: Israel lat: 32.175 lon: 34.90694 hasResults: False

 nctId: NCT06361212 id: BJXH-2022-002 briefTitle: Ethoximod Pharmacokinetics In Healthy Subjects overallStatus: COMPLETED date: 2022-09-01 date: 2022-09-20 date: 2024-01-12 date: 2024-04-11 date: 2024-04-11 name: Longevity Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects. The main questions it arms to answer are:

1. to evaluate the safety and tolerance of Ethoximod in healthy subjects after single or repeated doses.
2. to assess the pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects after single or repeated doses.
3. to evaluate of the effect of food on the pharmacokinetics of Ethoximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples. conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 65 type: ACTUAL name: Ethoximod measure: Peak plasma concentration (Cmax) measure: Time to peak plasma concentration (Tmax) measure: The lowest plasma concentration (Cmin) measure: Half-life (t1/2) measure: Number of adverse events and number of participants with adverse events measure: Lymphocyte count measure: Percentage of CD3+CD4+ and CD3+CD8+ T cells sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The first hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False

 nctId: NCT06361199 id: BJXH-2021-001 briefTitle: Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis overallStatus: COMPLETED date: 2021-12-16 date: 2022-02-16 date: 2023-10-08 date: 2024-04-11 date: 2024-04-19 name: Longevity Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects and patients with rheumatoid arthritis. The main questions it arms to answer are:

1. to evaluate the safety and tolerance of Proximod in health subjects after repeated doses.
2. to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses.
3. to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis.
4. to evaluate the pharmacokinetics and pharmacodynamics of Proximod in patients with rheumatoid arthritis.

Participants will receive test tablets or placebo at the indicated date and collect blood samples. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 22 type: ACTUAL name: Proximod name: Placebo measure: Peak plasma concentration (Cmax) measure: Time to peak plasma concentration (Tmax) measure: The lowest plasma concentration (Cmin) measure: Half-life (t1/2) measure: Area under the plasma concentration versus time curve (AUC) measure: Number of adverse events and number of participants with adverse events measure: Lymphocyte count measure: Percentage of CD3+CD4+ and CD3+CD8+T cells measure: ACR20 score in Patients With Rheumatoid Arthritis measure: Disease Activity Score（DAS28-CRP）in Patients With Rheumatoid Arthritis sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False

 nctId: NCT06361186 id: BJXH-2017-001 briefTitle: Proximod Pharmacokinetics In Healthy Subjects overallStatus: COMPLETED date: 2017-09-14 date: 2017-11-01 date: 2021-06-22 date: 2024-04-11 date: 2024-04-11 name: Longevity Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are:

1. to evaluate the safety and tolerance of Proximod in healthy subjects after single or repeated doses.
2. to learn the pharmacodynamics of Proximod in healthy subjects after single or repeated doses.
3. to evaluation of the effect of food on the pharmacokinetics of Proximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 134 type: ACTUAL name: Proximod name: Placebo measure: Peak plasma concentration (Cmax) measure: Time to peak plasma concentration (Tmax) measure: The lowest plasma concentration (Cmin) measure: Half-life (t1/2) measure: Number of adverse events and number of participants with adverse events measure: Lymphocyte count measure: Percentage of CD3+CD4+ and CD3+CD8+ T cells sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The first hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False

 nctId: NCT06361173 id: STUDY00004127 briefTitle: Spanish BMT4me Usability & Acceptability overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-11 date: 2024-04-11 name: Nationwide Children's Hospital class: OTHER name: Columbia University briefSummary: The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Nationwide Children's Hospital (NCH) will be the primary data collection site and Columbia University Irving Medical Center will be a secondary site. conditions: Bone Marrow Transplant studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: BMT4me measure: Assess app usability using the System Usability Scale (SUS) sex: ALL minimumAge: 0 Years maximumAge: 17 Years stdAges: CHILD facility: Columbia University Irving Medical Center city: New York state: New York zip: 10027 country: United States name: Melissa Beauchemin role: CONTACT email: mmp2123@cumc.columbia.edu lat: 40.71427 lon: -74.00597 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43215 country: United States name: Bianca Franklin, BS role: CONTACT name: Micah Skeens, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06361160 id: D23-P037 briefTitle: Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation acronym: HALLUSTIM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-11 date: 2024-04-11 name: Centre Hospitalier St Anne class: OTHER briefSummary: Approximately 1% of the general population will be affected by schizophrenia over the course of their lives, with life expectancy being reduced by 20 years on average and quality of life being severely diminished in affected individuals. One third of patients suffering from schizophrenia will evolve towards a resistant form of the disease, amongst which many will suffer from auditory-verbal hallucinations (AVH) that current therapeutic approaches struggle to alleviate. Previous work from our team has demonstrated the possibility of robustly inferring the periods of occurrence of AVH from fMRI data, paving the way for the development of a closed-loop neuromodulation system comprised of an electrode array positioned in Broca's area, which would detect AVH in real time, and effector electrodes which would stimulate the temporo-parietal cortex to interrupt them. The aim of this project is to assess the feasibility of this system. To do so, we will first test the ability of transcranial magnetic stimulation of the "continuous theta burst" (cTBS) type, applied at the time of AVH onset, to reduce their duration and intensity, and assess whether this is associated with therapeutic response to the current gold standard rTMS protocol for AVH reduction through neuroplasticity induction. Demonstrating the feasibility of acute suppression of AVH by cortical neurostimulation is an essential element in the feasibility of a closed-loop reactive neuromodulation system.

The research project comprises two phases:

-Phase 1: randomized controlled clinical trial (1 weekly session per patient over 12 weeks: 6 active stimulation sessions and 6 sham sessions) evaluating the phasic effects of rTMS on AVHs as they appear during the sessions.

Phase 2: open-label study offering patients a routine rTMS protocol which has demonstrated its effects on AVH (10 TMS sessions over one workweek - twice daily with 1-hour intervals, MULTIMODHAL study, NCT01373866). conditions: Treatment Resistant Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients (20) suffering from resistant schizophrenia will be enrolled over a 12-month period and will be randomized in a (1:1) ratio to start with either active or sham Transcranial Magnetic Stimulation (TMS) for the first of their 12 sessions, which will then alternate from one condition to the other for each patient. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Only the person conducting the experiment will know which condition each patient is in. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Active Transcranial Magnetic Stimulation (TMS) name: Sham Transcranial Magnetic Stimulation (TMS) measure: Duration of auditory-verbal hallucinations measure: Clinical scales scores measure: Measure of the duration and/or intensity of HAV (in seconds) during active phasic stimulation sessions compared to sham sessions (phase 1) among TMS responders and non-responders in phase 2 measure: Intensity of auditory-verbal hallucinations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06361147 id: 3764/2-10-2019 briefTitle: Psychoeducation of Adult Siblings of ASD People (Autism Spectrum Disorder). overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-28 date: 2024-07 date: 2024-10 date: 2024-04-11 date: 2024-04-11 name: Hellenic Mediterranean University class: OTHER briefSummary: The aim of this study is to apply a psychoeducational program in adult siblings of people with ASD as a means to provide knowledge related to the disorder and improving their quality of life.

The psycho-educational program will be implemented in adult siblings of people with ASD and its effectiveness will be assessed.

Participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with ASD and those related to them. No risk is identified. conditions: Autism Spectrum Disorder conditions: Sibling Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Interventional groups and Control groups primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ACTUAL name: Cygnet program for ASD measure: Psychoeducation effectiveness on siblings of ASD measure: Psychoeducation effectiveness on the knowledge of ASD measure: Psychoeducation effectiveness on siblings relationship measure: Psychoeducation effectiveness on resilience of siblings of ASD measure: Psychoeducation effectiveness on the well-being of siblings of ASD sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hellenic Mediterranean University city: Heraklion state: Crete zip: 82102 country: Greece lat: 35.32787 lon: 25.14341 hasResults: False

 nctId: NCT06361134 id: 14574941-302,08,01- briefTitle: Efficacy of Supporting SAFE Early Intervention overallStatus: COMPLETED date: 2021-01-15 date: 2022-05-15 date: 2022-11-15 date: 2024-04-11 date: 2024-04-11 name: Gazi University class: OTHER briefSummary: Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention. conditions: Infant Development conditions: Physiotherapy conditions: Early Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 26 type: ACTUAL name: SAFE Early İntervention name: NDT based therapy measure: Test of Infant Motor Profile measure: Bayley Scales of Infant and Toddler Development, Third Edition, measure: Infant/Toddler Sensory Profile 2 measure: Infant/Toddler HOME Inventory sex: ALL minimumAge: 1 Month maximumAge: 3 Months stdAges: CHILD facility: Erzurum Technical University city: Erzurum country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06361121 id: D361 briefTitle: Mid-point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block in Posterolateral Thoracotomy overallStatus: RECRUITING date: 2024-03-01 date: 2025-03 date: 2025-03 date: 2024-04-11 date: 2024-04-11 name: Fayoum University Hospital class: OTHER briefSummary: The ultrasound guided Thoracic paravertebral (TPV) block in the context of posterolateral thoracotomy offers targeted pain relief by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL)

Costach et al introduced the mid-point transverse process to pleura block (MTP) as a modification of conventional paravertebral block by placing the LA posterior to the (SCTL) under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks.

In recent studies ,the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy , video-assisted thoracic surgeries and cardiac surgeries.

In our study we hypothesized that the mid-point transverse process to pleura (MTP) block can provide an effective analgesia comparable with thoracic paravertebral (TPV) block in adult patients undergoing posterolateral thoracotomy incisions. conditions: Bronchiectasis conditions: Lung Neoplasm conditions: Emphysematous Bleb of Lung studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The patients will be randomized into two groups: MTP block group and TPV block group in a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided MTP and TPV block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: mid-point transverse process to pleura (MTP) block name: Thoracic Paravertebral Block measure: The total postoperative fentanyl consumption measure: Demographic data measure: visual analogue scale score both during rest and with cough measure: intra operative fentanyl consumption measure: Duration of surgery measure: Blood pressure measure: Heart rate measure: Oxygen saturation measure: complications related to the block measure: complications related to IV opioids measure: Hospital length of stay in days measure: Participant satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fayoum University Hospital status: RECRUITING city: Fayoum zip: 63514 country: Egypt name: Mohamed A Hamed, MD role: CONTACT phone: 01010509736 phoneExt: +20 email: mah07@fayoum.edu.eg name: Mohamed A Hamed, MD role: PRINCIPAL_INVESTIGATOR lat: 29.30995 lon: 30.8418 hasResults: False

 nctId: NCT06361108 id: YJ001-103 briefTitle: Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of YJ001 for Spray Use in Patients With Diabetic Peripheral Neuropathic Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-03-20 date: 2025-03-20 date: 2024-04-11 date: 2024-04-11 name: Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. class: INDUSTRY briefSummary: This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center.

In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects.

Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11. conditions: Diabetic Peripheral Neuropathic Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blinded with regard to the study treatment that subjects receive,without the investigator, the sponsor, or the subjects being aware of wether YJ001 or the placebo is administered. All decisions concerning dose escalation will be made in a blinded manner by the safety review committee.

The Safety Review Committee (SRC), comprised of the Principal Investigator, Medical Monitor, and Sponsor's qualified designee, will convene after completion of each cohort to evaluate available safety, PK, and other relevant data.

The SRC will determine whether to proceed to the next planned dose level, continue with the study and add additional safety evaluations, expand the number of subjects at the current level, reduce the dose, or stop the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: YJ001 for Spray Use name: Placebo of YJ001 for Spray Use measure: Safety Assessments - AEs measure: Safety Assessments -Number of Participants With Abnormal Laboratory Values measure: Safety Assessments - Skin Reaction measure: Pharmacokinetics-AUC measure: Pharmacokinetics- Cmax measure: Pharmacokinetics - tmax measure: Pharmacokinetics - tlag measure: Pharmacokinetics - t1/2 measure: Pharmacokinetics - CLr/f,ss measure: Efficacy evaluation indicator measure: Efficacy evaluation indicators - ADSIS measure: Efficacy evaluation indicators - SF-MPQ measure: Efficacy evaluation indicators - VPT sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Trials of Texas,LLC city: Fredericksburg state: Texas zip: 78229 country: United States name: Douglas Scott Denham role: CONTACT phone: 210-949-0122 lat: 30.2752 lon: -98.87198 hasResults: False

 nctId: NCT06361095 id: R01GABM briefTitle: Confirmatory Efficacy Trial of Attention Bias Modification for Depression overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-03-01 date: 2028-03-01 date: 2024-04-11 date: 2024-04-16 name: University of Texas at Austin class: OTHER name: Arcade Therapeutics briefSummary: The goal of this clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. The main aims are:

* Aim 1:examine whether gamified ABM leads to greater change in the primary and secondary outcomes than sham ABM
* Aim 1: establish that gamified ABM is at least as effective as traditional ABM.
* Aim 2: identify moderators of ABM efficacy and mechanisms responsible for its efficacy.
* Aim 3: Identify the durability of ABM on depression symptoms during short-term follow-up

Participants will complete self-report questionnaires, complete eye-tracking tasks, and be clinically assessed through interviews by clinician researchers.

If there is a comparison group: Researchers will compare sham, traditional, and gamified treatment groups to see if they moderate symptoms of depression. conditions: Depression studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Traditional Attention Bias Modification name: Gamified Attention Bias Modification name: Sham Attention Bias Modification measure: QIDS (Quick Inventory of Depression Symptoms) SR-16 measure: Sheehan Disability Scale (SDS) measure: Snaith-Hamilton Pleasure Scale (SHAPS) measure: Hamilton Depression Rating Scale (HAM-D) measure: Generalized Anxiety Disorder (GAD-7) measure: Perseverative Thinking Questionnaire (PTQ) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Mental Health Research city: Austin state: Texas zip: 78705 country: United States name: Christopher G Beevers, PhD role: CONTACT email: beevers@utexas.edu role: CONTACT email: beevers@utexas.edu lat: 30.26715 lon: -97.74306 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-05 uploadDate: 2024-04-08T12:13 filename: ICF_000.pdf size: 143608 hasResults: False

 nctId: NCT06361082 id: CORPG5N0061 briefTitle: Ultrasonic Backscatter Imaging for ACL Reconstruction and Shoulder Diseases overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-10 date: 2024-04-11 date: 2024-04-11 name: Chang Gung Memorial Hospital class: OTHER briefSummary: This study explores ultrasonic scattering imaging technology in patients undergoing anterior cruciate ligament (ACL) reconstruction and those with shoulder musculoskeletal disorders. Ultrasonography, widely utilized for diagnosing musculoskeletal conditions, faces limitations due to factors like operator experience and equipment settings, often lacking in quantifiable disease metrics. Nakagami imaging, employing the backscattering statistical distribution model, offers a quantitative assessment method that minimizes subjective interpretation by extracting tissue properties through the interaction between ultrasound and tissue microstructure. The Nakagami model effectively describes tissue scattering statistics, enabling the identification and classification of tissue features based on specific scattering conditions.

ACL reconstruction is commonly performed, with postoperative complications including joint stiffness and muscle strength decline, associated with changes in muscle quality and volume. Similarly, soft tissue injuries around the shoulder and ankle are prevalent in sports medicine, with ultrasound used to assess the severity of injuries to soft tissues such as the rotator cuff tendons/muscles and surrounding ligaments of the shoulder, as well as the medial and lateral ligament complexes of the ankle. Preliminary findings suggest that Nakagami imaging can differentiate layers within normal tendons, proposing its potential for visualizing and quantifying soft tissue lesions post-ultrasound, aiming for standardized diagnostic criteria.

The results of this project could significantly improve the diagnostic efficacy of musculoskeletal ultrasound, facilitating earlier treatment and reducing the socio-economic impacts. Academically, it positions the investigating team as pioneers in the application of ultrasound inverse scattering imaging technology. conditions: ACL Injury conditions: ACL Reconstruction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: ACL reconstruction measure: MRI of affected limb- Cross sectional area measured in squared cm of quadriceps muscles measure: Ultrasound Nakagami back scattering analysis- Nakagami index measure: Physical examination of limbs- Angles of Range of Motion of knee measure: MRI of affected limb- Quality of knee structures documented with descriptions for MR signals measure: Physical examination of limbs- Laxity of knee ligaments of subjects number with any positive knee physical findings measure: Ultrasound of affected limb- Cross sectional area measured in squared cm of quadriceps muscles measure: Ultrasound of affected limb- Quality of knee structures documented with descriptions for echogenicity sex: ALL minimumAge: 20 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06361069 id: aslıakdeniz briefTitle: Reducing Anxiety in Children Undergoing Day Surgery overallStatus: COMPLETED date: 2023-04-01 date: 2023-08-01 date: 2024-01-01 date: 2024-04-11 date: 2024-04-11 name: Bilecik Seyh Edebali Universitesi class: OTHER briefSummary: Aim: This study was conducted to determine the efﬁcacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery.

Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. The study was conducted between April 2023 and January 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. A total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between April 2023 and January 2024 and who met the inclusion criteria were included in the study. Descriptive statistics, Mann Whitney U test, Kruskal Wallis and regression analysis were used in the evaluation of the data. conditions: Anxiety conditions: Child, Only conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 85 type: ACTUAL name: distraction cards, kaleidoscope and finger puppet measure: Anxiety sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Bilecik Şeyh Edebali University city: Bilecik country: Turkey lat: 40.14192 lon: 29.97932 hasResults: False

 nctId: NCT06361056 id: LCCC2140 briefTitle: Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials overallStatus: RECRUITING date: 2022-05-02 date: 2025-01 date: 2026-01 date: 2024-04-11 date: 2024-04-17 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: This study explores the overall feasibility, impact, and satisfaction of using the "mHealth app" on clinic workflow for Black or African American women diagnosed with breast cancer.

The "mHealth app" which can be used as a platform to share clinical trial education and communication, was created and tested in previous steps of this study. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Survey name: mHealth app measure: Feasibility of Mobile Health Application (mHealth app)- subjects measure: Feasibility of Mobile Health Application (mHealth app) - Clinicians and staff measure: Overall satisfaction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Lineberger Comprehensive Cancer Center status: RECRUITING city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Lauren Matthews role: CONTACT phone: 919-843-5321 email: lauren_matthews@med.unc.edu name: Marjory Charlot, MD, MPH, MSc role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06361043 id: 2023-01833 briefTitle: Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer (ARTEC) acronym: ARTEC overallStatus: RECRUITING date: 2024-04-20 date: 2027-02-28 date: 2027-02-28 date: 2024-04-11 date: 2024-04-25 name: Insel Gruppe AG, University Hospital Bern class: OTHER briefSummary: Despite multimodal therapy, patients with esophageal cancer have poor prognosis with 5-year overall survival around 25%. Considering tumor-related death as main reason for high mortality rate in those patients, treatment-related cardio-pulmonary toxicities could also play a role in this regard. Online adaptive radiotherapy offers the possibility for daily re-planning and therefore helps radiation oncologists to better spare the organs at risk and reduce radiation-induced toxicity. Tha aim of ARTEC is to assess the pulmonary toxicity in patients with esophageal cancer treated with online adaptive radiotherapy. conditions: Esophageal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Number of patients with pulmonary toxicity measure: Number of patients with pathological complete response measure: Dosimetrical analysis between scheduled and adaptive plans sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inselspital, University of Berne, Deparftment of Radio-Oncology status: RECRUITING city: Berne zip: 3010 country: Switzerland name: Hossein Hammatazad, MD role: CONTACT phone: +41 31 632 26 32 email: hossein.hemmatazad@insel.ch name: Timo Nannen role: CONTACT phone: +41 31 632 90 74 email: timo.nannen@insel.ch lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06361030 id: HMPL-012-C2-PC01 briefTitle: Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-06-01 date: 2024-04-11 date: 2024-04-11 name: Wuhan Union Hospital, China class: OTHER briefSummary: To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer conditions: Pancreatic Cancer conditions: Pancreatic Cancer Non-resectable conditions: Pancreatic Ductal Adenocarcinoma, PDAC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: surufatinib combined with gemcitabine plus nab-paclitaxel measure: Surgical conversion rate measure: Objective Response Rate (ORR) measure: Disease control rate (DCR) measure: R0 surgical conversion rate measure: progression free survival(PFS) measure: Overall Survival (OS) measure: Adverse Event sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430000 country: China name: Heshui Wu role: CONTACT phone: +86 137-2011-7761 email: heshuiwu@hust.edu.cn name: Heshui Wu role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06361017 id: QNPY2022007 briefTitle: The Prediction of Hemorrhage Transformation by Cerebral Autoregulation in AIS Patient After Endovascular Thrombectomy acronym: PHASE overallStatus: ENROLLING_BY_INVITATION date: 2022-03-01 date: 2025-03-01 date: 2026-03-01 date: 2024-04-11 date: 2024-04-11 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome.

Patients: patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.

dCA Examination: dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.

The objectives of the study were as follows: The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed. So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes. conditions: Acute Ischemic Stroke conditions: Endovascular Thrombectomy conditions: Dynamic Cerebral Autoregulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: endovascular thrombectomy measure: The occurrence of hemorrhage transformation measure: Patients without hemorrhage transformation measure: The occurrence of unfavorable outcome measure: The occurrence of favorable outcome measure: The occurrence of long-term unfavorable outcome measure: The occurrence of long-term favorable outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University city: Beijing state: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06361004 id: DBS for TR-TS briefTitle: Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2028-12-31 date: 2029-12-31 date: 2024-04-11 date: 2024-04-11 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) in patients with Treatment-refractory Tourette's syndrome (TR-TS) implantation targeting the Antero-medial globus pallidus interna (GPi), Antero-medial globus pallidus interna (amGPi), Postero-ventrolateral GPi (pvGPi), Centromedian nucleus, substantia periventricularis and nucleus ventro-oralis internus (Cm-Spv-Voi), Centre median nucleus and nucleus ventro-oralis (Cm-Voi), or Nucleus Accumbens/ Anterior Limb of Internal Capsule (NA-ALIC), or other unreported nuclei targets. conditions: Tourette's Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients with Treatment-refractory Tourette's syndrome (TR-TS) primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Deep Brain Stimulation (DBS) measure: Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 6 months measure: YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12. measure: YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12. measure: YGTSS: remission, and response rate measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change in Y-BOCS at week 2, month 3, month 6, and month 12. measure: Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the HAMA total score. measure: Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months. measure: Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 3, Month 6, and Month 12. measure: Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity (CGI-S) measure: Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12. measure: EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 3, Month 6, and Month 12 in EQ-5D-5L. measure: Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12. measure: Safety as indicated by the number of Adverse Events: Week 2, Month 3, Month 6, and Month 12. measure: Change from baseline in the Verbal Fluency Test (COWAT) measure: Change from baseline in the Trailmaking Test A&B measure: Change in Rey-Osterrieth Complex Figure Test sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University city: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06360991 id: DBS for TR-OCD briefTitle: DBS for Treatment-resistant Obsessive-compulsive Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2028-12-31 date: 2029-12-31 date: 2024-04-11 date: 2024-04-11 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) implantation targeting the anteromedial region of subthalamic nucleus (amSTN), or nucleus accumbens (NAc), or bed nucleus of the stria terminalis (BNST), or ventral capsule/ventral striatum (VC/VS), or the ventral anterior limb of the internal capsule (vALIC) in patients with treatment-resistant obsessive-compulsive disorder (TR-OCD). conditions: Obsessive-Compulsive Disorder (OCD) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Deep brain stimulation (DBS) measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): the change from baseline to 1 year in the Y-BOCS total score. measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): remission, response, and partial response rate measure: Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in the HAMA total score. measure: Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year. measure: Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 1, Month 3, Month 6, and Month 1. measure: Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in Clinical Global Impression-Severity (CGI-S) measure: Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12. measure: EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12 in EQ-5D-5L. measure: Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12. measure: Safety as indicated by the number of Adverse Events Week 2, Month 1, Month 3, Month 6, and Month 12. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University city: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06360978 id: docetaxel as a radiosenstizer briefTitle: Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06 date: 2027-06 date: 2024-04-11 date: 2024-04-11 name: Assiut University class: OTHER briefSummary: Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The overall incidence of HNC continues to rise, with a predicted 30% increase annually by 2030., this increase has been recorded across both developed and developing countries.

Approximately 90% of HNCs are squamous cell carcinoma . The major risk factors of head and neck squamous cell carcinoma (HNSCC) are tobacco and heavy alcohol use and human papillomavirus infection . There has been a significant decline in smoking in high-income countries during the last few decades, which has led to a sharp decline in smoking related HNSCC . While increase in global incidence of human papillomavirus (HPV)-associated or positive (+) HNSCC Head and neck squamous cell carcinoma (HNSCC) is a highly challenging cancer, despite the advancements in treatment, the overall prognosis for HNSCC remains poor, with a five-year survival rate of around 50%.

Chemoradiation is one of the treatment options for locally advanced head and neck cancers, the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy (CRT) is the standard of care for locally advanced head and neck squamous cell carcinoma (LAHNSCC), cisplatin is contraindicated in many patients because of age, diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group.

The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC. conditions: Head and Neck Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Docetaxel measure: progression free survival measure: incidence of treatment adverse events measure: Overall survival (OS) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360965 id: Shoufa2024-3-7045 briefTitle: Clinical Trial of Acupoint Application in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain overallStatus: RECRUITING date: 2024-01-01 date: 2026-03-31 date: 2026-12-31 date: 2024-04-11 date: 2024-04-11 name: Beijing Hospital of Integrated Traditional Chinese and Western Medicine class: OTHER briefSummary: Chronic Pelvic Pain is one of the common gynecological symptoms, characterized by persistent and non periodic pain in the pelvic cavity and surrounding tissues. It is often seen as a sequelae of pelvic inflammatory diseases caused by the failure to receive timely and correct treatment. This study compares the effectiveness of warm meridians and relieve pain plaster in relieving the sequelae of pelvic inflammatory disease and chronic pelvic pain symptoms, and evaluates the safety of improved patches and traditional patches, further promoting it to community grassroots hospitals. conditions: Pelvic Inflammatory Disease conditions: Chronic Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 102 type: ESTIMATED name: Improved warm meridians and relieve pain plaster name: Traditional warm meridians and relieve pain plaster name: Placebo plaster measure: Main symptoms (lower abdominal pain) improvement level (visual analogue scale) measure: TCM syndrome score scale measure: Local physical sign rating scale measure: Pelvic masses and fluid accumulation measure: EuroQol Five Dimensions Questionnaire measure: Recurrence of abdominal pain during 1-month menstrual cycle was followed up. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Beijing Hospital of Integrated Traditional Chinese and Western Medicine status: RECRUITING city: Beijing country: China name: YuNa Liu role: CONTACT phone: 86-010-88223667 email: kjk882236672@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06360952 id: T23-03 briefTitle: A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-07-30 date: 2024-07-30 date: 2024-04-11 date: 2024-04-26 name: Tasso Inc. class: INDUSTRY name: The Leukemia and Lymphoma Society briefSummary: This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.

This investigation will include a minimum of 40 sample sets from unique patients. conditions: Leukopenia conditions: Leukocytosis conditions: Neutropenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Tasso+ CBC measure: Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count measure: Agreement between capillary and venous blood in the measurement of secondary biomarkers measure: Patient acceptance of Tasso device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lineberger Comprehensive Cancer Center city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06360939 id: ETH02659 briefTitle: Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease acronym: Radioablate overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2027-04-15 date: 2024-04-11 date: 2024-04-11 name: Western Sydney Local Health District class: OTHER name: University of Sydney name: National Heart Foundation, Australia briefSummary: The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are:

* What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months
* What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care). conditions: Ventricular Tachycardia conditions: Cardiomyopathies conditions: Arrhythmias, Cardiac conditions: Ventricular Arrythmia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: SBRT name: CA measure: VT burden measure: Recurrent sustained VT measure: VT storm measure: Absolute VT burden measure: Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI) measure: ICD shocks measure: Hospitalization measure: All cause mortality measure: Cardiovascular Mortality measure: Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation measure: Ventricular function measure: Quality of Life as per Short Form - 36 (SF-36) Score measure: Quality of Life as per Implantable Cardioverter Defibrillator Concerns Questionnaire (ICDC) score measure: Number of AADs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360926 id: 2024-A00526-41 briefTitle: Improvement Image Quality for SuperSonic® MACH Ultrasound System acronym: MACH IQ overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-11 date: 2024-04-11 name: SuperSonic Imagine class: INDUSTRY briefSummary: The aim of this Study is to collect radiologist feedback to support the further development and improvement of the imaging modes implemented on the embedded software in the SuperSonic® Ultrasound System (including the probe). conditions: Diagnosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: SuperSonic® Ultrasound System measure: Qualitative assessment of image quality sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360913 id: 2023/09AOU/346 briefTitle: Blood Spot and Urine Metabolomic Screening Applied to Rare Diseases acronym: BUSARD overallStatus: RECRUITING date: 2024-01-03 date: 2028-01 date: 2028-01 date: 2024-04-11 date: 2024-04-12 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: The primary goal of this study is to establish a biobank of dried blood spots and urines from a large control cohort and collect several cohorts as large as possible of patients affected or suspected of being affected by rare diseases (mainly hereditary metabolic diseases) or by autism spectrum disorders.

A metabolomic database using a high-resolution mass spectrometer (i.e. the "Device") will be generated and specific biomarkers for the diseases will be confirmed or uncovered. The ultimate goal is to facilitate and improve the diagnosis and screening of the patients affected by these disorders, but also to improve the knowledge about the biochemical mechanisms involved over the course of the selected pathologies.

High-resolution mass spectrometry allows the measurement of thousands of metabolites in a single analysis. The current biochemical tests used for the diagnosis of hereditary metabolic diseases are only using a combination of maximum a few dozens of biomarkers in one analysis.

Objectives Unravel new biomarkers for diagnosis (+/- explore the altered pathways...) Uncover and/or validate newborn screening biomarkers through retrospective analysis of preserved newborn DBS from confirmed patients (useful for first or second tier biochemical NBS testing!) Validation of LC-MS qTOF for metabolomics screening as first line diagnostic test (thousands of metabolites) using diagnostic algorithms (modified z-scores) \& continuous optimization by adding new cases and new controls in the database Generation of a biobank of urines and DBS from rare diseases (IEMs) \& from a large reference population useful for other research applications conditions: Inborn Errors of Metabolism conditions: Rare Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 3 groups:

1. Control subjects
2. Confirmed patients (rare diseases)
3. Suspected patients (rare diseases) primaryPurpose: DIAGNOSTIC masking: NONE count: 2286 type: ESTIMATED name: High resolution mass spectrometry measure: Uncover new biomarkers in dried blood spots and urines samples able to improve the diagnosis of rare diseases sex: ALL minimumAge: 1 Day maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Universitaire des enfants Reine Fabiola (HUDERF-ULB) status: NOT_YET_RECRUITING city: Brussels zip: B-1020 country: Belgium name: Lionel Marcélis, MSc, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Aurélie Empain, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Corinne De Laet, M.D., Ph.D. role: SUB_INVESTIGATOR name: Ebru Surgun, M.D. role: SUB_INVESTIGATOR name: Céline Morelli, M.D. role: SUB_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: Cliniques universitaires Saint Luc status: RECRUITING city: Brussels zip: B-1200 country: Belgium name: Joseph P. Dewulf, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Marie-Cécile Nassogne, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Xavier Stephenne, M.D., Ph.D. role: SUB_INVESTIGATOR name: Nicole Revencu, M.D., Ph.D. role: SUB_INVESTIGATOR name: Stéphanie Paquay, M.D. role: SUB_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: Institut de Pathologie et de Génétique (IPG) status: NOT_YET_RECRUITING city: Charleroi zip: B-6041 country: Belgium name: Dominique Roland, M.D. role: PRINCIPAL_INVESTIGATOR name: Damien Lederer, M.D., Ph.D. role: SUB_INVESTIGATOR name: Isabelle Maystadt, M.D., Ph.D. role: SUB_INVESTIGATOR lat: 50.41136 lon: 4.44448 facility: CHU Liege status: NOT_YET_RECRUITING city: Liège zip: B-4000 country: Belgium name: François-Guillaume Debray, MD PhD role: PRINCIPAL_INVESTIGATOR name: François Boemer, Pharm D PhD role: PRINCIPAL_INVESTIGATOR name: Caroline Dadoumont, MD role: SUB_INVESTIGATOR lat: 50.63373 lon: 5.56749 hasResults: False

 nctId: NCT06360900 id: 2024P000849 briefTitle: Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-03 date: 2029-03 date: 2024-04-11 date: 2024-04-11 name: Spaulding Rehabilitation Hospital class: OTHER briefSummary: The primary aims of this randomized, single-blinded, 2x2 sham-controlled trial are to 1) evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation (taVNS) + cognitive-behavioral therapy (CBT) on post-meal gut-brain communication; 2) determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia (FD) improvements and meal-induced physiological outcomes; 3) investigate whether post-treatment changes in gut-brain physiology mediate improvements in FD clinical outcomes. Using a fully non-invasive framework including gastric and brain magnetic resonance imaging (MRI) and taVNS, the investigators aim to evaluate the potential synergy of taVNS and CBT in FD, by assessing the gut-brain physiological response to prandial challenge, linking physiological with symptom improvements. conditions: Functional Dyspepsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: taVNS name: CBT name: Education Control name: Sham taVNS measure: Nepean Dyspepsia Index (NDI) measure: Visceral Sensitivity Index (VSI) measure: Gastric peristaltic velocity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360887 id: DRKS00030614 briefTitle: Management of Proximal Humerus Fractures in Adults: a Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-01-31 date: 2028-01-31 date: 2024-04-11 date: 2024-04-12 name: Regional Hospital of Bolzano class: OTHER briefSummary: Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment. conditions: Shoulder Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 351 type: ESTIMATED name: Conservative name: ORIF name: CRPP measure: Oxford Shoulder Score measure: The visual analogue scale measure: Rate of complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Academic Hospital of Bolzano (SABES-ASDAA) city: Bolzano state: Alto Adige zip: 39100 country: Italy name: Malte Nikolas Witte, Dr. role: CONTACT phone: 00393885787726 email: maltewitte@posteo.de lat: 46.49067 lon: 11.33982 hasResults: False

 nctId: NCT06360874 id: ND003-I-06 briefTitle: A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-02 date: 2024-04-11 date: 2024-04-11 name: Shenzhen NewDEL Biotech, Co., Ltd class: INDUSTRY name: Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd. briefSummary: The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: ND-003 40mg name: ND-003 placebo 40mg name: ND-003 80mg name: ND-003 placebo 80mg name: ND-003 160mg name: ND-003 placebo 160mg name: ND-003 240mg name: ND-003 placebo 240mg name: ND-003 300mg name: ND-003 placebo 300mg name: MAD_ND003_Dose 1 name: MAD_placebo_Dose 1 name: MAD_ND003_Dose 2 name: MAD_placebo_Dose 2 name: MAD_ND003_Dose 3 name: MAD_ placebo_Dose 3 name: Food effect_Cohort 1 name: Food effect_Cohort 2 measure: Adverse Events (AE) measure: maximum concentration (Cmax) measure: Time to maximum concentration (Tmax) measure: Elimination Half-life (t1/2) measure: Clearance (CLz/F) measure: AUC from time 0 to last time of quantifiable concentration (AUC0-t) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06360861 id: 1400-1-233-51589 id: IR.TUMS.MEDICINE.REC.1400.197 type: OTHER_GRANT domain: Tehran University of Medical Sciences briefTitle: Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis acronym: MS overallStatus: COMPLETED date: 2019-07-23 date: 2024-03-04 date: 2024-03-06 date: 2024-04-11 date: 2024-04-11 name: Tehran University of Medical Sciences class: OTHER briefSummary: To assess the safety and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells (PLMSCs) in patients with secondary progressive Multiple Sclerosis (SPMS) disease.

Monitoring will be encompassed baseline assessments and follow-ups over subsequent months, evaluating clinical signs, Expanded Disability Status Scale (EDSS), cytokines, diffusion tensor imaging (DTI), functional MRI (fMRI), cognitive \& psychological evaluations, and flow cytometry for B cell markers. conditions: Multiple Sclerosis conditions: Secondary-Progressive Multiple Sclerosis conditions: Mesenchymal Stem Cells studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open-label phase 1, single-center, pre-post comparison study primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: Allogenic placenta derived mesenchymal stem cells measure: Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability]. measure: Number of participants with a change in disability as measured by Expanded Disability Status Scale . measure: Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test . measure: Number of participants with a change in cognitive performance as measured by Persian version of minimal assessment of cognitive function in MS battery. measure: Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging . measure: Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging . measure: Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test . measure: Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition . measure: Proportion of patients with change in CD20 / CD19 B cells surface markers measure: Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines. measure: Proportion of patients with change in T2 lesion volume on brain MRI. measure: Proportion of patients with change in brain volume on MRI. measure: Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised . measure: Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test . measure: Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests. measure: Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test . measure: Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised . measure: Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale . measure: Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test. measure: Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test. sex: ALL minimumAge: 17 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT facility: Tehran University of Medical Sciences,Tehran, Iran city: Tehran country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False

 nctId: NCT06360848 id: IRB00001192 briefTitle: Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases) overallStatus: COMPLETED date: 2005-01-01 date: 2021-01-01 date: 2021-01-01 date: 2024-04-11 date: 2024-04-11 name: Ibn Jazzar Hospital class: OTHER briefSummary: Pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). It represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting.

The aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used. conditions: Humerus Fracture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 53 type: ACTUAL name: surgery measure: Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients) measure: Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients) measure: Time to consolidation depending on the type of pseudarthrosis (in months) measure: Average Constant score postoperatively according to the means of restraint sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360835 id: IRB00001193 briefTitle: Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases) overallStatus: COMPLETED date: 2015-01-01 date: 2021-12-01 date: 2021-12-02 date: 2024-04-11 date: 2024-04-11 name: Ibn Jazzar Hospital class: OTHER briefSummary: Osteosyntheses employed in treating fractures at the upper end of the femur play a critical role in facilitating a swift recovery by minimizing immobilization periods and enabling early rehabilitation of the affected joints, thereby promoting a speedy return to normal walking function.

Osteosynthesis alters the mechanical dynamics of the bone segment, which undergoes continual changes during the consolidation and mobilization phases of recovery. Throughout these stages, a range of mechanical complications may arise, posing challenges despite the successful prevention of infections. Non-infectious complications associated with the presence of osteosynthesis materials, especially in weight-bearing areas like the lower limb, remain a concern.

In light of these considerations, surgeons must exercise meticulous care in selecting synthetic materials to mitigate the risk of osteosynthesis failures. In cases where internal fixation fails, the standard recourse often involves converting to total hip arthroplasty (THA).

However, it is essential to note that THA subsequent to complications arising from proximal femur osteosynthesis presents a higher incidence of both intraoperative and postoperative complications compared to the implantation of primary total hip prostheses. Thus, while osteosynthesis remains a valuable intervention for femur fractures, careful attention to material selection and postoperative management is crucial in optimizing patient outcomes and minimizing complications. conditions: Proximal Femur Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 35 type: ACTUAL name: total hip arthroplasty measure: Surgical Approach measure: Preparation of the Patient measure: Anesthesia measure: Type of Surgical Revision measure: Types of Prosthesis measure: Age Distribution measure: Distribution by Sex measure: Distribution According to Affected Side measure: Distribution According to Circumstances of Trauma sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IBN jazzar hospital city: Kairouan zip: 3190 country: Tunisia lat: 35.6781 lon: 10.09633 hasResults: False

 nctId: NCT06360822 id: 19317 briefTitle: Increasing Equity in Lung Cancer Screening acronym: LUCARE overallStatus: RECRUITING date: 2023-12-01 date: 2027-02-01 date: 2027-02-01 date: 2024-04-11 date: 2024-04-11 name: Indiana University class: OTHER name: Eskenazi Health briefSummary: The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 144 type: ESTIMATED name: ED-LCS measure: Rate of patients receive Lung Cancer Screening measure: Patients ratings of intervention sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eskenazi Health status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: Nicholas Pettit, MD role: CONTACT phone: 317-962-5975 email: nrpettit@iu.edu lat: 39.76838 lon: -86.15804 hasResults: False

 nctId: NCT06360809 id: 2024 PARINEFC 00001 briefTitle: Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC) acronym: PEP_BC overallStatus: RECRUITING date: 2024-03-22 date: 2025-06 date: 2025-06 date: 2024-04-11 date: 2024-04-11 name: Institut Nacional d'Educacio Fisica de Catalunya class: OTHER name: ICFO - The Institute of Photonics Sciences name: Hospital Clinic of Barcelona name: Institut d'Investigacions Biomèdiques August Pi i Sunyer name: Universidad San Jorge briefSummary: To improve the health and quality of life of breast cancer (BC) patients, researchers are focusing on prehabilitation strategies like physical exercise, preparing patients both mentally and physically for clinical and surgical procedures, potentially reducing complications. Physical exercise is also recognized as pivotal in optimizing chemotherapy. It can improve blood flow and oxygen supply in the microenvironment of the tumor (MT), potentially enhancing chemotherapy effectiveness. Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types, including BC, further investigation is needed into the exact effects of prehabilitation exercise (PE) on MT physiology.

This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment. The hypothesis is that PE in BC patients will improve their quality of life, reduce fatigue, increase muscle mass, decrease fat mass, and enhance physical fitness. Additionally, beneficial acute hemodynamic changes, particularly increased blood flow following PE sessions, and hemodynamic adaptations involving higher levels of oxygenated hemoglobin, increased blood flow, greater oxygen saturation, and a higher metabolic rate of oxygen, are expected.

The study will include 76 participants aged 18-65 years, meeting specific criteria such as a diagnosis of hormone receptor-positive BC, no medical contraindications for exercise, no metastatic cancer, and no structured exercise in the last six months. These participants will be randomly assigned to a PE group or a control group. The study will consist of three phases: Phase 1 involves pre-intervention assessments, Phase 2 includes a 4-week PE intervention with three weekly sessions, and Phase 3 encompasses post-intervention and post-surgery assessments. The 4-week PE intervention in Phase 2 will include strength and aerobic training. Quality of life and fatigue assessments will use questionnaires, and measurements will be made for fat mass, lean mass, bone density, and cardiorespiratory fitness. Strength measurements will be taken, and shoulder mobility will be evaluated. Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: Prehabilitation exercise program measure: Quality of life score measure: Cancer quality of life score measure: Cancer-related fatigue measure: Body composition measure: Bone density measure: Cardiorespiratory fitness measure: Maximum isometric manual grip strength measure: Upper body maximum strength measure: Lower body maximum strength measure: Shoulder range of motion measure: Relative oxyhemoglobin concentration ([02Hb]) in the microenvironment of the tumor measure: Relative deoxyhemoglobin concentration ([HHb]) in the microenvironment of the tumor measure: Oxygen saturation (StO2) in the microenvironment of the tumor measure: Blood flow (BF) in the microenvironment of the tumor measure: Height measure: Body mass measure: Body mass index measure: Wait circumference measure: Anthropometric measurements measure: Bioimpedance measurements measure: Maximal heart rate sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínic status: RECRUITING city: Barcelona zip: 08036 country: Spain name: Eduard Mension, MD role: CONTACT email: mension@clinic.cat name: Albert Busquets, PhD role: PRINCIPAL_INVESTIGATOR name: Lucia Sagarra-Moreno, PhD role: PRINCIPAL_INVESTIGATOR name: Esther Valera, MSc role: SUB_INVESTIGATOR name: Graciela Martínez-Pallí, MD role: SUB_INVESTIGATOR name: Raquel Sebio, PhD role: SUB_INVESTIGATOR name: Blai Ferrer-Uris, PhD role: SUB_INVESTIGATOR name: Turgut Durduran, PhD role: SUB_INVESTIGATOR name: Mireia Mora, MD role: SUB_INVESTIGATOR name: Eduard Mension, MD role: SUB_INVESTIGATOR name: Helena Castillo, MD role: SUB_INVESTIGATOR name: Rosa Angulo-Barroso, PhD role: SUB_INVESTIGATOR name: Alfredo Irurtia, PhD role: SUB_INVESTIGATOR name: Marta Carrasco-Marginet, PhD role: SUB_INVESTIGATOR name: Alex Cebrián-Ponce, MSc role: SUB_INVESTIGATOR name: Ferran Faixat role: SUB_INVESTIGATOR name: Quim Rosales role: SUB_INVESTIGATOR name: Raquel Martinez-Reviejo, MSc role: SUB_INVESTIGATOR name: Paula Bonay, BS role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06360796 id: 2023-ADC189-I-010 briefTitle: Study of Pharmacokinetics and Metabolism on [(14)C]ADC189 overallStatus: RECRUITING date: 2023-11-24 date: 2024-06-30 date: 2024-07-30 date: 2024-04-11 date: 2024-04-11 name: Jiaxing AnDiCon Biotech Co.,Ltd class: INDUSTRY briefSummary: This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants. conditions: Pharmacokinetics conditions: Metabolism studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 6 type: ESTIMATED name: [(14)C]ADC189 measure: The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites measure: The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites measure: The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 μCi) measure: The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 μCi) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The First Affilicated Hospital of Bengbu Medical University status: RECRUITING city: Bengbu state: Anhui zip: 233004 country: China name: Huan Zhou role: CONTACT phone: +8613665527160 email: zhouhuanbest@vip.163.com lat: 32.94083 lon: 117.36083 hasResults: False

 nctId: NCT06360783 id: Pro00111388 briefTitle: COVID-19 Quick Start - Test and Treat in Africa overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-01 date: 2024-06 date: 2024-06 date: 2024-04-11 date: 2024-04-26 name: Duke University class: OTHER name: Duke Clinical Research Institute name: Clinton Health Access Initiative, Nigeria briefSummary: Duke University and the Clinton Health Access Initiative (CHAI), in partnership with the Ministries of Health (MoH) of Ghana, Malawi, Rwanda, Zambia, and Zimbabwe, aim to assess the implementation and impact of COVID-19 test -and -treat (T\&T) demonstration programs conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Stakeholder Perspectives sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke Global Health Institute city: Durham state: North Carolina zip: 27705 country: United States lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06360770 id: NIRSCovidSBCelje briefTitle: Assessement of Microcirculation With NIRS Predicts Sepsis Development in Patients With Severe Covid-19 Pneumonia overallStatus: COMPLETED date: 2021-12-01 date: 2023-02-28 date: 2023-04-30 date: 2024-04-11 date: 2024-04-12 name: General and Teaching Hospital Celje class: OTHER briefSummary: Sepsis and septic shock are among main causes of death in patients with severe Covid-19 pneumonia. A few factors are proven to predict sepsis in these patients. WIth near infrared spectroscopy it is possible to detect microcirculatory changes typical for sepsis early in the course of disease. The hypothesis that changes in tissue oxygene saturation during vasoocclusive test predict sepsis as well as mortality in mechancally ventilated patients withe severe Covid-19 pneumonia will be tested. conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 35 type: ACTUAL measure: sepsis development measure: mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SB Celje city: Celje zip: 3000 country: Slovenia lat: 46.23092 lon: 15.26044 hasResults: False

 nctId: NCT06360757 id: DHF-21-2141-1 briefTitle: Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19) overallStatus: RECRUITING date: 2024-02-06 date: 2024-09-01 date: 2024-09-01 date: 2024-04-11 date: 2024-04-11 name: QIAGEN Gaithersburg, Inc class: INDUSTRY briefSummary: A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems. conditions: SARS-CoV-2 Acute Respiratory Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1432 type: ESTIMATED name: NeuMoDx SARS-CoV-2 Assay measure: Sensitivity as compared to the comparator method measure: Specificity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: QIAGEN Gaithersburg, Inc status: RECRUITING city: Manchester zip: M130BH country: United Kingdom name: Sarah G Johnson role: CONTACT phone: 44 7825866041 email: Sarah.Johnson@qiagen.com name: Helen Green role: CONTACT phone: 44 7825866041 email: Helen.Green@qiagen.com lat: 53.48095 lon: -2.23743 hasResults: False

 nctId: NCT06360744 id: ENFORCE PLUS briefTitle: A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines. overallStatus: COMPLETED date: 2021-07-05 date: 2023-12-31 date: 2023-12-31 date: 2024-04-11 date: 2024-04-11 name: Jens D Lundgren, MD class: OTHER name: Ministry of the Interior and Health, Denmark briefSummary: A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.

The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme.

The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent). conditions: SARS CoV 2 Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. primaryPurpose: OTHER masking: NONE count: 25 type: ACTUAL name: Johnson & Johnson measure: Assessment of the J& J vaccine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus Universitetshospital, Skejby city: Aarhus state: Aarhus N zip: 8200 country: Denmark lat: 56.15674 lon: 10.21076 facility: Aalborg Universitetshospital Syd city: Aalborg zip: 8000 country: Denmark lat: 57.048 lon: 9.9187 facility: Hvidovre Hospital city: Hvidovre zip: 2600 country: Denmark lat: 55.65719 lon: 12.47364 facility: Odense Universitetshospital city: Odense zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: Sjællandsuniversitetshospital city: Roskilde zip: 4000 country: Denmark lat: 55.64152 lon: 12.08035 hasResults: False

 nctId: NCT06360731 id: 1018 briefTitle: The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-18 date: 2024-05-31 date: 2024-05-31 date: 2024-04-11 date: 2024-04-23 name: Ege University class: OTHER briefSummary: The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality.

There will be a parallel-group randomized controlled trial study and consists of two groups.

Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks. Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory, and perceived stress scale will be applied before and after the application. conditions: Tinnitus, Subjective studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study employs a parallel group randomised controlled trial design. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: In the study, patients do not know which group they were in. Therefore, blinding is performed among the participants. To prevent bias in the study, blinding is also performed between the researchers. Researchers (S.B. and A.O. from both clinics) make the pre- and post-test evaluations without knowing which group the patients are in. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: 4-7-8 breathing exercise technique and informative session on tinnitus name: Informative session on tinnitus measure: Visual Analog Scale (VAS) measure: Visual Analog Scale (VAS) measure: Tinnitus Handicap Inventory (THI) measure: Tinnitus Handicap Inventory (THI) measure: Insomnia severity index (ISI) measure: Insomnia severity index (ISI) measure: Perceived stress scale -10 (PSS-10) measure: Perceived stress scale -10 (PSS-10) measure: Trait Anxiety Scale (TAS) measure: Trait Anxiety Scale (TAS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gokce Saygi Uysal city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 facility: Audiology Unit of the Department of Otorhinolaryngology, Ege University Faculty of Medicine Hospital city: Izmir country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06360718 id: CHLA-23-00170 briefTitle: Effects of Using a Storybook, to Explain Leukemia to Children Versus the Standard Child Life Intervention, on Parental Stress. overallStatus: RECRUITING date: 2024-02-03 date: 2025-05-15 date: 2025-05-15 date: 2024-04-11 date: 2024-04-19 name: Children's Hospital Los Angeles class: OTHER briefSummary: The goal of this clinical trial is to measure the effects of using a storybook versus standard child life intervention with parents of children newly diagnosed with leukemia on parental stress.

The main questions it aims to answer are:

* What effect will the storybook have on parent/legal guardian stress at three timepoints: baseline, discharge, and follow up?
* Will this storybook impact parent/legal guardian comfort levels and improve their child's understanding?

Participants will be asked to complete surveys at three timepoints, prior to and following child life intervention and about 3.5 months later. During child life interventions, participants will receive resources and support to explain leukemia to their school aged, 3-16-year-old, child (patient or sibling).

Researchers will compare Intervention and Control Groups to see if parental stress is lower in those who received the storybook in addition to the standard child life intervention versus the standard child life intervention alone. conditions: Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: "Who is Luke Eemia?" Storybook measure: Parental Stress, prior to and following child life intervention measure: Parent perception of the child's stress measure: Parent's Comfort Explaining Aspects of Leukemia Diagnosis measure: Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline). measure: Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline). sex: ALL minimumAge: 3 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Hospital Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90027 country: United States name: Erin Shields, MA role: CONTACT lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06360705 id: CVVD003 briefTitle: StrataMGT for the Treatment of Vulvar Lichen Sclerosus overallStatus: RECRUITING date: 2024-04 date: 2024-09 date: 2024-10 date: 2024-04-11 date: 2024-04-19 name: Center for Vulvovaginal Disorders class: OTHER name: Stratpharma AG briefSummary: This study is designed to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus. conditions: Vulvar Lichen Sclerosus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: StrataMGT measure: Histopathologic Inflammation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centers for Vulvovaginal Disorders status: RECRUITING city: New York state: New York zip: 10036 country: United States name: Andrew Goldstein, MD role: CONTACT phone: 4102790209 email: obstetrics@yahoo.com name: Andrew Goldstein, MD role: PRINCIPAL_INVESTIGATOR name: Leia Mitchell, PA-C, MMSc, MSc role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06360692 id: Marta Lluesma Vidal Carden briefTitle: Impact of Nipple Micropigmentation in Mastectomized Women overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-30 date: 2025-12-31 date: 2024-04-11 date: 2024-04-11 name: Cardenal Herrera University class: OTHER briefSummary: This will be a multicenter prospective descriptive case series study following a cohort.

The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service.

CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women. conditions: Body Image conditions: Female Sexual Function conditions: Self Esteem conditions: Intimacy With Your Partner studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Body imagen measure: Self-esteem measure: Sexual Function measure: Intimacy with the partner sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360679 id: CIP000004 briefTitle: Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients. overallStatus: RECRUITING date: 2024-01-29 date: 2024-10-01 date: 2025-06-01 date: 2024-04-11 date: 2024-04-11 name: BariaTek Medical class: INDUSTRY briefSummary: Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Endoscopic gastric restriction and biliodigestive diversion measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: BMI Clinic Double Bay status: RECRUITING city: Sydney state: New South Wales zip: 2028 country: Australia name: Adrian Sartoretto, Dr role: CONTACT phone: 0290534688 phoneExt: 61 email: info@bmiclinic.com.au lat: -33.86785 lon: 151.20732 facility: BMI Clinic Liverpool status: RECRUITING city: Sydney state: New South Wales zip: 2170 country: Australia name: Adrian Sartoretto, Dr role: CONTACT phone: 0290534688 phoneExt: 61 email: info@bmiclinic.com.au lat: -33.86785 lon: 151.20732 hasResults: False

 nctId: NCT06360666 id: Neurax1 briefTitle: Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia acronym: NEURAX overallStatus: ENROLLING_BY_INVITATION date: 2022-10-01 date: 2024-01-31 date: 2024-12-31 date: 2024-04-11 date: 2024-04-11 name: Asst Melegnano e Martesana class: OTHER_GOV briefSummary: The goal of this observational study is to learn about postoperative mortality and postoperative length of stay outcomes after abdominal laparoscopic major surgery. The main question it aims to answer is:

Does general anesthesia lower complications compared to loco-regional anesthesia (keeping the patient spontaneously breathing and sedated) in laparoscopic abdominal major surgery? Participants are followed for neurological sequelae for 90 days following surgery conditions: Mortality conditions: Surgical Complication conditions: Neurological Complication conditions: Respiratory Complication conditions: Cardiovascular Complication conditions: Nephrotoxicity conditions: Metabolic Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 70 type: ESTIMATED measure: Mortality measure: Morbidity measure: Surgical revisions measure: organ dysfunctions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST Melegnano e Martesana - Ospedale Vizzolo Predabissi city: Vizzolo Predabissi state: Milan zip: 20070 country: Italy lat: 45.35587 lon: 9.34815 hasResults: False

 nctId: NCT06360653 id: 76CIVICO2023 briefTitle: a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer acronym: SISTER-RAY overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2026-06 date: 2024-04-11 date: 2024-04-11 name: ARNAS Civico Di Cristina Benfratelli Hospital class: OTHER briefSummary: The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Stereotactic Post-operative Radiotherapy for Endometrial Cancer measure: Acute G3 or higher Gastrointestinal and Genitourinary Toxicity measure: Late Gastrointestinal and Genitourinary Toxicity measure: Distant Progression Free Survival measure: Local Control measure: Overall Survival measure: Overall Quality of Life sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ARNAS Civico Hospital city: Palermo state: PA zip: 90100 country: Italy name: FRANCESCO CUCCIA, MD role: CONTACT phone: +393334393336 email: francesco.cuccia@arnascivico.it lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06360640 id: APC148-001 id: 2023-507939-38-00 type: OTHER domain: EU Trial no briefTitle: A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2025-03 date: 2024-04-11 date: 2024-04-11 name: AdjuTec Pharma AS class: INDUSTRY name: CTC Clinical Trial Consultants AB briefSummary: The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Placebo-controlled, 6 sequential cohorts. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: This is a double-blind trial. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 46 type: ESTIMATED name: APC148 and Placebo measure: Incidence and intensity of adverse events (AEs) measure: Incidence and intensity of serious adverse events (SAEs) measure: Incidence and intensity of infusion-related AEs measure: Time course of local tolerability reactions measure: Changes from baseline in blood pressure measure: Changes from baseline in respiratory rate measure: Changes from baseline in body temperature measure: Changes from baseline in heart rate measure: Changes from baseline in PQ/PR interval measure: Changes from baseline in QRS interval measure: Changes from baseline in QT interval measure: Changes from baseline in QTcF interval measure: Changes from baseline in Clinical Laboratory Profile measure: Changes from baseline in physical examination measure: APC148 plasma concentrations measure: APC148 urine concentrations measure: Pharmacokinetic (PK) parameter in plasma - Area under curve (AUC) 0-24 measure: PK parameter in plasma - AUC0-inf measure: PK parameter in plasma - AUC0-last measure: PK parameter in plasma - Cmax measure: PK parameter in plasma - Tmax measure: PK parameter in plasma - T1/2 measure: PK parameter in plasma - Clearance (CL) measure: PK parameter in plasma - Vz measure: PK parameter in plasma - Vss determination of plasma concentrations will be collected. measure: PK parameters in urine - A(e) measure: PK parameters in urine - fe measure: PK parameter in urine - renal clearance (CLr) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Clinical Trial Consultants AB city: Uppsala country: Sweden name: Erik Rein-Hedin, MD role: PRINCIPAL_INVESTIGATOR lat: 59.85882 lon: 17.63889 hasResults: False

 nctId: NCT06360627 id: 2022_D0008 briefTitle: Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT overallStatus: RECRUITING date: 2023-02-20 date: 2027-03-31 date: 2027-12-01 date: 2024-04-11 date: 2024-04-11 name: University of Zurich class: OTHER briefSummary: Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT conditions: Radiation Exposure conditions: Lung Embolism conditions: Lung Cancer conditions: Pneumonia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Computed Tomography measure: Dose Reduction by new scanner measure: stable Image Quality in reduced dose scans sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich - Diagnostic Radiology status: RECRUITING city: Zurich zip: 8091 country: Switzerland name: Thomas Frauenfelder, PD MD role: CONTACT phone: 0041442551111 email: thomas.frauenfelder@usz.ch name: Marga Rominger, Prof MD role: CONTACT phone: 0041442551111 email: marga.rominger@usz.ch name: Thomas Frauenfelder, PD MD role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06360614 id: 2024s01 briefTitle: The Effect of Hand Massage Applied to Palliative Care Oncology Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-06-01 date: 2024-04-11 date: 2024-04-15 name: murat koç class: OTHER_GOV name: Istanbul Sultanbeyli State Hospital briefSummary: World Health Organization (WHO) palliative care is defined as "an approach that aims to reduce or prevent suffering by early identification, evaluation and treatment of the physical, psychosocial and spiritual problems of patients and families accompanying life-threatening diseases, and thus to increase their quality of life." Palliative care is a multidisciplinary approach that provides appropriate health care for oncology patients, who have a wide variety of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply.

Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means. The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. is located. Studies in the literature have found that hand massage reduces anxiety levels, stress and agitation levels, pain levels, and increases comfort and sleep levels. As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients. conditions: Hand Massage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Before the application, data will be collected and recorded through a face-to-face interview (8-10 minutes) by a nurse who does not know which group the patients are in. Sleep times of patients will be measured with a smart bracelet. At this stage, the same procedure will be continued for the intervention and control groups.

Hand massage will be applied to the intervention group for 4 weeks, 2 days a week (Monday and Friday), 2 sessions each day. The control group will receive routine monitoring and nursing care for 4 weeks.

In the intervention and control groups, VAS-Pain, General Comfort Scale and Pittsburgh Sleep Quality were assessed by a face-to-face interview by a nurse who did not know which group the patients were in, on the 7th day (Monday), 14th day (Monday) and 28th day (Monday). Index measurement tools will be applied and patients' sleep times will be measured with a smart bracelet. primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Hand massage application name: routine monitoring and nursing care measure: İndividual Information Form measure: Patient Follow-up Form measure: General Comfort Scale measure: Pittsburgh Sleep Quality Index measure: Smart Bracelet sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sultanbeyli State Hospital city: Istanbul zip: 34000 country: Turkey name: Murat Koç role: CONTACT phone: +905436725093 email: mrtkoc49@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06360601 id: 36264PR589/3/24 briefTitle: Intravenous Labetalol Versus Hydralazine in Preeclampsia overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-09 date: 2024-09 date: 2024-04-11 date: 2024-04-11 name: Tanta University class: OTHER briefSummary: We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome conditions: Preeclampsia Severe studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Labetalol Injection name: HydrALAZINE Injection measure: Cerebral blood flow sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Medicine city: Tanta zip: 3511 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06360588 id: NCI-2024-01141 id: NCI-2024-01141 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-Z1G type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-Z1G type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G) overallStatus: ACTIVE_NOT_RECRUITING date: 2018-06-19 date: 2024-11-15 date: 2024-11-15 date: 2024-04-11 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: The phase II MATCH treatment trial tests how well copanlisib works to treat patients with cancer with PTEN loss. Copanlisib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Copanlisib name: Radiologic Examination measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06360575 id: NCI-2024-01127 id: NCI-2024-01127 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-C2 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-C2 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2) overallStatus: ACTIVE_NOT_RECRUITING date: 2016-05-30 date: 2024-11-15 date: 2024-11-15 date: 2024-04-11 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well crizotinib works to treat patients with cancers with MET exon 14 deletion genetic changes. Crizotinib is in a group of medications called tyrosine kinase inhibitors. It works by blocking enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Crizotinib name: Radiologic Examination measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06360562 id: 2020P002418 briefTitle: Reconnecting to Ourselves and Others in Virtual Meetings (ROOM) overallStatus: RECRUITING date: 2020-09-15 date: 2025-01-30 date: 2025-04-25 date: 2024-04-11 date: 2024-04-11 name: Massachusetts General Hospital class: OTHER briefSummary: This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality. conditions: Mood Disorders conditions: Anxiety Disorders conditions: Psychotic Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 174 type: ESTIMATED name: Resilience Training measure: Discomfort with Others measure: Intervention Feasibility and Acceptability measure: Penn Emotion Recognition Test measure: Stop Distance Paradigm measure: Beck Depression Inventory measure: Spielberger State-Trait Anxiety Inventory measure: Prodromal Questionnaire- Brief measure: Connor-Davidson Resilience Scale sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Charlestown state: Massachusetts zip: 02129 country: United States name: Daphne J Holt, MD, PhD role: CONTACT phone: 617-726-7618 email: dholt@mgh.harvard.edu name: Nicole DeTore, PhD role: CONTACT phone: 617-726-2065 email: ndetore@mgh.harvard.edu lat: 42.37787 lon: -71.062 hasResults: False

 nctId: NCT06360549 id: TJ-IRB202403019 briefTitle: Effect of Percutaneous Acupoint Electrical Stimulation on Delirium overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-30 date: 2025-06-30 date: 2024-04-11 date: 2024-04-11 name: Qin Zhang class: OTHER name: National Natural Science Foundation of China briefSummary: This study is a multicenter, prospective, randomized controlled clinical trial that aims to observe the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on plasma TK/MMP3 in a randomized controlled setting. The intervention group received percutaneous acupoint electrical stimulation, whereas the control group underwent conventional treatment. The primary objective is to enhance the management of postoperative delirium, specifically focusing on the occurrence and severity of delirium following thoracoscopic pulmonary resection. Additionally, various perioperative inflammatory markers, cognitive function, recovery quality, pain levels, anxiety, sleep patterns, postoperative complications, and overall hospital stay duration were monitored to elucidate the mechanisms through which percutaneous acupoint electrical stimulation improves postoperative delirium. conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group was percutaneous acupoint electrical stimulation treatment group, and the control group was conventional treatment group.

Inclusion criteria:

1. Voluntarily sign informed consent;
2. Age ≥18 years old;
3. Patients undergoing thoracoscopic pneumonectomy;
4. ASA Grade I-III; primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 238 type: ESTIMATED name: Transcutaneous Electrical Acupoint Stimulation measure: Delirium (using the Delirium Rating Scale, DRS) measure: Mini-Mental State Examination (MMSE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Hospital of Traditional Chinese Medicine status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Jiemin Deng role: CONTACT phone: 2780 email: qin4298@sina.com name: Jiemin Deng role: CONTACT lat: 23.11667 lon: 113.25 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Qin Zhang, phd role: CONTACT phone: 15717154768 email: qzhang8@tjh.tjmu.edu.cn name: Qin Zhang, phd role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06360536 id: IRB-300012634 id: P50MD017338 type: NIH link: https://reporter.nih.gov/quickSearch/P50MD017338 briefTitle: Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women acronym: OVERCOME-IT overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-06-01 date: 2026-06-30 date: 2024-04-11 date: 2024-04-11 name: University of Alabama at Birmingham class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The purpose of this study is to collect preliminary data on the feasibility, acceptability, and potential effects of a novel, remotely delivered resistance training program. conditions: Overweight or Obesity conditions: Prediabetes or Diabetes conditions: Prehypertension (Elevated Blood Pressure) or Hypertension conditions: Resistance Training studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Resistance Training measure: Feasibility of recruitment measure: Feasibility of retention measure: Intervention adherence measure: Change in resistance training behaviors measure: Change in blood pressure measure: Change in HbA1C measure: Change in body composition measure: Change in handgrip strength measure: Change in the number of chair stands sex: FEMALE minimumAge: 30 Years maximumAge: 64 Years stdAges: ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Jackie Grant role: CONTACT phone: 205-975-7108 email: jroche@uabmc.edu name: Amber Kinsey role: CONTACT phone: 205-934-9851 email: akinsey@uabmc.edu name: Amber W Kinsey, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06360523 id: CRE-2024.141 briefTitle: To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-31 date: 2025-07-20 date: 2024-04-11 date: 2024-04-11 name: Chinese University of Hong Kong class: OTHER briefSummary: It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 102 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 102 type: ESTIMATED name: AI modal measure: Prostate Cancer detection rate of ISUP grade group ≥2 measure: Diagnosis of any grade of prostate cancer sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Wales Hospital, Chinese University of Hong Kong city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06360510 id: 44 briefTitle: Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-05 date: 2024-05-05 date: 2024-05-05 date: 2024-04-11 date: 2024-04-11 name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital class: OTHER briefSummary: The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS). conditions: Carpal Tunnel Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: %5 dextrose injection name: betamethasone injection measure: vas measure: boston carpal tunnel syndrome questionnaire measure: median nerve cross sectional area measure: tinnel test positivity measure: phalen test positivity measure: duruöz hand index measure: global evaluation of treatment outcomes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06360497 id: 202206090070 briefTitle: The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress overallStatus: COMPLETED date: 2022-06-03 date: 2022-10-09 date: 2022-10-09 date: 2024-04-11 date: 2024-04-11 name: Beijing Normal University class: OTHER briefSummary: The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory. conditions: MM Group conditions: LKCM Group conditions: Waitlist Group studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 152 type: ACTUAL name: mindfulness meditation intervention and loving-kindness and compassion meditation intervention measure: The Depression Anxiety Stress Scale measure: The Philadelphia Mindfulness Scale measure: The Sensitivity to Punishment and Sensitivity to Reward Questionnaire measure: The Emotional Word Lists sex: ALL minimumAge: 18 Years maximumAge: 56 Years stdAges: ADULT facility: Xianglong Zeng city: Beijing state: Beijing zip: 100875 country: China lat: 39.9075 lon: 116.39723 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-27 uploadDate: 2024-03-27T06:37 filename: Prot_SAP_000.pdf size: 125410 hasResults: False

 nctId: NCT06360484 id: PrevelanceHDVSudan briefTitle: Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus overallStatus: COMPLETED date: 2022-06-01 date: 2022-09-01 date: 2022-09-10 date: 2024-04-11 date: 2024-04-11 name: National Center for Gastroentestinal and Liver Disease class: OTHER briefSummary: Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection.

Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG conditions: Hepatitis B conditions: Hepatitis D conditions: Viral Hepatitis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 90 type: ACTUAL name: investigations for Hepatitis D virus measure: the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases. sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Center for Gastrointestinal and Liver Diseases city: Khartoum zip: 15004 country: Sudan lat: 15.55177 lon: 32.53241 hasResults: False

 nctId: NCT06360471 id: FS-FMC briefTitle: Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer overallStatus: RECRUITING date: 2023-10-01 date: 2027-10-01 date: 2032-10-01 date: 2024-04-11 date: 2024-04-16 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy.

This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.

Statistical analysis of the data will be performed. conditions: Fertility Issues conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2800 type: ESTIMATED name: fertility preservation measure: 5-year cumulative live birth rate measure: Ovarian function(AMH levels) measure: Ovarian function(AFC counts) measure: Newborn malformation rate measure: Tumor recurrence rate measure: Tumor survival rate sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Xiang Ma, MD. PHD role: CONTACT phone: +8618001581878 email: sxmaxiang@126.com name: Nan Lu role: CONTACT phone: +8615950476023 email: nancylu1993@126.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06360458 id: MRCTA,ECFAH of FMU[2024]368 briefTitle: Methylprednisolone Adjunctive to Endovascular Treatment for Stroke overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2028-03-01 date: 2024-04-11 date: 2024-04-11 name: Wan-Jin Chen class: OTHER briefSummary: The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 735 type: ESTIMATED name: Methylprednisolone measure: Mortality at 90 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360445 id: HD1912BE202201 briefTitle: Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects overallStatus: COMPLETED date: 2022-05-26 date: 2022-08-21 date: 2022-08-21 date: 2024-04-11 date: 2024-04-11 name: CSPC Ouyi Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects were administered a single dose of 100 mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting conditions or 150mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting and Fed conditions. Venous blood samples were collected at pre-dose (0 h), and up to 72 h post dose. This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 2-period Crossover Assignment primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 102 type: ACTUAL name: Olaparib Tablet test formulation 100mg name: Olaparib Tablet reference formulation 100mg name: Olaparib Tablet test formulation 150mg name: Olaparib Tablet reference formulation 150mg measure: Cmax Description: Maximum observed plasma concentration measure: AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time measure: AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration measure: Time of maximum observed plasma concentration (Tmax) measure: Terminal elimination half-life (T1/2) measure: Apparent total body clearance (Cl/F) measure: Apparent volume of distribution (V/F) measure: Number of participants with Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06360432 id: HSEARS20240214001 briefTitle: Effects of the EatWelLog App on Diet Management for Older Adults With Sarcopenic Obesity overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-10-31 date: 2025-04-30 date: 2024-04-11 date: 2024-04-11 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Sarcopenic obesity, characterised by concurrent reduced muscle mass and excess body fat, affects 11% of older adults worldwide, rising to 23% in those over 75. Considering the negative synergistic impact on health, promoting muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies for managing SO. Exercise and nutrition are the primary interventions recommended for SO.

This project aims to evaluate the effects of the EatWellLog App developed by the investigators' team for local older adults, in improving:

* their sarcopenic obesity status, measured by all four diagnostic criteria, including grip strength, muscle mass, physical performance and body fat mass (primary outcome), and,
* nutritional self-efficacy, nutritional status, dietary quality, health-related quality of life, and adherence to diet and exercise regimens (secondary outcomes), by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group.

The EatWellLog App, designed for older adults with SO, incorporating Klasnja and Pratt's five-strategy framework for mobile health (mHealth) applications development to facilitate health behavioural change. This App supports users with SO in managing daily diets that promote gradual weight loss and muscle mass preservation, adhering to the dietary regimen for this population.

Forty older adults with SO will be recruited from local community health centres and then randomized to either m-health or control groups. Both groups will receive an 8-week supervised programme separately. The programme consists of personalised dietary modification programme and group-based exercise training which have been tested and used in the investigators' pilot and General Research Fund (GRF) project. Additionally, only the m-health group will be instructed to use the App for daily diet self-management.

Participants will be assessed on a variety of outcomes immediately after the 8-week supervised programme (T1), which will be compared to the baseline (T0). To explore the possible long-term effects of the intervention, other measurements will be conducted at 3-(T2) and 6-(T3) months after the supervised programme, which will be compared with those conducted at T0. conditions: Sarcopenic Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-arm, assessor-blinded, parallel design pilot randomized control trial (RCT) consisting of a M-health and a control group will be adopted to evaluate the effectiveness of the EatWellLog App in improving older adults' sarcopenic obesity (SO) status and other SO-related parameters by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: An independent assessor who is blinded to the group allocations will assess the participants' outcomes. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Dietary modification program name: Exercise training name: The EatWellLog App measure: Changes of muscle strength measure: Changes of muscle mass measure: Changes of body mass index measure: Changes of waist circumference measure: Changes of fat mass measure: The Short Physical Performance Battery (SPPB) scale measure: Mini Nutritional Assessment (MNA) Short-form measure: Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale measure: Dietary Quality Index-International (DQI-I) measure: EuroQoL 5D (EQ-5D) measure: Diet Adherence measure: Exercise Adherence sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hong Kong country: Hong Kong name: Amy Cheung, MA role: CONTACT phone: +852 27664145 email: amy-ka-po.cheung@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06360419 id: SOL-MDD-301 briefTitle: Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol acronym: PARADIGM overallStatus: RECRUITING date: 2024-03-18 date: 2025-12 date: 2025-12 date: 2024-04-11 date: 2024-04-11 name: Axsome Therapeutics, Inc. class: INDUSTRY briefSummary: PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Solriamfetol 300 mg name: Placebo measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Incidence of treatment-emergent adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Site status: RECRUITING city: Encino state: California zip: 91316 country: United States lat: 34.15917 lon: -118.50119 facility: Clinical Research Site status: RECRUITING city: Lemon Grove state: California zip: 91945 country: United States lat: 32.74255 lon: -117.03142 facility: Clinical Research Site status: RECRUITING city: Oceanside state: California zip: 92056 country: United States lat: 33.19587 lon: -117.37948 facility: Clinical Research Site status: RECRUITING city: Redlands state: California zip: 92374 country: United States lat: 34.05557 lon: -117.18254 facility: Clinical Research Site status: RECRUITING city: Riverside state: California zip: 92506 country: United States lat: 33.95335 lon: -117.39616 facility: Clinical Research Site status: RECRUITING city: Sherman Oaks state: California zip: 91403 country: United States lat: 34.15112 lon: -118.44925 facility: Clinical Research Site status: RECRUITING city: Upland state: California zip: 91786 country: United States lat: 34.09751 lon: -117.64839 facility: Clinical Research Site status: RECRUITING city: Cromwell state: Connecticut zip: 06416 country: United States lat: 41.5951 lon: -72.64537 facility: Clinical Research Site status: RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Clinical Research Site status: RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States lat: 30.33218 lon: -81.65565 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32801 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32806 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Chicago state: Illinois zip: 60634 country: United States lat: 41.85003 lon: -87.65005 facility: Clinical Research Site status: RECRUITING city: Boston state: Massachusetts zip: 02131 country: United States lat: 42.35843 lon: -71.05977 facility: Clinical Research Site status: RECRUITING city: Saint Charles state: Missouri zip: 63304 country: United States lat: 38.78394 lon: -90.48123 facility: Clinical Research Site status: RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States lat: 36.17497 lon: -115.13722 facility: Clinical Research Site status: RECRUITING city: Brooklyn state: New York zip: 11235 country: United States lat: 40.6501 lon: -73.94958 facility: Clinical Research Site status: RECRUITING city: Rochester state: New York zip: 14609 country: United States lat: 43.15478 lon: -77.61556 facility: Clinical Research Site status: RECRUITING city: Hickory state: North Carolina zip: 28601 country: United States lat: 35.73319 lon: -81.3412 facility: Clinical Research Site status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73118 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Research Site status: RECRUITING city: Media state: Pennsylvania zip: 19063 country: United States lat: 39.91678 lon: -75.38769 facility: Clinical Research Site status: RECRUITING city: Memphis state: Tennessee zip: 38119 country: United States lat: 35.14953 lon: -90.04898 facility: Clinical Research Site status: RECRUITING city: Wichita Falls state: Texas zip: 76309 country: United States lat: 33.91371 lon: -98.49339 facility: Clinical Research Site status: RECRUITING city: Everett state: Washington zip: 98201 country: United States lat: 47.97898 lon: -122.20208 hasResults: False

 nctId: NCT06360406 id: D1346R00009 briefTitle: Real-World Treatment Study of Koselugo (Selumetinib) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2031-09-30 date: 2031-09-30 date: 2024-04-11 date: 2024-04-11 name: AstraZeneca class: INDUSTRY briefSummary: As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea.

This study will provide information on the Korean patient population that is treated with the study drug. conditions: Neurofibromatosis 1 conditions: Neurofibroma, Plexiform studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 150 type: ESTIMATED measure: Adverse events (AEs) rate measure: Physeal dysplasia occurance rate measure: Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06360393 id: 17384 briefTitle: Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics acronym: OUTERSPACE-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-02 date: 2026-05 date: 2024-04-11 date: 2024-04-17 name: University Medical Center Groningen class: OTHER name: Trudell Medical International briefSummary: Severe refractory asthma affects about 3.5% of asthma patients, often necessitating biologic therapy in addition to standard treatment. However, little is understood about maintenance and reliever inhalation medication adherence in these cases which might impact overall biologic response. Objectively monitoring inhalation medication adherence remains a significant challenge. The Smart AeroChamber® device, capable of measuring adherence and inhalation technique, is untested in severe asthma patients on biologics, presenting a potentially cost-effective solution to monitor adherence and better understand treatment response.

This study aims to assess the feasibility of the Smart AeroChamber® device in severe asthma patients on biologic therapy, with objectives to:

1. Evaluate inhalation medication adherence patterns and inhaler technique, and comparing that adherence data with traditional measures e.g. the Test of Adherence to Inhalers (TAI), and an inhalation technique checklist.
2. Investigate the association between inhaled medication adherence and clinical outcomes such as exacerbations, short-acting beta-agonists (SABA) use, oral corticosteroids use (OCS), Fractional Exhaled Nitric Oxide (FeNO), blood eosinophil count, and Asthma Control Questionnaire (ACQ) scores.
3. Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber® device.

The study design is prospective and observational, with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy. Participants will be followed for 12 months, during which they will receive Smart AeroChamber® devices. These devices will measure medication adherence and inhaler technique, and undergo assessments of clinical outcomes at regular intervals. Usability and satisfaction will also be evaluated using the Systems Usability Scale (SUS) in patients and healthcare professionals.

The study will be conducted across five severe asthma clinics in the Netherlands. Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique, assessing clinical outcomes, and evaluating usability and satisfaction. The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber® to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Smart spacer measure: Comparative analysis of smart spacer medication adherence and inhaler technique against Test of Adherence to Inhalers (TAI-12) measure: Comparison of smart spacer medication adherence patterns (adherence and inhaler technique) with inhaler checklist examined by pulmonologist or pulmonary nurse measure: Assessing the association of smart spacer assessed adherence with annual exacerbation rate measure: Assessing the association of smart spacer assessed adherence with reliever inhaler use (e.g. SABA) measure: Assess the association of smart spacer assessed adherence with oral corticosteroids use measure: Assess the association of smart spacer assessed adherence with FeNO results measure: Assess the association of smart spacer assessed adherence with blood eosinophils measure: Assess the association of smart spacer assessed adherence with asthma control (ACQ-6) measure: Assess the association of smart spacer assessed adherence with spirometry results measure: Assess usability and patient satisfaction using the System Usability Scale measure: Assess usability and healthcare provider satisfaction using the System Usability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medisch Centrum Leeuwarden city: Leeuwarden state: Friesland zip: 8934AD country: Netherlands name: Akke-Nynke van der Meer, MD, PhD role: CONTACT phone: +31 58 286 3875 email: a.n.van.der.meer@mcl.nl lat: 53.20139 lon: 5.80859 facility: Isala city: Zwolle state: Overijssel zip: 8025AB country: Netherlands name: Niels Patberg, MD role: CONTACT email: k.w.patberg@isala.nl lat: 52.5125 lon: 6.09444 facility: Stichting Sint Franciscus Vlietland Groep city: Rotterdam state: Zuid-Holland zip: 3118JH country: Netherlands name: Yasemin Türk, MD, PhD role: CONTACT phone: +31 10 461 6161 email: yasemin.turk@Franciscus.nl lat: 51.9225 lon: 4.47917 facility: University Medical Center Groningen city: Groningen zip: 9713GZ country: Netherlands name: Maarten van den Berge, MD, PhD role: CONTACT phone: +31 6 24450194 email: m.van.den.berge@umcg.nl name: Titia Klemmeier, RN role: SUB_INVESTIGATOR name: Huib Kerstjens, MD, PhD role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: Foundation Martini Hospital city: Groningen zip: 9728NT country: Netherlands name: Marjolein J van Es, MD, PhD role: CONTACT phone: +31 50 524 5245 email: m.vanes@mzh.nl lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06360380 id: AQP-CLP-004 briefTitle: Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System acronym: REFORM-HF overallStatus: NOT_YET_RECRUITING date: 2024-07-03 date: 2024-11-03 date: 2024-12-29 date: 2024-04-11 date: 2024-04-11 name: AquaPass Medical Ltd. class: INDUSTRY briefSummary: The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.

Patients will wear a lightweight suit that helps remove excess fluids through their sweat.

We want to see if AquaPass can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.

Participants will select if to be treated at their home or in the outpatient clinic. conditions: Chronic Heart Failure conditions: CKD Stage 3 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A prospective, multicenter, single-arm, within-patient-controlled, pivotal trial, enrolling patients with decompensated heart failure and/or CKD stage 2-3 inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥40 mg furosemide or equivalent. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: AquaPass System measure: AquaPass Performance Evaluation measure: AquaPass Safety Evaluation sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360367 id: 2023-00060 briefTitle: mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii overallStatus: RECRUITING date: 2024-04-23 date: 2024-10-22 date: 2024-10-22 date: 2024-04-11 date: 2024-04-12 name: University of Hawaii class: OTHER name: United States Department of Agriculture (USDA) name: Pennington Biomedical Research Center briefSummary: The goal of this 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program.

PortionSize Ed is a dietary assessment and nutrition education mobile app, that provides real-time feedback on adherence to tailored dietary recommendations. HI-FLY is a healthy lifestyle program delivered in schools throughout Hawaii. PortionSize Ed also contains educational videos.

Participants in this study will be randomly assigned to either the HI-FLY only group (HI-FLY), where they will receive the standard HI-FLY program or to the HI-FLY + PortionSize Ed app (HI-FLY + PSEd) group where they will receive the standard HI-FLY program and a study iPhone with the PortionSize Ed app for the 8-week study. This will allow us to evaluate the effect of the PortionSize Ed app among early adolescents in HI-FLY. conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: HI-FLY Curriculum name: HI-FLY Curriculum + PortionSize Ed app measure: Feasibility- Study enrollment measure: Acceptability- User Satisfaction Survey (USS) scores and qualitative responses measure: Acceptability- Computer System Usability Questionnaire (CSUQ) scores measure: Acceptability- PortionSize Ed app usage data measure: Acceptability- Reason for study drop out measure: Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score measure: Efficacy- Change in HEI-2020 component scores measure: Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey measure: Feasibility- Study Attrition measure: Change in body weight sex: ALL minimumAge: 11 Years maximumAge: 14 Years stdAges: CHILD facility: University of Hawaii at Manoa status: RECRUITING city: Honolulu state: Hawaii zip: 96822 country: United States name: Chloe P Lozano, PhD role: CONTACT phone: 808-956-7095 email: cpanizza@hawaii.edu lat: 21.30694 lon: -157.85833 hasResults: False

 nctId: NCT06360354 id: 20230223 briefTitle: A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion overallStatus: RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2028-06-29 date: 2024-04-11 date: 2024-04-22 name: Amgen class: INDUSTRY briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers. conditions: Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 282 type: ESTIMATED name: AMG 193 name: Gemcitabine name: Nab-paclitaxel name: Cisplatin name: Pembrolizumab name: Modified FOLFIRINOX measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT) measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) measure: Number of Participants Experiencing Serious Adverse Events (SAE) measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) measure: Disease Control (DC) per RECIST v1.1 measure: Duration of Response (DOR) per RECIST v1.1 measure: Time to Response (TTR) per RECIST v1.1 measure: Overall Survival (OS) per RECIST v1.1 measure: Progression-free Survival (PFS) per RECIST v1.1 measure: Maximum Plasma Concentration (Cmax) of AMG193 measure: Time to Maximum Plasma Concentration (tmax) of AMG193 measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope National Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 hasResults: False

 nctId: NCT06360341 id: 202301946 briefTitle: Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-01-01 date: 2024-04-11 date: 2024-04-11 name: University of Florida class: OTHER briefSummary: The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes. conditions: Low Back Pain, Mechanical conditions: Acute Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Individuals in the pilot randomized controlled trial (RCT) intervention will be randomized to either the intervention or routine discharge care (RC) using REDCap randomizer and assigned to RC or Emergency Department Digital Pain Self-Management Intervention (EDPSI) + RC. primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomization to RC or Intervention group will not be masked to the Principal Investigator (PI), co-PI, or to participants. count: 30 type: ESTIMATED name: Emergency Department Digital Pain Self-Management Intervention (EDPSI) name: Routine Discharge Care measure: Improving Self-Management Health Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UF Health Shand's Adult Emergency Department city: Gainesville state: Florida zip: 32608 country: United States name: Alexandria A Carey, MSN, MBA-HC role: CONTACT phone: 661-607-1702 email: alexandria.carey@ufl.edu name: Angela R Starkweather, PhD role: CONTACT phone: (352) 273-6323 email: a.starkweather@ufl.edu lat: 29.65163 lon: -82.32483 hasResults: False

 nctId: NCT06360328 id: 033-2024 briefTitle: Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial) acronym: JuniorDoc-VL overallStatus: RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-08-01 date: 2024-04-11 date: 2024-04-15 name: University Hospital Heidelberg class: OTHER briefSummary: Securing the airway through endotracheal intubation (ETI) is a fundamental skill for anaesthetists. It is used during surgery, in the intensive care unit, during periprocedural anaesthesia and in emergency medicine. The clinical relevance of airway management is demonstrated in particular by the fact that the main cause of serious anaesthesia-related complications lies in the area of airway management. increasing technological developments in recent years (e.g. video laryngoscopy \[VL\]) aim to reduce the complication rate in the area of airway management. however, there are currently a large number of VLs available, which differ massively in their application. Therefore, it is essential to systematically collect data and develop structured training in airway management, taking into account current technological developments.While endotracheal intubation is traditionally performed with a direct laryngoscope, indirect video laryngoscopy, with chip-based camera technology at its tip, has been introduced across the board in recent years and is now part of standard clinical and preclinical equipment. Doctors in advanced training are trained with a focus on direct laryngoscopy; the use of and training in indirect video laryngoscopy does not follow any standards; in addition, the decision as to which method of securing the airway is chosen has so far been the responsibility of the individual doctor in anaesthesiology, although there is a tendency for the VL to be associated with a higher success rate in the first intubation attempt, the so-called "first-pass success".The main aim of this clinical prospective, randomised controlled trial is to train anaesthetists in advanced training in conventional direct laryngoscopy on the one hand and indirect video laryngoscopy (VL) on the other, with a focus on tracking the progress of their skills after 200 intubations with regard to first-pass success. conditions: Intubation Complication conditions: Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control group = direct laryngoscopy Intervention group = video laryngoscopy primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: video laryngoscopy measure: Rate of Successful tracheal intubation on the first attempt (First-Pass-Success). measure: Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma. measure: Specify the number of attempts made during laryngoscopy. measure: Compare the level of training with intubation success. measure: Mention any failures or transitions to other rescue techniques. measure: Specify the use of Optimal External Laryngeal Manipulation (OELM) techniques such as backward, upward and rightward pressure (BURP) Cricoid Pressure (CP) or adjustment of the participant's head and neck position. measure: When using VL, record the occurrence of fogging. measure: Assess the glottic view using the Cormack-Lehane-Score (I - IV). (I = good view) measure: assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%). (0%= no view, 100% best view) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University, status: RECRUITING city: Heidelberg state: Baden-Wuerttemberg zip: 69120 country: Germany name: Davut Deniz Uzun, MD role: CONTACT phone: 0049 62215639349 email: deniz.uzun@med.uni-heidelberg.de name: Felix Schmitt, MD role: CONTACT phone: 0049 62215639421 email: Felix.Schmitt@med.uni-heidelberg.de lat: 49.40768 lon: 8.69079 hasResults: False

 nctId: NCT06360315 id: 202201265 briefTitle: Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-02 date: 2024-04 date: 2024-06 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER briefSummary: Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure. conditions: Chronic Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12000 type: ESTIMATED name: Incentive letter for pneumococcal vaccination to the patient and to the GP measure: 1-year Pneumococcus vaccination rate measure: 1-year all-cause hospital admission rate measure: 1-year specific hospital admission rate measure: 1-year all-cause mortality rate sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montpellier University Hospital city: Montpellier zip: 34090 country: France lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06360302 id: RECHMPL22_0505 briefTitle: Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients acronym: KREBSome-IRC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER briefSummary: This prospective, multicenter, cross-sectional, repeated-measures comparative study compared functional and biochemical response profiles to exercise between 2 groups of chronically ill patients (chronic renal failure dialysis patients and patients with metabolic syndrome) and a group of healthy subjects.

The hypothesis is that the addition of plasma metabolic intermediates associated with energy disorders linked to insulin resistance, will improve the sensitivity of the assessment of muscle oxidative metabolism abnormalities, as reported in exercise intolerant subjects.

In this way, the metabolomics approach during exercise would provide a biological and functional "signature" of insulin resistance of muscular origin, discriminating between insulin-resistant patients, healthy control subjects and dialysis patients, with an exercise metabolic profile approaching that observed in insulin-resistant patients. A better understanding of metabolic abnormalities could guide muscle rehabilitation.

Participants will be asked to perform an exercise test, with several blood samples taken at different exercise intensities.

Researchers will compare the metabolic profile of three groups: patients with chronic kidney disease, patients with metabolic syndrome and healthy subjects:

* V'O2-adjusted lactate at rest and during exercise
* The combination of exercise energy metabolism intermediates reflecting insulin resistance among Krebs cycle cofactors/substrates, ß-oxidation cofactors/substrates, amino acids conditions: Metabolic Syndrome conditions: Dialysis; Complications studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cross-sectional comparative study with repeated measures primaryPurpose: BASIC_SCIENCE masking: NONE count: 42 type: ESTIMATED name: Exercise test name: Blood sample name: Impedancemetry measure: Compare V'O2-adjusted plasma lactate profile at rest and during exercise (metabolic stress test), between chronic renal failure patients, patients with metabolic syndrome and healthy subjects. measure: Compare between the 3 groups their metabolic profile (Krebs cycle cofactors/substrates) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (ß-oxidation cofactors/substrates) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (amino acids) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (acyl-carnitine profiles) adjusted to V'O2 at rest and during exercise. measure: Anthropometry Comparison between the 3 groups sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie city: Montpellier zip: 34295 country: France name: Jean-Paul CRISTOL, Prof role: CONTACT phone: +33(0)4 67 33 83 15 email: jp-cristol@chu-montpellier.fr lat: 43.61092 lon: 3.87723 facility: Montpellier University Hospital city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06360289 id: ALN-TTR-NT-003 briefTitle: Observational Study of Neurofilament Light Chain (NfL) as a Biomarker in Asymptomatic Carriers of the Transthyretin (TTR) Variants and Patients With Hereditary Transthyretin-mediated (hATTR) Amyloidosis With Polyneuropathy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-11 date: 2024-04-11 name: Alnylam Pharmaceuticals class: INDUSTRY briefSummary: This is a single-center observational study evaluating the potential value of NfL as a biomarker for diagnosis, detection of disease onset, monitoring of disease progression, and treatment response in asymptomatic carriers of TTR variants and symptomatic hATTR amyloidosis patients with polyneuropathy. conditions: Hereditary Amyloidosis, Transthyretin-Related conditions: Asymptomatic Carrier State studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Standard of Care measure: NfL Levels in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline measure: Change in NfL Levels Over Time in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy measure: Correlation Between the NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline measure: Correlation Between the Change in NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy measure: Comparison of the Measured NfL Levels to the Normal Levels Expected to be Seen in the General Population by Using the Existing Reference Ranges and Databases measure: Time to Onset of Active Disease in Asymptomatic Carriers of TTR Variants measure: Disease Progression in Symptomatic hATTR Amyloidosis Patients with Polyneuropathy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire (CHU) Le Kremlin-Bicêtre Assistance Publique-Hôpitaux de Paris (APHP) city: Paris state: Île-de-France zip: 94270 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06360276 id: 14012021 briefTitle: Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy overallStatus: COMPLETED date: 2022-03-14 date: 2022-08-02 date: 2022-08-12 date: 2024-04-11 date: 2024-04-11 name: Alexandria University class: OTHER briefSummary: This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.

Hypotheses for research:

1. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.
2. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.

A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping. conditions: Fatigue conditions: Coping Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Seated Exercises name: Psychoeducational Rehabilitation name: Routine Care measure: Piper Fatigue Scale measure: Mini-Mental Adjustment to Cancer Scale sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Nursing city: Alexandria zip: 56321 country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06360263 id: #1-6/2023 briefTitle: OSSEODENSIFICATION BY DENSAH BURS WITH ACTIVATED PLASMA ALBUMIN GEL FOR SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT overallStatus: RECRUITING date: 2023-07-11 date: 2024-08 date: 2024-08 date: 2024-04-11 date: 2024-04-11 name: Esraa Salem Kamal class: OTHER briefSummary: Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement. conditions: Bone Loss, Alveolar studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Densah bur in combination with activated plasma albumin gel measure: Postoperative pain measure: Implant stability measure: Vertical bone height gain measure: Bone density around implant sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry, Alexandria University status: RECRUITING city: Alexandria country: Egypt name: Esraa S Kamal, BDS role: CONTACT phone: 106 054 3345 phoneExt: +20 email: esraasalemkamal@gmail.com lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06360250 id: B2001-F20220601 briefTitle: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-10-30 date: 2024-10-30 date: 2024-04-11 date: 2024-04-11 name: Changchun BCHT Biotechnology Co. class: INDUSTRY name: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine name: Anning City First People's Hospital briefSummary: To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation conditions: Clostridium Tetanus studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 190 type: ESTIMATED name: Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation name: Tetanus human immunoglobulin (HTIG) name: Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo name: Adsorbed tetanus vaccine (TT) measure: Safety evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PD evaluation index measure: PD evaluation index measure: PD evaluation index measure: Immunogenicity evaluation index sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT hasResults: False

 nctId: NCT06360237 id: ISIS 678354 briefTitle: Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) overallStatus: AVAILABLE date: 2024-04-11 date: 2024-04-11 name: Ionis Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS). conditions: Familial Chylomicronemia Syndrome studyType: EXPANDED_ACCESS name: Olezarsen sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360224 id: CASES briefTitle: Collect Flow and Ultrasound Images of Coronary Bypass Grafts acronym: CASES overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2029-05-15 date: 2029-05-15 date: 2024-04-11 date: 2024-04-11 name: Medistim ASA class: INDUSTRY briefSummary: This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG). conditions: Cardiac Bypass Surgery (CABG) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes measure: Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360211 id: 22251 briefTitle: A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants overallStatus: RECRUITING date: 2024-04-17 date: 2024-06-11 date: 2024-06-11 date: 2024-04-11 date: 2024-04-22 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (HER2) mutations.

Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2 that cause uncontrolled cell growth and increased spread of cancer.

In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies on people with advanced NSCLC with EGFR or HER2 mutations.

BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.

Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity.

The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088:

* Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time
* Maximum observed concentration (Cmax): the highest amount of midazolam in participants' blood

The study will have 3 treatment periods:

Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY2927088

Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic.

Participants will visit the study clinic:

* More than/at least once, within 2 to 28 days before the treatment starts
* Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment
* Once, within 7 to 10 days after they finish treatment for a health checkup

During the study, the doctors and their study team will:

* do physical examinations
* collect blood samples from the participants to measure the blood levels of midazolam and of BAY2927088
* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. conditions: Advanced Non-small Cell Lung Cancer conditions: EGFR Mutation conditions: HER2 Mutation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: BAY2927088 name: Midazolam measure: Cmax of midazolam when given with and without BAY2927088 measure: AUC of midazolam when given with and without BAY2927088 measure: Number of participants with TEAEs measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: PAREXEL International, Baltimore status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06360198 id: 2022-874/08 briefTitle: The Relationship Between Posture, Sense of Position, Musculoskeletal Discomfort and Anxiety overallStatus: COMPLETED date: 2022-06-30 date: 2022-11-30 date: 2022-12-30 date: 2024-04-11 date: 2024-04-11 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: It is known that posture is affected by various factors such as somatosensation, visual perception and cognition. In addition, it is also thought to affect conditions such as stress and anxiety through receptors. The aim of this study was to investigate the relationship between postural changes such as thoracic kyphosis, musculoskeletal problems, trunk position sense and anxiety in young individuals who were asymptomatic in terms of musculoskeletal problems. conditions: Kyphosis Postural Thoracic conditions: Proprioception conditions: Musculoskeletal System conditions: Anxiety studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 67 type: ACTUAL name: No intervention measure: Throcic Kyphosis measure: Trunk Position Sense measure: Musculoskeletal Discomfort measure: Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Yıldırım Beyazıt University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06360185 id: Asthma V2 October 2023 briefTitle: Retrospective Study of Patients With Acute Presentation for Asthma to an Emergency Department in UK (RAPAE) acronym: RAPAE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-11 date: 2024-04-11 name: Norfolk and Norwich University Hospitals NHS Foundation Trust class: OTHER briefSummary: Study team will obtain a list of all patients who have been seen in A+E over the past 6 years with a discharge diagnosis of asthma. Their history will be reviewed from their A+E notes. Team will obtain weight and height from Electronic prescribing tool and will obtain compliance information and past medical history from participant's GP records. Team will use participant's postcode to word out socio economic status quintile using office of national statistics tool. The following information will be taken from hospital documentation and from GP records. conditions: Asthma Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED measure: Change in body weight measure: Change in body height sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360172 id: 3-2024 briefTitle: The Feasibility of Motivational Interviewing on Emotional Authenticity, Dispositional Optimism, And Academic Motivation Among Nursing Students: A Randomized Controlled Trial overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-20 date: 2024-06-01 date: 2024-06-15 date: 2024-04-11 date: 2024-04-11 name: Alexandria University class: OTHER briefSummary: Motivational interviewing, or MI, is a collaborative, person-centered counseling technique to uncover and enhance a person\&#39;s motivation for behavior change . MI was first created for the treatment of substance dependence, but it has since been successfully implemented in several fields, including healthcare and education (. Given the vital role that nursing students play in the healthcare system, Saudi Arabia, like many other nations, has realized how important it is to improve the motivation and well-being of its nursing students conditions: Nursing Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Motivational Interviewing measure: Kernis-Goldman Authenticity Inventory measure: The Life Orientation Test-Revised form for Adolescents measure: Academic Motivation Scale sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Alexandria university city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06360159 id: Massage on Newborns briefTitle: Massage for Newborns Receiving Nasal CPAP overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-05-15 date: 2026-05-15 date: 2024-04-11 date: 2024-04-15 name: Sultan Besiktas class: OTHER briefSummary: One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications.

Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP. conditions: Massage conditions: Stress conditions: Newborn conditions: Comfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group (Massage): Babies in the intervention group will be massaged three times a day for 3 days, each session lasting 15 minutes, in accordance with the field massage technique. Massage application will be applied 1 hour after the babies are fed. For massage application, apply oil, solution and cream etc. to the baby's skin will not be used. During the massage application, the baby will be placed in prone and supine positions. Massage will be applied to the newborns in the intervention group by the assistant researcher.

Control group: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Intervention measure: Stress Level measure: Salivary Cortisol Level measure: Comfort Score measure: Bilirubin Level measure: Nutrient ıntake amount measure: Abdominal Circumference Measurement measure: Defecation Frequency sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD hasResults: False

 nctId: NCT06360146 id: 120685123 briefTitle: Early Mobilisation of Post Cardiac Surgery in Geriatrics. overallStatus: ENROLLING_BY_INVITATION date: 2023-04-01 date: 2023-06-01 date: 2024-06-01 date: 2024-04-11 date: 2024-04-11 name: Ahi Evran University Education and Research Hospital class: OTHER briefSummary: Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease.

Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications.

After cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations.

A total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B).

Older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises. conditions: Cardiac Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE maskingDescription: Single count: 100 type: ESTIMATED name: Early mobilisation measure: International Physical Activity Questionnaire measure: Two Minute Walking Test sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: İsmail Ceylan city: Kırşehir state: Merkez zip: 40100 country: Turkey lat: 39.14583 lon: 34.16389 hasResults: False

 nctId: NCT06360133 id: VVN001-CCS-301 briefTitle: Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-04-11 date: 2024-04-11 name: VivaVision Biotech, Inc class: INDUSTRY briefSummary: This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease. conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 700 type: ESTIMATED name: VVN001 Ophthalmic Solution, 5% name: VVN001 Ophthalmic Solution, Vehicle measure: Corneal Fluorescein Staining measure: Eye Dryness sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eye & Ent Hospital of Fudan University city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06360120 id: 00023098816 briefTitle: Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke overallStatus: RECRUITING date: 2024-04-10 date: 2025-04-10 date: 2025-05-10 date: 2024-04-11 date: 2024-04-11 name: Kafrelsheikh University class: OTHER briefSummary: Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever large-vessel ischemic stroke patients treated with clopidogrel assessed through NIHSS, mRS, and possible adverse effects. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be composed of 2 arms atorvastatin arm, which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months, All the patients in the two groups received open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Our study was single-blinded to the investigators; an independent statistician generated a computer-generated randomization chart with a block size of four in a one-to-one ratio, and participants were randomly assigned to receive either atorvastatin or rosuvastatin by a specially trained and qualified nurse. None of the investigators included in the study knew the patients' assignments. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included atorvastatin bills, and Drug B included rosuvastatin bills. The statistical analysis was performed by an independent statistician. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Atorvastatin 40 Mg Oral Tablet name: Rosuvastatin 20mg measure: the rate of new stroke at 90 days measure: Value of National Institute of Health Stroke Scale (NIHSS) after one week measure: value of Modified Rankin Scale (mRS) at one week measure: value of Modified Rankin Scale(mRS) at three months measure: rate of composite recurrent stroke, myocardial infarction, and death due to vascular events measure: rate of drug adverse effects measure: Drug adverse effects: all side effects related to the drugs of our study will be reported sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: mohamed_gomaa@med.kfs.edu.eg lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06360107 id: 76729 briefTitle: RCT of a Brief Video Intervention Targeting Peer Inclusion to Reduce Depression-related Stigma in Adolescents overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-11 date: 2024-04-11 name: New York State Psychiatric Institute class: OTHER name: Columbia University briefSummary: The goal of this study is to test the efficacy of a brief video intervention emphasizing peer inclusion on depression-related stigma and stigma outcomes (e.g., help seeking attitudes, secrecy) among adolescents 14-18.

Timely identification and treatment of depression in adolescents is a public health priority. However, most youth with depression do not seek treatment, and stigma has been identified as the primary barrier to help-seeking. Experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of "social contact" with individuals affected by a stigmatized condition, effective in reducing depression-related stigma and increasing help-seeking among adolescents. However, given the extreme time constraints of these videos, optimizing the messaging is paramount. Prior research has indicated that concerns about peer social inclusion are fundamental in shaping stigma among adolescents.

In this 3-arm RCT, we will recruit adolescents aged 14-18 using an online crowdsourcing platform, to test the efficacy of a) standard BVI that addresses mental health treatment but does not address concerns about peer inclusion/exclusion, b) novel BVI focused on mental health treatment and peer inclusion, and c) control condition that provides information without social contact. conditions: Depression conditions: Adolescent - Emotional Problem conditions: Stigma, Social conditions: Help-Seeking Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 650 type: ESTIMATED name: brief video measure: Depression Stigma Scale (modified) measure: Ultra-brief Self-stigma of Help-Seeking measure: Adolescent Stigma Scale (modified) sex: ALL minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: New York State Psychiatric Institute city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06360094 id: 1490-0004 id: 2023-510249-79-00 type: REGISTRY domain: CTIS id: U1111-1301-1311 type: REGISTRY domain: WHO Registry (ICTRP) briefTitle: A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis overallStatus: NOT_YET_RECRUITING date: 2024-07-27 date: 2025-07-21 date: 2025-08-06 date: 2024-04-11 date: 2024-04-11 name: Boehringer Ingelheim class: INDUSTRY briefSummary: Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF.

Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF.

During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Idiopathic Pulmonary Fibrosis conditions: Progressive Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 230 type: ESTIMATED name: BI 1839100 name: Placebo measure: IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h) measure: IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h) measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm) measure: IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h) measure: IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL) measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm) measure: IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score measure: IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360081 id: 1479-0019 id: 2023-510495-31-00 type: OTHER domain: CTIS id: U1111-1303-4345 type: OTHER domain: WHO briefTitle: A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2024-06-24 date: 2024-06-24 date: 2024-04-11 date: 2024-04-11 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Zongertinib measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72h (AUC0-72h) measure: Maximum measured concentration of the analyte in plasma (Cmax) measure: Time from dosing to maximum measured concentration of the analyte in plasma (tmax) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06360068 id: SLE-SASP POC id: 82371767 type: OTHER_GRANT domain: National Natural Science Foundation of China briefTitle: A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-05-01 date: 2025-05-01 date: 2024-04-11 date: 2024-04-11 name: Qiong Fu class: OTHER briefSummary: The goal of this clinical trial is to learn if sulfasalazine is safe and feasible in the treatment of active lupus erythematosus (SLE). The main questions it aims to answer are:

Does drug sulfasalazine with stable background treatment help lower the disease activity (SLEDAI) at week 16? How many patients can reach SRI-4 at week 16? Can this regimen help lower the prednisone dosage the patients need at week 16? What about the change of the type I interferon related genes expression at week 16?

Participants will:

Take sulfasalazine 750mg/dose, twice a day for 16 weeks. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient could tolerate.

Visit the clinic once every 4 weeks for checkups and tests. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Sulfasalazine Tablets measure: the change of disease activity (SLEDAI score) measure: the number of patients who can reach SRI-4 measure: the change of prednisone dosage measure: the change of interferon stimulating genes (ISG) expression sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06360055 id: M2024130 briefTitle: Effect of Oral D-mannose Tablets on Pharmacokinetics of Dabigatranate in Healthy Adults overallStatus: RECRUITING date: 2024-04-01 date: 2024-11-30 date: 2024-12-31 date: 2024-04-11 date: 2024-04-11 name: Peking University Third Hospital class: OTHER briefSummary: The aim of this study is to investigate the effects of oral D-mannose tablets for 2 consecutive weeks on the pharmacokinetics of dabigatrun etexilate, a P-glycoprotein probe substrate drug, in healthy adults conditions: Health studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Dabigatran Etexilate name: D-mannose measure: Plasma concentration of dabigatran measure: Serum concentrations of glycoomics such as D-mannose sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Cheng Cui role: CONTACT email: cuicheng1226@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06360042 id: MA-HCC-II-021 briefTitle: Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC overallStatus: RECRUITING date: 2024-01-01 date: 2027-03-31 date: 2028-03-31 date: 2024-04-11 date: 2024-04-22 name: Peking University Cancer Hospital & Institute class: OTHER briefSummary: This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC. conditions: Unresectable Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 111 type: ESTIMATED name: Adebrelimab plus Apatinib name: Adebrelimab plus Bevacizumab name: Camrelizumab plus Apatinib measure: 12-month overall survival rate measure: ORR measure: DCR measure: DoR measure: TTR measure: TTP measure: PFS measure: OS measure: safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing state: Beijing country: China name: Jun Zhou role: CONTACT phone: 13366152815 email: Joelbmu@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06360029 id: LvL UP briefTitle: The LvL UP Pilot Trial overallStatus: RECRUITING date: 2024-04-15 date: 2024-06 date: 2024-06 date: 2024-04-11 date: 2024-04-17 name: Singapore ETH Centre class: OTHER name: ETH Zurich name: National University of Singapore name: Nanyang Technological University briefSummary: Non-communicable diseases (NCDs), such as cardiovascular disease, diabetes, or cancer, and common mental disorders (CMDs), such as depression or anxiety, represent the primary causes of death and disability worldwide, causing major health and financial burdens. Lifestyle behaviours, including physical activity, diet, stress and emotional regulation, tobacco smoking, alcohol consumption, and sleep are important modifiable risk factors associated with the prevention and management of both NCDs and CMDs.

LvL UP is a mHealth intervention aimed at preventing NCDs and CMDs in adults from multi-ethnic Southeast Asian populations (Castro et al., 2023). Building upon leading evidence- and theory-based frameworks in the areas of mental health and behaviour change, a multidisciplinary team of researchers developed LvL UP as a holistic intervention centred around three core pillars: Move More, Eat Well, Stress Less.

The goal of this pilot study is to assess the feasibility of a Sequential, Multiple Assignment, Randomized Trial (SMART) aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP and (ii) establishing the optimal blended approach in LvL UP that balances effective personalized lifestyle support with scalability. The main questions it aims to answer are:

1. What are the intervention's preliminary, short-term effects? What is the intervention's level of engagement? What is the number of dropouts? What is the percentage of missing data? What is the intervention's responder / non-responder rate after week 4? How easy was to recruit the target sample size and which channels worked best?
2. Considering the above pilot study results: What is the overall feasibility of the SMART research protocol in its current form? Are there any changes required for the main trial? This includes: recruitment approach, intervention content and delivery (app, provision of human support), and/or trial assessments (online and in-person). conditions: Health Behavior conditions: Noncommunicable Diseases conditions: Mental Health Issue conditions: Lifestyle Risk Reduction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: LvL UP name: LvL UP + MI name: Comparison measure: Mental well-being measure: Subjective well-being measure: Mental health (depression) measure: Mental health (stress) measure: Health-related quality of life measure: Health behaviours (physical activity) measure: Health behaviours (steps) measure: Health behaviours (diet 1) measure: Health behaviours (diet 2) measure: Health behaviours (sleep) measure: Health behaviours (smoking and alcohol consumption) measure: Anthropometry (body weight) measure: Anthropometry (body height) measure: Anthropometry (waist circumference) measure: Anthropometry (hip circumference) measure: Anthropometry (self-reported height and weight) measure: Resting blood pressure measure: Blood metabolic profile measure: LvL UP app: Response time measure: LvL UP app: Duration of app usage measure: LvL UP app: Actual usage of app components measure: LvL UP app: Coaching topic / sub-topic use measure: LvL UP app: Conversational turns measure: LvL UP app: Breeze (slow-paced breathing tool) usage measure: LvL UP app: Access to smartphone sensors (location - obfuscated) measure: LvL UP app: Access to smartphone sensors (location types) measure: LvL UP app: Access to smartphone sensors (raw gyroscope) measure: LvL UP app: Access to smartphone sensors (raw accelerometer) measure: LvL UP app: Access to smartphone sensors (physical activity) measure: LvL UP app: Access to smartphone sensors (WiFi connection status) measure: LvL UP app: Access to smartphone sensors (WiFi networks in range) measure: LvL UP app: Access to smartphone sensors (bluetooth scan) measure: LvL UP app: Access to smartphone sensors (battery % level and charging status) measure: LvL UP app: Access to smartphone sensors (screen on/off) measure: LvL UP app: Access to smartphone sensors (call and SMS metadata) measure: LvL UP app: Access to smartphone sensors (app usage & app name from notifications and action) measure: LvL UP app: Access to smartphone sensors (step count) measure: LvL UP app: Access to smartphone sensors (brightness) measure: LvL UP app: Access to smartphone sensors (breeze audio) measure: LvL UP app: Access to Apple Healthkit & Google Fit data measure: Process evaluation: Health literacy questionnaire measure: Process evaluation: Stages of change questionnaire measure: Process evaluation: Unintended consequences measure: Process evaluation (intervention group participants only): Net promoter score measure: Process evaluation (intervention group participants only): System usability scale measure: Process evaluation (intervention group participants only): Session alliance inventory measure: Process evaluation (intervention group participants only): Self-report habit index measure: Process evaluation (intervention group participants only): MITI-4 measure: Process evaluation (intervention group participants only): UMars measure: Process evaluation (intervention group participants only): Interview measure: Process evaluation (Research team): Field Notes measure: Exploratory aims: Sociodemographic measure: Exploratory aims: Use of digital health technologies measure: Exploratory aims: Ecologic Momentary Assessment of mood state measure: Exploratory aims: Personality measure: Exploratory aims: Work Engagement measure: Exploratory aims: Self-reported sickness absence sex: ALL minimumAge: 21 Years maximumAge: 59 Years stdAges: ADULT facility: Saw Swee Hock School of Public Health status: RECRUITING city: Singapore zip: 117549 country: Singapore name: Shenglin Zheng, MSc role: CONTACT email: shenglin.zheng@u.nus.edu lat: 1.28967 lon: 103.85007 facility: Singapore ETH Center status: ACTIVE_NOT_RECRUITING city: Singapore zip: 138602 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06360016 id: Protocol-RAP briefTitle: Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs acronym: Protocol-RAP overallStatus: COMPLETED date: 2023-02-13 date: 2023-05-31 date: 2024-02-01 date: 2024-04-11 date: 2024-04-11 name: Selcuk University class: OTHER name: University of Malaga briefSummary: Protocol of Self Regulation in Early Learners: The Role of Recreational Activity Program (RAP) RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants. conditions: Self Regulation conditions: Impulsive conditions: Attention Difficulties conditions: Emotion Regulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pre and post-test with the control group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double (Investigator, Outcomes Assessor) whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Recreation Activity Program measure: Self-Regulation Assessment sex: ALL minimumAge: 5 Years maximumAge: 6 Years stdAges: CHILD facility: Selcuk University city: Konya zip: 42400 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06360003 id: SAHoWMU-CR2024-01-109 briefTitle: "Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin overallStatus: RECRUITING date: 2023-04-01 date: 2025-04-01 date: 2025-08-01 date: 2024-04-11 date: 2024-04-11 name: Second Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation.

Researches will break the method of this investigation into two steps:

First step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site.

The second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group. conditions: Ventricular Outflow Tract Ventricular Arrhythmias conditions: Radio Frequency Catheter Ablation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Right Ventricular Outflow Tract Posterior Septum Pacing name: systemic mapping and ablation measure: Rate of Immediate Ablation Success measure: Rate of Ablation Complication measure: Accuracy of RVOT posterior septal pacing protocol measure: Incidence of Complications Post-operative measure: Incidence of Complication measure: Rate of Recurrence during Follow up measure: Incidence of Complication measure: Rate of Recurrence during Follow up sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang zip: 325000 country: China name: Cheng Zheng, PhD role: CONTACT phone: 86-0577-85676609 email: zhengcheng_wzmufey@163.com lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06359990 id: RushUMCEmezue briefTitle: BrotherlyACT: A Culturally Congruent and Technology-Enhanced Youth Violence and Substance Use Intervention for Black Boys and Men acronym: BrotherlyACT overallStatus: RECRUITING date: 2024-02-15 date: 2026-02-15 date: 2026-02-15 date: 2024-04-11 date: 2024-04-11 name: Rush University Medical Center class: OTHER briefSummary: This study will adapt and test a culturally tailored, multi-component, and trauma-focused digital intervention to reduce the risk and effects of youth violence and substance use and bridge service access gaps for young Black males (YBM) in pediatric emergency and community-based low-resource settings. conditions: Violence in Adolescence conditions: Substance Use conditions: Avoidance of Healthcare studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: BrotherlyACT name: BrotherlyACT Waitlist Control Group (WCG) measure: The Reactive-Proactive Aggression Questionnaire (RPQ) measure: Multidimensional Peer Victimization Scale (MPVS) measure: The Alcohol Use Disorders Identification Test (AUDIT) measure: Drug Use Disorders Identification Test (DUDIT) measure: Change in Attitude toward Substance Use measure: Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) measure: The Kessler Psychological Distress Scale (K-10) measure: The University of Rhode Island Change Assessment Scale (URICA) measure: Intensity-of-Care Measurements measure: Violent Intentions-Teen Conflict Survey sex: MALE minimumAge: 15 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Rush University Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Chuka N Emezue, PhD, MPH role: CONTACT phone: 312-942-6151 email: chuka_emezue@rush.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06359977 id: YB-202442 briefTitle: The Effect of Quantitative EEG Combined With Ultrasound and Sputum Volume on Predicting Weaning Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-05-15 date: 2024-04-11 date: 2024-04-11 name: Qingdao University class: OTHER briefSummary: Neurocritical patients often face the need for removal of endotracheal tubes. However, despite following the extubation criteria for general critical ill patients, neurocritical patients still exhibit a higher rate of weaning failure, significantly higher than that of general critical ill patients. The extubation criteria for general critical patients emphasize the assessment of lung conditions. However, neurological critical patients often have less severe lung damage, but factors such as consciousness level and coughing ability may significantly influence extubation. Quantitative EEG serves as an objective tool to reflect consciousness level status, while bedside ultrasound can assess respiratory muscle function. Additionally, sputum volume may reflect the condition of lung condition. Therefore, we believe that combination of these three indicators can better predict the success of extubation for neurocritical patients. conditions: Weaning Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Quantitative EEG monitoring and beside ultrasound evaluation measure: Quantitative EEG indicators measure: Respiratory muscles thickness in centimeter measure: Respiratory muscles thickening fraction (%) measure: Sputum volume in milliliter sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359964 id: CRE2023.195 briefTitle: Infective Complications in TP Biopsy Without Antibiotic Prophylaxis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-03-31 date: 2024-04-11 date: 2024-04-11 name: Chinese University of Hong Kong class: OTHER briefSummary: This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1900 type: ESTIMATED name: Transperineal Biopsy without antibiotics prophylaxis name: Transperineal Biopsy with antibiotics prophylaxis measure: The difference in UTI hospitalization rate between the two groups after biopsy measure: The difference in urosepsis rates between the two groups after biopsy measure: Post-biopsy UTI rates between the two groups measure: Assessment of bacteriology and antibiotic resistant profile between the two groups sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359951 id: 24-0103 briefTitle: Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-02-01 date: 2026-01-31 date: 2024-04-11 date: 2024-04-11 name: Ann & Robert H Lurie Children's Hospital of Chicago class: OTHER name: American Psychological Association Division 53 Society for Clinical Child & Adolescent Psychology briefSummary: This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety and eating disorder symptoms. conditions: Depression conditions: Eating Disorders conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Project YES measure: Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Generalized Anxiety Disorder -7 (GAD-7) measure: Dietary Restriction Screener - 2 (DRS 2) measure: Adult State Hope Scale measure: Self-Hate Scale measure: Beck Hopelessness -4 measure: Program Feedback Scale sex: ALL minimumAge: 13 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Ann & Robert H Lurie Children's Hospital of Chicago city: Chicago state: Illinois zip: 60611 country: United States name: Anna M Ros, PhD role: CONTACT phone: 312-227-5433 email: annaros@luriechildrens.org name: Lisa Kuhns, PhD role: CONTACT phone: 312-227-6119 email: lkuhns@luriechildrens.org lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06359938 id: Cer22/01 briefTitle: Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF acronym: RSA-PACE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-11 date: 2024-04-11 name: Ceryx Medical Ltd class: INDUSTRY name: Cardiff and Vale University Health Board briefSummary: The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out.

The main questions the trial aims to answer are:

* Is the new type of pacemaker safe?
* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)?

Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients. conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Atrial pacing with respiratory sinus arrhythmia (RSA) variability name: Monotonic right atrial overdrive pacing measure: Number of arrhythmia episodes per patient during pacing sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardiff & Vale University Health Board city: Cardiff zip: CF14 4XW country: United Kingdom name: Zaheer Yousef role: CONTACT email: CAV_research.development@wales.nhs.uk name: Avraj Virdi role: CONTACT lat: 51.48 lon: -3.18 hasResults: False

 nctId: NCT06359925 id: Suprazygomatic nerve block briefTitle: Suprazygomatic Nerve Block in Tonsillectomy Patients overallStatus: NOT_YET_RECRUITING date: 2024-10-22 date: 2025-09-20 date: 2026-02-20 date: 2024-04-11 date: 2024-04-11 name: Assiut University class: OTHER briefSummary: The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids. conditions: Tonsillectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine name: Suprazygomatic maxillary nerve block using Bupivacaine measure: time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score measure: time and amount of first postoperative rescue analgesia after two different blocks using Paediatric Anaesthesia Emergence Delirium (PAED) scale measure: Parents satisfaction score sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD hasResults: False

 nctId: NCT06359912 id: CNYX-EPCs-002-1 briefTitle: Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-07 date: 2024-04-11 date: 2024-04-11 name: Allife Medical Science and Technology Co., Ltd. class: INDUSTRY name: First Affiliated Hospital Xi'an Jiaotong University briefSummary: The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound. conditions: Critical Limb Ischemia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: EPCs name: Clinical standard treatment (CST) measure: adverse events measure: Painless walking and intermittent claudication distance measure: Blood flow of the affected limb measure: Rutherford grade measure: The area of skin ulcer measure: Vascular Quality of Life Questionnaire-6 score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hui Shi status: RECRUITING city: Beijing state: Beijing country: China name: Shaoying Lu, Dr role: CONTACT phone: +862985323473 phoneExt: +862985323473 email: xjyfyllh@163.com name: Fanggang Li role: CONTACT phone: 86-18911352611 email: lifanggang@allifetech.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06359899 id: AK0901-2001 briefTitle: A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-10 date: 2024-04-11 date: 2024-04-11 name: Shanghai Ark Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder（ADHD）. conditions: ADHD studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: AK0901 capsule name: Placebo measure: To evaluate the efficacy of AK0901 compared to placebo in children 6 to 12 years old with ADHD. measure: Change from baseline in ADHD-RS-5 total score at Week 4. measure: Changes in ADHD-RS-5 inattention subscale score from baseline to each visit in the Double-Blind Treatment Period measure: Changes in ADHD-RS-5 hyperactivity/impulsivity subscale score from baseline to each visit in the Double-Blind Treatment Period. measure: Change in CGI-S score from baseline to each visit in the Double-Blind Treatment Period measure: CGI-I scores from V3 at each visit in the Double-Blind Treatment Period measure: Change in WREMB-R score from baseline to each visit in the Double-Blind Treatment measure: Proportion of subjects with adverse events (AEs) occurring during the study measure: Proportion of subjects with serious adverse events (SAEs) occurring during the study measure: Changes in respiratory rate during the study measure: Changes in heart rate during the study measure: Changes in body temperature during the study measure: Changes in systolic blood pressure during the study measure: Changes in diastolic blood pressure during the study measure: Change from baseline in QT intervals from resting EKGs measure: Change from baseline in QTcF intervals from resting EKGs measure: Change from baseline in heart rate resting EKGs measure: Change from baseline in QRS intervals from resting EKGs measure: Change from baseline in PR intervals from resting EKGs measure: Change in CSHQ score from baseline to each visit in the Double-Blind Treatment Period sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Beijing anding hospital capital medical university city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking university sixth hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06359886 id: FMASU MD 292/2022 briefTitle: B-lynch Transverse Compression Suture overallStatus: RECRUITING date: 2024-03-20 date: 2025-04 date: 2025-09 date: 2024-04-11 date: 2024-04-11 name: Alexandria University class: OTHER briefSummary: Is B-Lynch transverse compression suture safe and effective in controlling excessive blood loss during conservative management of women with placenta previa? conditions: Blood Loss, Surgical studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A Pilot Study primaryPurpose: PREVENTION masking: NONE count: 25 type: ESTIMATED name: B-Lynch Transverse Compression Suture measure: Intraoperative blood loss measure: Postoperative blood loss measure: Number of received blood components measure: Peripartum haemoglobin level drop sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ain Shams University status: RECRUITING city: Cairo zip: 21526 country: Egypt name: Ahmed S Zeerban, Msc role: CONTACT phone: +201003119968 email: Ahmedzeerban@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06359873 id: LAD-AF briefTitle: Left Atrial Enlargement: A Crucial Indicator for Identifying Atrial Fibrillation in Patients With Hypertension overallStatus: COMPLETED date: 2022-05-01 date: 2022-09-30 date: 2023-05-01 date: 2024-04-11 date: 2024-04-11 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: Based on the data of inpatients with hypertension and a cross-sectional study with a large sample size, this study aims to find the early warning value of the left anteroposterior atrial diameter for the possible occurrence of atrial fibrillation in patients with hypertension, and compare the advantages and disadvantages of the above two methods for the early warning of the risk of atrial fibrillation in patients with hypertension, so as to achieve the purpose of early identification of high-risk groups that may develop atrial fibrillation. conditions: Atrial Fibrillation conditions: Hypertension,Essential conditions: Left Atrial Dilatation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 58427 type: ACTUAL name: CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD) measure: left atrial diameter (LAD) measure: CHA2DS2-VASc score measure: C2HEST score measure: Atrial fibrillation (AF) measure: Area under the curve (AUC) of LAD and occurrence of AF measure: AUC of CHA2DS2-VASc score and occurrence of AF measure: AUC of C2HEST score and occurrence of AF measure: the LAD cutoff value sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 2ndChongqingMU city: Chongqing state: Chongqing zip: 400010 country: China lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06359860 id: ST-1898-203 briefTitle: A Study of ST-1898 for Unresectable or Metastatic Melanoma overallStatus: RECRUITING date: 2023-11-07 date: 2025-09 date: 2025-09 date: 2024-04-11 date: 2024-04-11 name: Beijing Scitech-Mq Pharmaceuticals Limited class: INDUSTRY briefSummary: ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma.

In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy.

In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets. conditions: Unresectable or Metastatic Melanoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: ST-1898 tablets measure: Phase Ib Dose Escalation: The Number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs) measure: Phase Ib Dose Escalation: Recommended Phase 2 Dose (RP2D) measure: Phase II Expansion: Objective Response Rate (ORR) measure: Phase Ib Dose Escalation: Trough concentration of ST-1898 measure: Phase Ib Dose Escalation: Peak concentration of ST-1898 measure: Phase Ib Dose Escalation: ORR measure: Phase Ib Dose Escalation: PFS measure: Phase Ib Dose Escalation: DoR measure: Phase Ib Dose Escalation: DCR measure: Phase Ib Dose Escalation: TTP measure: Phase II Dose Expansion: The Number and frequency of treatment-related adverse events and serious adverse events (SAEs) measure: Phase II Dose Expansion: Trough concentration of ST-1898 measure: Phase II Dose Expansion: Peak concentration of ST-1898 measure: Phase II Dose Expansion: PFS measure: Phase II Dose Expansion: DoR measure: Phase II Dose Expansion: DCR measure: Phase II Dose Expansion: TTP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Cancer Hospital & Institute status: RECRUITING city: Beijing zip: 100142 country: China name: Jun GUO, MD role: CONTACT phone: 0086-10-88121122 email: guoj307@126.co name: Chuanliang CUI, MD role: CONTACT phone: 0086-10-88196348 email: 1008ccl@163.com name: Jun GUO, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06359847 id: ST-1898-202 briefTitle: Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer overallStatus: RECRUITING date: 2023-11-15 date: 2025-12 date: 2025-12 date: 2024-04-11 date: 2024-04-11 name: Beijing Scitech-Mq Pharmaceuticals Limited class: INDUSTRY briefSummary: ST-1898, a multi-targeted tyrosine kinase inhibitor, has demonstrated strong inhibitory activity for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT, etc. The primary purpose of this study is to evaluate the efficacy of ST-1898 tablets in patients with locally advanced or metastatic RAIR-DTC after failure of at least first-line TKI systemic therapy. All subjects will receive ST-1898 180 mg orally once daily until disease progression or intolerable toxicity. conditions: Differentiated Thyroid Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: ST-1898 tablets measure: Objective Response Rate (ORR) measure: The number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs) measure: PFS measure: PFS6m measure: DCR measure: DOR measure: OS measure: Thyroglobulin (Tg) measure: Thyroglobulin Antibody (TgAb) measure: Pharmacokinetic (PK) Parameter: Tmax measure: Pharmacokinetic (PK) Parameter: T1/2 measure: Pharmacokinetic (PK) Parameter: Cmax measure: Pharmacokinetic (PK) Parameter: AUC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Yansong Lin, MD role: CONTACT name: Xin Zhang, MD role: CONTACT name: Yansong Lin, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06359834 id: 4-2023-1693 briefTitle: Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography overallStatus: RECRUITING date: 2024-04-10 date: 2025-04-10 date: 2025-04-30 date: 2024-04-11 date: 2024-04-11 name: Yonsei University class: OTHER briefSummary: Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography. conditions: Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 112 type: ESTIMATED name: Remimazolam besylate name: Propofol measure: Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine status: RECRUITING city: Seoul zip: 120-752 country: Korea, Republic of name: Moon Jae Chung, MD role: CONTACT phone: +82-2-2228-1981 email: mjchung@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06359821 id: Z-001 briefTitle: Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2025-04-15 date: 2026-04-15 date: 2024-04-11 date: 2024-04-12 name: Sichuan University class: OTHER briefSummary: A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting Radiopharmaceutical, in metastatic castration resistant prostate cancer conditions: Metastatic Prostate Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 5 type: ESTIMATED name: ZA-001 measure: The absorbed radiation doses (Gray [Gy] /Megabecquerel [MBq] )for whole body and organ measure: Adverse Event sex: MALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359808 id: KY20232370 briefTitle: Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-11 date: 2024-04-11 name: Xijing Hospital class: OTHER briefSummary: Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients. conditions: Colitis, Ulcerative conditions: Sleep Quality conditions: Gastrointestinal Microbiome conditions: Autonomic Nervous System Imbalance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 152 type: ESTIMATED measure: Pittsburgh Sleep Quality Index (PSQI) measure: Disease activity measure: Heart Rate Variability (HRV) measure: Functional Magnetic Resonance Imaging measure: Neurotransmitter Agents measure: Gastrointestinal Microbiome measure: Patient Health Questionnaire (PHQ-9) measure: Generalized Anxiety Disorder (GAD-7) measure: Inflammatory Bowel Diseases Questionnaire (IBDQ) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359795 id: FAPI-TED briefTitle: Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease overallStatus: RECRUITING date: 2023-12-15 date: 2027-12-31 date: 2027-12-31 date: 2024-04-11 date: 2024-04-11 name: Peking University Third Hospital class: OTHER briefSummary: FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED. conditions: Thyroid Eye Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT measure: Diagnostic accuracy measure: The value to predict therapy response measure: Diagnostic accuracy comparison measure: FAPI expression and SUV metrics sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dept. of Nuclear Medicine, Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Hui Li, Dr. role: CONTACT phone: 86-13121136769 email: huilee1990@163.com name: Lingge Suo, Dr. role: CONTACT phone: 86-010-82264935 email: suolingge_1019@126.com name: Hui Li, Dr. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06359782 id: NL76082.058.20 briefTitle: Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH) acronym: CIAO@SAH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02 date: 2027-02 date: 2024-04-11 date: 2024-04-11 name: Haaglanden Medical Centre class: OTHER name: Leiden University Medical Center name: Takeda briefSummary: Aneurysmal subarachnoid hemorrhage (SAH) can lead to devastating outcomes for patients, like cognitive decline. This is caused by early brain injury (EBI) followed by delayed cerebral ischemia (DCI). Neuroinflammation, triggered by the complement system, has been investigated to be a key mediator in the pathophysiology of EBI and DCI. Inhibition of the complement system is therefore considered to be a potentially important new treatment for SAH.

This trial aims to study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with SAH. By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response. conditions: Subarachnoid Hemorrhage, Aneurysmal studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, multicenter, randomized, double-blind, placebo-controlled, phase II trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: C1 Esterase Inhibitor Injection [Cinryze] name: Placebo measure: Number of participants with delayed cerebral ischemia (DCI) measure: Number of participants with complications during hospitalization. measure: Number of participants with cerebral infarction on brain CT measure: Number of participants dying measure: Neurological condition measured by Glasgow Coma Scale measure: Complement activity markers measured in serum and CSF measure: Inflammatory markers measured in serum and CSF measure: Number of days in the hospital measure: Number of ICU days measure: Number of ventilator days measure: Clinical outcome measure: Clinical outcome measure: Clinical outcome measure: Clinical outcome measure: Clinical outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359769 id: GROUPCET briefTitle: Group Cognitive Evolutionary Therapy for Depression acronym: GRCET overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-11 date: 2024-04-11 name: University of Bucharest class: OTHER briefSummary: The goal of this clinical trial is to measure the effects of Group Cognitive Evolutionary Therapy on mental health, especially on depressive symptoms and anxiety.

Participants will be allocated in one of two conditions: (1) Group Cognitive Evolutionary Therapy (intervention) or (2) Waitlist. The intervention will consist of two 8-hour sessions of Group Cognitive Therapy, in two consecutive days.

The Group Cognitive Evolutionary Therapy group will be compared to the waitlist group to test the efficacy of the intervention. conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Group Cognitive Evolutionary Therapy measure: Depressive symptomatology measure: Anxiety symptomatology measure: Sleep quality measure: Perceived stress measure: Social provisions measure: Satisfaction with life measure: Self-perceived mate value sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359756 id: BRAIN-SAVE1 briefTitle: Ischemic Postconditioning in Carotid Surgery acronym: BRAIN-SAVE overallStatus: RECRUITING date: 2023-09-01 date: 2024-05-01 date: 2024-09-01 date: 2024-04-11 date: 2024-04-12 name: Institute for Cardiovascular Diseases "Dedinje" class: OTHER briefSummary: Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT). conditions: Ischemic Postconditioning conditions: Carotid Surgery conditions: Stroke conditions: Carotid Artery Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 250 type: ESTIMATED name: Ischemic postconditioning in carotid surgery name: Eversion Carotid Endarterectomy measure: Number of Participants with perioperative stroke measure: Number of Participants with perioperative death sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Cardiovascular Diseases Dedinje status: RECRUITING city: Belgrade zip: 11000 country: Serbia name: Jovan Petrović, MD role: CONTACT phone: +381113601705 email: jovanpetrovic1997@gmail.com name: Slobodan Pešić, MD role: SUB_INVESTIGATOR lat: 44.80401 lon: 20.46513 hasResults: False

 nctId: NCT06359743 id: 271/7 briefTitle: Ultrasound Guided QLB Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-11 date: 2024-04-11 name: Zagazig University class: OTHER_GOV briefSummary: Pain following laparoscopic hysterectomy may interfere with early ambulation, discharge of patient from hospital and interfere with enhanced recovery with more opioid consumption. Most of methods for postoperative pain depend on the use of high doses of opioids with more side effects such as nausea, vomiting, respiratory center depression, delay bowel motility and hemodynamics instability. To decrease of opioid consumption in postoperative pain management as well as related side effects, previous studies showed that quadratus lumborum block or superior hypogastric plexus block (SHPB) had shown promising success in management of postoperative pain in patients undergoing laparoscopic hysterectomy. The present study will be conducted to compare of ultrasound guided QL block and laparoscopic superior hypogastric plexus block as a part of multimodal analgesia may allow adequate analgesia and decrease the overall use of opioids and allow patient enhanced recovery. conditions: Post Hysterectomy Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 34 type: ESTIMATED name: Quadratus Lamborum versus superior hypogatric measure: Opioid consumption decrease sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of medicine, Zagazig university city: Zagazig state: Sharkia country: Egypt lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06359730 id: 253/26-March-2024 briefTitle: Incidence and Risk Factors of Low Anterior Resection Syndrome overallStatus: COMPLETED date: 2017-12-01 date: 2022-12-01 date: 2022-12-01 date: 2024-04-11 date: 2024-04-11 name: Zagazig University class: OTHER_GOV briefSummary: Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.

With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 120 type: ACTUAL name: LARS score questionnaire measure: age measure: sex measure: medical disease measure: site of tumor measure: neoadjuvant therapy measure: site of anastmosis measure: type of meso-rectal excision measure: adjuvant therapy measure: type of surgery measure: type of anastmosis measure: LARS score sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Zagazig University Hospitals city: Zagazig zip: 44519 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06359717 id: ZU-10490 briefTitle: Prospective Validation of PSMA-RADS acronym: PSMA-RADS overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-04-10 date: 2024-04-20 date: 2024-04-11 date: 2024-04-11 name: Zagazig University class: OTHER_GOV briefSummary: This is a prospective, multicenter study aimed at evaluating the diagnostic accuracy and reliability of the Prostate-Specific Membrane Antigen Reporting and Data System (PSMA-RADS) version 1.0 in detecting prostate cancer using 68Ga-PSMA-11 PET/CT imaging. The study also compared the performance of PSMA-RADS v1.0 with the updated version 2.0.

Key points:

* 186 patients with newly diagnosed or recurrent prostate cancer underwent 68Ga-PSMA-11 PET/CT imaging.
* Three radiologists independently evaluated the scans and assigned PSMA-RADS scores using v1.0, then retrospectively using v2.0.
* Diagnostic accuracy was assessed against histopathology and follow-up imaging as reference standards.
* Inter-rater agreement was evaluated using Fleiss\&#39; kappa statistic.
* The study aimed to validate the diagnostic utility of PSMA-RADS v1.0 and compare it to the updated v2.0. conditions: Cancer Prostate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 208 type: ESTIMATED measure: Diagnostic Accuracy of PSMA-RADS v1.0 and v2.0 measure: Inter-rater Agreement of PSMA-RADS v1.0 and v2.0 sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohammad Abd Alkhalik Basha city: Zagazig state: Select zip: 44631 country: Egypt lat: 30.58768 lon: 31.502 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-21 uploadDate: 2024-04-05T07:38 filename: Prot_SAP_000.pdf size: 692777 hasResults: False

 nctId: NCT06359704 id: kevinszc briefTitle: Intervention for Emotions in Caregivers of Dementia overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-01 date: 2025-02-01 date: 2024-04-11 date: 2024-04-12 name: The University of Hong Kong class: OTHER briefSummary: This study aims to evaluate the effectiveness of a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes). conditions: BPSD conditions: Expressed Emotion conditions: Depressive Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: controlled arm with waitlist treatment primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Caregivers Of dementia Processing Emotions (COPE) program measure: Expressed emotions measure: depressive symptoms measure: social dynamics measure: BPSD sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359691 id: 4UH3HL154302 type: NIH link: https://reporter.nih.gov/quickSearch/4UH3HL154302 id: 4UH3HL154302 type: NIH link: https://reporter.nih.gov/quickSearch/4UH3HL154302 briefTitle: Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-06 date: 2024-04-11 date: 2024-04-12 name: University of California, Los Angeles class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of the study is to promote equitable hypertension (HTN) management across the diverse patient population found in Los Angeles County Department of Health Services (LAC DHS) clinics.

To achieve this goal, the study team will conduct provider- and patient-focused outreach strategies to understand how to best support adoption of blood pressure management practices already available within LAC DHS.

LAC DHS clinics will be randomly assigned to one of three study conditions: 1) provider-focused outreach, 2) patient-focused outreach, and 3) usual outreach. The study will occur across 3 years with patient- and provider-focused outreach occurring in Year 1 and 2. In Year 3, study initiated patient- and provider-focused outreach will stop, and clinic use of patient- and provider-focused outreach practices will be observed by the study team.

Provider-focused outreach includes increasing cultural awareness of factors that hinder and support blood pressure control, increasing access to blood pressure medications, and providing blood pressure management education. Patient-focused outreach includes using culturally sensitive educational materials and reminders to improve patient understanding of blood pressure, education on how to manage the condition, and increasing awareness of available blood pressure management resources. Clinics assigned to the usual outreach condition will operate as per usual in Year 1 but will receive patient- and provider-focused outreach in Year 2. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Three-armed crossover trial design to test effectiveness and sustainment of our implementation strategies across LAC DHS clinics and the communities they serve. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 540 type: ESTIMATED name: Patient-focused strategies name: Provider-focused strategies name: Patient- and provider-focused strategies measure: Overall provider adoption of evidence based practices measure: Provider/Care Team EBP Acceptability, Appropriateness, Feasibility measure: Blood Pressure (BP) Control sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Olive View-UCLA Medical Center city: Sylmar state: California zip: 91342 country: United States name: Soma Wali, MD role: CONTACT phone: 747-210-3205 email: swali@dhs.lacounty.gov lat: 34.30778 lon: -118.44925 hasResults: False

 nctId: NCT06359678 id: NL85844.015.23 briefTitle: The Northstar Trial acronym: Northstar overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2025-01-01 date: 2024-04-11 date: 2024-04-11 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.

The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy. conditions: Flutter, Atrial studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: NorthStar measure: Accuracy of Catheter Localization measure: Influences of breathing pattern measure: Influences of procedure duration measure: Influences of complications during ablation measure: Influences of patient characteristics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam country: Netherlands name: Marco Gotte role: CONTACT lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06359665 id: HSR230544 briefTitle: Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-11 date: 2024-04-11 name: Brent DeGeorge class: OTHER briefSummary: The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis. Turmeric is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for thumb-joint arthritis. The main question\[s\] it aims to answer are:

* Is Turmeric more effective than placebo at relieving pain for thumb-joint arthritis? A placebo is a look-alike substance that contains no active drug.
* Is Turmeric more effective than placebo at improving patient-reported outcomes for CMC arthritis?
* Is Turmeric safe for participants with thumb-joint arthritis?

Participants will:

* take 4 weeks of daily Turmeric capsules,
* take 4 weeks of daily placebo capsules
* answer daily surveys about how they are feeling and functioning. conditions: Arthritis of Carpometacarpal Joint of Left Thumb conditions: Arthritis of Carpometacarpal Joint of Right Thumb studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study design will be a double-blind, randomized controlled trial with crossover. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind Randomized Controlled Trial whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Curcumin name: Placebo measure: Change from Baseline in Pain on the Visual Analog Pain (VAS) Score measure: Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover condition measure: Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score measure: Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition measure: Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score measure: Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - crossover condition measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover condition measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score measure: Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index measure: Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index measure: Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH). measure: Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition measure: Change from Baseline in perseverance on the Brief Resilience Index (BRI) measure: Change from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover condition measure: Number of Participants With Treatment-Related Adverse Events measure: Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure measure: Change from Baseline in heart rate measure: Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure measure: Change from Baseline in heart rate measure: Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST) measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: estimated glomerular filtration rate (eGFR) measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR) measure: Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets measure: Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin measure: Change from baseline in serum complete blood count (CBC) parameters: Hematocrit measure: Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV) measure: Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359652 id: IRB24-0421 briefTitle: Get Fit for Function overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-04 date: 2029-04 date: 2024-04-11 date: 2024-04-11 name: University of Chicago class: OTHER briefSummary: The purpose of this study will be to implement and evaluate a prehab program for pre-frail and frail adults who need to undergo thoracic surgery. The study team hypothesizes using an implementation framework will increase the reach, effectiveness, adoption, and implementation of the prehab program. conditions: Thoracic conditions: Frailty studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 100 type: ESTIMATED name: Prehabilitation Program (Apple Watch Series 6 with exercise flipbook) measure: The change of functional status using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for implementation evaluation. measure: Number of Participants with Postoperative Complications measure: Number of Participants length of hospital stay post-operative. measure: Number of Participants discharge to not-home post-operative. sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Chicago city: Chicago state: Illinois zip: 60637 country: United States name: Viviana Camacho role: CONTACT phone: 773-795-4391 email: vcamacho@bsd.uchicago.edu name: Leila Yazdanbakhsh role: CONTACT phone: 773-834-5087 email: leila.yazdanbakhsh@bsd.uchicago.edu name: Maria Madariaga, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06359639 id: USM/JEPeM/KK/23080645 briefTitle: Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth Among Malaysian Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-11 date: 2024-04-11 name: Michelle Choong Poh Kin class: OTHER briefSummary: The goal of this clinical trial is to assess the effectiveness of cognitive restructuring in reducing breakup distress and promoting personal growth among Malaysian young adults. Cognitive restructuring is a therapy skill that focuses on changing unhelpful thoughts. The main question it aims to answer is: Are there differences in their breakup distress and personal growth after receiving cognitive restructuring compared to counselling? Participants will receive five online sessions of either cognitive restructuring or counselling. Data on participants' breakup distress and personal growth will be collected before and after completion of sessions. The hypothesis is that cognitive restructuring will reduce breakup distress and increase personal growth more than counselling. conditions: Breakup Distress conditions: Posttraumatic Growth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Cognitive restructuring name: Supportive counselling measure: Breakup distress measure: Posttraumatic growth sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False

 nctId: NCT06359626 id: YHP2205 briefTitle: Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-07-09 date: 2024-07-19 date: 2024-07-24 date: 2024-04-11 date: 2024-04-11 name: Yuhan Corporation class: INDUSTRY briefSummary: A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: two-way crossover primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: YHP2205 name: YHR2401 measure: Area under the plasma drug concentration-time curve [AUCt] measure: Maximum plasma concentration [Cmax] measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] measure: Time of peak concentration [Tmax] measure: Terminal phase of half-life [t1/2] sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359613 id: 029/IRC/BMR briefTitle: Efficacy Assessment of Gluten Free Cupcakes overallStatus: COMPLETED date: 2019-10-03 date: 2019-12-15 date: 2020-01-03 date: 2024-04-11 date: 2024-04-22 name: University of Veterinary and Animal Sciences, Lahore - Pakistan class: OTHER briefSummary: Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 35 control group +35 intervention group, 3-8years of age). After consumer acceptance against various attributes of aglutenic cupcake, the product will be provided in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2 cupcakes for each day) providing approximately 20% daily value (DV) of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group. Further product will be provided on follow-up visits. The compliance to a gluten free diet GFD and supplemented product will be confirmed by a Food Frequency Questionnaire (FFQ). conditions: Celiac Disease in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The product will be provided to intervention group (n=50) in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2/day) providing approximately 20%DV of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group (n=50) primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 75 type: ACTUAL name: nutrient rich food product name: food product measure: Body Weight measure: Height of the patients measure: Mid upper Arm Circumference (MUAC) measure: Body Mass Index (BMI) measure: Complete Blood Count (CBC) measure: Total Protein measure: Lipid Profile measure: Liver Enzymes measure: Serum Electrolytes measure: Gastrointestinal Symptoms sex: ALL minimumAge: 3 Years maximumAge: 8 Years stdAges: CHILD facility: UVAS city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06359600 id: HS-10501-101 briefTitle: A Study of HS-10501 Tablets in Healthy Subjects overallStatus: RECRUITING date: 2024-03-14 date: 2025-01-31 date: 2025-06-30 date: 2024-04-11 date: 2024-04-11 name: Jiangsu Hansoh Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects. This is the first clinical study of HS-10501 tables. This study has 2 parts. Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days. Also, this part will also further explore the food effect. Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 84 type: ESTIMATED name: HS-10501 tablet name: Placebo measure: Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment. measure: Number of participants with clinically significant abnormalities in lab tests measure: Number of participants with clinically significant change from baseline in vital signs measure: Change from baseline in Electrocardiogram (ECG) measure: Pharmacokinetic (PK) profile of HS-10501 - AUC0-t measure: Pharmacokinetic (PK) profile of HS-10501 - AUC0-∞ measure: Pharmacokinetic (PK) profile of HS-10501 - Cmax measure: Pharmacokinetic (PK) profile of HS-10501 - Tmax measure: Pharmacokinetic (PK) profile of HS-10501 - t1/2 measure: Pharmacokinetic (PK) profile of HS-10501 - CL/F measure: Pharmacokinetic (PK) profile of HS-10501- Vz/F measure: Pharmacokinetic (PK) profile of HS-10501-λz measure: Pharmacokinetic (PK) profile of HS-10501- AUC0-τ measure: Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood glucose-time curve after oral glucose tolerance test (OGTT) measure: Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood insulin-time curve after oral glucose tolerance test (OGTT) measure: body weight changes sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The second hospital of Anhui University status: RECRUITING city: Hefei state: Anhui zip: 230601 country: China name: Wei Hu, MD role: CONTACT phone: 13856086475 email: ayefygcp@163.com lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06359587 id: H22-03005 briefTitle: Re-Purposing the Ordering of Routine Laboratory Tests in Hospitals in British Columbia acronym: RePORT-BC overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2026-10-01 date: 2026-10-01 date: 2024-04-11 date: 2024-04-15 name: University of British Columbia class: OTHER name: Providence Health & Services name: Vancouver Coastal Health name: Fraser Health name: Interior Health name: Northern Hospital, Australia name: Canadian Institutes of Health Research (CIHR) name: Island Health briefSummary: The goal of this stepped-wedge cluster randomized trial is to assess the impact of a laboratory test overuse intervention bundle on laboratory test utilization in 6 health authorities (16 hospitals) in British Columbia. The main question it aims to answer is if the intervention bundle, inclusive of healthcare provider and patient engagement tools, can be effectively implemented for hospitalized medical inpatients in 16 hospitals across BC and reduce laboratory test over-use. Researchers will compare hospital clusters that receive the intervention at different (sequential) time points to see if there are significant changes in the measured outcomes after the intervention. conditions: Hospital Acquired Condition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Intervention Arm (Intervention Bundle Implementation):

This arm involves the time periods where hospital units are actively receiving the intervention bundle, including healthcare provider (HCP) and patient engagement tools.

Control Arm (No Intervention Bundle Implementation):

This arm represents the time periods when the hospital units do not receive the intervention bundle. This time period is the control period. Each hospital will contribute to intervention and control period data. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 700000 type: ESTIMATED name: Laboratory test overuse (LTO) Bundle measure: Change in number of target laboratory tests ordered per patient-day with LTO bundle compared to control period without LTO bundle measure: Change in number of total laboratory tests ordered per patient-day with the LTO bundle measure: Rate of hospital re-admissions and mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359574 id: IRB-24-0209 briefTitle: Core Competency Model for Corrections acronym: CCM-C overallStatus: ENROLLING_BY_INVITATION date: 2024-04-05 date: 2024-12-31 date: 2025-01-30 date: 2024-04-11 date: 2024-04-16 name: University of North Carolina, Charlotte class: OTHER name: North Carolina Department of Adult Corrections name: North Carolina Department of Health and Human Services briefSummary: The overall goal of this project is to design, implement, and revise the Core Competency Model for Corrections (CCM-C), an evidence-based Self-Directed Violence (SDV) prevention training program for correctional mental health providers in the North Carolina Department of Adult Corrections (DAC). The proposed specific aims are:

Aim 1: To create the CCM-C training program. Aim 2: To assess preliminary training effectiveness. Aim 3: To gather training program quality improvement feedback from corrections stakeholders. conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Core Competency Model for Corrections (CCM-C) Self-Directed Violence Prevention Training measure: Feasibility measure: Acceptability measure: Appropriateness measure: Usability measure: Perceived self-directed violence prevention skills measure: Willingness to intervene with a suicidal person measure: Beliefs about incarcerated persons engaging in self-directed violence measure: Self-directed violence prevention knowledge measure: Perceived importance of training measure: Compassion fatigue: Job burnout measure: Compassion fatigue: Traumatic stress sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: North Carolina Department of Adult Corrections city: Raleigh state: North Carolina zip: 27699 country: United States lat: 35.7721 lon: -78.63861 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-14 uploadDate: 2024-03-20T14:21 filename: ICF_000.pdf size: 256435 hasResults: False

 nctId: NCT06359561 id: 2023-2201 - Cervical lead briefTitle: Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Patients With Cervical Lead Placement overallStatus: ENROLLING_BY_INVITATION date: 2023-10-05 date: 2025-12-31 date: 2025-12-31 date: 2024-04-11 date: 2024-04-11 name: Rijnstate Hospital class: OTHER name: Saluda Medical Pty Ltd briefSummary: This observational, prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement. conditions: Chronic Pain Syndrome conditions: Multi Focal Pain conditions: Failed Neck Surgery Syndrome conditions: Polyneuropathies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: cervical lead placement measure: Pain intensity in pain region(s) of pain using the 11-box pain numeric rating scale (NRS) measure: Pain distribution using Patient Reported Dermatomal Coverage Map measure: Assessment of holistic outcomes: quality of life in seven domains (physical function, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance) assessed by the PROMIS-29 questionnaire measure: Pain-related medication intake. measure: Programming parameters. measure: Programming parameters. measure: Evaluate stimulation sensation (awareness and quality) measure: Evaluate stimulation coverage in pain region(s) measure: Posture Change Measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rijnstate Hospital city: Arnhem state: Gelderland zip: 6815AD country: Netherlands lat: 51.98 lon: 5.91111 hasResults: False

 nctId: NCT06359548 id: XH-24-002 briefTitle: PEELED INTERNAL LIMITING MEMBRANE REPOSITION overallStatus: RECRUITING date: 2024-04-15 date: 2026-06 date: 2026-11 date: 2024-04-11 date: 2024-04-11 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling. conditions: Macular Holes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Peeled ILM Reposition name: ILM Peeling measure: The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively measure: The MH closure rate measure: The range of inner retinal dimpling measure: Postoperative retinal thickness measure: The fixation stability and sensitivity threshold measure: mfERG P1 wave density amplitudes measure: M-score values measure: NEI-VFQ-25 questionnaire scores sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School status: RECRUITING city: Shanghai country: China name: Tian Tian, Dr. role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06359535 id: HSK21542-IIT-02 briefTitle: An Economic Study of HSK21542 Injection for Prevention of Postoperative Nausea and Vomiting overallStatus: RECRUITING date: 2024-02-23 date: 2024-11-06 date: 2024-11-06 date: 2024-04-11 date: 2024-04-11 name: Mengchang Yang class: OTHER briefSummary: This study analyzed the efficacy and safety results of HSK21542 injection for the prevention of postoperative nausea and vomiting in a multicentre, randomized, double-blind, placebo-controlled dose-exploration study, as well as the real-world clinical routine use of troisisone and other (not limited to other setron drugs) for the prevention of postoperative nausea and vomiting and related adverse reaction treatment data. It was transformed into an effect indicator, and the possible costs involved in the study were analyzed, reasonable price parameters of HSK21542 injection were set, and the economic value of HSK21542 was explored. conditions: Nausea and Vomiting, Postoperative studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: HSK21542 name: Placebo measure: Total direct medical costs, direct non-medical costs, indirect costs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital status: RECRUITING city: Chengdu state: Sichuan country: China name: Mengchang Yang, Doctor role: CONTACT phone: +8618140049936 email: ymc681@126.com name: Mengchang Yang role: PRINCIPAL_INVESTIGATOR name: Yu He role: SUB_INVESTIGATOR name: Mengxia Lan role: SUB_INVESTIGATOR name: Ai Wei role: SUB_INVESTIGATOR name: Lina Yang role: SUB_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06359522 id: 22.0334 briefTitle: PDA Occlusion Using NIRS overallStatus: RECRUITING date: 2023-04-18 date: 2025-03-31 date: 2025-09-30 date: 2024-04-11 date: 2024-04-11 name: University of Louisville class: OTHER name: Norton Healthcare briefSummary: Our study will be a prospective observational study of all patients in the Norton Children's Hospital NICU (Neonatal Intensive Care Unit) who undergo a transcatheter PDA occlusion or medical closure of PDA to compare the two populations regarding changes in organ perfusion determined by using NIRS monitoring to follow the regional saturation of oxygen (rSO2) of the cerebral and renal regions. We suspect that medical treatment will have no significant change in rSO2 as described in previous literature. We also suspect that transcatheter occlusion will have minimal effects on rSO2 and be comparable to medical therapy. conditions: Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients who are being treated for PDA closure either via transcatheter occlusion or medical closure as part of routine care are eligible for this study. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: NIRS monitor measure: Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings. measure: Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol. measure: Compare rates of co-morbid conditions between the two groups such as but not limited to necrotizing enterocolitis, feedings intolerance, or failed to extubate within 5 days post treatment. sex: ALL minimumAge: 0 Months maximumAge: 3 Months stdAges: CHILD facility: Norton Children's Hospital status: RECRUITING city: Louisville state: Kentucky zip: 40202 country: United States name: Scott D Duncan, MD role: CONTACT phone: 502-629-5283 email: scottd.duncan@louisville.edu name: Janice E. Sullivan, MD role: CONTACT phone: 502-629-5283 email: sully@louisville.edu name: Joshua D Kurtz, MD role: SUB_INVESTIGATOR name: Joshua Lee, MD role: SUB_INVESTIGATOR name: John N Juneau, MD role: SUB_INVESTIGATOR lat: 38.25424 lon: -85.75941 hasResults: False

 nctId: NCT06359509 id: SYS6020-001 briefTitle: Study of SYS6020 in BCMA-positive Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-05 date: 2032-05 date: 2024-04-11 date: 2024-04-11 name: Wuhan Union Hospital, China class: OTHER briefSummary: This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: BCMA Targeted CAR T-cells measure: Incidence of adverse events (AEs) measure: Dose limiting toxicities (DLTs) measure: Overall response rate (ORR) measure: Percentage of subjects who achieved complete response or strict complete response (CR/sCR) measure: Percentage of subjects who achieved very good partial response (VGPR) and higher response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359496 id: CT2024-ZJU-OBS8 briefTitle: Split or Whole Liver Transplantation? A Multicenter Retrospective Cohort Study of Patients With Benign and Malignant Liver Disease overallStatus: COMPLETED date: 2024-02-23 date: 2024-04-02 date: 2024-04-02 date: 2024-04-11 date: 2024-04-11 name: Zhejiang University class: OTHER briefSummary: The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .

Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.

This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05. conditions: Zhejiang University studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1 type: ACTUAL name: No intervention factor measure: Postoperative complications were evaluated by postoperative imaging reports and serological indicators measure: The survival rate of each group was evaluated by follow-up survey and K-M curve sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Xiao Xu city: Hangzhou country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06359483 id: 108/2021 briefTitle: The Impact of Meal Frequency on Bone Remodeling in Healthy Adults overallStatus: COMPLETED date: 2021-06-19 date: 2021-07-04 date: 2021-07-04 date: 2024-04-11 date: 2024-04-11 name: University of Jordan class: OTHER name: United Arab Emirates University briefSummary: The study aimed to investigate the effect of meal frequency on bone remodeling using the marker Procollagen Type 1 N-terminal propeptide (P1NP). Thirty healthy adult males from Jordan participated in a randomized controlled intervention trial. They were randomly assigned to three or eight daily meals for three consecutive days over two phases. Blood samples were obtained at the beginning and end of each phase, and P1NP levels were analyzed. The results showed a substantial drop in P1NP levels compared to the baseline, indicating that meal frequency influences bone development. There were no significant changes between the groups eating three and eight meals per day. The study emphasizes the importance of dietary patterns in bone health and advises additional research to understand the relationship between meal frequency and bone metabolism. conditions: Healthy Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ACTUAL name: Meal Frequency Manipulation measure: The title of the primary outcome is "Procollagen Type 1 N-terminal propeptide (P1NP) Levels." sex: ALL minimumAge: 19 Years maximumAge: 30 Years stdAges: ADULT facility: University of Jordan city: Amman country: Jordan lat: 31.95522 lon: 35.94503 hasResults: False

 nctId: NCT06359470 id: CaiUni briefTitle: the Modified Reversed Contralateral Axial Rotation Position overallStatus: COMPLETED date: 2022-11-05 date: 2023-10-01 date: 2024-01-14 date: 2024-04-11 date: 2024-04-11 name: Noha Khaled Shoukry class: OTHER briefSummary: This study aimed to investigate the effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine conditions: Disc Prolapse With Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This study was conducted on ninety male patients (30 in each group), ages ranged from 20 - 40 years old, and were diagnosed with unilateral lumbar disc prolapse (group1: L3-L4), (group 2: L4- L5) and (group 3: L5-S1) for at least three months in a radiology center specialized in the spine (Egyscan center). Each group was imaged three times (from the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours). The oblique image was taken during a specific trunk position the modified reversed contralateral rotation (side-lying with side bending to the non-affected side and rotation to non affected side).The CSA of LIVF and SLR test was assessed at the three times of testing primaryPurpose: TREATMENT masking: NONE count: 90 type: ACTUAL name: Positioning technique measure: Straight leg raising test measure: Foraminal cross sectional area sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Physical Therapy city: Giza zip: 12556 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06359457 id: P.T.REC/012/005016 briefTitle: Correlation Between Serum Progesterone Level And Primary Dysmenorrhea overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-06 date: 2024-07 date: 2024-04-11 date: 2024-04-11 name: Cairo University class: OTHER briefSummary: This study will be conducted to determine Correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females conditions: Primary Dysmenorrhea studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: Serum progesterone level measure: Pain intensity measure: Physical and psychological symptoms sex: FEMALE minimumAge: 17 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06359444 id: ONZ-2023-0453 briefTitle: Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD acronym: CENSORIAL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-15 date: 2026-03-15 date: 2024-04-11 date: 2024-04-11 name: University Ghent class: OTHER name: University Hospital, Ghent briefSummary: Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD.

In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent. conditions: Exercise Therapy conditions: Metabolic Dysfunction-associated Steatotic Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized in two groups: (a) combined aerobic and strength and (b) combined high intensity and strength. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The training will be given by the care provider, but in exercise therapy it is not possible to mask. The assessor will assess the patients without knowing in which group they will be randomized. Randomization will be done by an external person who is only involved for randomization. The investigator, who will be analysing data afterwords, will only see 1 or 2 as group number, but will not know which number is corresponding to which group. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Combined aerobic + strength training name: Combined strength + HIIT training measure: Liver steatosis by CAP measure: Liver steatosis on ultrasound measure: Insulin sensitivity measure: Liver transaminases measure: Maximal exercise test measure: Strength measure: Cardiovascular function measure: Weight measure: Heigth measure: BMI measure: waist measure: BIA measure: Interleukine measure: TNF-alfa measure: Hepatokines measure: Myokines measure: Adipokines measure: SF-36 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-29 uploadDate: 2024-03-23T04:06 filename: SAP_000.pdf size: 133707 hasResults: False

 nctId: NCT06359431 id: 1604/CE/CNERSH/SP briefTitle: A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-07-30 date: 2024-04-11 date: 2024-04-11 name: GICMED class: OTHER briefSummary: Objective: The main objective of this study is to verify the level of comfort for patients and the degree of cervical visibility for health providers using a novel smart speculum compared to the standard speculum. In addition, establish the feasibility of using this novel smart speculum device with telemedicine for cervical cancer screening in a low-resource setting using VIA compared to the standard of care.

Study sites: The study will be carried out in six health facilities in the centre region of Cameroon.

Study Period: The study is expected to take 11 months; 4 months for protocol development and approval, 4 months for the training and implementation phase with data collection, 3 months for data analysis, reporting writing and dissemination.

Study design: The study will be a multicentre, randomised control single blind trial. Patient participation will be a single study visit. Eligible subjects, consenting to participate will act as their own controls, and will receive speculum examination and cervical cancer screening with both the novel speculum and a traditional speculum. The order of usage of the specula will be randomised, and the women will be blinded on knowing which speculum is being used at a particular time. Level of patient comfort will be evaluated using a visual analogue scale, percentage visualisation of the cervix will be determined following insertion of each of the specula, and results of cervical cancer screening following VIA screening method will be compared between the standard of care procedure to that using the novel smart speculum associated to telemedicine.

Patient population: All women between the ages of 21 years and 49 years who come in for consultation.

Enrolment size: 81 women will be enrolled in the study. Study procedure: A speculum examination will be done on the day of consultation. Level of patient comfort determined using a visual analogue scale and proportion of the cervix visualised would be recorded into questionnaires. Cervical cancer screening through VIA will be performed with results confirmed on site by the clinician using the standard speculum, while two other clinicians for each case will do a remote diagnosis after reviewing images captured through the novel speculum device and forwarded to them through telemedicine. The remote clinicians will be blinded on the diagnosis proposed by the clinician on site.

Primary endpoints: The proportion of clinicians with easy visualisation of the cervix with the 2 specula, level of patient comfort with the novel smart speculum compared to the Standard of care speculum (traditional speculum), reliability of the speculum in carrying out cervical cancer screening using telemedicine.

Ethical considerations: The protocol will be submitted for the approval of the National Human Health Research Committee. Written informed consent will be sought for all participants before enrolment into the study. conditions: Cervical Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 81 type: ESTIMATED name: Novel Smart Speculum name: Standard speculum measure: Visualization measure: Reliability in cervical cancer screening using a questionnaire sex: FEMALE minimumAge: 21 Years maximumAge: 49 Years stdAges: ADULT hasResults: False

 nctId: NCT06359418 id: 2024-007-KY briefTitle: Acupuncture for Obesity With Prediabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2026-12-10 date: 2027-03-30 date: 2024-04-11 date: 2024-04-11 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER name: Hubei Hospital of Traditional Chinese Medicine name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine name: Dongfang Hospital Beijing University of Chinese Medicine name: Guangdong Provincial Hospital of Traditional Chinese Medicine name: Heilongjiang Academy of traditional Chinese Medicine briefSummary: The clinical trial aims to evaluate the efficacy and safety of acupuncture on weight loss and changes of glucose and lipid metabolism in obese adults with pre-diabetes. conditions: Obesity conditions: Pre-diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 260 type: ESTIMATED name: Acupuncture name: Sham acupuncture measure: The percentage change in body weight from baseline to week 12 measure: The percentage change in body weight compared to the baseline measure: Achievement of a reduction in body weight of 5% or more compared to the baseline measure: Achievement of a reduction in body weight of 7% or more compared to the baseline measure: The change in 1hPG from baseline and percentage of patients who returned to normal measure: The change in 2hPG from baseline and percentage of patients who returned to normal measure: The change in FPG from baseline and percentage of patients who returned to normal measure: The change in HbA1c from baseline and percentage of patients who returned to normal measure: The change in waist circumference from baseline measure: The change in BMI from baseline measure: The change in WHR from baseline measure: The change in WHtR from baseline measure: The change in blood pressure from baseline measure: Changes in appetite VAS score from baseline measure: The change in FINS from baseline measure: The change in HOMA-IR from baseline measure: The change in HOMA-β from baseline measure: The change in Serum total cholesterol from baseline measure: The change in Triglyceride from baseline measure: The change in Low-Density Lipoprotein Cholesterol from baseline measure: The change in High-Density Lipoprotein Cholesterol from baseline measure: The change in Serum Uric Acid from baseline measure: Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline. measure: Changes of the PHQ-4 score from the baseline. measure: Expectance assessment measure: Assessment of belief in acupuncture measure: Blinding assessment measure: Safety assessment measure: Adherence assessment of acupuncture measure: Adherence assessment of life modification sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences city: Beijing country: China name: Zhishun Liu, PhD role: CONTACT phone: +861088002331 email: zhishunjournal@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06359405 id: UBeykentUni briefTitle: Evaluation of Nursing Students' Crisis Management Skills in Medication Safety Simulation acronym: RCS overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-01 date: 2024-05-02 date: 2024-04-11 date: 2024-04-16 name: University of Beykent class: OTHER briefSummary: This study aims to objectively evaluate student nurses' crisis management skills in drug safety simulation and examine an effective intervention to improve these skills through a randomized controlled study. The research aims to provide important findings that will contribute to the determination of strategies to increase the competencies of student nurses in the fields of drug safety and crisis management.

Research Hypotheses:

H1: The application of drug safety simulation has an effect on the crisis management skill level of nursing students.

The aim of the intervention is to develop a simulation program to enhance nursing students' crisis management skills in drug safety. This simulation program will provide students with the opportunity to recognize, assess, and effectively intervene in medication errors in real-world scenarios.

The simulation program will include interactive case scenarios, virtual patients, and simulation sessions led by an instructor providing feedback to students. Additionally, learning materials covering topics such as prevention, recognition, and correction of medication errors will be provided conditions: Nurse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was planned as a randomized controlled study to evaluate the crisis management skills of student nurses in drug safety simulation. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: The researchers declare that the data obtained from randomly formed groups will be numbered and entered into the statistical analysis program to hide the identity information and that two researchers will be assigned during the entry. whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: drug safety simulation measure: The effect of drug safety simulation application on the crisis management skill level of nursing students. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359392 id: DNZNC466DGR7 id: 1R21NR020383-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21NR020383-01 briefTitle: Palliative Care Messaging for American Indians overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-05-15 date: 2024-05-15 date: 2024-04-11 date: 2024-04-11 name: South Dakota State University class: OTHER name: Great Plains Tribal Leaders Health Board name: National Institute of Nursing Research (NINR) briefSummary: The investigators will be conducting a randomized trial in 3 reservation communities to test the efficacy of the narrative as culture-centric health promotion model for increasing American Indian tribal members' palliative care knowledge and intentions to discuss palliative care. conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 360 type: ESTIMATED name: No message name: Culture-centric message name: General messge measure: Palliative Care Knowledge Scale (PaCKS) measure: Knowledge of Care Options (KOCO) measure: Hospice and Palliative Care Questionnaire (HPCQ) measure: Identification and Transportation with Palliative Care Message measure: Attitudes and Intentions to Discuss Palliative Care sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Dakota State University city: Rapid City state: South Dakota zip: 57701 country: United States name: Mary J Isaacson, PhD, RN, RHNC, CHPN, FPCN role: CONTACT phone: 605-670-0975 email: mary.isaacson@sdstate.edu name: Karla Hunter, PhD role: CONTACT phone: 605-212-0894 email: karla.hunter@sdstate.edu name: Mary J Isaacson, PhD, RN, RHNC, CHPN, FPCN role: PRINCIPAL_INVESTIGATOR lat: 44.08054 lon: -103.23101 hasResults: False

 nctId: NCT06359379 id: S22-11168 briefTitle: Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-08 date: 2027-02 date: 2024-04-11 date: 2024-04-11 name: Shuttle Pharmaceuticals, Inc. class: INDUSTRY briefSummary: This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy. conditions: Glioblastoma, IDH-wildtype studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Ropidoxuridine measure: Number of patients treated with oral ropidoxuridine at dose levels of 960 and 1200 mg once daily, with treatment-related adverse events assessed by CTCAE v5.0. measure: adiographic response rate, disease control rate, best overall response, and duration of overall response in patients treated with oral ropidoxuridine at 960 and 1200 mg daily doses, assessed using the Response Assessment in Neuro-Oncology criteria. measure: Maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. measure: Trough plasma concentration of orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily measure: Time to maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. measure: Area under the curve for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. measure: Half-life for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. measure: Overall survival at 12 months measure: Radiographic Response Rate measure: Disease Control Rate measure: Best Overall Response measure: Duration of Response measure: Overall Survival measure: Progression-Free Survival measure: Six-Month Progression-Free Survival measure: Fraction of patients with tumor progression outside of the treatment area. measure: Quantification of 9 relevant neurologic domains based on the NANO scale. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lombardi Comprehensive Cancer Center at Georgetown University city: Washington state: District of Columbia zip: 20007 country: United States lat: 38.89511 lon: -77.03637 facility: Sylvester Comprehensive Cancer Center city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 facility: John Theurer Cancer Center at the Hackensack University Medical Center city: Hackensack state: New Jersey zip: 07601 country: United States lat: 40.88593 lon: -74.04347 facility: Memorial Sloan Kettering Cancer Center city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 facility: Allegheny General Hospital city: Pittsburgh state: Pennsylvania zip: 15212 country: United States lat: 40.44062 lon: -79.99589 facility: University of Virginia city: Charlottesville state: Virginia zip: 22903 country: United States lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06359366 id: ShenzhenH-guo briefTitle: Perineal Massage Combined With Hip Joint Training overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-07-31 date: 2024-08-31 date: 2024-04-11 date: 2024-04-11 name: Shenzhen Hospital of Southern Medical University class: OTHER briefSummary: The goal of this clinical trial is to learn if perineal massage combined with hip joint training works to improve pelvic function (urinary incontinence, constipation and hip motion) in pregnant women. The main questions it aims to answer are:

Does the perineal massage combined with hip joint training lower the prevalence of participants who have urinary incontinence and constipation? Does the perineal massage combined with hip joint training improve the flexibility of the hip joint? Researchers will compare an intervention (perineal massage combined with hip joint training) to a comparison(regular training and treatment) to see if the intervention (perineal massage combined with hip joint training) works to improve pelvic function.

Participants will:

receive the intervention (perineal massage combined with hip joint training ) or regular training and treatment fifth a week at 36 weeks gestation before participants receive first-time intervention, they complete Demographic sociological , ICI-Q-LF, Wexner constipation and hip motion questionnaires conditions: Pelvic Floor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: when the participants are enrolled in this study, they will be allocated to groups randomly by an independent researcher and sign the consent form. The care providers will not know the outcomes of this study, they just provide treatment for pregnant women; therefore, the care providers could be masked. an independent investigator will send a questionnaire to the participant, and the investigator does not know the intervention participants received; thus they could be masked. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: perineal massage combined hip joint training measure: pelvic floor function(constipation) measure: pelvic floor function (urinary incontinence score) measure: hip motion sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06359353 id: B-1902-520-004 briefTitle: Effect of Pitavastatin on Bone overallStatus: COMPLETED date: 2019-04-08 date: 2022-02-10 date: 2023-12-19 date: 2024-04-11 date: 2024-04-11 name: Seoul National University Bundang Hospital class: OTHER name: JW Pharmaceutical briefSummary: This clinical trial investigates the effects of pitavastatin on bone health in postmenopausal women with osteopenia or osteoporosis and hypercholesterolemia. Given the high prevalence of osteoporosis in aging populations and the associated risks, even with existing treatments, this study addresses a critical gap in medical research. Statins, specifically HMG-CoA reductase inhibitors, are suggested to benefit bone metabolism by promoting bone formation and reducing resorption. However, the specific impact of pitavastatin on bone metabolism lacks clinical evidence.

The study's primary goal is to determine the effects of a 12-month pitavastatin regimen on bone metabolism markers in this population. This research could significantly contribute to developing more effective osteoporosis treatments for postmenopausal women, combining bone health and cholesterol management strategies. conditions: Osteoporosis, Osteopenia conditions: Hypercholesterolemia conditions: Menopausal Osteoporosis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 70 type: ACTUAL name: Pitavastatin measure: Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months measure: Change in blood C-Telopeptide of Type I Collagen levels measure: Change in blood Osteocalcin levels measure: Change in urinary N-Telopeptide of Type I Collagen levels measure: Change in blood Procollagen Type 1 N-Terminal Propeptide levels measure: Change in blood LDL-cholesterol levels measure: Change in blood HbA1c levels measure: Changes in bone mineral density measure: Changes of the outcomes after 12 months sex: FEMALE maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Bundang Hospital city: Seongnam state: Gyeonggi zip: 463-707 country: Korea, Republic of lat: 37.43861 lon: 127.13778 hasResults: False

 nctId: NCT06359340 id: OBOT-2018C2-13158 briefTitle: Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder overallStatus: RECRUITING date: 2020-03-13 date: 2024-04-30 date: 2025-04-30 date: 2024-04-11 date: 2024-04-11 name: Public Health Management Corporation class: OTHER name: Boston University name: Patient-Centered Outcomes Research Institute name: Philadelphia College of Osteopathic Medicine name: University of Pennsylvania briefSummary: Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, the investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined. conditions: Opioid-use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 440 type: ESTIMATED name: Psychosocial treatment measure: Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry measure: Days Retained in Office-Based Buprenorphine Treatment measure: Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year post-study entry measure: Changes in multidimensional problem severity from baseline through one year post-study entry measure: Changes in the percentage of individuals engaging in urinalysis-confirmed use of other (non-opioid) drugs from baseline to one year post-study entry measure: Changes in ED utilization from baseline to one year post-study entry measure: Changes in opioid overdose rates measure: Changes in treatment satisfaction from baseline to one year post-study entry measure: Job satisfaction and stress sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Philadelphia College of Osteopathic Medicine status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19131 country: United States name: David S Festinger, Ph.D. role: CONTACT phone: 215-871-6546 email: DavidFe@pcom.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06359327 id: Pro00075623 briefTitle: Effect of Consumption of Pep19 on Quality of Life overallStatus: RECRUITING date: 2024-04-17 date: 2024-07-17 date: 2024-08-15 date: 2024-04-11 date: 2024-04-19 name: Proteimax Biotechnology Israel LTD class: INDUSTRY briefSummary: Pep19 is a naturally occurring peptide (protein) that triggers loss of body fat. It has been certified Generally Recognized as Safe (GRAS) at up to 3.8 grams per day and may be included in various foods. Pep19 has no effect on the brain, heart, pancreas or skeletal muscle. It is highly purified, not allergenic or mutagenic, and free of microbes, metals and other contaminants. Preliminary, open-label, uncontrolled studies have shown that Pep19 is well tolerated in rodents, dogs, and humans. This placebo-controlled study will evaluate the effects of two doses of Pep19™ -- 2 mg and 5 mg - on quality of life and sleep quality in obese subjects. conditions: Quality of Life conditions: Obesity conditions: Sleep Quality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Placebo name: Pep19 2 mg name: Pep19 5 mg measure: Improvement on QoL measure: Improvement on Sleep quality measure: Temperature measure: Blood pressure measure: Heart rate measure: circumference measure: blood tests measure: Body fat measure: Body weight sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Precision Clinical Research, LLC status: RECRUITING city: Sunrise state: Florida zip: 33351 country: United States name: Jason Haffizulla, MD role: CONTACT lat: 26.13397 lon: -80.1131 hasResults: False

 nctId: NCT06359314 id: STU00219362 briefTitle: Anxiety Lowering and Deprescribing Through Emotion Regulation acronym: ALDER overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-11 date: 2024-04-11 name: Northwestern University class: OTHER briefSummary: The goal of this clinical trial is to test ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation), an online self-guided positive emotion intervention, in patients over the age of 65 who are candidates for benzodiazepine receptor agonist (BZRA, commonly called benzos, or z-drugs) deprescribing. The main questions it aims to answer are:

* Is ALDER relevant to and satisfactory for older adult BZRA users?
* Does ALDER help to increase positive emotions and decrease anxiety, trouble sleeping, and use of BZRA medications?

Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments, one before the intervention and one after. conditions: Benzodiazepine Dependence conditions: Anxiety Disorders conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: ALDER measure: Feasibility of intervention measure: Acceptability of intervention measure: Adoption of intervention measure: Patient benzodiazepine receptor agonist (BZRA) use measure: Patient attitude towards deprescribing BZRAs measure: Patient-reported sleep disturbance measure: Patient-reported anxiety measure: Patient-reported stress measure: Patient-reported depression measure: Patient-reported positive affect measure: Patient-reported meaning and purpose measure: Patient-reported comorbidities sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359301 id: H-34 briefTitle: H-34 DELTA Revision Cup overallStatus: RECRUITING date: 2021-09-14 date: 2026-03-31 date: 2029-03-31 date: 2024-04-11 date: 2024-04-11 name: Limacorporate S.p.a class: INDUSTRY briefSummary: THis study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup. conditions: Hip, Osteoarthritis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 49 type: ESTIMATED name: DELTA Revision acetabular cup measure: Harris Hip Score (HHS) measure: ROM measurement measure: Oxforn Hip Score (OHS) measure: Survival rate measure: Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup measure: Incidence, type and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP status: RECRUITING city: Otwock zip: 05-400 country: Poland name: Jerzy Bialecki role: CONTACT lat: 52.10577 lon: 21.26129 hasResults: False

 nctId: NCT06359288 id: 2023/01.11/2023/6 briefTitle: Preterm Newborn Mothers' Anxiety and Self-Efficacy overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-01 date: 2024-03-23 date: 2024-04-11 date: 2024-04-11 name: Kocaeli University class: OTHER briefSummary: The aim of this study was to evaluate the effect of QR code supported infant care training given to mothers of preterm newborns on maternal self-efficacy and maternal anxiety level . conditions: Nursing Care conditions: Mother-Infant Interaction conditions: Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted experimentally with a pre-test and post-test control group. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double blinding was used in the study. For this purpose, the participants were not specified in which group they belonged to the research. Therefore, a separate informed consent form was prepared for each group. In order to avoid bias in the analysis of the research data, statistician blinding was also applied.

While coding the research data, the research groups were coded as A and B, and the statistician was prevented from knowing which letter represented which group. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ACTUAL name: Group receiving QR code supported training measure: Perceived Maternal Self-Efficacy Scale (PMES)- Survey measure: State-Trait Anxiety Inventory (STAI)- Survey Scale sex: FEMALE minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: Kocaeli University city: Kocaeli state: İzmit zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06359275 id: iPULSAR-PC briefTitle: PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2027-10-01 date: 2024-04-11 date: 2024-04-11 name: Fudan University class: OTHER briefSummary: This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: PD-1 name: Nab-paclitaxel name: Gemcitabine name: PULSAR measure: Progression-free survival (PFS) measure: Progression-free survival (ORR) measure: Overall survival (OS) measure: Surgical Conversion Rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanhai country: China name: Weijing Zhang role: CONTACT phone: 021-64175590 email: andwater@163.com hasResults: False

 nctId: NCT06359262 id: KI-HAS-001 briefTitle: Evaluating the Hope@School Prevention Program acronym: Hope@School overallStatus: NOT_YET_RECRUITING date: 2027-01-01 date: 2027-12-30 date: 2028-12-30 date: 2024-04-11 date: 2024-04-11 name: Karolinska Institutet class: OTHER briefSummary: This multi-center cluster-randomized controlled trial aims to evaluate the feasibility, effectiveness and overall impact of the Hope@School (H@S) program by comparing mental health outcomes in students participating in the H@S program with students having only access to regular student health care (treatment as usual - TAU).

The primary objectives of the study are:

To determine if the H@S program is feasible, acceptable, usable and safe for students, families, teachers and school leaders To establish if the H@S program is associated with improvements in quality of life, everyday functioning, peer relations and general mental health. conditions: Mental Health Wellness 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 3220 type: ESTIMATED name: Hope@School name: Treatment as usual measure: KIDSCREEN-27 Child version measure: KIDSCREEN-27 Parent version measure: Mental Health-Promoting Knowledge (MHPK-10) measure: Healthy Behaviours in School-aged Children survey protocol (HBSC) part 1 measure: Digital Addiction Scale for Children (DASC) measure: Healthy Behaviours in School-aged Children survey protocol (HBSC) part 2 sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06359249 id: V.3-06/02/2024 briefTitle: Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage? overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2026-12-28 date: 2026-12-28 date: 2024-04-11 date: 2024-04-11 name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina class: OTHER name: Universitat de Vic briefSummary: Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term. conditions: Constipation Chronic Idiopathic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: change of habits name: change of habits + auto abdominal massage measure: Degree of constipation measure: Stool characteristics measure: Quality of life focused on patients with constipation measure: The number of laxatives taken by each participant measure: Other patient characteristics such as sex, age, previous conditions, and level of physical activity with the VREM questionnaire. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cristina Segura Bayona city: Igualada state: Barcelona zip: 08700 country: Spain lat: 41.58098 lon: 1.6172 hasResults: False

 nctId: NCT06359236 id: 122S049 briefTitle: Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application "BI'KILO" overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-01 date: 2024-01-01 date: 2024-04-01 date: 2024-04-11 date: 2024-04-11 name: Eskisehir Osmangazi University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: The primary purpose of this project is to observe the effects of Cognitive Behavioral Psychotherapy-based weight-loss mobile application (Bi' Kilo) in 4 essential areas (Anthropometric, Biochemical, Psychometric, Cognitive) in overweight and obese individuals and to test whether these effects will persist after ten weeks. In this context, the original value of the proposed study is that a mobile application will be produced that is suitable for the culture and whose effectiveness has been scientifically proven.

In our current project proposal, the measurements of the participants will be evaluated holistically together with both tests and inventories, as well as physical measurements and biochemical data. In this study, the usability of the mobile application to be developed will also be evaluated and reported.

The study group of the research will consist of overweight and obese individuals. The first stage will be a pilot study to identify the shortcomings of the Bi'Kilo mobile application. After eliminating the deficiencies of the Bi' Kilo mobile application, a working group will be formed in the second phase of the research. At this stage, the sample will be divided into two different groups within the scope of the study and a study group and a control group will be formed.

The study consists of three phases as preparation, implementation, and follow-up. Measurements of the participants will be made at the beginning (Anthropometric, Biochemical, Psychometric, Cognitive), at the end of the six-week implementation phase (Anthropometric), and at the end of the four-week follow-up phase (Anthropometric, Biochemical, Psychometric, Cognitive). conditions: Weight Loss conditions: Obesity conditions: Overweight and Obesity conditions: Eating Behavior conditions: Eating Habit studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: BI'KILO Intervention measure: Body Mass Index (BMI) measure: Weight measure: Height measure: Waist Circumference (WC) measure: Hip Circumference measure: Waist-Hip Ratio (WHR) measure: Body Fat Percentage (BFP) measure: Visceral Fat measure: Blood Glucose Level measure: Blood Insulin Level measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) measure: Serum Leptin Level measure: Serum Ghrelin Level measure: Emotional Eating Scale (EES) Turkish Form measure: Mindful Eating Questionnaire (MEQ) Turkish Form measure: Modified Yale Food Addiction Scale Version 2.0 Turkish Form (mYFAS 2.0) measure: Motor Screening Task (MOT) measure: Spatial Working Memory (SWM) measure: Stop Signal Task (SST) measure: Rapid Visual Information Processing (RVP) measure: Cambridge Gambling Test (CGT) measure: Demographic Information Form measure: Structured Clinical Interview for DSM-5 Disorders (SCID-5) measure: The Eating Disorder Assessment for DSM-5 (EDA-5) measure: Blood ACTH Level (ACTH) measure: Blood Growth Hormone Level (GH) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eskisehir Osmangazi University Faculty of Medicine city: Eskişehir country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False

 nctId: NCT06359223 id: 2400602 briefTitle: Effect of Coffee Consumption on Pain and Intestinal Motility After Caesarean Section: overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-07-15 date: 2024-12-30 date: 2024-04-11 date: 2024-04-11 name: TC Erciyes University class: OTHER briefSummary: Purpose: It will be performed to minimize the problems that the mother and the newborn may experience in the postpartum period by eliminating the negative symptoms related to postpartum pain and delayed intestinal motility.

Design: It will be conducted as a randomized controlled experimental study. Method: It will consist of women who had cesarean section surgery at Necmettin Erbakan University Faculty of Medicine Hospital between April and July 2024. The sample of the research; The sample will consist of women who meet the selection criteria and voluntarily agree to participate in the research. Considering the possible 10% data loss in randomized controlled studies, a total of 50 women, 25 in each group, were planned to be sampled. Data will be collected using a personal information form and visual pain scale (VAS). . Immediately before coffee application (6-12-18 hours after surgery), women\&#39;s pain intensity and bowel motility will be evaluated. Women will then be asked to consume 100 ml of unsweetened caffeinated coffee at 6, 12 and 18 hours after surgery. 6,12,18. Half an hour after coffee consumption, women will be evaluated for pain using VAS. In the control group, no procedure will be applied and pain assessment will be made with VAS at the same hours.

Conclusion: It is aimed to reduce the pain and increase intestinal motility of patients who consume coffee after cesarean section.

Key Words: Caesarean Section, Coffee, Pain, Motility conditions: Operation conditions: Cesarean Section studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: coffee consumption name: control group measure: Postoperative Pain measure: intestinal motility sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: KTO Karatay Unıversty city: Konya state: Karatay zip: 42000 country: Turkey name: HÜMEYRA YÜKSEL, Ph.D Student role: PRINCIPAL_INVESTIGATOR name: Hafize Tüzmen, Ph.D student role: SUB_INVESTIGATOR name: Merve Yazar, Ph.D student role: SUB_INVESTIGATOR name: Jule Horasanlı, MD role: SUB_INVESTIGATOR name: Serap Sayar, Assis. Prof. role: SUB_INVESTIGATOR lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06359210 id: 4973 id: 4R33CA256656-03 type: NIH link: https://reporter.nih.gov/quickSearch/4R33CA256656-03 briefTitle: Sustaining Physical Activity After Cancer Exercise Sessions acronym: SPAACES overallStatus: RECRUITING date: 2024-03-04 date: 2026-03-01 date: 2026-12-31 date: 2024-04-11 date: 2024-04-11 name: Colorado State University class: OTHER name: National Cancer Institute (NCI) briefSummary: The goal of this clinical trial is to develop and test an adaptive physical activity (PA) maintenance intervention for cancer survivors, after participating in a community-based exercise oncology program. The main questions it aims to answer are:

* Aim 1: Examine the feasibility and acceptability of the intervention among cancer survivors and community partners. The researchers will utilize quantitative surveys, focus groups, and semi-structured interviews to collect information about feasibility, implementation, adaptation, and sustainability.
* Aim 2: Examine the effects of the intervention among cancer survivors. The researchers will compare the proportion of participants achieving the exercise guidelines for cancer survivors six-months following completion of the initial exercise program.

Participants will participate in a community-based exercise oncology program and then return to three months of free living. Based on the PA measured at the three-month follow-up, participants will be categorized as a "Responder" or "Incomplete Responder", and then randomized to the PA maintenance intervention. Researchers will compare those that are classified as Responders (meeting exercise guidelines for cancer survivors) and Incomplete Responders (not meeting guidelines for cancer survivors) to see what level of intervention is needed to influence sustainable behavior change in this population. conditions: Exercise Oncology conditions: Physical Activity Behavior conditions: Behavior Change Interventions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: An adaptive design results in a final total of 4 possible subgroups, depending upon responder/non-responder status, and researchers plan to compare the proportion of participants achieving the minimum exercise guidelines for cancer survivors within the responders and incomplete responder subgroups. Admittedly however, it is not possible to fully elucidate the analyses the researchers will conduct, as researchers cannot predict the number of subgroups that participants will represent at the end of the trial (e.g., if there are no "incomplete responders" the design reduces to randomization to only two groups), nor the number of participants who will be in those subgroups primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: Responder Monthly Behavior Change Discussion Sessions name: Incomplete Responder Monthly Behavior Change Discussion Sessions name: Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions measure: Physical Activity program measure: Quality of Life (QOL) measure: Physical Fitness - Aerobic measure: Physical Fitness - muscular strength and endurance measure: Feasibility and acceptability of the PA maintenance intervention components sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anschutz Medical Center status: NOT_YET_RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Ryan Marker, PhD, PT role: CONTACT phone: 720-848-0300 email: ryan.marker@cuanschutz.edu name: Ryan Marker, PhD, PT role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Colorado State University status: RECRUITING city: Fort Collins state: Colorado zip: 80526 country: United States name: Heather J Leach, PhD role: CONTACT phone: 970-491-8951 email: heather.leach@colostate.edu name: Heather J Leach, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.58526 lon: -105.08442 facility: University of Wyoming status: RECRUITING city: Laramie state: Wyoming zip: 82072 country: United States name: Derek Smith, PhD role: CONTACT phone: 307-766-5271 email: smithdt@uwyo.edu name: Derek Smith, PhD role: SUB_INVESTIGATOR lat: 41.31137 lon: -105.5911 hasResults: False

 nctId: NCT06359197 id: 2024-17022-GRA briefTitle: Effect of Caffeine Consumption on Protein Biomarkers and Cardiovascular Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-08-10 date: 2025-06-01 date: 2024-04-11 date: 2024-04-11 name: Hamilton Health Sciences Corporation class: OTHER briefSummary: Caffeine is one of the most widely consumed substances worldwide. This study looks to test and measure the changes in different biomarkers in the blood before and after having caffeine using capillary and venous blood sampling methods. A biomarker is a measurable indicator of biological processes. The primary goal of this clinical trial is to evaluate participant rate and adherence. It will also learn about how caffeine affects different biomarkers that may be related to cardiovascular disease. Finally, it will assess the accuracy of the capillary blood samples compared to the venous blood samples. The main questions it aims to answer are:

* What is the feasibility of recruiting and retaining participants?
* Are the study procedures appropriate to be translated to a larger future study?

Researchers will compare caffeine to a placebo (a look-alike substance that contains no drug) to see if

Participants will:

* Be randomly assigned to the control group or the caffeine group. Individuals in the control group will be taking a placebo pill with no effect and those in the caffeine group will be taking 400mg of caffeine in pill form.
* Be asked to undergo a fast of at least 8 hours overnight before taking two placebo pills or the 400 mg of caffeine via two caffeine pills. They will be required to stay fasted for 6 hours after taking the pill as well. The total time fasted will be at least 14 hours.
* Have blood collected using three different methods before taking the two pills, 3 hours after taking the pills and 6 hours after taking the pills. The 3 methods include intravenous (IV) blood sampling, finger prick and collection on Whatman 903 Protein Saver Card and collection using the TASSO+ device. The TASSO+ blood collection device is a small capillary blood collection device that is designed to be easy to use and able to be used outside of a hospital/lab setting. Whatman 903 Protein Saver Cards are special filter paper with five circles for samples, that are designed for the collection and storage of blood. conditions: Healthy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An external party will prepare an equal number of kits (n=18) containing all the required materials for the participants, both in the placebo and caffeine group. They will assign a unique random number to each of the packages; each number will correlate to either the placebo or caffeine group. When a participant agrees to the study, they will be given a unique participant ID number ranging from 0-36. Then, the external party will use a random number generator to pick the kit given to that participant. They will record the number associated with that kit, and link the kit number to the participant ID for tracking purposes. At the end of the study, the investigators will determine which participants received caffeine vs placebo based on the assigned random numbers. primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Caffeine Pill name: Placebo name: TASSO+ Device name: Finger prick and collection on Whatman Protein 903 Saver Cards name: Intravenous Sampling measure: Participant rate measure: Participant Adherence measure: Participant satisfaction measure: Significant changes in biomarkers observed after the ingestion of caffeine measure: Determine the correlation between capillary sampling and intravenous sampling measure: Determine the stability of capillary samples sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: David Braley Research Institute city: Hamilton state: Ontario zip: L8L 2X2 country: Canada name: Luca Malatesta role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: caffeine@crlb-gmel.ca name: Megan Robertson role: CONTACT phone: 905-527-527-4322 phoneExt: 40311 email: caffeine@crlb-gmel.ca name: Guillaume Pare, MD role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: Hamilton General Hospital city: Hamilton state: Ontario zip: L8L 2X2 country: Canada name: Luca Malatesta role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: caffeine@crlb-gmel.ca name: Megan Robertson role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: caffeine@crlb-gmel.ca name: Guillaume Pare, MD role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: McMaster University, Department of Pathology and Molecular Medicine city: Hamilton state: Ontario zip: L8S 4L8 country: Canada name: Luca Malatesta role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: caffeine@crlb-gmel.ca name: Megan Robertson role: CONTACT phone: 905-527-4322 phoneExt: 40311 email: caffeine@crlb-gmel.ca name: Guillaume Pare, MD role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 hasResults: False

 nctId: NCT06359184 id: GO21/1011 briefTitle: Yoga, Mother's Stress and Baby overallStatus: COMPLETED date: 2023-11-01 date: 2024-02-01 date: 2024-02-15 date: 2024-04-11 date: 2024-04-11 name: Hacettepe University class: OTHER briefSummary: The aim of this study is to examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby. 55 mothers with babies with sleep and feeding problems were included in the study. Mothers were randomly divided into two groups: yoga (n=29) and control group (n=26). Yoga training was applied to 29 mothers in the study group via video conferencing, 2 days a week, 1 hour a day for 8 weeks, while the mothers in the control group were given second evaluations 8 weeks after the first evaluation, without any intervention. Mothers were evaluated with the Perceived Stress Scale (PSS) for stress levels, with Parent-Child Containing Function Scale for the mother-infant relationship, with the Infancy and Early Childhood Feeding Process Mother'sAttitudes Scale for their attitudes towards the feeding process of their babies, and with Attitude Scale for Healthy Nutrition (ASHN) for their own nutrition attitudes, with Pittsburg Sleep Quality (PSQI) for sleep quality and babies with Infancy Period Adaptive Eating Behavior Scale for feeding problems, with Brief Infant/Child Sleep Questionnaire (BISQ) for sleep problems. conditions: Mother-Child Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 55 type: ACTUAL name: yoga name: control measure: Perceived Stress Scale (PSS) measure: Infancy and Early Childhood Feeding Process Mother's Attitudes Scale measure: Pittsburg Sleep Quality (PSQI) measure: Period Adaptive Eating Behavior Scale measure: Brief Infant/Child Sleep Questionnaire (BISQ) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ayşe Nur Ozan city: Istanbul state: Sarıyer zip: 34460 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06359171 id: RBHP 2023 LANHERS briefTitle: Effectiveness of the ARTH-e Application on Adherence to Physical Exercises in Patients Suffering From KOA: RCT acronym: ARTH-e3 overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2025-06-01 date: 2026-01-31 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: The aim of this study is to investigate the effectiveness of a smartphone-based e-health application (intervention group) compared with standard care (control group) in terms of changes in adherence in patients with knee osteoarthritis using the EARS questionnaire. In addition, other questionnaires presented in the appendix (KOOS, TSK, EPAP, EQ-5D-3L, pain) will be given to all patients in order to meet the secondary evaluation criteria. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The investigators plan to conduct a multicenter, prospective, comparative, randomised trial. Participants will be randomized to one of two groups: control or experimental. In each group (control or experimental), each participant will be able to use the application for a period of 6 months.

* Control group: physician's advice with examples of self-exercise (knee osteoarthritis booklet) + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet.
* Intervention group: download the application + adapted physical activity session with an APA/physiotherapist + delivery of the knee osteoarthritis booklet + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The investigating physician who will carry out the inclusion visit will know the result of the randomization which will be carried out during the consultation. The second evaluator, who will carry out the end-of-study visit, will not know the patient's group. As a result, the assessment will be neutral and the second assessor will evaluate the patient without being influenced by the study group. whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Application ARTH-e measure: Exercise Adherence Rating Scale measure: Pain Visual Analog Scale measure: EPAP questionnaire measure: TSK questionnaire measure: Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire measure: EQ-5D-3L questionnaire measure: Mobility measure: Average number of steps per day measure: Parameters for use of the ARTHE application measure: Functional tests - 30 sec chair lifts measure: Functional tests - Stair Climbing Test measure: Functional tests - 6MWT measure: Functional tests - quadriceps isometric strength test with dynamometer measure: Medico-economic analysis sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Clermont-Ferrand city: Clermont-Ferrand country: France name: Lise Laclautre role: CONTACT phone: 04 73 75 11 95 email: promo_interne_drci@chu-clermontferrand.fr name: Charlotte Lanhers, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: CH Emile Roux city: Le Puy-en-Velay country: France name: Gaëlle VIAL role: PRINCIPAL_INVESTIGATOR lat: 45.04366 lon: 3.88523 facility: CHU Montpellier city: Montpellier country: France name: Isabelle TAVARES FIGUEIREDO, Dr role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: CHU Nantes city: Nantes country: France name: Alban FOUASSON CHAILLOUX, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06359158 id: eStethoscope for Med Student briefTitle: Enhancing Respiratory Auscultation Skills Among Medical Students: Digital Stethoscopes in Medical Education overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-31 date: 2024-01-31 date: 2024-04-11 date: 2024-04-11 name: Chung Shan Medical University class: OTHER name: Ministry of Education, Taiwan briefSummary: Objectives: This study aims to assess the effectiveness of a novel digital stethoscope curriculum integrated into respiratory auscultation training for medical students. It seeks to compare the auscultation proficiency gained through this innovative approach with that from traditional teaching methods, to understand the potential of digital stethoscopes in reinvigorating clinical skills training.

Methods: In a single-center, controlled, longitudinal, randomized experimental design, 84 medical students undergoing clinical clerkship rotations at Chung Shan Medical University Hospital were enrolled. Participants were randomly assigned to either the intervention group, receiving training with digital stethoscopes and the Eko auscultation software, or the control group, following a traditional curriculum. Pre- and post-intervention assessments measured auscultation skills, and student feedback on teaching quality was collected. The primary outcome was the improvement in auscultation proficiency, while secondary outcomes included student engagement and feedback on the educational approach.

Expected Results: The investigators hypothesize that the integration of digital stethoscopes into the curriculum will significantly improve the auscultation skills of medical students compared to traditional methods. Enhanced engagement and positive feedback from students are anticipated, underscoring the pedagogical value of incorporating digital health technologies in medical education. conditions: Auscultation conditions: Breathing Sound conditions: Asthma conditions: Pneumonia conditions: Pleural Effusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 84 type: ACTUAL name: Digital stethoscope use measure: Pre-test and Post-test using the Zuvio Interactive Response System (Zuvio, Taipei, Taiwan) measure: Student Feedback sex: ALL minimumAge: 21 Years maximumAge: 30 Years stdAges: ADULT facility: Chung Shan Medical University Hospital city: Taichung state: South zip: 402 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06359145 id: EIT and COPD briefTitle: Prediction of COPD Severity Using Electrical Impedance Tomography overallStatus: RECRUITING date: 2023-04-01 date: 2024-06-01 date: 2024-08-01 date: 2024-04-11 date: 2024-04-11 name: Chinese PLA General Hospital class: OTHER briefSummary: The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD. conditions: Electric Impedance conditions: Respiratory Function Tests conditions: Pulmonary Disease, Chronic Obstructive studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 150 type: ESTIMATED measure: The predictive power of EIT and PFT for CT visual scoring of emphysema sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PLA status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Zhimei Duan role: CONTACT phone: 13716376758 email: 549117002@qq.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06359132 id: TeleConvert-AF briefTitle: mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients. acronym: TeleConvert-AF overallStatus: RECRUITING date: 2022-01-01 date: 2025-01-01 date: 2025-01-01 date: 2024-04-11 date: 2024-04-11 name: Maastricht University Medical Center class: OTHER briefSummary: Despite a clear definition in the European Society of Cardiology (ESC) guidelines, the differentiation between paroxysmal (self-terminating) and persistent (nonself- terminating) atrial fibrillation (AF) remains challenging in clinical practice. Some patients with presumed persistent AF are planned for electrical cardioversion (ECV) but appear to have a paroxysmal pattern or present in sinus rhythm (SR) at the scheduled ECV appointment. This results in unnecessary visits or interventions for patients, and costs and burden for the hospitals and health insurances. Based on the feasibility of the TeleCheck-AF approach, which is an on-demand mobile health (mHealth) infrastructure incorporating app-based heart rate and rhythm monitoring to support remote AF management through teleconsultation, the investigators aim to extend this mHealth approach to the management of presumed persistent AF patients planned for ECV. conditions: Atrial Fibrillation conditions: Arrhythmia conditions: Mobile Health conditions: Electrical Cardioversion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 264 type: ESTIMATED measure: The number of cancelled unnecessary scheduled ECV appointments in patients with presumed persistent AF scheduled for ECV unnecessary scheduled ECV appointments measure: Number of patients that agreed the refined TeleCheck-AF approach is usable and userfriendly as assessed by the System Usability Scale questionnaire extended with additional questions measure: Number of patients that agreed the refined TeleCheck-AF approach is anxious as assessed by the HADS-A scale questionnaire measure: Amount of saved costs for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments measure: Number of patients with paroxysmal AF measure: Time to recurrence of AF measure: Time period of monitoring heart rate and rhythm using the mHealth-based application measure: Amount of burden for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center status: RECRUITING city: Maastricht state: Limburg country: Netherlands name: Dominik Linz role: CONTACT phone: 043-3877098 email: dominik.linz@mumc.nl name: Astrid Hermans role: CONTACT phone: 043-3871613 email: astrid.hermans@mumc.nl lat: 50.84833 lon: 5.68889 facility: Viecuri Medical Center status: RECRUITING city: Venlo state: Limburg country: Netherlands name: Wilfred Heesen role: CONTACT phone: (077) 320 56 04 email: wheesen@viecuri.nl lat: 51.37 lon: 6.16806 hasResults: False

 nctId: NCT06359119 id: IMAPing SUBDEP briefTitle: Implementation of Apnoea Test for Patients With Suspected Brain Death overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-07-31 date: 2024-04-11 date: 2024-04-11 name: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged class: OTHER_GOV name: Veszprém County Ferenc Csolnoky Hospital briefSummary: This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death. conditions: Brain Death studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: Number of apnoea tests measure: Timeframe between apnoea tests measure: Preoxygenation measure: Baseline arterial carbon dioxide (CO2) level measure: Detection of possible spontaneous breath movements measure: Satisfaction with current practice measure: Continuous positive airway pressure (CPAP) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359106 id: 2024.3.1 briefTitle: Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia overallStatus: RECRUITING date: 2024-05-10 date: 2025-12-31 date: 2025-12-31 date: 2024-04-11 date: 2024-04-25 name: China Medical University, China class: OTHER briefSummary: This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. conditions: Oxygenation Index studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1098 type: ESTIMATED name: 80% Oxygen name: 40% Oxygen measure: Oxygenation Index measure: pH value in blood gas analysis 48 hours after the operation measure: oxygen inhalation time measure: inspired oxygen concentration measure: oxygen uptake rate measure: 7 days pulmonary complications measure: 30-day Mortality measure: PaCO2 in blood gas analysis 48 hours after the operation measure: Lactic acid in blood gas analysis 48 hours after the operation sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Fourth Affiliated Hospital of China Medical University status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110001 country: China name: Ayong Tian role: CONTACT lat: 41.79222 lon: 123.43278 facility: the First Hospital of China Medical University status: RECRUITING city: Shenyang state: Liaoning zip: 110001 country: China name: Wenfei Tan, M.D.,Ph.D role: CONTACT phone: 024-83283100 email: winfieldtan@hotmail.com lat: 41.79222 lon: 123.43278 facility: Beijing Friendship Hospital, Capital Medical University status: NOT_YET_RECRUITING city: Beijing country: China name: Yun Wang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Sichuan Provincial People's Hospital status: NOT_YET_RECRUITING city: Chendu country: China name: Qian Shi role: CONTACT facility: Chifeng Municipal Hospital status: NOT_YET_RECRUITING city: Chifeng country: China name: Jiannan Song role: CONTACT lat: 42.26833 lon: 118.96361 facility: First Affiliated Hospital of Chongqing Medical University status: NOT_YET_RECRUITING city: Chongqi country: China name: Ke Wei role: CONTACT lat: 27.00943 lon: 117.18179 facility: Dalian Third People's Hospital status: NOT_YET_RECRUITING city: Dalian country: China name: Shiling Zhao role: CONTACT lat: 38.91222 lon: 121.60222 facility: First Affiliated Hospital, Dalian Medical University status: NOT_YET_RECRUITING city: Dalian country: China name: Yong Luan role: CONTACT lat: 38.91222 lon: 121.60222 facility: First Affiliated Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin country: China name: Kun Wang role: CONTACT lat: 45.75 lon: 126.65 facility: Harbin Medical University Cancer Hospital status: NOT_YET_RECRUITING city: Harbin country: China name: Fei Han role: CONTACT lat: 45.75 lon: 126.65 facility: First Hospital, Jilin University status: NOT_YET_RECRUITING city: Jilin country: China name: Xuesong Song role: CONTACT lat: 43.85083 lon: 126.56028 facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine status: NOT_YET_RECRUITING city: Jinan country: China name: Yongliang Chi role: CONTACT lat: 36.66833 lon: 116.99722 facility: First Medical University and Shandong Provincial Qianfoshan Hospital status: NOT_YET_RECRUITING city: Jinan country: China name: Jianbo Wu role: CONTACT lat: 36.66833 lon: 116.99722 facility: First Affiliated Hospital of Kunming Medical University status: NOT_YET_RECRUITING city: Kunming country: China name: Jianlin Shao role: CONTACT lat: 25.03889 lon: 102.71833 facility: Affiliated Hospital of Qingdao University status: NOT_YET_RECRUITING city: Qingdao country: China name: Wei Feng role: CONTACT lat: 36.06488 lon: 120.38042 facility: Liaoning Cancer Hospital and Institute status: NOT_YET_RECRUITING city: Shenyang country: China name: Zeqing Huang role: CONTACT lat: 41.79222 lon: 123.43278 facility: Shenzhen People's Hospita status: NOT_YET_RECRUITING city: Shenzhen country: China name: Chaoran Wu role: CONTACT lat: 22.54554 lon: 114.0683 facility: First Hospital of Hebei Medical University status: NOT_YET_RECRUITING city: Shijia Zhuang country: China name: Li Wang role: CONTACT lat: 34.17775 lon: 109.84894 facility: Second Hospital of Hebei Medical University status: NOT_YET_RECRUITING city: Shijia Zhuang country: China name: Lining Huang role: CONTACT lat: 34.17775 lon: 109.84894 facility: Tianjin Fifth Central Hospital status: NOT_YET_RECRUITING city: Tianjin country: China name: Shimin Shan role: CONTACT lat: 39.14222 lon: 117.17667 facility: YANBIAN University Hospital（Yanbian Hospital） status: NOT_YET_RECRUITING city: Yanbian country: China name: Yongshan Nan role: CONTACT hasResults: False

 nctId: NCT06359093 id: 14422023557605 briefTitle: Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients. overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2026-09 date: 2024-04-11 date: 2024-04-22 name: Cairo University class: OTHER briefSummary: The aim of this study is to describe the prevalence of non-carious cervical lesions in middle adulthood patients attending the Cairo University Dental Educational Hospital and to analyze the distribution of lesions by gender and age, tooth functional group, jaw, arch side and tooth surface. Moreover, to explore the associated risk indicators of the lesions as well as the quantity of saliva, as one of the potential etiological factors, will be assessed. conditions: Non-carious Cervical Lesions studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1532 type: ESTIMATED measure: Prevalence of non-carious cervical lesions (NCCLs) in Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital. measure: Associated risk indicators for all participants. 3.Salivary assessment regarding flow rate and pH for subgroup diagnosed with non-carious cervical lesions. sex: ALL minimumAge: 41 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06359080 id: 120200004OL briefTitle: Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL) overallStatus: COMPLETED date: 2022-05-08 date: 2022-12-11 date: 2022-12-11 date: 2024-04-11 date: 2024-04-11 name: JelikaLite LLC class: INDUSTRY briefSummary: The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 10 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open Label Study

This will be an one-arm, open label study. Participants who were in the placebo condition in the previous study, will receive the treatment. Participants who were in the active condition in the previous study will repeat the course of treatment after the intermission of 3-6 months (depending on when they completed the study). primaryPurpose: TREATMENT masking: NONE count: 22 type: ACTUAL name: Cognilum TM: Light Treatment Condition measure: Change in Autism Symptoms sex: ALL minimumAge: 2 Years maximumAge: 7 Years stdAges: CHILD facility: Dr. Steingold Psychology PC city: Brooklyn state: New York zip: 11229 country: United States lat: 40.6501 lon: -73.94958 facility: Dr. Steingold Psychology PC city: New York state: New York zip: 10019 country: United States lat: 40.71427 lon: -74.00597 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2022-05-01 uploadDate: 2024-04-08T10:25 filename: Prot_000.pdf size: 332012 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2022-05-01 uploadDate: 2024-04-08T10:25 filename: SAP_001.pdf size: 134095 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-05-01 uploadDate: 2024-04-08T10:26 filename: ICF_002.pdf size: 172416 hasResults: False

 nctId: NCT06359067 id: APHP240295 briefTitle: A Real-World Study of Bispecific Antibodies in Multiple Myeloma acronym: BISPEMM overallStatus: COMPLETED date: 2022-07-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-11 date: 2024-04-11 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP). conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ACTUAL name: Treated by bispecific antibodies, teclistamab or elranatamab in usual care name: Not treated by bispecific antibodies in usual care measure: Infection rate measure: Global survival measure: Progression-free survivals sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assistance Publique - Hôpitaux de Paris (AP-HP) city: Paris state: IDF zip: 75004 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06359054 id: CelalBayarNRG briefTitle: The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging overallStatus: COMPLETED date: 2020-11-11 date: 2023-05-15 date: 2023-09-15 date: 2024-04-11 date: 2024-04-11 name: Celal Bayar University class: OTHER briefSummary: Currently, F-18 FDG PET/CT is routinely used for breast cancer staging and treatment response assessment. Most breast cancers express Estrogen Receptor (ER) and Progesterone Receptor (PR) and this subtype shows lower activity on FDG imaging. 68Ga DOTATATE PET/CT is an effective imaging option for somatostatin receptor (SSTR) positive neuroendocrine tumors. There are case reports showing 68Ga DOTATATE uptake in non-Hodgkin lymphoma, meningioma, breast cancer, thyroid adenoma and papillary carcinoma. There are also histochemical studies showing that SSTR is a potential radiopharmaceutical target for ER+/PR+ breast cancer . Its hypothesized that 68Ga DOTATATE PET/CT may be superior to 18F FDG PET/CT primarily in hormone receptor (HR) positive breast cancer. In this study, its aimed to compare the uptake pattern of breast cancer lesions and HR status with 68Ga DOTATATE and 18F FDG uptake in lesions. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 16 type: ACTUAL name: 18F FDG PET/CT name: 68Ga DOTATATE PET/CT measure: Comparative Diagnostic Accuracy of 68Ga DOTATATE and 18F FDG PET/CT sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manisa Celal Bayar University Faculty of Medicine, General Surgery Department city: Manisa zip: 45030 country: Turkey lat: 38.61202 lon: 27.42647 facility: Manisa Celal Bayar University Faculty of Medicine, Nuclear Medicine Department city: Manisa zip: 45030 country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False

 nctId: NCT06359041 id: CAB-201-004 briefTitle: RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2029-09 date: 2029-09 date: 2024-04-11 date: 2024-04-25 name: Cabaletta Bio class: INDUSTRY briefSummary: RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis conditions: Generalized Myasthenia Gravis (gMG) studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: CABA-201 measure: To evaluate incidence and severity of adverse events (AEs) measure: To evaluate the incidence and severity of adverse events (AEs) measure: To characterize the pharmacodynamics (PD) measure: To characterize the pharmacokinetics (PK) measure: To evaluate disease-related biomarkers measure: To evaluate efficacy by change in Myasthenia Gravis - Activities of Daily Living (MG-ADL) score over time. measure: To evaluate efficacy by change in Quantitative Myasthenia Gravis (QMG) score over time. measure: To evaluate efficacy by change in Myasthenia Gravis Composite (MGC) score over time. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06359028 id: 300103 briefTitle: Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-25 date: 2024-06-20 date: 2024-06-20 date: 2024-04-11 date: 2024-04-25 name: HALEON class: INDUSTRY briefSummary: The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste. conditions: Dentin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 111 type: ACTUAL name: Stannous fluoride toothpaste name: Crest cavity protection toothpaste measure: Change from Baseline in Schiff Sensitivity Score at Day 56 measure: Change from Baseline in Tactile Threshold at Day 56 measure: Change from Baseline in Schiff sensitivity score at Day 28 measure: Change from Baseline in Tactile Threshold at Day 28 measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 measure: Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56 measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Salus Research city: Fort Wayne state: Indiana zip: 46825 country: United States lat: 41.1306 lon: -85.12886 hasResults: False

 nctId: NCT06359015 id: 41138 id: 605095 type: OTHER domain: DDD briefTitle: Metformin and Esomeprazole in Preterm Pre-eclampsia overallStatus: ACTIVE_NOT_RECRUITING date: 2021-02-11 date: 2025-06 date: 2025-06 date: 2024-04-11 date: 2024-04-11 name: Christiana Care Health Services class: OTHER briefSummary: The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia. conditions: Preeclampsia Severe conditions: Pre-Eclampsia conditions: Preeclampsia conditions: Preeclampsia Second Trimester conditions: Preeclampsia Complicating Childbirth conditions: Preeclampsia Puerperium conditions: Preterm studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups: experimental and control. The control group receives expectant management. The experimental group receives expectant management and medication treatment. primaryPurpose: TREATMENT masking: NONE count: 4 type: ACTUAL name: Metformin name: Esomeprazole measure: Mean plasma difference in sFlt-1 measure: Mean plasma difference in vascular endothelial growth factor (VEGF) measure: Mean plasma difference in placental growth factor (PIGF) measure: Mean plasma difference in soluble endoglin (sEng) measure: sFlt-1:PIGF ratio measure: Prolongation of gestation sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Christianacare Health System city: Newark state: Delaware zip: 19718 country: United States lat: 39.68372 lon: -75.74966 hasResults: False

 nctId: NCT06359002 id: BYON4413.001 id: 2023-507781-13-00 type: CTIS briefTitle: Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-03 date: 2024-04-11 date: 2024-04-11 name: Byondis B.V. class: INDUSTRY briefSummary: This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS. conditions: Relapsed / Refractory AML conditions: Relapsed / Refractory MDS studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: BYON4413 measure: Incidence of dose-limiting toxicities (dose escalation) measure: Composite Complete Remission Rate (expansion) measure: Incidence and severity of adverse events measure: Number of patients with dose modifications measure: Rate of early death measure: Maximum Plasma Concentration (Cmax) BYON4413 measure: Time to Cmax (Tmax) BYON4413 measure: Area under the curve (AUC) BYON4413 measure: Percentage of patients with confirmed anti-BYON4413 antibodies measure: Composite Complete Remission Rate (dose escalation) measure: Percentage of blasts in bone marrow change from baseline measure: Percentage of blasts in peripheral blood change from baseline measure: Objective response rate measure: Duration of response measure: Relapse-free survival measure: Event-free survival measure: Time to response measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358989 id: Insulin resistance briefTitle: Association Between Triglycerides Glucose Ratio With HOMA -IR as Indicators of Insulin Resistance in Obese Adults overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-11 date: 2024-04-11 name: Assiut University class: OTHER briefSummary: The aim of the present study was to investigate the correlation between the triglyceride/glucose index (TyG index) and homeostasic model assessment of insulin resistance (HOMA-IR) to predict insulin resistance (IR) in obese adults conditions: Insulin Resistance studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: HOMA IR measure: Association between triglycerides glucose ratio with HOMA -IR as indicators of insulin resistance in obese adults sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358976 id: Spasticity splint and FMV briefTitle: Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2024-11-30 date: 2024-12-30 date: 2024-04-11 date: 2024-04-15 name: Arab American University (Palestine) class: OTHER briefSummary: Title: The Effect of Vibrating Splint on Hand Function After Stroke

Summary:

This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Stroke is a major global health issue, often resulting in long-term disability and impairments in the upper limbs. Spasticity, a common complication of stroke, causes stiffness and involuntary muscle contractions, leading to difficulties in performing daily activities.

Current treatment options for spasticity include medications and physical therapy techniques. However, these approaches may have limitations in terms of effectiveness and duration of benefits. Therefore, non-pharmacological interventions are being explored to enhance rehabilitation outcomes.

The hypothesis of this study is that the use of a vibrating splint, which applies mechanical vibrations to the hand muscles, will decrease spasticity and improve hand functionality in individuals with chronic stroke. The vibrations from the splint stimulate the sensory receptors in the skin and muscles, leading to muscle relaxation and improved motor control.

The study will be conducted as a pilot randomized controlled trial, involving participants who meet specific eligibility criteria. The participants will be divided into three arms, with each arm receiving a different intervention. Outcome measures, including assessments of spasticity, range of motion, pain levels, and functional abilities, will be collected before and after the intervention period.

The findings from this study will contribute to the understanding of non-pharmacological approaches in managing spasticity and improving hand function after stroke. If the vibrating splint proves to be effective, it could offer a safe and accessible option for stroke survivors to enhance their recovery and regain independence in daily activities.

This research is essential as it addresses the need for more effective interventions for spasticity management and hand rehabilitation after stroke. By providing valuable insights into the potential benefits of the vibrating splint, this study has the potential to improve the quality of life for individuals who have experienced a stroke and empower them to regain control over their hand movements. conditions: Spasticity as Sequela of Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: The interventional study model for this clinical study is a pilot randomized controlled trial. Participants will be randomly assigned to one of three arms: Group A (vibrating splint intervention), Group B (standard splint intervention), or Group C (control group receiving no splint intervention). This model allows for the comparison of different interventions and the evaluation of their effectiveness in improving hand function and reducing spasticity after stroke. Randomization helps ensure that each group is comparable in terms of baseline characteristics, minimizing bias and increasing the validity of the study results. primaryPurpose: OTHER masking: SINGLE maskingDescription: In this clinical trial, due to the nature of the interventions, it may not be possible to mask or blind the participants or therapists to the treatment received. However, efforts will be made to blind the outcome assessors who will be responsible for evaluating the participants' hand function, spasticity, and other outcome measures. Blinding the outcome assessors helps minimize potential bias and ensures the objective assessment of the intervention's effectiveness. By keeping the assessors unaware of the participants' group allocations, the integrity and reliability of the study findings can be enhanced. whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: Vibration plus anti-spastic hand splint name: Anti-spastic hand splint name: Vibration measure: Modified Ashworth Scale (MAS) measure: Fugl-Meyer Assessment of Upper Extremity (FMA-UE) measure: Range of Motion Assessment measure: Numeric pain rating scale (NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arab American University city: Jenin zip: 240 country: Palestinian Territory, occupied name: Hisham Arab Alkabeya, PhD role: CONTACT phone: 0595637776 email: hisham.arabkkabeya@aaup.edu lat: 32.45943 lon: 35.30086 hasResults: False

 nctId: NCT06358963 id: 131 briefTitle: CoQ10 and Omega-3 as Adjuncts to Periodontal Therapy, TAC of Saliva. overallStatus: ENROLLING_BY_INVITATION date: 2024-02-20 date: 2024-04-20 date: 2024-05-10 date: 2024-04-11 date: 2024-04-17 name: Amirhossein Farahmand class: OTHER briefSummary: Comparative evaluation of CoQ10 and Omega-3 as adjuncts to periodontal therapy and total antioxidant capacity of saliva (randomized Double-Blind Clinicalials) conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-blind, Controlled design. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The research was conducted using a double-blind methodology. To ensure impartiality, both the omega-3, Coq10, and control groups were given medications that had identical appearance, packaging, and color. To further eliminate bias, a clinician who had no involvement in the study labeled teh medications as A, B, and C (empty) based on their content, and distributed them among teh patients. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Receive 30 mg of Coq10 name: Non-Medicare Drugs measure: reduction of bleeding on probing measure: total Antioxidant capacity of saliva sex: ALL minimumAge: 28 Years maximumAge: 35 Years stdAges: ADULT facility: Amirhossein Farahmand city: Tehran zip: 1947833113 country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False

 nctId: NCT06358950 id: ALKS 2860-201 briefTitle: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 acronym: Vibrance-1 overallStatus: RECRUITING date: 2024-03-28 date: 2025-07 date: 2025-07 date: 2024-04-11 date: 2024-04-11 name: Alkermes, Inc. class: INDUSTRY briefSummary: The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone. conditions: Narcolepsy Type 1 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: ALKS 2680 name: Placebo measure: Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6 measure: Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6 measure: Mean weekly cataplexy rate (WCR) as derived by subject cataplexy measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alkermes Investigational Site status: RECRUITING city: Huntersville state: North Carolina zip: 28708 country: United States lat: 35.41069 lon: -80.84285 hasResults: False

 nctId: NCT06358937 id: #7/2023 briefTitle: Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis overallStatus: RECRUITING date: 2023-11-01 date: 2024-05 date: 2024-05 date: 2024-04-11 date: 2024-04-11 name: Mahmoud Salem class: OTHER briefSummary: The aim of the present study is to compare the efficacy of LANAP to conventional scaling and root planing in the management of stage II periodontitis. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 27 type: ESTIMATED name: Laser Assisted New Attachment Procedure using ND:YAG laser name: Laser Assisted New Attachment Procedure using diode laser name: Scaling and Root Planing using ultrasonic and curettes measure: Microbiological assessment of Fusobacterium nucleatum measure: Microbiological assessment of Porphyromonas gingivalis measure: Microbiological assessment of Tannerella forsythia measure: Gingival index measure: Plaque index measure: Clinical attachment loss measure: Probing depth sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry, Alexandria University status: RECRUITING city: Alexandria country: Egypt name: Mahmoud Salem, BDS role: CONTACT phone: 111 144 7745 phoneExt: +20 email: Masalem30192@gmail.com lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06358924 id: FDASU-RecID032004 briefTitle: Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity and Shade Stability overallStatus: COMPLETED date: 2021-11-13 date: 2023-08-25 date: 2023-09-20 date: 2024-04-11 date: 2024-04-23 name: Ain Shams University class: OTHER briefSummary: This study compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure. The follow-up periods ranged from 24 hours to 1 year. conditions: Tooth Hypersensitivity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This clinical study was conducted to evaluate the effect of using different desensitizing agents:

1. As recommended by manufacturer
2. Casein phosphopeptide-amorphous calcium phosphate/fluoride (CPP-ACPF) containing desensitizing agent
3. Hydroxyapatite/fluoride/xylitol containing desensitizing agent
4. Poly (amido amine) dendrimer with carboxylic acid terminal functional group containing desensitizing agent.

On patients subjected to bleaching procedure using hydrogen peroxide containing bleaching agent.

The clinical evaluation included:

1. Post-bleaching hypersensitivity.
2. Post-bleaching long-term shade stability. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: This clinical trial was double blinded trial in which both the participant and outcome assessor were blinded to allocation, thus the participant was unaware of which experimental material had been assigned to him/her. Also the outcome assessors were blinded to the treatment that each participant had received. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 48 type: ACTUAL name: Potassium nitrate with fluoride name: Casein phosphopeptide-amorphous calcium phosphate with fluoride name: Hydroxyapatite with fluoride name: PAMAM-carboxylic acid dendrimer measure: Post-bleaching hypersensitivity measure: Shade stability sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Dentistry, Ain Shams University city: Cairo state: El Weilli zip: 4393005 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06358911 id: FDASU-RecID022001 briefTitle: A Clinical Study for the Effect of 4th Generation Poly AmidoAmine Dendrimer on Post-Bleaching Hypersensitivity and Shade Stability overallStatus: COMPLETED date: 2021-11-13 date: 2023-08-05 date: 2023-09-10 date: 2024-04-11 date: 2024-04-23 name: Ain Shams University class: OTHER briefSummary: This study assessed the impact of four desensitizing agents on both color stability and dental sensitivity following a bleaching procedure, spanning from the 24-hour to the 1-year follow-up assessment periods. conditions: Tooth Hypersensitivity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This clinical study will be conducted to evaluate the effect of using 4th generation Poly amido amine dendrimer (PAMAM-COOH) as a desensitizing agent and compared with three different commercially available desensitizing materials: 3% potassium nitrate and 0.11% fluoride (Ultra EZ), as described by manufacturer, Casein-phosphopeptide-amorphous calcium phosphate with F, (MI paste plusTm), and Hydroxyapatite, Fluoride and Xylitol, Hydroxyapatite and F (ReminPro), on:

1. Long-term Post-bleaching hypersensitivity.
2. Long-term Post-bleaching shade stability. For Patients treated with 40% hydrogen-peroxide bleaching agent. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: This clinical trail was a double blinded trail in which the participant and outcome assessor were blinded to allocation, thus the participant was unaware of which experimental material had been assigned to him/her. Also outcome assessors were blinded to the treatment that each participant had received whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Poly amido amine dendrimer (PAMAM) name: Manufacturer's desensitizing agent, Ultra EZ name: MI paste plus, desensitizing agent name: Hydroxyapatite and F (ReminPro), desensitizing agent measure: Post-bleaching dental hypersensitivity measure: Shade stability sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Dentistry - Ain Shams University city: Cairo state: El Weili zip: 4393005 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06358898 id: 20221207 briefTitle: Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2026-05-31 date: 2026-12-31 date: 2024-04-11 date: 2024-04-12 name: Chinese University of Hong Kong class: OTHER briefSummary: Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment. conditions: Insomnia conditions: Depression conditions: Adolescent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 343 type: ESTIMATED name: Standard dCBT-I name: Modified Mood enhanced CBT-I (M-dCBT-I) measure: Depressive symptoms measure: Assessor-rated depressive symptomatology measure: Overall severity of depression symptoms measure: Severity of insomnia symptoms measure: Sleep-wake pattern measure: Sleep-related beliefs and cognitions measure: Daytime sleepiness measure: Anxiety and depression symptoms measure: Quality of life by KIDSCREEN-27 measure: Major life events and self-perceived stress measure: Chronotype measure: Pubertal status sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Psychiatry, the Chinese University of Hong Kong city: Sha Tin state: New Territories country: Hong Kong lat: 22.38333 lon: 114.18333 hasResults: False

 nctId: NCT06358885 id: 22-3123 id: R01AA030480 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA030480 briefTitle: IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention acronym: EBAI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-11 date: 2024-04-11 name: University of North Carolina, Chapel Hill class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) name: National Institutes of Health (NIH) name: Hanoi Medical University name: Johns Hopkins University name: University of Washington name: Washington University School of Medicine briefSummary: This study is a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Facilitation is a flexible strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits. In the other arm, in addition to facilitation, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves as experiential learning (EBAI) to address their own alcohol-related attitudes and behaviors. Clinic staff responsible for delivering the BAI to patients will also be offered 3 consolidation activities to integrate their own experiences with their delivery of the BAI. conditions: HIV-1-infection conditions: Unhealthy Alcohol Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-arm cluster-randomized implementation trial comparing two strategies to scale-up an evidence-based brief alcohol intervention (BAI), in Vietnam, examining the mechanisms of BAI scale-up and the impact of experiential BAI (EBAI) on clinic staff. The two implementation approaches are facilitation only (FAC) and facilitation plus an experiential brief alcohol intervention (EBAI+FAC). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 930 type: ESTIMATED name: Facilitation (FAC) name: Experiential Brief Alcohol Intervention (EBAI) measure: Fidelity Score measure: Viral Suppression measure: BAI Acceptability Score - Clinic Staff: Acceptability of Intervention Measure (AIM) scale measure: BAI Acceptability score Counselors: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Providers measure: BAI Acceptability PWH: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Consumers measure: Penetration- Proportion of PWH Screened with the AUDIT-C measure: Penetration - Proportion of PWH who screen positive who receive at least one counseling session measure: Costs measure: Sustainability Score: Provider Support of Sustainment Scale (PRESS) measure: AUDIT (total score) - Clinic staff measure: AUDIT (total score) - PWH measure: Fidelity (Extended Window) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hanoi Medical University city: Hanoi country: Vietnam name: Le Minh Giang, MD, PhD role: CONTACT email: leminhgiang@hmu.edu.vn lat: 21.0245 lon: 105.84117 hasResults: False

 nctId: NCT06358872 id: 23-39839 briefTitle: Azithromycin for Child Survival in Niger II acronym: AVENIR II overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2028-04-29 date: 2028-04-29 date: 2024-04-11 date: 2024-04-12 name: University of California, San Francisco class: OTHER name: Centre de recherche et interventions en santé publique (CRISP) name: Ministère de la Santé Publique du Niger name: Le Programme National de Santé Oculaire name: Centre de Recherche Médicale et Sanitaire name: Bill and Melinda Gates Foundation briefSummary: Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years. conditions: Mortality conditions: Antimicrobial Resistance studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention will involve biannual oral azithromycin MDA to children 1-59 months old distributed by community health workers. The Centre de Santé Integré (CSI) will be randomized to receive azithromycin MDA or delayed treatment in a stepped wedge design for the first 2 years. The delayed intervention arm will receive usual care for the first 2 years, then will receive the intervention for the next 2 years. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants, community health workers delivering the intervention, and team members supervising the program will not be masked. One biostatistician and one data analyst will remain unmasked to prepare the randomization sequence. Masked personnel include outcome assessors as well as the biostatistician and data analyst conducting the data analyses. whoMasked: OUTCOMES_ASSESSOR count: 3300000 type: ESTIMATED name: Azithromycin for Oral Suspension measure: All-cause mortality measure: All-cause mortality measure: Prevalence of resistance to macrolides - nasopharyngeal swabs measure: Prevalence of resistance to macrolides - nasopharyngeal swabs measure: Load of genetic determinants of resistance to macrolides - rectal swabs measure: Load of genetic determinants of resistance to macrolides - rectal swabs measure: Number of clinic visits - infectious measure: Number of clinic visits - infectious measure: Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs measure: Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs measure: Program Cost Per Dose Delivered sex: ALL minimumAge: 1 Month maximumAge: 59 Months stdAges: CHILD facility: Program National de Santé Oculaire city: Niamey country: Niger lat: 13.51366 lon: 2.1098 hasResults: False

 nctId: NCT06358859 id: STUDY00004203 id: 1R01MD018208-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MD018208-01 briefTitle: Delta GREENS Food is Medicine Intervention overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-11 date: 2024-04-11 name: Tufts University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) name: Tougaloo College, Mississippi name: Delta Health Center, Mississippi name: Reuben V. Anderson Center for Justice at Tougaloo briefSummary: Though the Mississippi Delta has a rich agricultural history and some of the nation's most fertile soil, residents have experienced the legacy of slavery and economic exploitation through food insecurity and poverty for generations. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and \~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. The Delta Growing a Resilient, Enriching, Equitable, Nourishing food System (GREENS) Food is Medicine (FIM) Project, is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. The project's primary goal is to improve health outcomes by creating a FIM intervention. The Delta GREENS FIM Project aims to become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide. conditions: Cardiometabolic Risk Factors conditions: Diabetes conditions: High Blood Pressure conditions: Obesity conditions: Nutrition Security studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The primary objective is to test whether a multi-level, community-engaged intervention with a food-is-medicine program in the Mississippi Delta can improve metabolic disease in specific minority groups. The basic study design is a cluster randomized controlled trial (RCT), with equal numbers of participants randomized to intervention and control groups. Each participant will be enrolled in the study for 12 months. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group during their 12-month study period. The control group will receive produce boxes later, after their 12-month study participation has ended. Participants will be patients at participating Delta Health Center (DHC) clinics in Mississippi. primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Food is Medicine measure: Change in hemoglobin A1c (HbA1c) measure: Change in cardiometabolic risk factor composite score measure: Change in BMI measure: Change in LDL cholesterol measure: Change in non-HDL cholesterol measure: Change in blood pressure measure: Change in nutrition security, assessed via a survey measure: Change in dietary intake of fruits and vegetables, assessed via a survey measure: Change in health care utilization, assessed via review of Electronic Health Records (EHR) measure: Change in food insecurity, assessed via a survey sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts University city: Boston state: Massachusetts zip: 02111 country: United States name: Daniel Schultz, MS, RDN, LD role: CONTACT phone: 262-627-0155 email: daniel.schultz@tufts.edu name: Shanti Sharma, PhD role: CONTACT email: shanti.sharma@tufts.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06358846 id: 00004 briefTitle: Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan. overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-07-15 date: 2024-07-31 date: 2024-04-11 date: 2024-04-12 name: SINA Health Education and Welfare Trust class: OTHER name: Aga Khan University briefSummary: There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial. conditions: Diabetic Foot conditions: Educational Intervention conditions: Foot Care conditions: Foot Ulcer, Diabetic conditions: Foot Cellulitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control arm =75 Interventional arm = 75 primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: Self-care behavior to promote foot care through educational guidance among individual with diabetes measure: Improved Foot Care Knowledge measure: Behavior Change measure: Reduction in Foot Complications measure: Empowerment and Self-efficacy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358833 id: 24-82-03 briefTitle: Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems overallStatus: RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-11 date: 2024-04-18 name: Qassim University class: OTHER briefSummary: Summary:

After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain. conditions: Postoperative Pain conditions: Irreversible Pulpitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients will be masked from the procedure whoMasked: PARTICIPANT count: 34 type: ESTIMATED name: endodontic needle (EN) name: Endodontic activation (EA) measure: Postoperative pain measure: Postoperative pain measure: Postoperative pain measure: Postoperative pain measure: Irrigation time measure: Adverse event measure: Rescue medication sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Muhammad Zubair Ahmad status: RECRUITING city: Ar Rass state: Qassim zip: 58883 country: Saudi Arabia name: Muhammad Zubair Ahmad, BDS, FCPS role: CONTACT phone: 0163011111 phoneExt: 10685 email: m.muhammad@qu.edu.sa lat: 25.86944 lon: 43.4973 hasResults: False

 nctId: NCT06358820 id: PHGaozhou briefTitle: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution overallStatus: RECRUITING date: 2023-12-03 date: 2025-01 date: 2025-07 date: 2024-04-11 date: 2024-04-11 name: The People's Hospital of Gaozhou class: OTHER briefSummary: This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded. conditions: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status of Maintenance Peritoneal Dialysis Patients studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: Amino acid peritoneal dialysis solution measure: blood albumin measure: prealbumin sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gaozhou People's Hospital status: RECRUITING city: Gaozhou state: Guangdong zip: 525200 country: China name: Deng shanshan role: CONTACT phone: 8613927596600 email: 276531255@qq.com lat: 21.93924 lon: 110.84607 hasResults: False

 nctId: NCT06358807 id: M2023438 briefTitle: Microfracture With Platelet Rich Plasma Gel Injection for Ostechondral Lesion of the Talus overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-12-31 date: 2024-04-11 date: 2024-04-11 name: Peking University Third Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:

* Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score?
* Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.

Participants will:

* Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel
* Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment
* Take MRI preoperatively and 6, 12 and 24 months after surgery conditions: Osteochondral Lesion of Talus conditions: Microfractures conditions: Platelet Rich Plasma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Arthroscopic microfracture with intraoperative local PRP gel injection name: Isolated microfracture measure: American Orthopedic Foot and Ankle Society Score (AOFAS) measure: Foot and Ankle Outcome Score (FAOS) measure: Ankle Activity Score (AAS) measure: Visual Analogue Scale (VAS) measure: Patient Satisfaction measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) measure: Return-to-Sport Rate measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing country: China name: Guo Qinwei role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06358794 id: IRB00006761-M2022692 briefTitle: Machine Learning Based-Personalized Prediction of Sperm Retrieval Success Rate overallStatus: COMPLETED date: 2022-06-01 date: 2022-12-31 date: 2023-05-31 date: 2024-04-11 date: 2024-04-11 name: Peking University Third Hospital class: OTHER briefSummary: Non-obstructive azoospermia (NOA) stands as the most severe form of male infertility. However, due to the diverse nature of testis focal spermatogenesis in NOA patients, accurately assessing the sperm retrieval rate (SRR) becomes challenging. The current study aims to develop and validate a noninvasive evaluation system based on machine learning, which can effectively estimate the SRR for NOA patients. In single-center investigation, NOA patients who underwent microdissection testicular sperm extraction (micro-TESE) were enrolled: (1) 2,438 patients from January 2016 to December 2022, and (2) 174 patients from January 2023 to May 2023 (as an additional validation cohort). The clinical features of participants were used to train, test and validate the machine learning models. Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models. conditions: Infertility, Male conditions: Azoospermia, Nonobstructive studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2612 type: ACTUAL name: Machine learning-based predictive model measure: SRR of micro-TESE sex: MALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100191 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06358781 id: xuyajun197673-002 briefTitle: A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-05-30 date: 2024-06-30 date: 2024-04-11 date: 2024-04-11 name: Peking University class: OTHER briefSummary: Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains. conditions: Chronic Disease Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 48 type: ESTIMATED name: Whole grain wheat flour measure: whole grain plasma and urine biomarkers discovery and identification measure: Validate the performance of the potential WG biomarkers. measure: Dose-response of WG wheat biomarkers. sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Department of Nutrition and Food Hygiene, School of Public Health, Peking University city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06358768 id: ObGynEASC005 briefTitle: Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations acronym: PPH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-09-30 date: 2024-04-11 date: 2024-04-16 name: G. d'Annunzio University class: OTHER name: A.O. Ospedale Papa Giovanni XXIII briefSummary: Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management conditions: PPH - Postpartum Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: teamwork job improvement overall name: teamwork job improvement in actor scenario vs mannequin scenario measure: teamwork measure: skills measure: scenario quality sex: ALL minimumAge: 19 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Claudio Celentano city: Pescara state: PE zip: 65100 country: Italy name: Claudio Celentano, MD role: CONTACT phone: +393285577305 email: celentanoclaudio70@gmail.com lat: 42.4584 lon: 14.20283 facility: Ospedale Giovanni XXIII city: Bergamo country: Italy name: Luisa Patanè, MD role: CONTACT phone: 349 3503920‬ phoneExt: +39 email: luisapatane@me.com lat: 45.69601 lon: 9.66721 hasResults: False

 nctId: NCT06358755 id: 10211476 id: P0041308 type: OTHER domain: The Hong Kong Polytechnic University briefTitle: Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-10-31 date: 2024-04-11 date: 2024-04-11 name: The Hong Kong Polytechnic University class: OTHER name: The University of Hong Kong briefSummary: The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. conditions: Myopia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible participants will be randomly allocated into 2 groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigators, including ophthalmologists and optometrists, who are responsible for collection of data related to myopia progression and analysis of data will be blinded to study intervention. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 112 type: ESTIMATED name: Defocus Incorporated Multiple Segments lenses name: single vision spectacle lenses name: Low dose atropine measure: Changes in cycloplegic refraction measure: Changes in axial length sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong city: Hong Kong zip: No postcode country: Hong Kong name: Rachel Ka Man Chun, PhD role: CONTACT phone: +852-27664224 email: rachel.chun@polyu.edu.hk name: Dennis Yan-yin Tse, PhD role: CONTACT phone: +852-27666096 email: dennis.tse@polyu.edu.hk name: Christopher Kai-shun Leung, MD and Prof role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06358742 id: ORL-GUM-2787 briefTitle: Evaluation of the Effect of Zinc Citrate Trihydrate Toothpaste on the Oral Plaque Microbiome overallStatus: COMPLETED date: 2017-01-10 date: 2017-05-19 date: 2017-05-19 date: 2024-04-11 date: 2024-04-11 name: Unilever R&D class: INDUSTRY name: Intertek briefSummary: This study is of a double-blind, randomised, parallel group study. Subjects will be enrolled onto the study according to the inclusion/exclusion criteria. After recruitment, subjects will be given a fluoride toothpaste without gum care agents to use for the 4-week run-in period prior to the commencement of the test phase of the study. Following the run-in period, baseline supragingival plaque samples will be collected 12 hours after last brushing, from the upper and lower jaws separately. Subjects will then then randomly allocated to one of two products (zinc citrate trihydrate \[ZCT\] toothpaste or control toothpaste) according to the randomization. Subjects will be instructed to use the toothpaste at home, brushing twice a day for 12-weeks. Supragingival plaque samples will be collected again from the upper and lower jaws after 2, 6 and 12 weeks. Plaque samples will then undergo metataxonomic and metatranscriptomic analyses. conditions: Dental Plaque studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE maskingDescription: Toothpaste packaged in white tubes with a study label which only differentiates products with a alphanumeric code. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 142 type: ACTUAL name: ZCT toothpaste name: Control toothpaste measure: Plaque microbiome sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358729 id: HUM00239775 briefTitle: Pre-Pregnancy Weight Loss and Baby Behavior Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-11 date: 2024-04-11 name: University of Michigan class: OTHER briefSummary: This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple. conditions: Obesity; Familial conditions: Pregnancy Related conditions: Infant Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Order of nipple size use is counter-balanced, caregivers are blind to nipple size and amount of milk in the bottle (i.e., the bottle is covered) to minimize their influence over the infant's consumption. Research assistants will not be blind to nipple size as they will need to set the bottles ups for the mothers. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Typical Nipple name: Challenging Nipple measure: Suck effect measure: Sucking pressure measure: Sucking frequency measure: Milk/Formula intake measure: Milk/Formula consumption rate measure: Number of Feedings Over 24 Hours measure: Total Hours of Sleep per 24 Hours within 24 hours of intervention measure: Total Night Wake-ups within 24 hours of intervention sex: ALL minimumAge: 3 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Amanda Crandall, PhD role: CONTACT name: Amanda Crandall, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06358716 id: CEIC-3037 briefTitle: Glycaemic Index Determination in Oral Nutrition Supplements acronym: BEGINS overallStatus: RECRUITING date: 2024-04-15 date: 2024-07-15 date: 2024-08-15 date: 2024-04-10 date: 2024-04-10 name: Universitat de Lleida class: OTHER name: Lactalis briefSummary: The glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. This property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with Diabetes Mellitus. The objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response. conditions: Glucose Metabolism Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 15 type: ESTIMATED name: Complete Oral Nutrition Supplement 1 name: Complete Oral Nutrition Supplement 2 name: Complete Oral Nutrition Supplement 3 name: Complete Oral Nutrition Supplement 4 name: Complete Oral Nutrition Supplement 5 name: Complete Oral Nutrition Supplement 6 name: Complete Oral Nutrition Supplement 7 name: Complete Oral Nutrition Supplement 8 name: Complete Oral Nutrition Supplement 9 name: Glucose measure: Glycemic Index sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT facility: University of Lleida status: RECRUITING city: Lleida zip: 25198 country: Spain name: Jose Serrano, PhD role: CONTACT phone: 973702408 email: josecarlos.serrano@udl.cat name: Manuel Portero, PhD role: CONTACT phone: 973702408 email: manuel.portero@udl.cat lat: 41.61674 lon: 0.62218 hasResults: False

 nctId: NCT06358703 id: P400 briefTitle: Impact of Acute iTTP Therapies on Long Term Neurologic and Cognitive Outcomes in iTTP Survivors acronym: NeST overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2028-05 date: 2024-04-10 date: 2024-04-10 name: US Thrombotic Microangiopathy Alliance class: OTHER briefSummary: 1. We expect to find that the silent cerebral infarct (SCI) rate is two fold higher in patients treated without caplacizumab. We also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab.
2. We expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. We also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation.
3. We expect to find that SCI and cognitive impairment is associated with worse scores on the health related quality of life instrument (SF-36)
4. Based on studies in non-TTP populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have SCI compared with patients who do not have SCI conditions: Immune Thrombotic Thrombocytopenia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 116 type: ESTIMATED name: Caplacizumab measure: Silent cerebral infarction measure: Cognitive impairment measure: Depression scores on BDI-II measure: SF-36 scores for quality of life measure: Patient reported cognitive performance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USTMA city: Groveport state: Ohio zip: 43125 country: United States name: Clare Martin role: CONTACT phone: 614-999-4900 email: Clare@ustma.org lat: 39.8784 lon: -82.88379 hasResults: False

 nctId: NCT06358690 id: HSC-MS-24-0050 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-10 date: 2024-04-10 name: [Redacted] hasResults: False

 nctId: NCT06358677 id: HCI171997 briefTitle: Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Metastatic Colorectal Cancer acronym: FACE overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2029-07 date: 2024-04-10 date: 2024-04-17 name: University of Utah class: OTHER briefSummary: The goal of this clinical trial is to learn if using topical tretinoin will help patients with colorectal cancer who are experiencing an acneiform rash as a side effect of their treatment.

Researchers will compare the use of tretinoin on one side of the face to the use of a placebo on the other side of the face to see if there is an impact. conditions: Metastatic Colon Cancer conditions: Metastatic Rectum Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, double-blind, split-face, phase II study of topical tretinoin prophylaxis for anti-EGFR treatment-induced skin toxicity in metastatic colorectal cancer. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Patients will apply topical tretinoin to one half of the face and topical moisturizer (placebo) to the other half of the face daily starting the day that anti-EGFR treatment is initiated. The sides of the face tretinoin and moisturizer are applied to will be randomized. Standardized photographs of the face will be obtained at screening and every two weeks from Week 1 Day 1 until after six weeks of treatment. Photographs will be graded by a dermatologist who will be blinded to treatment sidedness. Facial rash severity will be graded using a modified Investigators Global Assessment (IGA) score. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 25 type: ESTIMATED name: Topical Tretinoin name: Placebo measure: The maximum difference in modified Investigators Global Assessment (IGA) score between the treated and untreated sides of the face at any assessment. measure: Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE version 5.0 and the modified IGA), seriousness, duration, and relationship to study treatment. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huntsman Cancer Institute at University of Utah city: Salt Lake City state: Utah zip: 84112 country: United States lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06358664 id: Caffeine Vitrectomy briefTitle: Caffeine and Cataract After Pars Plana Vitrectomy overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-04-10 date: 2024-04-12 name: Vienna Institute for Research in Ocular Surgery class: OTHER briefSummary: Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 74 type: ESTIMATED name: Pars plana vitrectomy measure: Significant cataract formation at year 1 measure: Significant cataract formation at month 6 measure: Distance corrected visual acuity (DCVA) sex: ALL minimumAge: 18 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna status: RECRUITING city: Vienna zip: 1140 country: Austria name: Andreas Schlatter, MD role: CONTACT phone: +4391021 phoneExt: 57564 email: office@viros.at name: Christoph Leisser, MMD role: CONTACT phone: +4391021 phoneExt: 57564 email: office@viros.at lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06358651 id: PH94B-CL042 briefTitle: Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3) acronym: PALISADE-3 overallStatus: RECRUITING date: 2024-03-28 date: 2025-06 date: 2026-06 date: 2024-04-10 date: 2024-04-10 name: VistaGen Therapeutics, Inc. class: INDUSTRY briefSummary: This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study. conditions: Social Anxiety Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 236 type: ESTIMATED name: Fasedienol Nasal Spray name: Placebo Nasal Spray measure: Subjective Units of Distress Scale (SUDS) measure: Global Impression Scale of Improvement (CGI-I) measure: Patient Global Impression of Change (PGI-C) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vistagen Clinical Site status: RECRUITING city: Oceanside state: California zip: 92056 country: United States lat: 33.19587 lon: -117.37948 facility: Vistagen Clinical Site status: RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States lat: 30.33218 lon: -81.65565 facility: Vistagen Clinical Site status: RECRUITING city: Orlando state: Florida zip: 32801 country: United States lat: 28.53834 lon: -81.37924 facility: Vistagen Clinical Site status: RECRUITING city: New York state: New York zip: 10128 country: United States lat: 40.71427 lon: -74.00597 facility: Vistagen Clinical Site status: RECRUITING city: Memphis state: Tennessee zip: 38119 country: United States lat: 35.14953 lon: -90.04898 hasResults: False

 nctId: NCT06358638 id: STUDY00000859 briefTitle: Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY acronym: SUN-RAY overallStatus: RECRUITING date: 2024-04 date: 2044-09 date: 2054-09 date: 2024-04-10 date: 2024-04-10 name: Children's National Research Institute class: OTHER name: Alberta Children's Hospital name: The Hospital for Sick Children name: Levine Children's Hospital name: Ann & Robert H Lurie Children's Hospital of Chicago name: Nationwide Children's Hospital name: Children's Hospital at Montefiore name: Doris Duke Charitable Foundation name: Janssen Pharmaceuticals briefSummary: This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor red blood cell antibodies, achieving an event-free survival similar to transplanted patients without such antibodies. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Sickle cell patients, who have matched sibling donors with anti-donor RBC antibodies. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Daratumumab name: Alemtuzumab name: Sirolimus name: Total Body Irradiation measure: To determine the event-free survival of children and adolescents with SCD undergoing nonmyeloablative HCT who received 4 doses of pre-HCT daratumumab for donor-directed red blood cell antibodies. measure: To evaluate changes in antibodies to red blood cell antigens pre and post exposure to daratumumab and HCT. measure: To characterize the safety of adding pre-HCT daratumumab to the conditioning regimen, as defined by adverse events grade 3 or greater. measure: To compare alemtuzumab levels, in mcg/mL, post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study. measure: To compare immune reconstitution among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study. measure: To compare donor chimerism (lymphoid vs myeloid) post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study. sex: ALL minimumAge: 2 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Children's National Hospital status: RECRUITING city: Washington state: District of Columbia zip: 20010 country: United States name: Maryanne Odinakachukwu role: CONTACT phone: 202-476-2957 email: modinakach@childrensnational.org name: Robert Nickel role: PRINCIPAL_INVESTIGATOR name: David Jacobsohn role: SUB_INVESTIGATOR name: Anant Vatsayan role: SUB_INVESTIGATOR name: Blachy Dávila-Saldaña role: SUB_INVESTIGATOR name: Evelio Perez-Albuerne role: SUB_INVESTIGATOR name: Catherine Bollard role: SUB_INVESTIGATOR lat: 38.89511 lon: -77.03637 hasResults: False

 nctId: NCT06358625 id: 2023-4-1-001 briefTitle: Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer acronym: CRANIUM overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2031-04-30 date: 2031-04-30 date: 2024-04-10 date: 2024-04-10 name: Center Eugene Marquis class: OTHER briefSummary: HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease.

At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-).

The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy.

International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases.

To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised.

New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment. conditions: HER2-positive Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Pre-treatment biopsy measure: Transcriptomic profile change of HER2+ primary breast tumours before any treatment measure: Transcriptomic profile change on circulating tumour DNA (ctDNA) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358612 id: DALNSHA2024ABR001 briefTitle: Evaluation of an Anxiety Reduction Tool During Thyroid and Prostate Biopsy Procedures overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-20 date: 2025-08-31 date: 2024-04-10 date: 2024-04-10 name: Nova Scotia Health Authority class: OTHER briefSummary: Patients undergoing either thyroid or prostate biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after a thyroid or prostate biopsy procedure that they undergo. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool. conditions: Anxiety State studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: Stress Balls name: No Stress Balls measure: Change in anxiety level of greater than 20% based on Visual Analog Score (VAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358599 id: TUO-UR-21-01 briefTitle: The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Bladder Cancer Who Underwent Radical Cystectomy overallStatus: COMPLETED date: 2021-01-07 date: 2023-10-20 date: 2024-01-15 date: 2024-04-10 date: 2024-04-10 name: Ankara Etlik City Hospital class: OTHER_GOV briefSummary: The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen. conditions: Bladder Cancer conditions: Bladder Cancer Stage I conditions: Bladder Cancer Stage II studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 221 type: ACTUAL name: Cisplatin measure: Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy. measure: Factors associated with worse survival outcomes in cox-regression analysis at 2-year follow-up of all patients with variant histology who underwent radical cystectomy. sex: ALL minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Etlik City Hospital city: Ankara zip: 06170 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06358586 id: 044(H)MD21176 id: CRO-PK-21-356 type: OTHER domain: CRO code briefTitle: New Paediatric Formulation of Tachipirina® overallStatus: COMPLETED date: 2022-04-09 date: 2022-04-25 date: 2022-04-25 date: 2024-04-10 date: 2024-04-10 name: Aziende Chimiche Riunite Angelini Francesco S.p.A class: INDUSTRY name: Cross S.A. briefSummary: This is a single centre, single dose, single-arm, open-label, palatability study.

The aim of the present study is to investigate the palatability of the newly developed Tachipirina® 120 mg/5 mL oral suspension with strawberry flavour. The study will be conducted in paediatric volunteers that represent the target population for this product. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single centre, single dose, single-arm, open-label, palatability study primaryPurpose: OTHER masking: NONE count: 20 type: ACTUAL name: Tachipirina® 120 mg/5 mL oral suspension, new flavour measure: Palatability of new flavour - Taste (1) measure: Palatability of new flavour - Taste (2) measure: Palatability of new flavour - Smell measure: Palatability of new flavour - Aftertaste (1) measure: Palatability of new flavour - Aftertaste (2) measure: Palatability of new flavour - Aftertaste (3) measure: Palatability of new flavour - Texture (mouthfeel) measure: Palatability of new flavour - Overall measure: Treatment emergent adverse events (TEAEs) sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: CROSS Research S.A. - Phase I Unit, city: Arzo zip: CH-6864 country: Switzerland lat: 45.87606 lon: 8.94103 hasResults: False

 nctId: NCT06358573 id: SAKK 66/22 briefTitle: Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-03 date: 2029-12 date: 2024-04-10 date: 2024-04-10 name: Swiss Group for Clinical Cancer Research class: OTHER briefSummary: About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66/22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined. conditions: Triple-negative Breast Cancer conditions: TNBC - Triple-Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, open-label multicenter phase 2 clinical study to determine the clinical activity, safety and tolerability of INT230-6 in patients with early stage, operable TNBC who undergo neoadjuvant systemic treatment. primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: INT230-6 name: neoadjuvant immuno-chemotherapy measure: Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0). measure: pCR (invasive and in-situ, only invasive, respectively) in the breast measure: pCR in lymph nodes measure: Pattern of non pCR measure: Overall response according to RECIST v1.1 measure: Radiological tumor response using two perpendicular diameters measure: Event free survival (EFS) measure: Rate of breast conserving surgery (BCS) at the time of definitive surgery measure: Conversion of intention for mastectomy to BSC and axillary lymph node dissection (ALND) to sentinel lymph node dissection (SLND) or tailored axillary surgery (TAS) after treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tumor Zentrum Aarau city: Aarau zip: 5000 country: Switzerland name: Razvan Popescu, MD role: CONTACT phone: +41 62 836 78 33 email: razvan.popescu@hirslanden.ch name: Razvan Popescu, MD role: PRINCIPAL_INVESTIGATOR lat: 47.39254 lon: 8.04422 facility: St. Claraspital city: Basel zip: 4058 country: Switzerland name: Thomas Schmid, MD role: CONTACT phone: +41 61 685 88 65 email: thomas.schmid@claraspital.ch name: Thomas Schmid, MD role: PRINCIPAL_INVESTIGATOR lat: 47.55839 lon: 7.57327 facility: Istituto Oncologico della Svizzera Italiana (IOSI) city: Bellinzona zip: 6500 country: Switzerland name: Lorenzo Rossi, MD role: CONTACT phone: +41 91 811 85 77 email: lorenzo.rossi@eoc.ch name: Lorenzo Rossi, MD role: PRINCIPAL_INVESTIGATOR lat: 46.19278 lon: 9.01703 facility: Kantonsspital Graubünden city: Chur zip: 7000 country: Switzerland name: Michael Schwitter, MD role: CONTACT phone: +41 81 256 75 68 email: michael.schwitter@ksgr.ch name: Michael Schwitter, MD role: PRINCIPAL_INVESTIGATOR lat: 46.84986 lon: 9.53287 facility: Kantonsspital Baselland city: Liestal zip: 4410 country: Switzerland name: Marcus Vetter, MD role: CONTACT phone: +41 61 925 2715 email: marcus.vetter@ksbl.ch name: Marcus Vetter, MD role: PRINCIPAL_INVESTIGATOR lat: 47.48455 lon: 7.73446 facility: Kantonsspital St. Gallen city: St. Gallen zip: 9007 country: Switzerland name: Markus Jörger, MD role: CONTACT phone: +41 76 559 10 70 email: markus.joerger@kssg.ch name: Markus Jörger, MD role: PRINCIPAL_INVESTIGATOR lat: 47.42391 lon: 9.37477 facility: TBZO - Tumor- & Brustzentrum Ostschweiz city: St. Gallen zip: 9016 country: Switzerland name: Markus Niemeyer, MD role: CONTACT phone: +41 71 243 02 57 email: markus.niemeyer@tbz-ost.ch name: Markus Niemeyer, MD role: PRINCIPAL_INVESTIGATOR lat: 47.42391 lon: 9.37477 facility: Kantonsspital Winterthur city: Winterthur zip: 8401 country: Switzerland name: Ursina Zürrer, MD role: CONTACT phone: +41 52 266 25 83 email: ursina.zuerrer@ksw.ch name: Ursina Zürrer, MD role: PRINCIPAL_INVESTIGATOR lat: 47.50564 lon: 8.72413 facility: Universitätsspital Zürich - Klinik für Gynäkologie city: Zürich zip: 8091 country: Switzerland name: Isabell Witzel, Prof role: CONTACT phone: +41 43 253 64 05 email: isabell.witzel@usz.ch name: Isabell Witzel, Prof role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06358560 id: BrainHealthClinics briefTitle: Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers overallStatus: RECRUITING date: 2024-03-04 date: 2024-12-15 date: 2024-12-15 date: 2024-04-10 date: 2024-04-10 name: Dylan Saulsbery class: OTHER briefSummary: The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study. conditions: Stress studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Therapeutic exercises measure: NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Brain Health Clinics status: RECRUITING city: Nashville state: Tennessee zip: 37217 country: United States name: Tyler Hurst, DC role: CONTACT phone: 615-922-0977 email: drhurst@thebrainhealthclinics.com name: Dylan Saulsbery, DC role: PRINCIPAL_INVESTIGATOR name: Tyler Hurst, DC role: SUB_INVESTIGATOR name: Dominic Fetterly, DC role: SUB_INVESTIGATOR lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06358547 id: H-23072469 briefTitle: Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2029-04-01 date: 2024-04-10 date: 2024-04-10 name: Rigshospitalet, Denmark class: OTHER briefSummary: A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 590 type: ESTIMATED name: PGT-A measure: Live birth rate per first embryo transfer measure: Cumulative live birth rate after one complete ART treatment sex: FEMALE minimumAge: 18 Years maximumAge: 41 Years stdAges: ADULT facility: Rigshospitalet city: København Ø zip: 2100 country: Denmark name: Nathalie F Wang, MD role: CONTACT phone: +4535454071 email: nathalie.friis.wang.03@regionh.dk name: Kristine Løssl, MD role: CONTACT email: kristine.loessl@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06358534 id: RTEU-SBF-KB-01 briefTitle: The Effect of Acceptance and Commitment Therapy in Patients With Chronic Renal Failure overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-01 date: 2023-11-30 date: 2024-07-30 date: 2024-04-10 date: 2024-04-26 name: Recep Tayyip Erdogan University class: OTHER briefSummary: Psychological flexibility, life satisfaction and adaptation to the disease of individuals with chronic kidney disease were increased with psychoeducation based on acceptance and commitment therapy to be given to individuals with chronic kidney disease. conditions: Kidney Failure, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pretest-posttest, control and intervention groups primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 32 type: ACTUAL name: psychoeducation based on acceptance and commitment therapy measure: Chronic Disease Adaptation Scale (CHAS): measure: Acceptance and Action Questionnaire-II Scale (AAQ-II) measure: Life Satisfaction Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Recep Tayyip Erdoğan University Faculty of Health Sciences city: Rize state: Güneysu zip: 53100 country: Turkey lat: 41.02083 lon: 40.52194 hasResults: False

 nctId: NCT06358521 id: 6040471 briefTitle: Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial overallStatus: RECRUITING date: 2023-10-02 date: 2025-11-01 date: 2025-11-01 date: 2024-04-10 date: 2024-04-10 name: Queen's University class: OTHER name: Canadian Institutes of Health Research (CIHR) name: The Arthritis Society, Canada briefSummary: This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for hip and knee pain in Canada. conditions: Hip Osteoarthritis conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a cluster randomized controlled trial randomizing 14 sites to the PT-led primary care model for hip/knee pain or to the usual physician/nurse practitioner-led care model primaryPurpose: TREATMENT masking: NONE maskingDescription: Due to the nature of the new model of care and comparison, it is not possible to blind the patient participants or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention. count: 728 type: ESTIMATED name: Physiotherapist-led primary care model for hip and knee pain name: Usual physician-led primary care model for hip and knee pain measure: Self-Reported Functioning measure: Self-Reported Pain Intensity measure: Health-Related Quality of Life measure: Pain Self Efficacy measure: Catastrophic Thinking measure: Fear of Movement measure: Depression Subscale measure: Global Rating of Change measure: Satisfaction with Health Care measure: Adverse Events measure: Health-Care Utilization - Consultations in Electronic Medical Record (EMR) measure: Health-Care Utilization Survey - Visits to health professionals measure: Health-Care Utilization Survey - Medications measure: Health-Care Utilization Survey - Walk-In Clinic Visits measure: Health-Care Utilization Survey - Emergency Department Visits measure: Health-Care Utilization Survey - Inpatient Hospital Stays measure: Health-Care Utilization Survey - Surgeries, Procedures, Injections measure: Health-Care Utilization Survey - Specialist Visits measure: Health-Care Utilization Survey - Diagnostic Imaging measure: Process Outcome - Medications prescribed measure: Process Outcome - Diagnostic Imaging Ordered measure: Process Outcome - Exercises Prescribed measure: Process Outcome - Education Provided measure: Process Outcome - Referrals to other health care providers (HCPs) measure: Process Outcome - Primary Care Visits measure: Process Outcome - Notes to Employers or Insurers measure: Self-Report Time Lost measure: Assistance Needed measure: Extra Expenses measure: Cost outcomes measure: Health Care Accessibility measure: Baseline Characteristics measure: Comorbidities measure: Chronicity of Pain measure: Participant Treatment Fidelity sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen's University status: RECRUITING city: Kingston state: Ontario zip: K7L3N6 country: Canada name: Jordan Miller role: CONTACT lat: 44.22976 lon: -76.48101 hasResults: False

 nctId: NCT06358508 id: VP-0786 briefTitle: Sapphire 3 CTO Study overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2025-07 date: 2024-04-10 date: 2024-04-15 name: OrbusNeich class: INDUSTRY name: Avania briefSummary: A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention.

One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first. conditions: Coronary Artery Disease conditions: Coronary Disease conditions: Myocardial Ischemia conditions: Heart Diseases conditions: Arteriosclerosis conditions: Cardiovascular Diseases conditions: Chronic Total Occlusion conditions: Chronic Total Occlusion of Coronary Artery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: Sapphire 3 Coronary Dilatation Catheter measure: Number of Participants With Device Procedural Success measure: Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) measure: Number of Deaths (Cardiac and Non-Cardiac) measure: Number of Participants With Myocardial Infarctions (MI) measure: Number of Participants With Target Lesion Revascularization (TLR) measure: Number of Participants With In-hospital stent thrombosis (ST) Within the Target Vessel measure: Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) measure: Number of Participants With Absence of Sapphire 3 Study Balloon Rupture measure: Number of Participants That Had Improvement in the Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (independently measured by the Angiographic Core Lab using QCA) measure: Number of Participants With Technical Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358495 id: REB24-0253 briefTitle: Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-07-30 date: 2024-04-10 date: 2024-04-15 name: University of Calgary class: OTHER name: Hotchkiss Brain Institute, University of Calgary briefSummary: Emerging evidence has shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for improves sleep and subthreshold depressive and anxiety symptoms in adolescents at risk (i.e., with a parental history of depressive or anxiety disorders). conditions: Insomnia conditions: Sleep Disturbance conditions: Depressive Symptoms conditions: Anxiety Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either CBT for insomnia or TAU waitlist with a psychoeducational pamphlet about sleep hygiene. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes assessor will be blinded to participants' assigned condition. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Cognitive Behavioral Therapy for Insomnia name: Active Control measure: Insomnia Severity Index measure: Pittsburgh Sleep Quality Index measure: Internalizing Symptoms Subscale of the Youth Self-Report measure: Sleep Logs - Total sleep time measure: Sleep Logs - Onset latency measure: Sleep Logs - Wake after sleep onset measure: Sleep Logs - Sleep efficiency sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06358482 id: ORAL1 briefTitle: Electric Toothbrush Efficacy in Preventing Dental Plaque Development acronym: E-TOOTH overallStatus: RECRUITING date: 2023-01-30 date: 2024-04-30 date: 2024-07-30 date: 2024-04-10 date: 2024-04-15 name: Riccardo Polosa class: OTHER briefSummary: The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology. conditions: Dental Plaque conditions: Calculus, Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: oscillating toothbrush name: standard manual toothbrush measure: fluorescence intensity of at least 30% (ΔR30) measure: the fluorescence intensity of at least 120% (ΔR120) measure: oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state. sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: ADDENDO status: RECRUITING city: Catania zip: 95100 country: Italy lat: 37.49223 lon: 15.07041 hasResults: False

 nctId: NCT06358469 id: VU2 briefTitle: STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision acronym: STRIVE overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2030-06-30 date: 2031-11-30 date: 2024-04-10 date: 2024-04-10 name: Canadian Cancer Trials Group class: NETWORK name: Australia New Zealand Gynaecological Oncology Group briefSummary: This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach? conditions: Vulvar Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 249 type: ESTIMATED name: Surgery name: Active Surveillance measure: Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance measure: HPV-I and HPV-A VSCC cohorts: Recurrence-free survival measure: HPV-I and HPV-A VSCC cohorts: Disease-specific survival measure: HPV-I and HPV-A VSCC cohorts: Overall-survival measure: HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30 measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34 measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale measure: HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358456 id: 20-928 briefTitle: Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices overallStatus: COMPLETED date: 2020-11-20 date: 2022-04-22 date: 2022-04-22 date: 2024-04-10 date: 2024-04-10 name: University Clinic Frankfurt class: OTHER briefSummary: The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:

* Do artificial tears alter the measurements of the corneal surface
* Is there a difference between the devices used in this study

This is relevant because high quality measurements improve the postoperative outcome after cataract surgery. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: one arm for each diagnostic device (three in total) primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: The investigator and patient knew which device they were tested on count: 145 type: ACTUAL name: Artificial tear name: No artificial tears measure: Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) measure: Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application? measure: Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) measure: If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)? sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Goethe University Hospital city: Frankfurt state: Hesse zip: 60590 country: Germany lat: 50.11552 lon: 8.68417 hasResults: False

 nctId: NCT06358443 id: PF-Jarlsberg/IIIB briefTitle: The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia acronym: PF-JB3 overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-10-18 date: 2025-02-23 date: 2024-04-10 date: 2024-04-10 name: Meddoc class: OTHER name: Tine briefSummary: Aim: To estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese in patients with Osteopeni (OP).

Study population: Post-menopausal women and men above 55 years of age in risk of Osteoporosis Treatment: Daily OED Jarlsberg cheese + vitamin D and Calcium tablets. Design: An open and one-armed observational study. Main variables: Bone Mineral Density (BMD), Bone turnover markers (BTMs), Osteocalcin and K2 vitameres.

Study Procedure: Prior to inclusion in this study, all the patients have undergone 32 days of daily OED intake of Jarlsberg cheese + vitamin D and caicium tablets. Thid is the baseline of this observational study. The duration of this study is 12 months with clinical examination and bloodsampling after 6 and 12 months.

Sample size: At least 16 patients will be included conditions: Osteoporosis conditions: Osteopenia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One armed observational study primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Jarlsberg cheese measure: Bone Mineral Density measure: Bone Turnover Markers measure: Osteocalcin measure: Vitamin K2 sex: ALL maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358430 id: 2023-1017 id: NCI-2024-03107 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2027-01-18 date: 2029-01-18 date: 2024-04-10 date: 2024-04-10 name: M.D. Anderson Cancer Center class: OTHER name: Bellicum Pharmaceuticals, Inc. briefSummary: To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC. conditions: Colorectal Cancer conditions: Minimal Residual Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Fludarabine Phosphate name: Cyclophosphamide name: Cetuximab name: TROP2-CAR-NK Cells name: Rimiducid (AP1903) name: Lymphodepleting Chemotherapy measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Maria Pia Morelli, MD, PhD role: CONTACT phone: 713-745-1297 name: Maria Pia Morelli, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06358417 id: 2024P000873 briefTitle: CHW Intervention to Improve Nutrition Security of Patients With Hypertension acronym: HeartWell overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-01-31 date: 2027-05-01 date: 2024-04-10 date: 2024-04-10 name: Massachusetts General Hospital class: OTHER briefSummary: The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months. conditions: Hypertension conditions: Nutrition, Healthy conditions: Food Insecurity conditions: Community Health Worker studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Nutrition-enhanced CHW name: Basic CHW measure: Feasiblity measure: Feasibility of CHW nutrition intervention (intervention arm only) measure: Acceptability (intervention arm only) measure: Diet quality measure: Blood pressure sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358404 id: 2024P000615 briefTitle: Developing a Peer Support Intervention for Depression in SCD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-04-10 date: 2024-04-10 name: Massachusetts General Hospital class: OTHER name: National Institutes of Health (NIH) briefSummary: The purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline. conditions: Subjective Cognitive Decline conditions: Depression in Old Age studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: PeersCOG measure: Feasibility of Intervention measure: Acceptability of Intervention measure: Fidelity of Intervention sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358391 id: TS-RF system briefTitle: To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-03-31 date: 2024-04-10 date: 2024-04-16 name: Starmed class: INDUSTRY name: Helptrial briefSummary: The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device. conditions: Arrhythmias, Cardiac conditions: Atrial Fibrillation conditions: Heart Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: TS-RF Transseptal Needle name: BRK Transseptal Needle measure: First-pass TSP Success Rate (percent) measure: TSP Time (Second) measure: Fluoroscopy Time (Second) for TSP measure: Needle cross-over between the study and control groups measure: Intra-TSP procedural device-associated complications measure: Changes in patient's quality of life measure: Complications measure: Intra-TSP procedural Adverse Events measure: Overall Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358378 id: 995 briefTitle: Accuracy of Cuffless Ambulatory Blood Pressure Monitors Compared to Cuff-based Monitors in an Ambulatory Elderly Population: A Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-30 date: 2024-09-30 date: 2024-04-10 date: 2024-04-10 name: Sligo General Hospital class: OTHER briefSummary: Hypertension is extremely common amongst the elderly, typically manifesting as a silent disease with potentially devastating consequences if left undetected and untreated. Such consequences include stroke, myocardial infarction, kidney and eye disease. Opportunistic screening for hypertension is therefore standard in clinical practice. Currently, the standard of care for screening in the western world is with 24-hour ambulatory cuff-based devices which are often intolerable, particularly for elderly patients.

Several novel cuffless wearables have been developed to overcome the limitations of cuff-based monitors. These devices offer significant advantages over cuff-based devices, including improved patient tolerance and user acceptability. Numerous cuffless monitors are now commercially available. However, validation of such devices is challenging as there is no current universal standard for validating such devices.5 This is highlighted by the heterogenous and often inadequate study methods used to demonstrate accuracy of commercially available cuffless devices for blood pressure measurements. Indeed, the uncertainty about their merit is reflected in international guidelines. The 2023 European Society of Hypertension guidelines currently do not recommend routine use of such devices in clinical practice for evaluation of blood pressure.

There are limited clinical trials comparing 24-hour cuff-based devices directly to cuffless devices, and even fewer specifically in an elderly population where they may be particularly advantageous due to design features that improve tolerability. This study thus aims to address this important gap in the literature to better understand if cuffless devices provide reliable blood pressure measurements in the elderly population by directly comparing these devices to the current standard of care in blood pressure evaluation. The Aktiia device will be used as a surrogate for cuffless wearables while a standard 24-hour ambulatory cuff-based device will represent cuff-based devices. The Aktiia device is a cuffless solution worn as a bracelet on the wrist. It contains optical sensors which collect photoplethysmography signals from arteries in the patient's wrist and uses these to estimate blood pressure. This device is commercially available and clinically validated for use in patients up to age 85. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Aktiia SA Bracelet measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements taken in a resting state measure: Mean difference between mean 24-hour cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements on a per patient basis measure: Tolerability : Mean paired differences on Comfort Rating Scale (CRS) between devices measure: User Acceptability: Mean paired differences on System Usability Scale (SUS) between devices measure: Proportion of recruited patients who provide at least 5 daytime cuffless blood pressure readings per day measure: Proportion of total measurements taken which can be paired (i.e. taken within 1-hour of a measurement from the other device) measure: Proportion of missing data from activity diaries measure: Proportion of recruited patients who provide at least 3 paired blood pressure readings for 3 consecutive days sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358365 id: AQP-DCL-026 briefTitle: Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients overallStatus: COMPLETED date: 2023-03-29 date: 2023-11-02 date: 2023-11-07 date: 2024-04-10 date: 2024-04-10 name: AquaPass Medical Ltd. class: INDUSTRY briefSummary: To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin. conditions: Acute Kidney Failure conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: The AquaPass System measure: Differences in weight gain over the long interdialytic period measure: Device related Adverse Events measure: Changes in NT-proBNP measure: Changes in Blood Urea Nitrogen measure: Effect on Quality of Life measure: Affect on Ultrafiltration Rates after the long inter dialytic gap sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nazareth Hospital EMMS city: Nazareth state: Al Wadi Al Jawani 1611 zip: 16100 country: Israel lat: 32.69925 lon: 35.30483 hasResults: False

 nctId: NCT06358352 id: M18080921 briefTitle: Clinical and Radiographic Assessment of PRF Versus Lutein Placement overallStatus: COMPLETED date: 2021-10-01 date: 2022-02-01 date: 2023-05-01 date: 2024-04-10 date: 2024-04-10 name: Mansoura University class: OTHER briefSummary: Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

Inclusion criteria: 1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.

Exclusion criteria: 1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers.

7

Patients grouping: Patients will be randomly divided into three groups:

Group A: Immediate implant placement with leaving the gap distance empty

Group B: Immediate implant placement then placement of PRF around the implant in the gap distance

Group C: Immediate implant placement then placement of lutein around the implant in the gap distance

Clinical evaluation:

Patients will be evaluated clinically for:

1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions.

3. Sulcus Bleeding Index (SBI) An early sign of gingivitis is bleeding on probing and, in 1971, Muhlemann and Son described the Sulcus Bleeding Index (SBI). It will be assessed at 3, 6 and 12 months intervals.

4. Peri-implant probing depth: Depth of the peri-implant sulcus will be made at 3, 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue.

Radiographic evaluation:

conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement , after 3 months and after 12 months conditions: Osteogenesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Lutein / Zeaxanthin name: Platelet rich fibrin measure: bone formation sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: faculty of dentistry,Mansoura university city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06358339 id: 72374095 briefTitle: TEEM-GIFTS: A Gamified mHealth to Reduce Post-Discharge Suicide Risk overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-08-31 date: 2027-12-31 date: 2024-04-10 date: 2024-04-10 name: Shenzhen Kangning Hospital class: OTHER briefSummary: Patients with mental disorders are at significantly higher risk of suicide after discharge compared to the general population and patients with other diseases. Currently, there is a lack of post-discharge community suicide risk management services in China. The research team's preliminary research suggests that mHealth interventions are well-accepted and feasible for reducing the suicide risk in patients with mental disorders. Furthermore, the inclusion of gamification elements can enhance treatment adherence and user engagement. However, determining the appropriate combination of gamification elements and evaluating the implementation effectiveness of gamified mHealth interventions for suicide risk are challenges in transforming these into regular community mental health services. This study will leverage gamification theory and community-based participatory research to design a gamified mHealth intervention model aimed at reducing suicide risk among discharged patients with mental disorders, and to develop a corresponding management strategy. Using the multi-phase optimization strategy (MOST), the study will identify the optimal combination of gamification elements to reduce suicide risk and increase the outpatient follow-up rate. Through an implementation science framework, the investigators will evaluate the process, outcomes, feasibility, and sustainability of this management strategy with the goal of reducing suicide risk among these patients. The findings from this study will provide a scientific basis for innovative suicide risk management models for discharged patients with mental disorders in China, thereby paving the way for the application of implementation science in mental health. conditions: Suicide studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 17 to Group 18 randomly, with 160 participants in each group. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: After recruitment and the baseline survey, participants will be assigned into Group 1 to Group 16 by simple randomization in R program. The allocation ratio in randomization will be 1:1. Participants, LHSs, nurses who perform recruitment and baseline survey, and investigators who perform follow-ups will be blinded to the assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 640 type: ESTIMATED name: TEEM measure: Suicide ideation at three months after discharge measure: The rate of re-visits to outpatient clinic at three months after discharge measure: Self-determination at at three months after discharge measure: Social connectedness at three month after discharge measure: Social support at three months after discharge measure: Times of re-hospitalization for mental disorders measure: Attitudes towards the acceptability of the intervention measure: Attitudes towards the adoption of the intervention measure: The adoption rate of the intervention in patients measure: Attitudes towards the equity of the intervention measure: Attitudes towards the feasibility of the intervention measure: Attitudes towards the patient-centeredness of the intervention measure: Cost for implementing the TEEM-GIFTS measure: Fidelity of the study measure: Efficiency of the intervention measure: Attitudes towards the safety of the intervention measure: The timeliness of the intervention measure: Patients' perceived stigma from baseline to three months after discharge measure: Patients' self-efficacy from baseline to three months after discharge measure: Patients' compliance to treatment from baseline to three months after discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shenzhen Kangning Hospital city: Shenzhen state: Guangdong zip: 518020 country: China lat: 22.54554 lon: 114.0683 hasResults: False

 nctId: NCT06358326 id: Karabuk-1 briefTitle: Dry Needling and Rehabilitatin Carpal Tunnel Syndrome overallStatus: RECRUITING date: 2024-04-05 date: 2024-08-30 date: 2024-09-30 date: 2024-04-10 date: 2024-04-10 name: Karabuk University class: OTHER briefSummary: Dry needling is used for myofascial release. However, its effectiveness in carpal tunnel syndrome (CTS) is not well known. It is thought that dry needling may also be an effective treatment for CTS by providing relaxation in the fascial tissue. Therefore, this study will examine the effects of dry needling treatment on pain, function, range of motion, proprioception and disability in patients with CTS. conditions: Dry Needling conditions: Carpal Tunnel Syndrome conditions: Myofacial Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dry needling name: Control group measure: Pain severity measure: Wrist range of motion measure: Position sense measure: Severity of symptoms measure: Functional status measure: Hands activity level measure: neuropathic pain severity measure: Nerve cross-sectional area sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pursaklar State Hospital status: RECRUITING city: Ankara country: Turkey name: Fidan Yılmaz, Msc role: CONTACT phone: 0551 207 2954 email: fdnylmz07@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06358313 id: 0023098816 briefTitle: Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Minor Stroke or TIA overallStatus: RECRUITING date: 2024-04-10 date: 2025-04-10 date: 2025-05-10 date: 2024-04-10 date: 2024-04-10 name: Kafrelsheikh University class: OTHER briefSummary: Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever minor stroke or TIA patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be composed of 2 arms atorvastatin arm, which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months, All the patients in the two groups received open-label aspirin at a loading dose of 75 to 300 mg and then 75 mg daily till the end of the 3 months and an open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Our study was single-blinded to the investigators; an independent statistician generated a computer-generated randomization chart with a block size of four in a one-to-one ratio, and participants were randomly assigned to receive either atorvastatin or rosuvastatin by a specially trained and qualified nurse. None of the investigators included in the study knew the patients' assignments. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included atorvastatin bills, and Drug B included rosuvastatin bills. The statistical analysis was performed by an independent statistician. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Atorvastatin 40mg name: Rosuvastatin 20mg measure: the rate of new stroke at 90 days measure: Value of National Institute of Health Stroke Scale (NIHSS) after one week measure: value of Modified Rankin Scale (mRS) at one week measure: value of Modified Rankin Scale(mRS) at three months measure: rate of composite recurrent stroke, myocardial infarction, and death due to vascular events measure: rate of drug adverse effects measure: Drug adverse effects: all side effects related to the drugs of our study will be reported sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: mohamed_gomaa@med.kfs.edu.eg lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06358300 id: Usakpcos2 briefTitle: Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome overallStatus: COMPLETED date: 2022-01-01 date: 2022-09-01 date: 2023-07-20 date: 2024-04-10 date: 2024-04-10 name: Uşak University class: OTHER briefSummary: We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls. conditions: Visceral Adiposity Index conditions: Polycystic Ovary Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ACTUAL measure: Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Usak Training and Research Hospital city: Usak zip: 64100 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False

 nctId: NCT06358287 id: STUDY19030375 briefTitle: Neural Correlates of Auriculotherapy overallStatus: COMPLETED date: 2021-07-15 date: 2022-11-07 date: 2022-11-07 date: 2024-04-10 date: 2024-04-10 name: Keith M. Vogt, MD, PhD class: OTHER briefSummary: Chronic pain continues to be a major health issue, creating a significant societal burden, as it is an independent risk factor for opioid use disorder (OUD) and deaths. Acute pain episodes can often engender OUD due to lack of effective strategies to treat pain and prevent the transition to chronic pain. One potential non-opioid method for pain relief is auriculotherapy (AT), where acupuncture-like treatment is administered to the ear. The objective of this pilot study is to illustrate that AT-related brain effects can be found using functional connectivity MRI (fcMRI) in patients with low back pain. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: cryogenic auriculotherapy measure: Default Mode Network (DMN)-to-Anterior Cingulate Cortex (ACC) connectivity measure: Brief Pain Inventory (BPI) Severity Scores MRI #1 measure: BPI Pain Severity Scores MRI #2 measure: General Anxiety Disorder-7 (GAD-7) Scoring sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC Montefiore city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06358274 id: MED-2024-32848 briefTitle: Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2024-07-01 date: 2024-04-10 date: 2024-04-10 name: University of Minnesota class: OTHER briefSummary: Thru-hiking the Colorado Trail presents distinct challenges owing to its diverse landscapes and high altitudes. The study aims to delve into the physiological and nutritional facets of extended wilderness trekking among thru-hikers. Activities encompass participant recruitment from the Colorado Trail Foundation community, baseline and post-trail assessments including blood lipid panel analysis and anthropometric measurements, data collection during the trail period involving recording daily mileage, exertion levels, and dietary intake, rigorous statistical analysis to explore correlations among various parameters, and adherence to ethical considerations including obtaining formal approval and ensuring informed consent procedures are followed to safeguard participants' rights and privacy. Through this endeavor, the study seeks to offer insights into the metabolic responses and cardiovascular implications associated with thru-hiking, shedding light on the interplay between diet, lifestyle factors, and metabolic health in challenging environments.

The specific aims include examining the metabolic responses and cardiovascular implications associated with thru-hiking, exploring correlations between dietary intake and blood lipid profiles, and elucidating the interplay between lifestyle factors and metabolic health in demanding environments. This study is not limited to program evaluation, quality assurance, or improvement activities within a specific department or setting but rather seeks to contribute to scientific knowledge and inform evidence-based recommendations for individuals engaging in thru-hiking or similar high-intensity activities. conditions: Thru-hiking studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Thru-hiking measure: blood lipid panel: total cholesterol measure: blood lipid panel: high-density lipoprotein (HDL) measure: blood lipid panel: low-density lipoprotein (LDL) measure: blood lipid panel: triglycerides sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358261 id: IRB00433279 id: R03DK135898 type: NIH link: https://reporter.nih.gov/quickSearch/R03DK135898 briefTitle: Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2025-09 date: 2024-04-10 date: 2024-04-23 name: Johns Hopkins University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation. conditions: PreDiabetes conditions: Lifestyle, Healthy conditions: Activation, Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pilot group-randomized controlled trial primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Diabetes Prevention Patient Activation Clinical Decision Support Tool measure: patient activation as assessed by the Patient Activation Measure Survey (PAM) measure: number of participants referred to Diabetes Prevention Program measure: number of participants prescribed metformin measure: percent of participants who make diet changes measure: change in amount and frequency of physical activity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358248 id: SPHERE briefTitle: Standardized Physician-modified Fenestrated Endograft Registry acronym: SPHERE overallStatus: RECRUITING date: 2023-10-01 date: 2028-10-01 date: 2033-10-01 date: 2024-04-10 date: 2024-04-16 name: University Hospital Padova class: OTHER briefSummary: Multicenter retrospective study including all consecutive patients treated by PMEG using a standard modification technique of Valiant Captivia (Medtronic, Minneapolis, MN-USA). conditions: Aortic Aneurysm, Thoracoabdominal conditions: Aortic Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Physician-modification of Valiant Captivia Endograft (Medtronic, Minneapolis, MN-USA). measure: Technical success measure: Freedom from target vessel instability measure: Freedom from endograft instability measure: Early (30-days) Major Adverse Event (MAE) measure: Aneurysm sac dynamics sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vascular and Endovascular Clinic - Padova University status: RECRUITING city: Padova zip: 35020 country: Italy name: Michele Piazza, Pr role: CONTACT phone: 3498644688 email: michele.piazza@unipd.it lat: 45.40797 lon: 11.88586 hasResults: False

 nctId: NCT06358235 id: SDU-IH-HA-01 briefTitle: The Effect of Music Therapy on Dyspnea Severity and Vital Signs overallStatus: RECRUITING date: 2024-01-07 date: 2024-05-30 date: 2024-06-30 date: 2024-04-10 date: 2024-04-10 name: Suleyman Demirel University class: OTHER briefSummary: This study aims to investigate the effect of music therapy on dyspnea severity and quality of life indicators in patients with Chronic Obstructive Pulmonary Disease (COPD) admitted to the intensive care unit. The study will be conducted at Isparta City Hospital and Kumluca State Hospital in Antalya, Turkey, using an experimental design. Patients will be divided into experimental and control groups, selected using randomization.

Patients in the experimental group will receive music therapy in the Hüseyni maqam, while those in the control group will not receive any music therapy. Life indicators and Modified Borg Scale (MBS) values of patients in the experimental group will be recorded before, immediately after, and 30 minutes post-application. Music therapy will be administered to patients for only one day, once in the morning. Data for patients in the control group will be collected at the same time intervals. The results of this study aim to contribute to the literature on the impact of music therapy on dyspnea severity and quality of life indicators in COPD patients. conditions: Dyspnea conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: Music Therapy name: No Music therapy measure: Patient Identification Form measure: Modified Borg Scale measure: Vital Signs Record Chart measure: Blood Test Results Record Chart sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suleyman Demırel University status: RECRUITING city: Isparta zip: 32200 country: Turkey name: Hafize Aydemir role: CONTACT phone: +905078380979 email: aydemirhafize1998@gmail.com lat: 37.76444 lon: 30.55222 hasResults: False

 nctId: NCT06358222 id: LUNon-invasive briefTitle: Predicting Non-small Cell Lung Cancer (NSCLC) Lymph Node Metastasis: Integrating Circulating Tumor DNA (ctDNA) Mutation/ Methylation Profiling With Positron Emission Tomography-computed Tomography (PET-CT) Scan overallStatus: RECRUITING date: 2023-12-15 date: 2027-12-31 date: 2027-12-31 date: 2024-04-10 date: 2024-04-10 name: Shanghai Chest Hospital class: OTHER briefSummary: This is a single center, prospective and observational study conducted in three stages to predict the NSCLC lymph node metastasis based on ctDNA/specific methylation molecular features combined with PET-CT imaging features and intervention study. conditions: Carcinoma conditions: Non-small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Blood ctDNA + methylation + PET-CT and Postoperative pathology name: MRD+ methylation (or combined with PET-CT) and Invasive mediastinoscopy /EBUS-TBNA name: Intraoperative lymph node dissection measure: Negative prediction value (NPV) of lymph node metastasis rates measure: Disease-free survival (DFS) measure: ctDNA-free interval (CFI) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: ShangHai country: China name: Feng Yao, PhD role: CONTACT phone: 021-22200000 email: yaofeng@shsmu.edu.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06358209 id: LY2024-045-B briefTitle: Safety and Efficacy of Ventricular Irrigation for Ventriculitis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-30 date: 2026-05-30 date: 2024-04-10 date: 2024-04-10 name: RenJi Hospital class: OTHER name: Southern Medical University, China name: First Affiliated Hospital of Zhejiang University name: 904 Hospital of the People's Liberation Army Joint Logistic Support Force name: Shenzhen Second People's Hospital name: First Affiliated Hospital of Wannan Medical College name: Huashan Hospital briefSummary: Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy.

Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. High-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.

This multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for severe ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with severe ventriculitis. conditions: Central Nervous System Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Ventricular irrigation measure: Mortality rate measure: GOSE measure: CRS-R measure: DRS measure: mRS measure: Microbial culture measure: CSF glucose measure: CSF protein measure: CSF WBC count measure: Length of stay measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Wannan Medical College city: Wuhu state: Anhui country: China name: Xuefei Shao, Dr role: CONTACT lat: 31.33728 lon: 118.37351 facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong country: China name: Qinghua Wang, Dr role: CONTACT lat: 23.11667 lon: 113.25 facility: Shenzhen Second People's Hospital city: Shenzhen state: Guangdong country: China name: Xianjian Huang, Dr role: CONTACT lat: 22.54554 lon: 114.0683 facility: 904 Hospital of the People's Liberation Army Joint Logistic Support Force city: Wuxi state: Jiangsu country: China name: Likun Yang, Dr role: CONTACT lat: 31.56887 lon: 120.28857 facility: Huashan Hospital city: Shanghai state: Shanghai country: China name: Jin Hu, Dr role: CONTACT lat: 31.22222 lon: 121.45806 facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University city: Shanghai state: Shanghai country: China name: Jiyao Jiang, Dr role: CONTACT phone: 021-68383729 email: jiyaojiang@126.com name: Junfeng Feng, Dr role: CONTACT phone: 13611860825 email: fengjfmail@163.com lat: 31.22222 lon: 121.45806 facility: First Affiliated Hospital of Zhejiang University city: Hangzhou state: Zhejiang country: China name: Xiaofeng Yang, Dr role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06358196 id: CESAH briefTitle: Complex Exploratory Study of Alcohol-Associated Hepatitis acronym: CESAH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2026-04-30 date: 2024-04-10 date: 2024-04-10 name: Pavol Jozef Safarik University class: OTHER name: L Pasteur University Hospital name: Hospital Agel Kosice-Saca name: Technical University in Kosice name: Western University name: University of Roma La Sapienza briefSummary: Alcohol-associated hepatitis is a clinical syndrome distinct from steatohepatitis or liver cirrhosis. It is associated with high mortality and characterized by an absence of effective treatment, while corticosteroids, which are currently used as the first-line treatment are effective only in a subpopulation of patients and only on 28-days survival - their effect on survival does not last beyond this interval. The proposed study is a complex exploratory study of alcohol-associated hepatitis with several epidemiology- and prognosis-related aims. conditions: Alcoholic Hepatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Standardized annual incidence of (severe) alcoholic hepatitis in the Kosice Urban Area measure: Threshold of alcohol consumption associated with (an increased risk of) developing AH measure: Diagnostic accuracy of NIAAA and NIAAAm-CRP measure: Prognostic performance of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score measure: Prognostic performance of SOFA and CLIF-C measure: An update of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score measure: Alternative to Lille model measure: Prognostic model for 90 day survival measure: Uper limit of MELD or Maddrey scores beyond which patients no longer derive any therapeutic benefit from corticosteroid treatment measure: Natural course of nonsevere alcoholic hepatitis measure: Natural course of severe alcoholic hepatitis measure: Risk score for bacterial infection before corticosteroid treatment in patients with alcoholic hepatitis measure: Distinguishing sterile Inflammation from infection in alcoholic hepatitis measure: GUT microbiome and treatment response in alcoholic hepatitis measure: Hypothalamus-pituitary-adrenal axis and treatment response in alcoholic hepatitis measure: Adherence to outpatient psychiatric management measure: Nutritional status and treatment response in alcoholic hepatitis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pavol Jozef Safarik University city: Kosice zip: 04012 country: Slovakia name: Jakub Gazda, MD, PhD role: CONTACT phone: +421911115288 email: jakub.gazda@upjs.sk name: Martin Janicko, MD, PhD role: CONTACT email: martin.janicko@upjs.sk lat: 48.71395 lon: 21.25808 hasResults: False

 nctId: NCT06358183 id: ESC001 briefTitle: Surgical Capacity in Zimbabwean Public Hospitals overallStatus: COMPLETED date: 2019-04-24 date: 2024-02-25 date: 2024-03-15 date: 2024-04-10 date: 2024-04-10 name: Parirenyatwa Hospital class: OTHER briefSummary: This study aimed to understand how ready Zimbabwe's public hospitals are to perform essential surgeries, which are critical for treating a wide range of health issues from emergencies like car accidents to planned procedures such as childbirth by caesarean section. The researchers looked at hospitals across Zimbabwe to see what kind of surgery facilities, equipment, and specialists were available. conditions: Surgery conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 80 type: ACTUAL name: No intervention measure: Bellwether procedures measure: Procedures measure: SAO density measure: Infrastructure sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Parirenyatwa Hospital city: Harare country: Zimbabwe lat: -17.82772 lon: 31.05337 hasResults: False

 nctId: NCT06358170 id: NYCU112169AF briefTitle: Effects of Circuit Training Combine With Square-Stepping Exercise, Strength Training and Balance Training on Senior Fitness and Fall Risk in Elderly in the Community acronym: SSE overallStatus: RECRUITING date: 2024-03-01 date: 2024-07-01 date: 2024-07-01 date: 2024-04-10 date: 2024-04-10 name: Hsin-ching, Tsai class: OTHER briefSummary: According to the cause of death statistics compiled by the Ministry of Health and Welfare in 2022, among the causes of death among the elderly, falls ranked second among the causes of death from accidental injuries over the age of 65. Exercise has been proven to prevent falls in many studies, especially Square-Stepping Exercise can not only train strength and balance, but also improve cognitive function and reduce the fear of falling in the elderly. Therefore, this study will use Square-Stepping Exercise as the core and circuit training as the structure to design a set of exercise training that combines muscle strength and balance and is easy to implement in the community. The purpose of the study is to determine whether exercise training that combines circuit training with block stepping, muscle strength, and balance exercises can reduce the risk of falls among elderly people in the community (primary results: muscle strength, flexibility, cardiorespiratory endurance, balance; secondary results: cognitive function, Fear of falling, fall rate). This study will collect participant in the community, and subjects will be randomly assigned to the experimental group and the control group on a community basis. The experimental group will receive 12 weeks of exercise training, while the control group will follow their usual lifestyle, with 48 people in each group. The experimental design is exercise intervention for 12 weeks, twice a week, 90 minutes each time (30 minutes of main exercise). The exercise is designed into two stages according to the difficulty of Square-Stepping Exercise. The training of muscle strength and dynamic/static balance will also gradually increase in difficulty over the weeks. The research look forward to seeing the effects of multi-component exercise on physical fitness, cognitive function, fear of falling and fall rate. conditions: Circuit-Based Exercise conditions: Exercise Test conditions: Community Health Nursing conditions: Aged conditions: Physical Fitness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 126 type: ESTIMATED name: Circuit Training Combine with Square-Stepping Exercise measure: Senior Fitness - upper body muscle strength (Arm Curl Test) measure: Senior Fitness - lower body muscle strength (Chair Stand Test ) measure: Senior Fitness - upper body flexibility (Back Scratch Test) measure: Senior Fitness - lower body flexibility (Chair Sit and Reach Test) measure: Senior Fitness - cardio respiratory endurance ( 2 Minute Step in Place Test) measure: Senior Fitness - dynamic balance (8-Foot Up and Go Test) measure: Senior Fitness - static balance (Single-Leg Balance with Eyes Open) measure: cognitive function measure: Fear of falling measure: fall rate sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei zip: 112 country: Taiwan name: Wei Tzu Lo role: CONTACT phone: 02-2823-9753 phoneExt: 66378 lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06358157 id: CLN02001 briefTitle: The Ladera Large Bore Closure Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2025-02 date: 2024-04-10 date: 2024-04-10 name: Ladera Medical class: INDUSTRY name: Avania briefSummary: This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a large-bore procedure sheath. conditions: Vascular Closure conditions: Femoral Arteriotomy Closure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, non-randomized primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ladera LBC System measure: Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications measure: Primary Performance Endpoint: Time to Hemostasis measure: Secondary Safety Endpoint: Minor Arterial Access Site Closure-related Complications measure: Secondary Performance Endpoint: Time-to-Ambulation measure: Secondary Performance Endpoint: Time-to-Discharge Eligibility measure: Secondary Performance Endpoint: Incidence of Procedural Success measure: Secondary Performance Endpoint: Incidence of Device Technical Success sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358144 id: IRB00111438 id: R01DA053209 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA053209 briefTitle: Cannabis Edibles Packaging Imagery Experiment overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-07 date: 2024-04-10 date: 2024-04-10 name: Wake Forest University Health Sciences class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without packaging imagery. conditions: Cannabis Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will complete a 15-minute online survey, where they will be randomized to one of five conditions: four intervention conditions with a different image on the package and one without any imagery. primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 1250 type: ESTIMATED name: Packaging imagery name: No Imagery (Control) measure: Product Appeal Scoring measure: Harm Perceptions (Absolute) Scoring measure: Willingness to Try Product Scoring measure: Appeal to Children Scoring measure: Harm Perceptions (Relative) Scoring measure: Perception of Quality Scoring sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Alexandra Zizzi, MSPH role: CONTACT lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06358131 id: R.21.10.1493 briefTitle: Propofol Versus Midazolam in Sedation for Upper and Lower Gastrointestinal Endoscopy. overallStatus: RECRUITING date: 2022-01-01 date: 2024-08-01 date: 2024-08-01 date: 2024-04-10 date: 2024-04-10 name: Mansoura University class: OTHER briefSummary: There has been rapid growth in the number and complexity of gastrointestinal (GI) endoscopic procedures performed during the last decade. To ensure safe and effective upper GI endoscopy, the choice of an appropriate sedative agent is crucial. Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation. Benzodiazepines still the most common sedative agents used for conscious sedation, either solely or in combination with opioids for upper GI endoscopy. Propofol is a hypnotic drug used for induction of anesthesia with short half-life that permits rapid patient recovery and discharge. Thus, its use is for upper GI endoscopy was adopted in many endoscopy centers. So we are going to Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.Also we are going to Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia. conditions: Gastrointestinal Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 656 type: ESTIMATED name: Endoscopy measure: Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events. measure: Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University status: RECRUITING city: Mansoura state: Dakhlia zip: 35516 country: Egypt name: Asmaa Gameel, MD role: CONTACT phone: 01025835429 email: asmaagameel@mans.edu.eg lat: 31.03637 lon: 31.38069 facility: MansouraU status: RECRUITING city: Mansoura country: Egypt name: Asmaa Gameel, MD role: CONTACT phone: 201025835429 email: asmaagameel165@gmail.com lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06358118 id: 2024-003-KY briefTitle: Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-07-01 date: 2025-07-01 date: 2024-04-10 date: 2024-04-10 name: Qing Ni class: OTHER briefSummary: The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments.

The main questions it aims to answer are:

1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity?
2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders.

Participants will:

1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months；
2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months;
3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events;
4. Urine and serum samples were collected before and after treatment; conditions: Diabete Mellitus conditions: Aging conditions: Metabolic Disorders conditions: Traditional Chinese Medicine conditions: Randomized Controlled Trial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Buyuan Zhixiao Formula name: Placebo measure: HbA1c measure: Fasting blood glucose measure: 2-hour postprandial blood glucose measure: blood pressure measure: weight measure: waist circumference measure: BMI measure: Total Cholesterol measure: Triglycerides measure: High density lipoprotein cholesterol measure: Low density lipoprotein cholesterol measure: Ankle-Brachial Index（ABI） measure: Fasting insulin measure: C-peptide measure: insulin resistance index measure: islet β-cell function index measure: lipid Lipid accumulation product measure: visceral adiposity index measure: Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points measure: Concentration Variation of Interleukin-10 measure: Change in Homocysteine Levels measure: Average Concentration of Interleukin-6 measure: Change in Endothelin-1 Levels measure: Average Concentration of Nitric Oxide measure: Concentration Variation of Von Willebrand Factor measure: Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points measure: Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration measure: Average Concentration of Soluble Intercellular Adhesion Molecule-1 measure: Change in Serum Tau Protein Levels measure: Average Concentration of Aβ40 measure: Average Concentration of Aβ42 measure: Change in Neurofilament Light Chain Protein Levels measure: Carotid Ultrasound; Carotid Intima-Media Thickness. measure: Activities of Daily Living Scale score; Fried Frailty Phenotype Scale; Mini Nutritional Rating Scale; MoCA scale score; Traditional Chinese Medicine Kidney Deficiency and Blood Stasis Syndrome Scale score. measure: Montreal Cognitive Assessment Score measure: Fried Frailty Phenotype Scale measure: Activities of Daily Living Scale score measure: Mini Nutritional Rating Scale measure: Serum and urine metabolomics sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: China Academy of Chinese Medical Sciences Guang'anmen Hospital city: Beijin state: Beijing zip: 100053 country: China name: Qing Ni, postgraduate role: CONTACT phone: 010-88001245 email: 1831479145@qq.com name: zhige Wen, postgraduate role: CONTACT phone: 15890643963 email: 1831479145@qq.com facility: Cangzhou integrative medicine hospital city: Hebei country: China name: zhongyong zhang, postgraduate role: CONTACT phone: 18031783396 email: zzyhappy666@126.com facility: Hohhot Mongolian Traditional Chinese Medicine Hospital city: Neimeng country: China facility: Binzhou Traditional Chinese Medicine Hospital city: Shandong country: China name: lijuan Du, postgraduate role: CONTACT phone: 18800102622 email: 137425497@qq.com facility: Yantai Baishi Traditional Chinese Medicine Hospital city: Shandong country: China facility: The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine city: Tianjin country: China name: bin Wang, postgraduate role: CONTACT phone: 13051395068 lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06358105 id: id. 6457 briefTitle: Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial acronym: STARTERS overallStatus: NOT_YET_RECRUITING date: 2024-11-15 date: 2024-11-15 date: 2025-11-15 date: 2024-04-10 date: 2024-04-10 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.

The main questions it aims to answer are:

* Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?
* Will major and minor procedural complications be reduced after simulator-based training?

Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.

They will be supervised during their cath lab period as first operators by senior interventional cardiologists.

During their first 50 procedures performed as supervised first operator, specific procedural data will be collected. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Simulator-based training name: Standard training measure: Mean total fluoroscopy radiation time (expressed in seconds) measure: Mean arterial cannulation time (expressed in seconds) measure: Total radiation dose (expressed in cGy*cm2) measure: Total contrast dose (expressed in ml) measure: Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant) measure: Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant) measure: Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant) measure: Number of catheters used measure: Any major or minor procedural and clinical complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS city: Rome zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06358092 id: ZSSYXHNK2401 briefTitle: Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2026-01-01 date: 2024-04-10 date: 2024-04-10 name: Third Affiliated Hospital, Sun Yat-Sen University class: OTHER briefSummary: Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research. conditions: Cirrhosis, Liver conditions: Portal Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 112 type: ESTIMATED name: Hepatic venous pressure gradient name: Two-Dimensional Shear Wave Elastography measure: the diagnostic performance of liver and spleen stiffness by E imaging technology for clinically significant portal hypertension measure: the diagnostic performance of microvessel imaging of hepatic microcirculation by E imaging technology for clinically significant portal hypertension measure: the difference among left, middle and right hepatic venous pressure gradient sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358079 id: 258 briefTitle: Re-infusion of Unwashed Shed Blood During Off-pump Surgery overallStatus: RECRUITING date: 2024-03-27 date: 2026-03-30 date: 2026-03-30 date: 2024-04-10 date: 2024-04-10 name: Damascus University class: OTHER briefSummary: To assess the efficacy and side-effects of re-infusion of unwashed shed blood during off-pump coronary artery surgery using a novel cardiotomy circuit. conditions: Coronary Artery Disease conditions: Blood Transfusion Complication conditions: Cardiovascular Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective study involving patients undergoing off-pump coronary artery bypass surgery. Patients will be randomized to two groups; an isolated cardiotomy circuit for re-infusion of unwashed shed blood will be used in group (a) and the conventional no re-infusion technique will be used in group (b). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessor will be blinded to the group type when analyzing data whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Re-infusion of unwashed shed blood measure: blood transfusion requirements measure: inflammatory response measure: alveolar/arterial oxygen pressure gradients measure: cost-benefit measure: Neuro-markers measure: myocardial marker CK-MB measure: myocardial marker troponin-I measure: blood loss measure: complement response sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus University Cardiac Surgery Hospital status: RECRUITING city: Damascus country: Syrian Arab Republic name: Mohammad Bashar Izzat, FRCS role: CONTACT phone: +963943240820 email: mbizzat@gmail.com name: Albaraa Bara, MD role: CONTACT phone: 0934206291 email: mbizzat@damascusuniversity.edu.sy lat: 33.5102 lon: 36.29128 hasResults: False

 nctId: NCT06358066 id: self assembling peptides briefTitle: The Remineralization of Early Enamel Caries in Permanent Teeth overallStatus: NOT_YET_RECRUITING date: 2024-04-06 date: 2024-10-06 date: 2024-12-06 date: 2024-04-10 date: 2024-04-10 name: Tanta University class: OTHER briefSummary: Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth. conditions: White Spot Lesion studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: diagnodent name: ICDAS 2 measure: measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system measure: measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system sex: ALL minimumAge: 10 Years maximumAge: 14 Years stdAges: CHILD hasResults: False

 nctId: NCT06358053 id: CRTE7A2-2302C briefTitle: CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-12-31 date: 2028-04-30 date: 2024-04-10 date: 2024-04-10 name: Corregene Biotechnology Co., Ltd class: INDUSTRY briefSummary: A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A\*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection. conditions: Cervical Cancer conditions: Anal Cancer conditions: Head and Neck Cancers conditions: Other Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: CRTE7A2-01 TCR-T cell therapy measure: DLT measure: RP2D measure: cevents (SAEs). measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Progression-Free Survival (PFS) measure: Overall Survival(OS) measure: Peripheral blood TCR-T cell copy number sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358040 id: 2023-0328 briefTitle: Opioid Dispenser for Microdiscectomy/Laminectomy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-07 date: 2024-04-10 date: 2024-04-22 name: Hospital for Special Surgery, New York class: OTHER briefSummary: The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. Pain after surgery is often treated with opioid medications. Opioid medications can have side effects. Some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. Opioid pain medications when used the wrong way may also be addictive. Due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. However, when used properly and safely, opioid pain medications are excellent pain relievers.

Addinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. Half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. The other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. For this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. The investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. Results from this study will help understand if the Addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles. conditions: Opioid Use conditions: Pain, Postoperative conditions: Medical Device conditions: Laminectomy conditions: Diskectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Opioid-Dispensing Device name: App name: Standard Opioid Pill Bottle measure: Cumulative Opioid Consumption at Postoperative Day 14 (POD14) measure: NRS pain intensity ratings measure: Patient satisfaction with the app and with the dispensing device measure: Frequency of reported difficulties using the device measure: Frequency of reported difficulties using the app measure: Opioid prescription refill rates measure: Concordance of app data and medication left in the device or pill bottle (medication reconciliation) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital for Special Surgery city: New York state: New York zip: 10021 country: United States name: William Chan, MEng role: CONTACT phone: 917-260-4788 email: chanw@hss.edu name: Alexandra Sideris, PhD role: CONTACT phone: 212-774-2602 email: siderisa@hss.edu lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06358027 id: DokuzEU-ACC-BOtlu-01 briefTitle: Evaluation of the Effects of Different Ventilation Modes Used During Anesthesia Awakening on the Frequency of Postoperative Atelectasis overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-04-21 date: 2024-04-30 date: 2024-04-10 date: 2024-04-10 name: Dokuz Eylul University class: OTHER briefSummary: In our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis. conditions: Atelectasis, Postoperative Pulmonary studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 278 type: ESTIMATED name: lung ultrasound measure: Modified Transthoracic Ultrasound Score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06358014 id: YX2021-02 briefTitle: Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen overallStatus: RECRUITING date: 2023-05-12 date: 2024-12-30 date: 2024-12-30 date: 2024-04-10 date: 2024-04-10 name: Xiao Wang class: OTHER briefSummary: After menopause, there is a certain tendency towards depression, with the risk of developing depression being about 3 to 4 times higher than before menopause. Additionally, postmenopausal women experience varying degrees of cognitive decline, which are closely associated with hormonal changes. Therefore, we should pay more attention to the cognitive levels of postmenopausal depression patients. Increasing evidence suggests that changes in cognitive function during menopause may be related to the effects of estrogen on cognitive function, and estrogen therapy can effectively improve cognitive decline. Estrogen is not only associated with cognitive symptoms after menopause, but estrogen intervention is also an adjunctive treatment for postmenopausal depression symptoms. There is a close relationship between cognitive levels and depression, as depression itself is accompanied by cognitive decline, and early cognitive decline can also manifest depressive symptoms. Therefore, the cognitive levels of postmenopausal depression patients are also worthy of further attention.This study is an 8-week randomized controlled trial. The subjects are patients with postmenopausal depression accompanied by cognitive decline, all of whom have undergone natural menopause for at least one year; with HAMD-17 scores ≥17 points; and MOCA scores ≤26 points. This study aims to recruit patients with postmenopausal depression accompanied by cognitive decline from the outpatient or inpatient departments of Beijing Anding Hospital, Capital Medical University. Patients who meet the inclusion criteria will be randomly assigned to the combination group and the control group using a random number method. The combination group will receive estrogen combined with SSRIs, while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention. Patients' cognitive function and depressive symptoms will be assessed using scales at baseline, 2 weeks, 4 weeks, and the end of 8 weeks of treatment, and safety evaluations will be conducted. The primary efficacy endpoint is the change in MoCA scores from baseline to the end of the study. Secondary efficacy endpoints include changes in HAMD-17, modified Kupperman Scale, ADL Scale, and hormone levels from baseline to the end of the study. The safety of the study drug will be evaluated through adverse event reporting, clinical laboratory tests, and physical examinations. conditions: Postmenopausal Depression conditions: Estrogen studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The combination group will receive estrogen combined with Selective serotonin reuptake inhibitors (SSRIs) , while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention.SSRIs include Citalopram (Celexa) , Escitalopram (Lexapro) ,Fluoxetine (Prozac) ,Paroxetine (Paxil, Pexeva) and Sertraline (Zoloft) primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs name: SSRIs measure: The average change value of MOCA total scores from baseline to 8 weeks of treatment, as assessed by raters, is the primary efficacy endpoint(0-8week). measure: The average change value of HAMD-17 total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures measure: The average change value of HAMA total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures measure: The average change value of Kupperman total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures measure: The average change value of PSQI total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures measure: The average change value of ADL total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures sex: FEMALE maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anding Hospital Affiliated to Capital Medical University status: RECRUITING city: Beijing country: China name: xiao wang, prof role: CONTACT phone: +8658303103 email: wangxiaofight2016@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06358001 id: 21-07 briefTitle: EchoTip AcuCore Post-Market Clinical Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-10 date: 2024-04-10 name: Cook Research Incorporated class: INDUSTRY briefSummary: The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore. conditions: Adenocarcinoma conditions: Neuroendocrine Tumors conditions: Hepatocellular Carcinoma conditions: Cholangiocarcinoma conditions: Malignant Lymphoma conditions: Metastasis conditions: Chronic Pancreatitis conditions: Autoimmune Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 183 type: ESTIMATED name: EchoTip AcuCore measure: Technical Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357988 id: NCI-2024-01149 id: NCI-2024-01149 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-T type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-T type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T) overallStatus: ACTIVE_NOT_RECRUITING date: 2016-02-24 date: 2024-11-04 date: 2024-11-04 date: 2024-04-10 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well GDC-0449 (vismodegib) works for treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have a smoothened or patched 1 genetic mutation. Vismodegib is a type of medication called a hedgehog signaling pathway antagonist and works by blocks a type of protein involved in tissue growth and repair and may block the growth of cancer cells. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Echocardiography name: Radionuclide Imaging name: Vismodegib measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06357975 id: NCI-2024-01126 id: NCI-2024-01126 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-C1 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-C1 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1) overallStatus: ACTIVE_NOT_RECRUITING date: 2016-05-30 date: 2024-11-15 date: 2024-11-15 date: 2024-04-10 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well crizotinib works in treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have MET gene amplification. Crizotinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Crizotinib name: Radiologic Examination measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06357962 id: CSAPG-40 briefTitle: Semi-permanent Acupuncture Effect on Cervical Ripening overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2025-10 date: 2024-04-10 date: 2024-04-12 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture. conditions: Pregnancy Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 30 type: ESTIMATED name: Semi-permanent acupuncture name: Sham of semi-permanent acupuncture measure: Pharmacological induction measure: Change on score of Bishop scale measure: Onset of spontaneous labor measure: Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period measure: Duration of labor period measure: Satisfaction of pregnants sex: FEMALE maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Consorci Sanitari Alt Penedes i Garraf city: Vilafranca Del Penedès state: Barcelona zip: 08720 country: Spain name: Gloria Villena role: CONTACT phone: +34 938180440 phoneExt: 43197 email: gvillena@csapg.cat name: Noemí Casaponsa role: CONTACT phone: +34 938960025 phoneExt: 43197 email: recerca@csapg.cat lat: 41.34618 lon: 1.69713 hasResults: False

 nctId: NCT06357949 id: E2-23-3615 briefTitle: The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke Patients overallStatus: RECRUITING date: 2024-04-05 date: 2024-09 date: 2024-09 date: 2024-04-10 date: 2024-04-29 name: Hitit University class: OTHER briefSummary: The aim of this study is to investigate the effectiveness of high-intensity laser therapy for treating plantar flexor muscle spasticity in subacute and chronic stroke patients, focusing on its impact on spasticity, joint range of motion, pain, muscle thickness, functional ambulation, and quality of life. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: High-intensity laser name: Sham laser measure: 10-Meter Walk Test measure: Visual analogue scale for pain (VAS- pain) measure: Modified Ashworth Scale measure: Joint Range of Motion (ROM) Measurement measure: Ultrasonography measure: Timed Up and Go test measure: Stroke Specific Quality of Life Scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital status: RECRUITING city: Ankara country: Turkey name: Tuğba Atan role: CONTACT phone: +90 312 2911000 phoneExt: 1414 email: tubaatan@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06357936 id: CNMT002 briefTitle: Nanofat Grafting as a Method of Treating Critical Limb Ischemia overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-11-20 date: 2025-02-20 date: 2024-04-10 date: 2024-04-10 name: Center of New Medical Technologies class: OTHER briefSummary: This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior abdominal wall, followed by preparation and injection of nano fat into the tissues of the foot and leg without additional drug therapy. The novelty of this method lies in the use of autologous stem cells and growth factors, differing from current treatments like neovasculgen, which is a plasmid DNA-based treatment. The trial aims to assess the safety and effectiveness of nano fat grafting, including pain relief, the frequency of intraoperative complications, increased distance of pain-free walking, limb preservation, and mortality rates.

The trial will involve patients with diagnosed occlusive lesions of the femoral-popliteal-tibial segment and chronic ischemia of III-IV degree according to Fontaine and 5-6 categories according to Rutherford, excluding those with contraindications for surgical intervention on the femoral-popliteal-tibial segment, chronic heart failure of III-IV NYHA class, severe liver or kidney failure, among others.

The study design includes preoperative examinations, hospital phase activities including the surgery and post-operative assessments, and follow-up visits at 6 and 12 months post-operation to evaluate the method's safety, complications, and effectiveness based on various parameters like pain, trophic disturbances, and limb ischemia severity.

Statistical methods will involve quantitative data presented as mean ± standard deviation, with qualitative traits compared using the Chi-square test or Fisher's exact test. The planned patient number is 40, aiming to demonstrate the effectiveness and safety of nano fat grafting for critical limb ischemia treatment compared to current treatments. conditions: Limb Ischemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: nano-fat grafting in chronic limb ischaemia name: sham comparator measure: Percent of pain absence in experimental group measure: Number of any intraoperative complications measure: Number of any inhospital complications measure: Number of saved limbs measure: Percent change in visual analog pain score (VAS) change sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of New Medical Technologies city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Andrey V Ponomarenko, MD role: CONTACT lat: 55.0415 lon: 82.9346 hasResults: False

 nctId: NCT06357923 id: 23-PP-13 id: 2024-A00321-46 type: OTHER domain: ANSM briefTitle: Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance in Age overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-02 date: 2026-05-01 date: 2024-04-10 date: 2024-04-10 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Recruitment on the RAV pole in consultation or day hospital. Competitive recruitment of subjects \> 60 years of age respecting a male/female ratio = 1. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: dosage measure: Expression level of LAMP2 (protein and isoform A and B mRNA) measure: Presence of mutation in the "Oncomin Myeloid Reasearch Assay" gene panel targeting approximately 40 Different genes sex: ALL minimumAge: 60 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu de Nice city: Nice zip: 06003 country: France name: Andrea CICCONE role: CONTACT phone: 0492034702 email: ciccone.a@hu-nice.fr name: marion causeret role: CONTACT phone: 0492034702 email: causeret.m@chu-nice.fr name: Andrea CICCONE role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 hasResults: False

 nctId: NCT06357910 id: HM-EMMA-102 briefTitle: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions overallStatus: NOT_YET_RECRUITING date: 2024-05-17 date: 2024-06-29 date: 2024-06-29 date: 2024-04-10 date: 2024-04-12 name: Hanmi Pharmaceutical Company Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: HCP2303 name: RLD2302 name: RLD2102 measure: AUCt measure: Cmax measure: AUCinf measure: Tmax measure: t1/2 measure: CL/F measure: Vd/F sex: ALL minimumAge: 19 Years maximumAge: 54 Years stdAges: ADULT facility: Jeonbuk University Hospital city: Jeonju state: Jeollabuk-do country: Korea, Republic of name: Jin A Lee, Researcher role: CONTACT phone: 063-259-3550 name: Min-gul Kim, MD role: PRINCIPAL_INVESTIGATOR lat: 35.82194 lon: 127.14889 hasResults: False

 nctId: NCT06357897 id: 0093/67 briefTitle: The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-06 date: 2024-04-10 date: 2024-04-12 name: Chulalongkorn University class: OTHER briefSummary: This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups. conditions: Functional Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group received PEG-Chula Control group received Forlax primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The intervention and control were prepared in the similar sachet and was blinded to investigatiors, participants and guardians whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 52 type: ESTIMATED name: Local PEG4000 name: Commercial PEG4000 measure: The frequency of stool measure: Stool consistency assessed by Bristol stool chart measure: Fecal incontinence measure: Rectal diameter measure: Adverse events measure: Palatability of medication assessed by facial Hedonic scale sex: ALL minimumAge: 6 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine, Chulalongkorn University city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06357884 id: CREC2023.572 briefTitle: Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients overallStatus: RECRUITING date: 2024-02-23 date: 2024-04-20 date: 2024-04-30 date: 2024-04-10 date: 2024-04-10 name: Chinese University of Hong Kong class: OTHER name: Princess Margaret Hospital, Hong Kong briefSummary: Diabetes peripheral neuropathy (DPN) affects up to 50% of the diabetes population. In the diabetic neuropathic foot, it commonly manifests as loss of protective sensation, foot deformity and skin dryness. Alongside with day-to-day weightbearing activities, this can lead to formation of callus over plantar pressure points. Studies have proven that callus formation leads to high plantar pressure and increased risk of diabetic foot ulcers. For podiatrists, diabetic foot screening and treatment is our daily practice. Plantar callus are commonly treated by sharp debridement to relief pressure from the hard skin build up and thus reducing the risk of ulceration. However, the effectiveness of callus sharp debridement is not commonly studied in researches. Only a few studies in the past evaluated the effectiveness of callus treatment by different outcome measurements. Among those studies only 2 were specifically done in diabetic patients, in which one reported results of diabetic neuropathic patients. All the available studies used peak plantar pressure only as their pedobarographic outcome measure. In this study, the treatment effect of podiatric sharp debridement of callus in diabetic neuropathic patients will be evaluated using a range of pedobarographic parameters and Foot and Ankle Outcome Score (FAOS) questionnaire. The immediate and short-term (3-4 weeks) effect of sharp debridement in DPN patients with callus could be quantified. Change in loading pattern could also be analysed based on different areas of the foot. conditions: Diabetic Neuropathies conditions: Plantar Callus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Callus debridement measure: Peak plantar pressure (PPP) (unit: kPa) measure: Pressure time integral (PTI) (unit: kPa*sec) measure: Peak pressure gradient (PPG) (unit: kPa/cm) measure: Forefoot to rearfoot peak pressure ratio (F/R ratio) measure: Foot and Ankle Outcome Score (FAOS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Podiatry Department, Princess Margaret Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Joanne Tze Yan Lai role: CONTACT phone: 29903901 lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06357871 id: 2023PI178 briefTitle: Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer acronym: NEPHROTOX overallStatus: RECRUITING date: 2023-11-28 date: 2025-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: Central Hospital, Nancy, France class: OTHER name: University Hospital, Strasbourg, France name: CHU de Reims name: Centre Hospitalier Régional Metz-Thionville name: European Georges Pompidou Hospital briefSummary: Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.

Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.

We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible. conditions: Chemotherapeutic Toxicity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU de Nancy status: RECRUITING city: Vandoeuvre les nancy zip: 54500 country: France name: Adrien Flahault, MD PhD role: CONTACT phone: 0383858585 email: a.flahault@chru-nancy.fr lat: 48.65 lon: 6.18333 hasResults: False

 nctId: NCT06357858 id: CASE6323 briefTitle: ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-02-28 date: 2026-02-28 date: 2024-04-10 date: 2024-04-10 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The goal of this clinical trial is to see if the combination of experimental drug ASTX727 and Nivolumab enhances the antitumor immune response in participants will recurrent or metastatic squamous cell carcinoma of the head and neck.

Participants will take a pill called ASTX727 for 4 or 5 days every month followed by an injection of Nivolumab one week after the first dose of study medication. conditions: Recurrent Squamous Cell Carcinoma of the Head and Neck conditions: Metastatic Squamous Cell Carcinoma conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: INQOVI (decitabine and cedazuridine) name: Nivolumab measure: Pharmacodynamics Effect of ASTX727 on global DNA methylation status measure: Immunogenicity of ASTX27 in combination with Nivolumab measure: Maximum Tolerated Dose measure: Safety of ASTX measure: Objective Response Rate (ORR) measure: Overall Survival (OS) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44106 country: United States name: Kyunghee Burkitt, DO, PhD role: CONTACT phone: 216-844-0512 email: Kyunghee.Burkitt@UHhospitals.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06357845 id: CASE5Z24 id: 1R21ES036031-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21ES036031-01 briefTitle: Linking Somatic Mutation Rate With Baseline Exposure in East Palestine overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-09-01 date: 2026-01-31 date: 2024-04-10 date: 2024-04-10 name: Case Comprehensive Cancer Center class: OTHER name: National Institutes of Health (NIH) name: National Institute of Environmental Health Sciences (NIEHS) briefSummary: The goal of this study is to This research team is conducting this study to develop methods to measure the biological impact of exposure to the chemicals released following the February 3, 2023 train derailment on residents of East Palestine, Ohio, and surrounding communities. The main question it aims to answer is:

* What biological impact will be measured based on DNA damage?
* In participants who provide a biospecimen, how are biomarker changes related to proximity to the derailment and variations in residents' health histories and behaviors?

Participants will:

* Complete a brief survey asking about experiences related to the February 3, 2023 train derailment, health experiences, and concerns following the derailment, and background information regarding health history.
* Possibly contribute biospecimens such as blood, spit, hair, and/or toenail clippings.
* Receive communication about study updates and future research opportunities.
* A total of 40 study participants will be recruited to participate in a 90-minute interview. The interviews will be video and audio recorded. conditions: Somatic Mutation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A cross-sectional study design will be implemented. primaryPurpose: SCREENING masking: NONE count: 500 type: ESTIMATED name: Survey name: Biological specimen collection name: Communications about study updates and future research opportunities name: Qualitative interview measure: Geographic Association of Somatic Mutation Rates measure: Self-reported Symptomology Association of Somatic Mutation Rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357832 id: CTP-ACCiTBS-00 briefTitle: New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD) overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-10-15 date: 2024-12-15 date: 2024-04-10 date: 2024-04-12 name: Brainsway class: INDUSTRY briefSummary: The BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. The purpose of the current study is to evaluate the safety and effectiveness of a new investigational stimulation protocol delivered with the BrainsWay Deep TMS device, for the treatment of MDD, demonstrating that it is non-inferior to the current standard-of-care stimulation protocol, in a randomized, controlled study. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Brainsway Deep TMS System measure: Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group measure: Response rate in the investigational group measure: Remission rate in the investigational group measure: Change in Clinical Global Impression-Severity (CGI-S) scores in the investigational group measure: Change in Clinical Global Impression Improvement (CGI-I) scores in the investigational group sex: ALL minimumAge: 22 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novus Neurology city: Tuscaloosa state: Alabama zip: 35401 country: United States name: Timothy Prestley, MD role: CONTACT phone: 205-523-5618 email: timprestley@gmail.com lat: 33.20984 lon: -87.56917 facility: DTMS Center LLC city: Palm Beach state: Florida zip: 33401 country: United States name: Aron Tendler, MD role: CONTACT phone: 561-749-9999 email: aron.tendler@gmail.com lat: 26.70562 lon: -80.03643 facility: Fermata Health city: Brooklyn state: New York zip: 11249 country: United States name: Owen Muir, MD role: CONTACT phone: 929-346-4317 email: owen@fermata.health lat: 40.6501 lon: -73.94958 facility: Complete Mind Care of PA city: Abington state: Pennsylvania zip: 19001 country: United States name: Samson Seplow, MD role: CONTACT phone: 215-254-6000 email: Dr.Seplow@cmcofpa.com lat: 40.12067 lon: -75.11795 facility: ClearPath Psychiatry city: Seattle state: Washington zip: 98105 country: United States name: Molly Davis, MD role: CONTACT phone: 206-486-8150 email: mollydavis@clearpathpsychiatry.com lat: 47.60621 lon: -122.33207 facility: PsyCare city: South Charleston state: West Virginia zip: 25303 country: United States lat: 38.36843 lon: -81.69957 hasResults: False

 nctId: NCT06357819 id: CLS-017A id: HSTAR010 type: OTHER domain: HSTAR Programme id: EZIMOM012 type: OTHER domain: Ezintsha briefTitle: INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation overallStatus: COMPLETED date: 2023-10-12 date: 2023-12-17 date: 2023-12-17 date: 2024-04-10 date: 2024-04-10 name: bioLytical Laboratories class: INDUSTRY briefSummary: The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization \[demonstration\]. conditions: Hepatitis C studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 405 type: ACTUAL name: INSTI HCV Self Test measure: Successful Interpretation of contrived devices sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: bioLytical Laboratories Inc. city: Richmond state: British Columbia zip: V6V 2A2 country: Canada lat: 49.17003 lon: -123.13683 hasResults: False

 nctId: NCT06357806 id: PIN-CHB-1 briefTitle: The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2025-09-30 date: 2024-04-10 date: 2024-04-10 name: Beijing 302 Hospital class: OTHER briefSummary: This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PDL-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment. conditions: Chronic Hepatitis B studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Sintilimab name: Peg-IFNα-2b name: NAs measure: The rate of HBsAg loss at 24 weeks and 48 weeks. measure: Incidence of treatment-emergent adverse events/serious adverse events measure: The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks measure: The rate of HBsAb positive at 24 weeks and 48 weeks. measure: The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks. measure: The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks. measure: The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks. measure: Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Fifth Medical Center, Chinese PLA General Hospital city: Beijing state: Beijing zip: 100039 country: China name: Junliang Fu, MD role: CONTACT phone: 010-66933214 email: fjunliang@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06357793 id: camsakuraftr briefTitle: Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-11-15 date: 2024-12-15 date: 2024-04-10 date: 2024-04-18 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity. conditions: Fibromyalgia conditions: Work Productivity conditions: Quality of Life conditions: Pain, Chronic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 122 type: ESTIMATED measure: Work Productivity and Activity of Fibromyalgia Patients' Relatives measure: Quality of life Fibromyalgia Patients' Relatives sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357780 id: 240396837 briefTitle: Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients acronym: CHESTSPAN overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-08-30 date: 2024-12-31 date: 2024-04-10 date: 2024-04-18 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: The study is a multicentric prospective randomised cross-over study. It evaluates the compatibility of patients with the device without altering the routine treatment applied. During this evaluation, either the clinician-adjusted values on the device or the standard pre-set values are used to obtain hourly and 30-minute PVA (Patient Ventilator Asynchrony) recordings. These recordings will be analysed offline to identify the settings used and to compare the hourly and 30-minute PVA (Patient Ventilator Asynchrony) values when synchronisation is automatically set. The relationships and differences between these values will be analysed. For this purpose, the IntelliSync+ option, already available on the device, will be used. This software continuously analyses waveform signals at least a hundred times per second. This allows for the immediate detection of patient efforts and the initiation of inspiration and expiration in real time, thereby replacing traditional trigger settings for inspiration and expiration. If the patient is already synchronised with this option, it will then be possible to switch to traditional synchronisation settings for comparison. Statistical analyses will be conducted using SPSS 24.0, JASP (Just Another Statistical Programme), Jamovi ( fork of JASP), or R software. Initially, all numerical and categorical data will be evaluated using descriptive statistical methods. The distributions of numerical variables will be examined using visual (histograms and probability plots) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Mean/SD (standard deviation) or median/interquartile range (IQR) will be used as measures of distribution. For comparing numerical data that follows a normal distribution, the Student-t test will be used, and for non-normally distributed data, the Mann-Whitney U or Wilcoxon signed-rank tests will be employed. PVA (Patient Ventilator Asynchrony) values will be statistically compared. For the analysis of categorical data, the Chi-Square test will be applied. Bayesian analysis may also be used as necessary during the writing of the study. The results obtained will be interpreted and reported by the researchers. Results with a "p" value below 0.05 will be considered statistically significant. conditions: Acute Respiratory Failure conditions: Acute Respiratory Distress Syndrome conditions: Chronic Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 38 type: ESTIMATED name: close-loop synchronization controller with spontaneous mode name: Conventional measure: Asynchrony Index measure: Major Asynchrony index measure: Minor Asynchrony index measure: Dyspnea Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr.Suat Seren Chest Diseasees Hospital city: Izmir zip: 35230 country: Turkey name: Cenk Kirakli, professor role: CONTACT lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06357767 id: S06GM146079 type: NIH link: https://reporter.nih.gov/quickSearch/S06GM146079 briefTitle: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-07-31 date: 2026-01-31 date: 2024-04-10 date: 2024-04-22 name: Black Hills Center for American Indian Health class: OTHER name: Yale University briefSummary: The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate partner violence (IPV). The primary aims of this study are to: (a) use a community-based participatory approach to refine intervention materials and finalize pilot intervention methodology for a culturally tailored, trauma-informed smoking cessation intervention for AI women who have experienced IPV; (b) examine feasibility, acceptability, satisfaction, and preliminary efficacy of the intervention; and (c) explore changes in alcohol and drug use over the course of the intervention.

Participants will be asked to participate in the 8-week Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, and complete interviews at baseline, end-of-treatment, and three months from the end of treatment. conditions: Smoking Cessation conditions: Cigarette Smoking studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence measure: Trauma-Informed Practice Scales (TIPS) measure: Session Rating Scale (SRS) measure: Group Attitude Scale (GAS) measure: Biochemical verification of smoking status measure: Biochemical verification of smoking status measure: Biochemical verification of smoking status measure: Quit Attempts measure: Quit Attempts measure: Quit Attempts measure: Alcohol Use Disorders Identification Test (AUDIT) measure: Alcohol Use Disorders Identification Test (AUDIT) measure: Alcohol Use Disorders Identification Test (AUDIT) measure: NIDA ASSIST measure: NIDA ASSIST measure: NIDA ASSIST sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357754 id: CA082-085 briefTitle: Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Secondary Malignancy overallStatus: RECRUITING date: 2023-10-06 date: 2038-10-06 date: 2038-10-06 date: 2024-04-10 date: 2024-04-10 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this transgene assay testing service is to evaluate the tumor samples for transgene levels in patients who received a Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying secondary malignancy. conditions: Non-Hodgkin Lymphoma conditions: Chronic Lymphocytic Leukaemia conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Idecabtagene vicleucel name: Lisocabtagene maraleucel measure: Participant in situ hybridization (ISH) transgene testing results measure: Participant insertion site (ISA) analysis testing results sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CellCarta status: RECRUITING city: Antwerp country: Belgium lat: 51.21989 lon: 4.40346 hasResults: False

 nctId: NCT06357741 id: 202286 briefTitle: Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis acronym: CSODITTOKO overallStatus: COMPLETED date: 2023-03-02 date: 2024-02-02 date: 2024-03-10 date: 2024-04-10 date: 2024-04-10 name: Wuhan Union Hospital, China class: OTHER briefSummary: As an activator of inhibiting nuclear factor kB receptor, denosumab affects osteoclast differentiation and development by inhibiting OPG/RANKL-RANK bone regulatory axis pathway. Therefore, denosumab is widely used in the treatment of bone diseases such as osteoporosis. Osteoporosis is closely related to knee osteoarthritis. RANKL-RANK pathway also plays a key role in the pathogenesis of knee osteoarthritis. Therefore, the investigators propose the hypothesis that denosumab can effectively treat knee osteoarthritis. conditions: Knee Osteoarthritis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 8 type: ACTUAL name: Denosumab measure: Knee pain relief sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wuhan Union Hospital city: Wuhan state: Hubei zip: 430000 country: China lat: 30.58333 lon: 114.26667 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-04-03 uploadDate: 2024-04-04T11:01 filename: Prot_000.pdf size: 398739 hasResults: False

 nctId: NCT06357728 id: 2024/2035 briefTitle: Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy acronym: I-CHAP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-12-01 date: 2024-04-10 date: 2024-04-10 name: KK Women's and Children's Hospital class: OTHER_GOV briefSummary: Our study named Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test (I-CHAP) aims to establish much needed preliminary evidence in our Asian population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. This study aims to test the following aims and hypotheses in a single-armed intervention pilot trial study of pregnant women undergoing the oral glucose tolerance test:

Aim 1. To characterize CGM glucose values with the 3-point blood glucose measured during the OGTT procedure.

The investigators hypothesize that the CGM glucose values at single time points while fasted, and after the 75-g glucose load will be positively correlated with 3-timepoint blood glucose values captured during the OGTT.

Aim 2. To correlate the CGM glucose excursions and CGM-derived metrics (glycaemic variability and glycaemic control) with maternal-fetal outcomes and treatment outcomes.

The investigators hypothesize that higher AUC, glycemic variability and poorer glycaemic control will better distinguish maternal-fetal outcomes and treatment outcomes, compared to the OGTT.

Aim 3. To describe the acceptability of using the Dexcom G6 CGM as a diagnostic tool instead of the OGTT. The investigators hypothesize that a higher proportion of participants will report CGM to be more acceptable than the OGTT for GDM diagnosis. conditions: Gestational Diabetes conditions: Glucose Metabolism Disorders conditions: Metabolic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will be given a continuous glucose monitoring device to wear for 10 days before during and after the oral glucose tolerance test. primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Continuous glucose monitoring measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L) measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 1-hour (mmol/L) measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 2-hour (mmol/L) measure: Maternal obstetric outcomes - Pre-eclampsia measure: Maternal obstetric outcomes- Pregnancy-induced hypertension measure: Maternal obstetric outcomes - C-section measure: Neonatal outcomes- Large-for-gestational-age measure: Neonatal outcomes-Birth weigh measure: Neonatal outcomes- Small-for-gestational-age measure: Neonatal outcomes-Pre-term birth measure: Neonatal outcomes-Neonatal hypoglycaemia measure: Types of treatment received for gestational diabetes diagnosis sex: FEMALE minimumAge: 21 Years maximumAge: 45 Years stdAges: ADULT typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-02-20 uploadDate: 2024-03-18T04:35 filename: Prot_SAP_ICF_000.pdf size: 218503 hasResults: False

 nctId: NCT06357715 id: 2021/373/HP briefTitle: Effectiveness of Neurodynamic Sliding Mobilisation in the "Slump" Position in Relation to the Perceptible Pain Threshold in Asymptomatic People acronym: SPEAKER 2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-09 date: 2026-05-09 date: 2024-04-10 date: 2024-04-10 name: University Hospital, Rouen class: OTHER briefSummary: According to the French National Health Agency, the use of manual therapy techniques is "possible" \[grade B\] as part of a multimodal combination of treatments for low back pain. These include so-called "neurodynamic" neural mobilisations, which aim in particular to desensitise the pain system and activate descending inhibitory pathways, with effects on pain and function in patients with nerve-related low back pain. Most of the available evidence does not explain the mechanisms involved in neural mobilisation in the slump position. Pain reduction is observed in more areas of the body with sliding techniques than with traction techniques.

In this cross-over, randomised controlled trial, we therefore hypothesise that the neurodynamic sliding technique in the slump position acts on mechanisms linked to central pain modulation processes conditions: Voluntary studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE maskingDescription: the second physiotherapist who evaluate the pressure pain whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: "slump"position name: no" slump" position measure: Difference in pressure at the moment when the volunteer indicates that the sensation of pressure becomes pain sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357702 id: 81313 id: K23DE031807 type: NIH link: https://reporter.nih.gov/quickSearch/K23DE031807 briefTitle: K23- Physical Self Regulation vs Placebo overallStatus: RECRUITING date: 2024-04-04 date: 2028-06-01 date: 2028-08-31 date: 2024-04-10 date: 2024-04-15 name: Ian Boggero, PhD class: OTHER name: National Institute of Dental and Craniofacial Research (NIDCR) briefSummary: This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, \>75% retention, \>95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects. conditions: Temporomandibular Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Physical Self Regulation Telehealth name: Psycho-education Telehealth measure: Change in pain intensity measure: Change in pain interference measure: Change in quality of life measure: Recruitment rate measure: Retention rate measure: Interventionist Fidelity Session 1 measure: Interventionist Fidelity Session 2 measure: Treatment Acceptability measure: Treatment Credibility measure: Research Burden measure: Treatment Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky status: RECRUITING city: Lexington state: Kentucky zip: 40506 country: United States name: Ian Boggero, Ph.D. role: CONTACT phone: 859-562-3291 email: ian.boggero@uky.edu lat: 37.98869 lon: -84.47772 hasResults: False

 nctId: NCT06357689 id: REC ID 6 briefTitle: Association of SNPs in Long Intergenic Noncoding RNA 00511 (LINC00511) With Breast Cancer Among the Egyptian Population overallStatus: COMPLETED date: 2021-10-24 date: 2023-03-11 date: 2023-04-29 date: 2024-04-10 date: 2024-04-10 name: Ain Shams University class: OTHER name: British University In Egypt briefSummary: Long non-coding RNAs (lncRNAs) play an important role in different types of cancer, including breast cancer, through regulation of gene expression and epigenetic signatures. Genetic variations such as single nucleotide polymorphisms (SNPs) in lncRNAs have been found to be associated with cancer. Our aim was to provide information about the role of LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859, rs4432291 and rs1558535) in breast cancer susceptibility in the Egyptian population. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 417 type: ACTUAL measure: Investigating the relationship of the genotypes of each SNP of the LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) with either increased or decreased risk of breast cancer or no effect in the Egyptian population measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Estrogen receptor measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Progesterone receptor measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and HER2 status measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor stage measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor grade measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and lymph node metastasis sex: FEMALE minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of pharmacy, Ain Shams University, Advanced Biochemisrty Research Lab city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 facility: Faculty of Pharmacy, The British University in Egypt, Pharmacology and Biochemistry Research lab city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06357676 id: STUDY00025355 id: NCI-2024-01208 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00025355 type: OTHER domain: OHSU Knight Cancer Institute briefTitle: Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2029-05-01 date: 2024-04-10 date: 2024-04-10 name: OHSU Knight Cancer Institute class: OTHER name: Oregon Health and Science University name: Genentech, Inc. briefSummary: This phase IB/II trial tests the safety, side effects and effectiveness of glofitamab plus ibrutinib with obinutuzumab for the treatment of patients with mantle cell lymphoma (MCL). Glofitamab is in a class of medications called bispecific monoclonal antibodies. It works by killing cancer cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). In the body, glofitamab binds to a receptor called CD3 on T-cells (a type of immune cells) and a receptor called CD20 on B-cells, a receptor that is often over-expressed on the surface of cancerous B-cells. When glofitamab binds to CD3 and CD20 receptors, it causes an immune response against the CD20-expressing cancerous B-cells. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Glofitamab plus ibrutinib with obinutuzumab may be safe tolerable and/or effective in treating patients with MCL. conditions: Mantle Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Biospecimen Collection name: Bone Marrow Biopsy name: Computed Tomography name: Echocardiography name: FDG-Positron Emission Tomography name: Glofitamab name: Ibrutinib name: Magnetic Resonance Imaging name: Obinutuzumab measure: Incidence of dose-limiting toxicities (DLT) measure: Proportion of participants who achieve a complete response (CR) measure: Incidence of grade 3 or above adverse events (AEs) measure: Proportion of patients treated with tocilizumab (TCZ) measure: Number of doses of TCZ per participant measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Duration of response (DOR) measure: Duration of complete response (DOCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHSU Knight Cancer Institute city: Portland state: Oregon zip: 97239 country: United States name: Knight Cancer Clinical Trials Hotline role: CONTACT phone: 503-494-1080 email: trials@ohsu.edu name: Stephen E. Spurgeon role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06357663 id: Pro00071128 briefTitle: Subtle Energy Transmission and Tao Calligraphy Mindfulness in Telomere Length in Peripheral Blood Leukocytes overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-15 date: 2025-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-16 name: Sha Research Foundation class: OTHER briefSummary: Effect of Subtle Energy Transmission and Tao Calligraphy Mindfulness Practice on Telomere Length in Peripheral Blood Leukocytes A Follow-up Pilot Study

The goal of this Pilot clinical trial is to learn if a Subtle Energy Transmission and Tao Calligraphy Mindfulness Practice works to increase Telomere Length in Peripheral Blood Leukocytes in adults. The main questions it aims to answer are:

* Does A Subtle energy transmission and Tao Calligraphy Mindfulness increase Telomere Length in Peripheral Blood Leukocytes in adults?
* Will this increase of Telomere Length in Peripheral Blood Leukocytes in adults be statistically significant? Researchers will compare the length of Telomere in peripheral blood Leukocytes at beginning of the mindfulness practices to the length of Telomere in peripheral blood Leukocytes at 3 months and at 9 months of regular daily practices.

Participants will:

* Receive a transmission of Subtle energy at beginning of practices
* Visit the Laboratory for a blood sample taken at beginning, at 3 months and at 9 months of practices.
* Fill the Study Questionnaires at beginning, at 3 months and at 9 months of practices.
* Practice the Mindfulness with Tao Calligraphy daily 1 hour in the morning and 1 hour in the evening. conditions: Telomere Length conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study will be performed as a Pilot follow-up study, should the 0 Hypothesis be successfully rejected, this study will be followed by a formal Double Blind Randomized Crossover Study.

We plan subjects may enter the study as a group and will have measurements done within short time frame from each other at beginning and at the end of 3 and 9 months.

As this is a pilot study, there will be no randomization into treatment and control group, as a control we will use the "Normal" values of telomere from general population. All subjects will receive a transmission and then will be practicing Tao Calligraphy mindfulness daily during the 9 months.

Every subject who is accepted into the study, will have blood sample taken for analysis and will fill Rand SF 36 Questionnaire. Afterwards, will receive transmission of subtle energy by Zhi Gang Sha (or his designee) and will be instructed on how to practice mindfulness with Tao Calligraphy. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 12 type: ACTUAL name: Mindfulness practice with Calligraphy measure: Telomere Length in Peripheral blood leukocytes measure: Quality of Life by John Ware's SF-36 Quality of Life questionnaire (that produces eight scores with 0-to-100 scale, 100 being the best possible outcome). sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sha Research Foundation (Branch) city: North Vancouver state: British Columbia zip: V7R 1P5 country: Canada lat: 49.31636 lon: -123.06934 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-04-10 uploadDate: 2024-03-28T15:14 filename: Prot_SAP_000.pdf size: 428331 hasResults: False

 nctId: NCT06357650 id: CSQ-2024-001 briefTitle: Collaborative Open Research Initiative Study (CORIS-1) acronym: CORIS-1 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2025-06-30 date: 2024-04-10 date: 2024-04-10 name: Chisquares Incorporated class: INDUSTRY briefSummary: The Collaborative Open Research Initiative Study (CORIS) is a groundbreaking international research endeavor aimed at exploring vital topics within the field of health professions education. At its core, CORIS embodies the spirit of inclusivity by opening its doors to contributors from all corners of the globe, putting the power of research into the hands of the global community and fostering an environment of open collaboration and meaningful contribution. We invite anyone and everyone to join as collaborators and suggest questions for inclusion in the survey, ensuring that the research process is enriched by diverse perspectives. As a collaborator, you will not only have the opportunity to actively engage in survey design, question formulation, and the entire research process from start to finish, but also gain the prospect of achieving valuable publications, which may boost your professional career. conditions: Patient Engagement conditions: COVID-19 conditions: Preventable Disease, Vaccine conditions: Burnout, Professional conditions: Emerging Infectious Disease conditions: Artificial Intelligence conditions: Climate Change conditions: Online Education conditions: Mental Health Issue conditions: Substance Use Disorders studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 15000 type: ESTIMATED name: No intervention. This is an observational study measure: Percentage of health professions schools implementing changes in patient care strategies before versus after the COVID-19 pandemic. measure: Percentage of personnel in health professions education with adequate epidemic preparedness and readiness. measure: Percentage of faculty and staff in health professions schools experiencing burnout. measure: Percentage of healthcare professionals who report the integration and utilization of artificial intelligence (AI) in their education and practice. measure: Percentage of participants expressing positive attitudes and perceptions towards climate change and the role of individuals and society in mitigating it. measure: Percentage of participants reporting effectiveness and challenges of remote learning and online education in health professions schools. measure: Percentage of personnel within health professions education reporting substance use behaviors and their implications. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357637 id: 59/2023 briefTitle: Abdominal Circumference Measure in Caesarian Section acronym: ACirCuS overallStatus: RECRUITING date: 2023-12-01 date: 2024-05-01 date: 2024-05-31 date: 2024-04-10 date: 2024-04-10 name: CHU Mohammed VI Marrakech class: OTHER briefSummary: The goal of this observational study is to evaluate preoperative measures of abdominal circumference in patients admitted for a cesarean section. The main questions it aims to answer are:

* Can preoperative abdominal circumference predict patients with difficult spinal anesthesia
* Can preoperative abdominal circumference predict the occurrence of maternal hypotension during cesarean section Participants will be examined preoperatively in terms of visibility and palpation of spinous processes, abdominal circumference will be measured in the supine and sitting positions with other clinical parameters. Spinal anesthesia will be performed by the same experienced anesthesiologist with a standardized procedure. The number of skin punctures, needle reorientations, traumatic Cerebrospinal fluid, need for a paramedian approach or failure will be recorded. Maternal blood pressure and vasopressor requirements will also be monitored. conditions: Anesthesia, Spinal conditions: Cesarean Section studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Measure of abdominal circumference measure: Number of patients with difficult spinal anesthesia measure: Rate of Maternal hypotension sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Mohammed VI status: RECRUITING city: Marrakech zip: 40000 country: Morocco name: MERYEM ESSAFTI, MD role: CONTACT phone: +212662393700 email: essafti.m@gmail.com name: MARINA BOKOBA, MD role: CONTACT phone: +242065166209 email: marinande00@gmail.com name: MERYEM ESSAFTI, MD role: PRINCIPAL_INVESTIGATOR name: MARINA NDE BOKOBA, MD role: SUB_INVESTIGATOR lat: 31.63416 lon: -7.99994 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-01-10 uploadDate: 2024-01-23T03:56 filename: Prot_000.pdf size: 162775 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-01 uploadDate: 2024-04-06T11:11 filename: ICF_001.pdf size: 350456 hasResults: False

 nctId: NCT06357624 id: Physiotherapy briefTitle: Effectiveness of Mulligan Mobilization Technique overallStatus: COMPLETED date: 2023-01-01 date: 2023-05-30 date: 2023-05-30 date: 2024-04-10 date: 2024-04-10 name: Karabuk University class: OTHER briefSummary: The aim of this study was to investigate the effects of the Mulligan mobilization technique (MMT) on pain intensity, joint position sense (JPS), kinesiophobia, and disability level in individuals with nonspecific neck pain. A total of 34 female individuals with nonspecific neck pain were included in the study. Pain intensity, JPS, kinesiophobia, and disability levels of all participants were evaluated before and after the 3-week intervention. Participants were randomly divided into two groups. In the first group, the participants received MMT by the physiotherapist twice a week for 3 weeks, and self-mobilization techniques as a home exercise program. The second group was trained only self-mobilization techniques. conditions: Neck Pain conditions: Disability Physical conditions: Kinesiophobia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 34 type: ACTUAL name: Mulligan mobilization name: Self-Mobilization measure: Disability measure: Neck Pain Severity measure: Joint Position Sense sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tarik Ozmen city: Karabük country: Turkey lat: 41.20488 lon: 32.62768 hasResults: False

 nctId: NCT06357611 id: OST1_015 briefTitle: Combination of Two Osteopathic Techniques for the Hamstring's Stretching Capacity in Basketball Female Players overallStatus: RECRUITING date: 2024-09-16 date: 2024-12-01 date: 2024-12-17 date: 2024-04-10 date: 2024-04-10 name: Natália Maria Oliveira Campelo class: OTHER briefSummary: It is known that there are studies that prove the effectiveness of muscle energy techniques and the fourth ventricle technique separately, however, information is scarce regarding the combination of the two and their effectiveness in the population. The aim of this randomized controlled study is to compare the immediate effects of the techniques compared to the muscle energy technique alone in female basketball players. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In order to allocate each participant to an intervention group, each voluntary participation questionnaire was assigned a number. Subsequently, all the numbers of the participants in the sample were randomly distributed among the 3 groups by the principal investigator. primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Simulated technique name: Muscle energy technique name: 4th ventricle technique and muscular energy technique measure: Altered range of motion of the hamstring muscles. sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Escola Superior de Saúde do Porto status: RECRUITING city: Porto zip: 4200-072 country: Portugal name: Natália Campelo role: CONTACT phone: +35122 206 1000 email: nmc@ess.ipp.pt name: Natália MO Campelo role: PRINCIPAL_INVESTIGATOR lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06357598 id: QYFYEC2023-95 briefTitle: Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung Cancer acronym: PILOT overallStatus: RECRUITING date: 2024-01-18 date: 2024-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: The Affiliated Hospital of Qingdao University class: OTHER briefSummary: Explorative study, which evaluates the effect of Tislelizumab combined with chemotherapy in neoadjuvant treatment of stage Ⅲ unresectable non-small-cell lung carcinoma. conditions: Non-small-cell Lung Cancer (NSCLC) studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Tislelizumab name: Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC) name: Carboplatin or Cisplatin name: Surgery measure: R0 Resection Rate measure: Objective Response Rate (ORR) measure: Resectability Rate measure: Major Pathological Response (MPR) Rate measure: Rate of grade 3 and higher grade treatment-related adverse events measure: Progression-Free Survival (PFS) measure: Pathological Complete Response (pCR) Rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Affiliated Hospital of Qingdao University status: RECRUITING city: Qingdao state: Shandong zip: 266000 country: China name: Zhe Wu, PhD role: CONTACT phone: +86 17863934867 email: 17863934867@163.com lat: 36.06488 lon: 120.38042 hasResults: False

 nctId: NCT06357585 id: SBUBURCUCALİK briefTitle: Providing Web-based Training to Parents Of Children With Leukemia overallStatus: RECRUITING date: 2021-09-24 date: 2024-04 date: 2024-04 date: 2024-04-10 date: 2024-04-10 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Following and implementing innovations and current developments in care practices for children diagnosed with leukemia and their parents will allow the quality of care to increase. The purpose of this research is to evaluate the effect of web-based education given to parents of children diagnosed with leukemia on their knowledge level, satisfaction and self-efficacy.

The research is a single-blind randomized controlled experimental research type. The research will be conducted in a single center, Ankara Bilkent City Hospital MH4 Children's Hospital Hematology-Oncology Clinics and Leukemia Polyclinic. The population of the research consists of parents of children diagnosed with leukemia between the ages of 2-18 who are followed and treated in the specified places. The sample of the research consists of 72 participants, 36 in the experimental group (the group that received web-supported training) and 36 in the control group (the group that continued routine treatment).

The consent of the parents who meet the research criteria and voluntarily agree to participate in the study will be obtained with the "Informed Voluntary Consent Form" and the parents in both the experimental group and the control group will be given the "Child and Parent Introductory Information Form", "Child with Leukemia Parent Information Level Pre-Test Evaluation Form". ", "Generalized Perceived Self-Efficacy Scale" will be applied. Once the sufficient number is reached, web-based training will be provided to the parents in the experimental group. "Parents of Children with Leukemia Knowledge Level Post-Test Evaluation Form", "Generalized Perceived Self-Efficacy Scale" and "Web-Based Parents of Children with Leukemia Training Satisfaction Evaluation Form" will be applied to the parents who complete the training. No intervention will be made to the parents in the control group, and the children will continue their routine care and treatment process. The "Child with Leukemia Parent Knowledge Level Posttest Evaluation Form" and the "Generalized Perceived Self-Efficacy Scale" will also be applied to the parents in the control group. conditions: Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Web-based training will be provided to parents in the experimental group, and parents in the control group will continue their routine treatment and care process. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Participant blinding was done because the parents who participated in the study voluntarily did not know which group they were in until the end of the study. whoMasked: PARTICIPANT count: 72 type: ESTIMATED name: Web based education name: inactive group measure: Child with Leukemia Parent Knowledge Level Pre-Test Evaluation Form measure: Child with Leukemia Parent Knowledge Level Post-Test Evaluation Form measure: Web-Based Child with Leukemia Parent Education Satisfaction Evaluation Form measure: Generalized Perceived Self-Efficacy Scale measure: Generalized Perceived Self-Efficacy Scale sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Health Sciences status: RECRUITING city: Ankara state: Keçiören zip: 06018 country: Turkey name: Burcu ÇALIK BAĞRIYANIK role: CONTACT phone: 05067075349 email: brc_clk@outlook.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06357572 id: ENZ13-2024 briefTitle: Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem overallStatus: COMPLETED date: 2024-03-26 date: 2024-03-27 date: 2024-03-27 date: 2024-04-10 date: 2024-04-10 name: Enzyre B.V. class: INDUSTRY name: Instytut Hematologii i Transfuzjologii, Warschau, Poland briefSummary: The goal of this observational study is to assess if the version A of the HemA EnzySystem, a novel portable coagulation testing platform, can be used in patients with hemophilia A treated with Factor VIII Bypassing Agent (FEIBA). The main question\[s\] it aims to answer are:

* Can the version A of the HemA EnzySystem can record thrombin generation within a time frame of 60 min in fresh whole blood samples of patients with hemophilia A treated with FEIBA?
* Are the TGA results of the version A of the HemA EnzySystem in agreement with the TGA results obtained with conventional methods in fresh non frozen plasma?

Participants are asked to fill in a questionnaire regarding their general health and hemophilia treatment. Subsequently, blood will be drawn from the patients before, and at 30, 120, and 240 minutes after FEIBA administration. Whole blood is immediately tested using the Version A HemA EnzySystem, and plasma is generated for testing with the Ceveron s100 (Technoclone). Leftover samples are frozen for later additional coagulation testing. conditions: Hemophilia A With Inhibitor conditions: Hemophilia A studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 6 type: ACTUAL name: Thrombin generation assay (EnzySystem HemA version A - whole blood) name: Thrombin generation assay (Ceveron s100 (Technoclone) - fresh plasma) name: Additional coagulation tests measure: Time between venipuncture and TGA result measure: Agreement between TGA obtained with the EnzySystem HemA version A and conventional TGA results sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology and Blood Transfusion city: Warsaw state: Mazowieckie Województwo country: Poland lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06357559 id: OCTA in Myopic CNV briefTitle: OCTA Changes in Choroidal Neovascularization in High Myopia overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-09-15 date: 2024-12-01 date: 2024-04-10 date: 2024-04-10 name: Sohag University class: OTHER briefSummary: To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV.. conditions: Myopic Choroidal Neovascularisation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: OCTA measure: Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA sex: ALL minimumAge: 10 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357546 id: RECHMPL23_0411 id: 2023-A02424-41 type: OTHER domain: N° ID-RCB briefTitle: Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section acronym: C2S overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2024-09-01 date: 2024-04-10 date: 2024-04-10 name: University Hospital, Montpellier class: OTHER briefSummary: The hypothesis of this trial is that the absence of systematic bladder catheterization in patients performing spontaneous urination in the hour preceding the planned cesarean section under spinal anesthesia would not lead to more bladder heterocatheterization for postpartum urinary retention (RUPP) in the 24 hours post-cesarean section than systematic intraoperative bladder catheterization up to 2 hours post-surgery. conditions: Pregnant Women conditions: Cesarean Section studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomization list by blocks of random size and stratified by center, by scarred uterus (with or without scar) and Body Mass Index (BMI) at the start of pregnancy (\<30 and ≥30), will be established by a methodologist independent of the study. Patients will be randomized into each group at a ratio of 1:1. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The care provider carrying out the heterocatheterization will be blinded to the participant's randomization group. whoMasked: CARE_PROVIDER count: 500 type: ESTIMATED name: Spontaneous urination during the hour before caesarean section. name: Systematic bladder catherization during caesarean section. measure: Necessity of heterocatheterization within 24 hours following the cesarean section. measure: Experience of childbirth measure: Duration of preoperative preparation measure: Operating time measure: Duration of post-operative hospitalization measure: Time to resume ambulation measure: First urination measure: Pain during the first urination or the first heterocatheterization measure: Discomfort during the first urination or the first heterocatheterization measure: Additional prescription for painkillers measure: Urinary infection detection measure: Occurrence of surgical difficulties measure: Occurrence of operative complications measure: Amount of bleeding measure: Presence of symptoms suggestive of a urinary infection measure: Presence of functional signs (dysuria, incontinence, delayed bleeding or others) measure: Time before resuming spontaneous urination sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montpellier University Hospital city: Montpellier zip: 34295 country: France name: Martha DURAES, MD role: CONTACT phone: +334.67.33.65.32 email: m-duraes@chu-montpellier.fr name: Martha DURAES, MD role: PRINCIPAL_INVESTIGATOR name: Florent FUCHS, MD PhD role: SUB_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: Nîmes University Hospital city: Nîmes zip: 30029 country: France name: Audrey LAMOUROUX, MD role: CONTACT email: audrey.lamouroux@chu-nimes.fr name: Audrey LAMOUROUX, MD role: PRINCIPAL_INVESTIGATOR name: Vincent LETOUZEY, MD PhD role: SUB_INVESTIGATOR lat: 43.83333 lon: 4.35 hasResults: False

 nctId: NCT06357533 id: D7632C00001 briefTitle: Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations acronym: TROPION-Lung10 overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2030-05-24 date: 2030-05-24 date: 2024-04-10 date: 2024-04-10 name: AstraZeneca class: INDUSTRY name: Daiichi Sankyo briefSummary: The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations. conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Open-label, sponsor-blinded whoMasked: OUTCOMES_ASSESSOR count: 675 type: ESTIMATED name: Datopotamab Deruxtecan name: Rilvegostomig name: Pembrolizumab measure: Progression-Free Survival (PFS) in TROP2 biomarker positive participants. measure: Overall Survival (OS) in TROP2 biomarker positive participants. measure: Progression-Free Survival (PFS) in the intent-to-treat (ITT) population. measure: Overall Survival (OS) in the intent-to-treat (ITT) population. measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Participant-reported lung cancer symptoms of NSCLC in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab. measure: Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab. measure: Participant-reported GHS/QoL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab. measure: Pharmacokinetics (PK) measure: Immunogenicity measure: Second Progression-Free Survival (PFS2). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Clayton zip: 3168 country: Australia lat: -37.91667 lon: 145.11667 facility: Research Site city: Melbourne zip: 3000 country: Australia lat: -37.814 lon: 144.96332 facility: Research Site city: South Brisbane zip: QL 4101 country: Australia lat: -27.48034 lon: 153.02049 facility: Research Site city: Innsbruck zip: 6020 country: Austria lat: 47.26266 lon: 11.39454 facility: Research Site city: Krems zip: 3500 country: Austria lat: 48.40921 lon: 15.61415 facility: Research Site city: Linz zip: 4020 country: Austria lat: 48.30639 lon: 14.28611 facility: Research Site city: Rankweil zip: 6830 country: Austria lat: 47.27108 lon: 9.64308 facility: Research Site city: Wien zip: 1140 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wien zip: 1210 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Rio de Janeiro zip: 22211-230 country: Brazil lat: -22.90278 lon: -43.2075 facility: Research Site city: Vancouver state: British Columbia zip: VSZ 4E6 country: Canada lat: 49.24966 lon: -123.11934 facility: Research Site city: Winnipeg state: Manitoba zip: R3E 0V9 country: Canada lat: 49.8844 lon: -97.14704 facility: Research Site city: London state: Ontario zip: N6A 4L6 country: Canada lat: 42.98339 lon: -81.23304 facility: Research Site city: Newmarket state: Ontario zip: L3Y 2P9 country: Canada lat: 44.05011 lon: -79.46631 facility: Research Site city: Oshawa state: Ontario zip: L1G 2B9 country: Canada lat: 43.90012 lon: -78.84957 facility: Research Site city: Toronto state: Ontario zip: M4N 3M5 country: Canada lat: 43.70011 lon: -79.4163 facility: Research Site city: Lévis state: Quebec zip: G6V 0B8 country: Canada lat: 46.80326 lon: -71.17793 facility: Research Site city: Montreal state: Quebec zip: H3T 1E2 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Montreal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Rimouski state: Quebec zip: G5L 5T1 country: Canada lat: 48.44879 lon: -68.52396 facility: Research Site city: Trois-Rivieres state: Quebec zip: G8Z 3R9 country: Canada lat: 46.34515 lon: -72.5477 facility: Research Site city: Chicoutimi zip: G7H 5H6 country: Canada lat: 48.41963 lon: -71.06369 facility: Research Site city: Gauting zip: 82131 country: Germany lat: 48.06919 lon: 11.37703 facility: Research Site city: Budapest zip: 1121 country: Hungary lat: 47.49801 lon: 19.03991 facility: Research Site city: Gyula zip: 5700 country: Hungary lat: 46.65 lon: 21.28333 facility: Research Site city: Győr zip: 9024 country: Hungary lat: 47.68333 lon: 17.63512 facility: Research Site city: Kecskemét zip: 6000 country: Hungary lat: 46.90618 lon: 19.69128 facility: Research Site city: Salgótarján zip: 3100 country: Hungary lat: 48.09872 lon: 19.80303 facility: Research Site city: Szekszárd zip: 7100 country: Hungary lat: 46.35014 lon: 18.70905 facility: Research Site city: Székesfehérvár zip: 8000 country: Hungary lat: 47.18995 lon: 18.41034 facility: Research Site city: Törökbálint zip: 2045 country: Hungary lat: 47.42931 lon: 18.91356 facility: Research Site city: Bergamo zip: 24125 country: Italy lat: 45.69601 lon: 9.66721 facility: Research Site city: Genoa zip: 16132 country: Italy lat: 44.40478 lon: 8.94438 facility: Research Site city: Milano zip: 20141 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site city: Milano zip: 20162 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site city: Monza zip: 20052 country: Italy lat: 45.58005 lon: 9.27246 facility: Research Site city: Padova zip: 35128 country: Italy lat: 45.40797 lon: 11.88586 facility: Research Site city: Pavia zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 facility: Research Site city: Ravenna zip: 48100 country: Italy lat: 44.41344 lon: 12.20121 facility: Research Site city: Roma zip: 00128 country: Italy lat: 41.89193 lon: 12.51133 facility: Research Site city: Rozzano zip: 20089 country: Italy lat: 45.38193 lon: 9.1559 facility: Research Site city: Kawasaki-shi zip: 216-8511 country: Japan lat: 35.52056 lon: 139.71722 facility: Research Site city: Nagoya-shi zip: 460-0001 country: Japan lat: 35.18147 lon: 136.90641 facility: Research Site city: Sagamihara-shi zip: 252-0375 country: Japan lat: 35.54899 lon: 139.26064 facility: Research Site city: Sapporo-shi zip: 003-0804 country: Japan lat: 43.06667 lon: 141.35 facility: Research Site city: Takatsuki-shi zip: 569-8686 country: Japan lat: 34.84833 lon: 135.61678 facility: Research Site city: Tokushima-shi zip: 770-8503 country: Japan lat: 34.06667 lon: 134.56667 facility: Research Site city: Utsunomiya-shi zip: 320-0834 country: Japan lat: 36.56667 lon: 139.88333 facility: Research Site city: Changwon zip: 51353 country: Korea, Republic of lat: 35.22806 lon: 128.68111 facility: Research Site city: Incheon zip: 21565 country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Research Site city: Seongnam-si zip: 13496 country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: Research Site city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Suwon-si zip: 16499 country: Korea, Republic of lat: 37.29111 lon: 127.00889 facility: Research Site city: Suwon zip: 16247 country: Korea, Republic of lat: 37.29111 lon: 127.00889 facility: Research Site city: Olsztyn zip: 10-357 country: Poland lat: 53.77995 lon: 20.49416 facility: Research Site city: Poznań zip: 60-569 country: Poland lat: 52.40692 lon: 16.92993 facility: Research Site city: Warszawa zip: 01-138 country: Poland lat: 52.22977 lon: 21.01178 facility: Research Site city: Alicante zip: 03010 country: Spain lat: 38.34517 lon: -0.48149 facility: Research Site city: Barcelona zip: 08003 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Jerez de la Frontera zip: 11407 country: Spain lat: 36.68645 lon: -6.13606 facility: Research Site city: Reus,Tarragona zip: 43204 country: Spain facility: Research Site city: Salamanca zip: 37007 country: Spain lat: 40.96882 lon: -5.66388 facility: Research Site city: Kaohsiung zip: 80756 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site city: New Taipei zip: 220 country: Taiwan lat: 25.01111 lon: 121.44583 facility: Research Site city: Taichung zip: 40447 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site city: Tainan zip: 704 country: Taiwan lat: 22.99083 lon: 120.21333 facility: Research Site city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 112 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: TAIWAN country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taoyuan zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 facility: Research Site city: Adapazarı zip: 54100 country: Turkey lat: 40.78056 lon: 30.40333 facility: Research Site city: Ankara zip: 06560 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site city: Ankara zip: 6200 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site city: Antalya zip: 07070 country: Turkey lat: 36.90812 lon: 30.69556 facility: Research Site city: Diyarbakir zip: 21280 country: Turkey lat: 37.91363 lon: 40.21721 facility: Research Site city: Istanbul zip: 34030 country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site city: Istanbul zip: 34890 country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site city: Inverness zip: IV2 3UJ country: United Kingdom lat: 57.47908 lon: -4.22398 facility: Research Site city: London zip: SE1 9RT country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site city: London zip: SW10 9NH country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site city: London zip: SW17 0QT country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site city: Truro zip: TR1 3LJ country: United Kingdom lat: 50.26526 lon: -5.05436 hasResults: False

 nctId: NCT06357520 id: D6970C00005 briefTitle: A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants overallStatus: RECRUITING date: 2024-04-16 date: 2024-06-06 date: 2024-06-06 date: 2024-04-10 date: 2024-04-25 name: AstraZeneca class: INDUSTRY briefSummary: The main purpose of this study is to assess the effect of itraconazole on the pharmacokinetic (PK) of baxdrostat. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 14 type: ESTIMATED name: Baxdrostat name: Itraconazole measure: Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) measure: Maximum Observed Plasma Drug Concentration (Cmax) measure: Extrapolated Area Under The Curve From Tlast to Infinity (AUCextr) measure: Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) measure: Apparent Total Body Clearance (CL/F) measure: Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F) measure: Terminal Elimination Half-life (t1/2λz) measure: Terminal Rate Constant (λz) measure: Mean Residence Time (MRTinf) measure: Time To Reach Maximum Observed Concentration (tmax) measure: Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on Maximum Plasma Concentration (RCmax) measure: Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUClast (RAUClast) measure: Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUCinf (RAUCinf) measure: Number of Participants with Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Research Site status: RECRUITING city: Brooklyn state: Maryland zip: 21225 country: United States lat: 39.23039 lon: -76.60219 hasResults: False

 nctId: NCT06357507 id: hayam hamdy briefTitle: Molecular Characterization of Moraxella Catarrhalis From Pneumonic Children at Pediatric Assiut University Hospital acronym: Mcatarrhalis overallStatus: NOT_YET_RECRUITING date: 2024-12-01 date: 2027-12-01 date: 2027-12-20 date: 2024-04-10 date: 2024-04-16 name: Assiut University class: OTHER briefSummary: moraxella catarrhalis is responsible for respiratory tract infection in children and adults with streptococcus pneumonia and haemophilus influenza.Moraxella catarrhalis is gram negative diplococci, non-motile and non spore bearing bacteria. Until, 1995 it was considered as a non pathogenic respiratory tract flora.This bacteria is an important pathogen and a common cause of both upper and lower respiratory tract infections, pneumonia, sinusitis and conjunctivitis in infants, children and in elderly patients. In adults, M. catarrhalis also causes chronic obstructive pulmonary disease (COPD) and pneumonia. However, it is associated with a number of respiratory infections affecting both children and adults, including laryngitis, bronchitis and pneumonia . conditions: Respiratory Tract Infections studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED measure: isolation of moraxella catarrhalis measure: detection of virulence genes of moraxella catarrhalis measure: detetion of antibiotic resistance sex: ALL minimumAge: 1 Month stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357494 id: Thyroid Doppler in Graves' briefTitle: Assessment of Thyroid Doppler Ultrasound in Followup of Pediatric Graves' Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2027-04-05 date: 2028-04-05 date: 2024-04-10 date: 2024-04-10 name: Assiut University class: OTHER briefSummary: All cases of the study will be diagnosed as Graves' by History, examination, laboratory (FT3, FT4, TSH \& TRAbs), X-ray on left wrist for bone age, neck grey scale ultrasonography for thyroid gland size, shape, echotexture, vascularity and nodule characters if present with TIRAD score calculation.

Then Color flow doppler ultrasound will be done to asses thyroid volume, number of vessels per square cm and inferior thyroid artery peak systolic velocity, end diastolic velocity and resistive index. Patients then will receive carbimazole antithyroid drug at dose 0.25-0.5 mg/kg/day PO \& the dose will be titrated according to thyroid function test after 4-6 weeks.

Beta-adrenergic blockade will be added to all symptomatic cases. Regular follow up will be done every month of first 3 months of diagnosis and then every 3 months for 2 years by clinical and thyroid function test to asses response, compliance, complications, drug side effects, remission and relapses.

Doppler ultrasound will be done at 0, 12 and 24 months. conditions: Doppler Ultrasound in Follow up of Graves' Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 32 type: ESTIMATED measure: To make follow up of graves disease easier and improve patients adherence to treatment and follow up plan. measure: better control of disease in our patients, less complications, less mortality and better prognosis. sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06357481 id: SaglikBilimleriU-22-122 briefTitle: Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth acronym: Endodontics overallStatus: COMPLETED date: 2023-01-26 date: 2023-01-30 date: 2024-01-28 date: 2024-04-10 date: 2024-04-17 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Introduction: The aim of this study comparing the post operative pain after the retreatment of asymptomatic and symptomatic teeth that during single visit treatment with rotary and reciprocal nickel titanium files.

Methods: One hundred and forty one patients scheduled for non-surgical endodontic retreatment were included for evaluation. Eighty five patients who needed endodontic retreatment were assingned to 2 groups according to semptomatic or asemptomatic teeth and 4 subgroups with rotary and resiprocal files. Endodontic filling material was removed with One Flare and MicroMega REMOVER files in the retreatment kit. Patients then recorded their postoperative pain on a VAS scale at 24h, 48h, 72h, 7 days and 14 days post-treatment. Results were analyzed using the Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, Dunn-Bonferroni and Pearson Chi-square tests. conditions: Post-operative Pain conditions: Retreatment conditions: Symptomatic Periapical Periodontitis conditions: Endodontic Disease conditions: Asymptomatic Periapical Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eighty patients who needed endodontic retreatment were assingned to 2 groups according to symptomatic or asymptomatic teeth and 4 subgroups with rotary and resiprocal files. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ACTUAL name: Endodontic Retreatment measure: Post-operative pain sex: ALL minimumAge: 18 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hüseyin Gürkan Güneç city: Istanbul state: Uskudar zip: 34450 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06357468 id: UKGEB003 briefTitle: Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women With Vaginal Births in Difference Between Physician-led and Midwife-led Birth overallStatus: RECRUITING date: 2023-01-01 date: 2024-06-30 date: 2024-12-31 date: 2024-04-10 date: 2024-04-10 name: Martin-Luther-Universität Halle-Wittenberg class: OTHER briefSummary: The aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births conditions: Pain, Labor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: midwife-led births in low risk women in pregnancy measure: Pain perception measure: Satisfaction with pain therapy measure: Pain perception in women with perineal tear grade III sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Halle status: RECRUITING city: Halle state: Saxony Anhalt zip: 06120 country: Germany name: Marcus Riemer, MD role: CONTACT phone: 03455573946 email: marcus.riemer@uk-halle.de lat: 51.48159 lon: 11.97948 hasResults: False

 nctId: NCT06357455 id: Platelet CellSaver Liver trnsp briefTitle: Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery acronym: PLFLTS overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-10 date: 2024-04-10 name: Eduardo Schiffer class: OTHER name: University Hospital, Geneva name: Insel Gruppe AG, University Hospital Bern briefSummary: Intraoperative cell salvage is commonly used in surgeries that carry a major hemorrhagic risk to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation status after these types of surgeries, especially liver transplantation.

There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are re-transfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the liver transplant surgery population.

The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function. conditions: Liver Transplant conditions: Hemorrhage, Surgical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Cell Salvage Autotransfusion: SAME™ device name: Cell Salvage Autotransfusion: Autolog™ device measure: Platelet number measure: Platelet function measure: Platelet function measure: Platelet function measure: Platelet function measure: Platelet function measure: Platelet function measure: Blood plasma albumin level measure: Blood hemoglobin level measure: Blood lactate level measure: Free hemoglobin level measure: Anti-Xa activity measure: Number of allogeneic blood products used measure: Number of coagulation concentrates used measure: Amount of autologous blood at the end of the liver transplantation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Geneva University Hospitals city: Geneva zip: 1211 country: Switzerland name: Eduardo Schiffer, MD role: CONTACT email: eduardo.schiffer@hcuge.ch name: Tony Mouawad, MD role: PRINCIPAL_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False

 nctId: NCT06357442 id: 23-2305 briefTitle: Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-10 date: 2024-04-10 name: University of Colorado, Denver class: OTHER briefSummary: The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection.

The main questions it aims to answer are:

Aim 1: Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy

Aim 2: Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone

Aim 3: Assess satisfaction, side effects, bleeding patterns, any progesterone modifications, and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesterone

Participants will be asked to:

* Get two pelvic ultrasounds
* Fill out two surveys
* Continue their current hormone replacement therapy
* Initiate one of two progesterone therapies (prometrium 100mg daily or Nexplanon)

Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups. conditions: Primary Ovarian Insufficiency conditions: Hypogonadotropic Hypogonadism conditions: Hormone Replacement Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 34 type: ESTIMATED measure: Mean change in endometrial thickness after 6 months of progesterone therapy measure: Measure the mean endometrial thickness on estrogen replacement therapy measure: Satisfaction of progesterone replacement therapy measure: Bleeding patterns on progesterone replacement therapy measure: Side effects of progesterone replacement therapy measure: Adherence to progesterone replacement therapy measure: Rate of enrollment and attrition measure: Number of patients willing to be randomized in future trial sex: FEMALE minimumAge: 12 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06357429 id: 171002100 briefTitle: Evaluation of the Effect of the LI4 Cold Application acronym: LI4 overallStatus: COMPLETED date: 2022-02-23 date: 2022-11-18 date: 2022-11-18 date: 2024-04-10 date: 2024-04-10 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: It is an experimental study conducted to evaluate the effectiveness of cold application to the LI4 point of the hand to reduce/eliminate pain, nausea and anxiety in postoperative patients. The population of the study consisted of 116 individuals who underwent abdominal surgery with the open surgery method in a state hospital between February 2022 and November 2022 and were followed up in the inpatient ward. The study was completed with 80 individuals constituting the experimental group (n=40) and the control group (n=40). Patient information form, Mcgill Melzack short pain form, Visual Analog Scale, STAI - TX and Cold Application Evaluation Form were used to collect data. Patients in the experimental group underwent cold application with ice cubes for a total of 20 minutes as 2 minutes of cold application and 15 seconds of waiting 4-6 hours after the patient was admitted to the clinic after surgical intervention. Follow-up was performed before cold application, immediately after cold application, 30 minutes after the end of cold application, 1 hour and 2 hours after the end of cold application. conditions: Pain conditions: Nausea conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ACTUAL name: Cold Application measure: Pain Level measure: Nausea Level measure: Anxiety Level measure: Sensory characteristics, intensity and impact of pain sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saglik Bilimleri University city: Istanbul state: Uskudar zip: 34674 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06357416 id: CCR5573 briefTitle: The Man Van Project acronym: MV overallStatus: RECRUITING date: 2022-04-13 date: 2025-10-01 date: 2026-12-01 date: 2024-04-10 date: 2024-04-10 name: Royal Marsden NHS Foundation Trust class: OTHER name: RM Partners West London Cancer Alliance name: Institute of Cancer Research, United Kingdom name: Imperial College London briefSummary: National Health Service (NHS) England has commissioned The Royal Marsden Hospital NHS Foundation Trust to run a novel mobile clinical outreach service called 'Man Van' with the aim of enabling male patients' easy access to care at the site of their work and in their communities. The initial focus of this new standard of care clinic is to access workplaces with large manual workforces where large scale working from home is not possible. These will include logistics firms and bus companies. These companies employ large numbers of black and minority ethnic men who also have poorer outcomes with a range of other diseases, including Coronavirus disease (COVID)-19. The novel clinical service will collaborate with Unite (and other unions) as well as employers in order to reach our target groups effectively. There is also the opportunity to target higher risk groups e.g. Afro Caribbean communities whose rates of prostate cancer are 1 in 41 as well as occupational higher risk categories. The Man Van has the potential to swing the balance of evidence in favour of Prostate-Specific Antigen (PSA) screening, with a targeted screening program directed at high-risk groups including ethnic minorities and manual workers. Reasons for poorer outcomes amongst these groups are multi-factorial and complex. Levels of education are often a factor which can impact the understanding of the disease and how to seek assistance. Distrust of medical organisations has also been cited as a factor.

The aim of the Man Van mobile outreach service is to enable men access to a specific men's health service - focusing on general health and wellbeing (including BMI assessment, blood pressure, blood sugar/diabetes checks etc) and a prostate check for those who raise concerns. This will include a PSA test where relevant. This will be the core data gathered from the project.

Patients will receive PSA results in the 'Man Van' by a clinical nurse specialist with patients with raised PSA levels being referred into the standard rapid referral cancer pathways. Similar considerations will apply to men with haematuria detected on dip stick testing or who present with a testicular mass or penile lesion (both rare but important).

The clinical data generated from each routine health screening appointment will be analysed to determine the effectiveness of the Man Van mobile outreach model in identifying prostate and other male cancers and other co-morbidities much earlier than if patients had waited to present to their General Practitioner (GP) or other healthcare provider.

Patients who receive an early diagnosis of clinically significant prostate cancer will have access to early curative treatments, which are typically less invasive and shorter in timescales. Similar interventions have shown large scale success in particular with breast and cervical cancer.

The NHS sees many patients accessing cancer care at a late stage. Reducing this trend is a key objective of the NHS Long Term Plan. The COVID-19 pandemic has further exacerbated health inequalities and mobile clinics can potentially be a model for alleviating this. To enable patients access to medical treatment earlier there is a need to make the 'seeking advice on men's health and prostate issues' less daunting, more normal and easily accessible. The 'Man Van' has the ability to do just that and it is anticipated that the findings of this research, using the data generated from each patient's routine health screening, will demonstrate that a mobile outreach model is more effective in identifying cancers at an earlier stage than 'traditional' diagnostic pathways.

We also hope to evaluate the Man Van with a qualitative study looking at the patient perspectives from those who utilise the Man Van.

The reasons for high risk in prostate cancer are heavily linked to genetics. This is an issue as there is less recruitment of high risk groups to studies. We hope to gather genetic data from a higher proportion of genetically susceptible men via the Man Van, which can be used in future to further genetic knowledge of prostate cancer. conditions: Prostate Cancer conditions: Urologic Cancer conditions: Urologic Diseases conditions: Bladder Cancer conditions: Diabetes conditions: Hypertension conditions: Mental Health Issue conditions: Alcoholism conditions: Smoking conditions: Renal Cancer conditions: Testis Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 4000 type: ESTIMATED name: MV-POCT Sub-study name: Main Man Van Group Sub-study name: MV-QualQ Sub-study name: MV-PRS Sub-study name: MV-DNA and MV-UctDNA Sub-study name: Man Van patients measure: Cancer detection rates measure: Detection rates of other diseases sex: MALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Marsden Hospital NHS Foundation Trust status: RECRUITING city: London zip: SW3 6JJ country: United Kingdom name: Ann Gandolfi role: CONTACT phone: 02086613903 email: ann.gandolfi@rmh.nhs.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06357403 id: AntiXa-ICU 1881/2023 briefTitle: Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients acronym: AntiXa-ICU overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-08 date: 2024-04-10 date: 2024-04-10 name: Medical University of Vienna class: OTHER briefSummary: The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are:

* What is the association between antiXa and VTE?
* What is the association between antiXa and symptomatic, respectively incidental, VTE?
* How is pharmacological anticoagulation with enoxaparin related to measured antiXa?
* What is the association between antiXa and bleeding complications.
* What is the incidence of venous thromboembolism in patients treated at an intensive care unit?
* How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital. conditions: Thrombosis conditions: Pulmonary Embolism conditions: Enoxaparin studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1300 type: ESTIMATED name: Anti-factor Xa activity calibrated for enoxaparin measure: Number of patients with new-onset venous thromboembolism measure: Number of patients with new-onset upper extremity deep vein thrombosis measure: Number of patients with new-onset lower extremity deep vein thrombosis measure: Number of patients with new-onset central vein thrombosis measure: Number of patients with new-onset symptomatic upper extremity deep vein thrombosis measure: Number of patients with new-onset symptomatic lower extremity deep vein thrombosis measure: Number of patients with new-onset incidental upper extremity deep vein thrombosis measure: Number of patients with new-onset incidental lower extremity deep vein thrombosis measure: Number of patients with new-onset pulmonary embolism measure: Number of patients with new-onset symptomatic pulmonary embolism measure: Number of patients with new-onset incidental pulmonary embolism measure: Number of patients with venous thromboembolism measure: Number of patients with deep vein thrombosis measure: Number of patients with pulmonary embolism measure: Number of patients with new-onset venous thromboembolism measure: Number of days with any bleeding measure: Number of days with major and/or fatal bleeding measure: Number of red blood cell concentrates administered measure: Number of days on which either procoagulant medication, platelet transfusion or fresh frozen plasma was administered measure: Length of stay in the intensive care unit measure: Length of stay in the hospital measure: Death measure: Days alive and out of the intensive care unit measure: Days alive and out of the hospital measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) index value measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) visual analogue scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357390 id: 202106174RINB briefTitle: Physiologic and Clinical Effect of High-flow Oxygen Therapy in Tracheostomized Patients With Prolonged Mechanical Ventilation Undergoing Weaning Trials overallStatus: COMPLETED date: 2021-10-07 date: 2022-07-25 date: 2024-02-15 date: 2024-04-10 date: 2024-04-10 name: National Taiwan University Hospital class: OTHER briefSummary: This study is aimed at patients who have been admitted to the respiratory care center of this hospital who meet the PMV conditions (defined as continuous use of the ventilator for at least ten days) who are about to receive the ventilator out of training. After obtaining the explanatory consent, they will undergo continuous complete Before and after spontaneous breathing training, collect various relevant physiological data of lung volume and ventilation perfusion distribution, and analyze and predict the correlation of ventilator detachment. conditions: High Flow Oxygen Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ACTUAL measure: ventilation perfusion distribution measurement sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06357377 id: NEO100-03 briefTitle: A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-10-31 date: 2024-04-10 date: 2024-04-10 name: Neonc Technologies, Inc. class: INDUSTRY briefSummary: This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas. Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid). conditions: Pediatric Tumor of CNS conditions: Pediatric Tumor of Brain conditions: Diffuse Midline Glioma, H3 K27M-Mutant conditions: Pediatric Tumor of Brain Stem conditions: Pineocytoma conditions: Choroid Plexus Carcinoma, Childhood conditions: Spinal Cord Tumor conditions: High Grade Glioma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: NEO100 measure: Nature and severity of adverse events measure: Identify the maximum tolerated dose (MTD) of NEO100 measure: Determine the recommended Phase 2 dose (RP2D) of NEO100 measure: Measurement of NEO100 and its metabolite perillic acid in brain tumor tissue measure: Blood brain barrier penetration measure: Characterize the pharmacokinetics (PK) of NEO100 as measured by Peak Plasma Concentration measure: Characterize the pharmacokinetics (PK) of NEO100 as measured by the Time to Peak Plasma Concentration measure: Characterize the pharmacokinetics (PK) of NEO100 as measured by Area Under the Curve measure: To assess efficacy of NEO100 based on objective response rate (ORR). measure: To assess efficacy of NEO100 based on progression free survival (PFS). measure: To assess efficacy of NEO100 based on overall survival (OS). sex: ALL minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06357364 id: CBT_Procrastination_Neuro briefTitle: Neural Changes Following Cognitive Behavior Therapy for Procrastination overallStatus: RECRUITING date: 2024-04-08 date: 2026-01-15 date: 2026-01-15 date: 2024-04-10 date: 2024-04-10 name: Nencki Institute of Experimental Biology of the Polish Academy of Sciences class: OTHER_GOV name: SWPS University of Social Sciences and Humanities name: Institute of Psychology, Polish Academy of Sciences briefSummary: The aim of this study is to compare the efficacy of and the neural changes following two cognitive behavior therapy (CBT) protocols for procrastination with a wait-list control group. The interventions will be delivered online in group settings. Both protocols include identical psychoeducation and cognitive modules aiming at identification and modification of dysfunctional automatic thoughts related to procrastination but will differ in the behavioral modules. The behavioral module in the first protocol is focused on timely beginning and realistic planning. The second protocol implements working time restriction. The wait-list control group will receive one of the CBT protocols after a waiting period that will last as long as the CBT intervention and the assessments performed directly after treatment. It is assumed that the interventions will be superior to the wait-list control. Primary (procrastination) and secondary (depression and anxiety) measures will be collected prior to and after the interventions (or waiting period in the wait-list group) and after 6 months in the two active condition groups. Additionally, neuroimaging measurements will be conducted before and after the interventions (or waiting period in the wait-list group). Approximately half of the participants will undergo functional Magnetic Resonance Imaging (fMRI), and another half will undergo electroencephalography (EEG). Both methods are aimed at exploring neural correlates of the expected improvements in participants' self-regulation abilities. conditions: Procrastination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A researcher not having direct contact with participants will create a script generating random sequence using a computer random sequence generator (Matlab). Randomization will take place at an individual level, stratified by age, gender and procrastination severity (block randomization). Participants will be randomized into three groups with an allocation ratio of 1:1:1.

Pairs of experienced psychotherapists trained in one of the therapy protocols will deliver the interventions in an online group setting. whoMasked: PARTICIPANT count: 276 type: ESTIMATED name: Psychoeducation and cognitive modules name: Behavioral module: Starting on Time and Planning Realistically name: Behavioral module: Working Time Restriction measure: Change in Polish version of the Pure Procrastination Scale (PPS) measure: Change in Polish version of the Aitken Procrastination Inventory (API) measure: Change in Polish version of the Patient Health Questionnaire (PHQ-9) measure: Change in Polish version of the Generalized Anxiety Disorder Questionnaire-7 (GAD-7) measure: Percentage of completion of a particular project that the participant decided to work on during the training (e.g. a thesis, an essay, a report). measure: Change in Polish version of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire - Short Form (SPSRQ-SF) measure: Change in Polish version of the Multidimensional-Multiattributional Causality Scale (MMCS) measure: Change in Polish version of the Performance Failure Appraisal Inventory (PFAI) measure: Change in Polish version of the Difficulties in Emotion Regulation questionnaire (DERS) measure: Change in Polish version of the Motivation Diagnostic Test (MDT) measure: Change in Polish version of the Zimbardo Time Perspective Inventory measure: Change in Polish version of the Metacognitive Beliefs about Procrastination Questionnaire (MBPQ) measure: Change in Polish version of the Impulsivity Scale (UPPS-P) measure: Change in Polish version of the Self-control Scale (NAS-50) measure: Change in Polish version of the Procrastination Diagnostic Criteria Questionnaires (PDCQ) measure: Change in Polish version of Positive and Negative Affect Schedule (PANAS) in relation to a project that the participant decided to work on during the training (e.g. a thesis, an essay, a report) measure: Polish version of the Group Session Rating Scale (GSRS) measure: Several items concerning homework compliance (cf. Kazantzis et al., 2005). measure: Polish version of the Credibility Expectancy Questionnaire (CEQ) measure: Polish version of the Negative Effects Questionnaire (NEQ) measure: Polish version of the Client Satisfaction Questionnaire (CSQ) measure: fMRI measurements measure: Electroencephalography (EEG) measurements sex: ALL minimumAge: 18 Years maximumAge: 26 Years stdAges: ADULT facility: Nencki Institute of Experimental Biology, Polish Academy of Sciences status: RECRUITING city: Warsaw zip: 02-093 country: Poland name: Marek Wypych, Phd, DSc role: CONTACT email: prokrastynacja@nencki.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06357351 id: VISTA in gingival recession briefTitle: Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-01 date: 2024-04 date: 2024-05 date: 2024-04-10 date: 2024-04-10 name: Mansoura University class: OTHER briefSummary: To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification. conditions: Gingival Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: vestibular incision sub periosteal tunnel access ( VISTA) technique. measure: Measuring the recession width in millimeter measure: Measuring the recession depth in millimeter measure: Measuring the width of keratinized gingiva in millimeter measure: Mean of root coverage measure: Measuring the probing depth measure: Measuring the plaque index measure: Measuring the gingival index measure: Clinical attachment level sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mansoura university city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06357338 id: Soh-Med-24-03-15MS briefTitle: Differential Expression and Potential Value of c-MYC in Non-Invasive and Invasive Mammary Carcinoma overallStatus: ENROLLING_BY_INVITATION date: 2024-03-19 date: 2025-04-01 date: 2026-04-01 date: 2024-04-10 date: 2024-04-10 name: Marwa Mahmoud Hassan class: OTHER name: Qena Oncology Center briefSummary: Retrospective observational study to evaluate c-MYC expression in non invasive and invasive mammry carcinoma conditions: Invasive Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 70 type: ESTIMATED name: no intervention measure: role of c-MYC in breast cancer sex: FEMALE minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06357325 id: E-74555795-050.01.04-52290 briefTitle: 2023 Problems Faced by Women Earthquake Survivors in Kahramanmaraş overallStatus: COMPLETED date: 2023-06-22 date: 2023-09-30 date: 2023-12-01 date: 2024-04-10 date: 2024-04-10 name: Maltepe University class: OTHER briefSummary: Objective:

This study was conducted to evaluate the opinions of earthquake victims about the problems affecting women's health physically and psychosocially after the 2023 Kahramanmaraş earthquake.

Method:

The study was designed in a qualitative type (semi-structured). The population of the study consisted of women affected by the 2023 Kahramanmaraş-Pazarcık earthquake. 15 women were interviewed. conditions: Psychosocial Problem conditions: Nurse-Patient Relations conditions: Disaster; Personality conditions: Gender studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 15 type: ACTUAL name: a qualitative study. measure: Personal Information Form measure: A semi-structured interview form measure: consists of questions about changes experienced after the earthquake sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ozeninam city: Istanbul state: Maltepe zip: 34857 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06357312 id: 2023/11P briefTitle: Influence of Static Distal Locking of a Short Proximal Femoral Nail overallStatus: RECRUITING date: 2024-04-01 date: 2024-04-01 date: 2024-04-01 date: 2024-04-10 date: 2024-04-10 name: Elda University Hospital class: OTHER briefSummary: Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw. conditions: Hip Fracture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, comparative, randomized and double-blind study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinding of the patient included in the study and the investigator evaluating the results whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: hip trochanteric nail measure: Evaluation of functional status using the Barthel index measure: Postoperative mechanical complications measure: Parker mobility scale sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elda University Hospital status: RECRUITING city: Elda state: Comunidad Valenciana zip: 03600 country: Spain name: FRANCISCO ANTONIO MIRALLES MUÑOZ role: CONTACT phone: 651552115 email: fr_miralles@hotmail.com lat: 38.47783 lon: -0.79157 hasResults: False

 nctId: NCT06357299 id: Pro00115060 briefTitle: Assessing Better Bottles for Babies acronym: AB3 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-02-01 date: 2026-02-01 date: 2024-04-10 date: 2024-04-17 name: Duke University class: OTHER name: National Institutes of Health (NIH) briefSummary: This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain. conditions: Pediatric Obesity conditions: Weight Gain Trajectory conditions: Infant Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: 2x2 factorial design primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: Small Bottle Size name: Standard Bottle Size name: Clear Bottle name: Opaque Bottle measure: Conditional weight gain z-score changes (CWGz) measure: Formula volume per feed measure: Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS) sex: ALL minimumAge: 3 Days maximumAge: 1 Month stdAges: CHILD hasResults: False

 nctId: NCT06357286 id: IRB0148156 briefTitle: Income Volatility and Mental Health, Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-10 date: 2024-10-10 date: 2024-04-10 date: 2024-04-10 name: Cornell University class: OTHER briefSummary: Income instability is a defining aspect of the lives of the poor, who also disproportionately suffer from poor mental and physical health. Our research is the first to assess the causal effects of predictable and unpredictable income instability on the psychological and physical health of the poor. It will advance the scientific knowledge on the effects of economic instability as well as our understanding of health disparities. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 400 type: ESTIMATED name: Work opportunities measure: Depression sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357273 id: WhiteTeaAY briefTitle: The Effect of White Tea Consumption on Obesity overallStatus: COMPLETED date: 2023-07-01 date: 2023-11-01 date: 2023-12-15 date: 2024-04-10 date: 2024-04-10 name: Recep Tayyip Erdogan University class: OTHER briefSummary: Obesity is an increasing global public health issue. In general, tea consumption have been shown to offer benefit to obese patients. However, the potential of white tea (WT) to treat and protect from the adverse effects of obesity have not been addressed so far. The aim of this study was to examine the efficacy and impact WT consumption highest in catechins on levels of anthropometric and biochemical values in obese patients. conditions: Obesity conditions: Obesity; Endocrine conditions: Obesity Adult Onset studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 91 type: ACTUAL measure: Weight loss measure: Waist Circumference measure: Body Mass Index measure: Tumor Necrosis Factor - alpha measure: Total cholesterol measure: Low-Density Lipoprotein cholesterol measure: High-Density Lipoprotein cholesterol sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Recep Tayyip Erdogan University city: Rize zip: 53100 country: Turkey lat: 41.02083 lon: 40.52194 hasResults: False

 nctId: NCT06357260 id: Shifa OMR briefTitle: Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-03 date: 2024-04-10 date: 2024-04-10 name: Postgraduate Institute of Dental Sciences Rohtak class: OTHER briefSummary: Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated. conditions: Trigeminal Neuralgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Test group-1 will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks.

control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Pregabalin and Carbamazepine name: Carbamazepine measure: VAS score measure: Brief pain inventory ● Brief pain inventory assessment of pain. ● Brief pain inventory assessment of pain. Brief pain inventory measure: Patient Global Impression of change(PGI) measure: mean dose of carbamazepine measure: Liverpool scale sex: ALL minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PGIDS city: Rohtak state: Haryana zip: 124001 country: India name: DR. Lavina Arya, MDS role: CONTACT phone: 09212795285 email: aryalavina@gmail.com name: Dr. Ambika Gupta, MDS role: CONTACT phone: 09315903300 email: drambika79@rediffmail.com name: Shifa Akhtar, MDS role: PRINCIPAL_INVESTIGATOR lat: 28.89447 lon: 76.58917 hasResults: False

 nctId: NCT06357247 id: HM20027093 briefTitle: The Effect of SRS on Hemiplegia in Stroke Survivors overallStatus: RECRUITING date: 2024-03-04 date: 2024-08 date: 2024-08 date: 2024-04-10 date: 2024-04-10 name: Virginia Commonwealth University class: OTHER briefSummary: Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Sensory Threshold name: Nine Hole Peg Test name: Semmes Weinstein Monofilament Assessment measure: Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients measure: Optimal level of stochastic resonance vibration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth University status: RECRUITING city: Richmond state: Virginia zip: 232398 country: United States name: Virginia Chu role: CONTACT phone: 804-828-1564 email: vchu@vcu.edu lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06357234 id: APRE-2023 briefTitle: Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-03 date: 2026-04 date: 2024-04-10 date: 2024-04-10 name: IWK Health Centre class: OTHER briefSummary: This research trial will measure how useful Aprepitant is in preventing nausea and vomiting in children having surgery to correct scoliosis (curvature of the spine). conditions: Spinal Fusion conditions: Nausea and Vomiting, Postoperative conditions: Anesthesia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized double-blind placebo controlled study primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Treatment arm of participants will be masked until data collection is complete. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Aprepitant name: Placebo measure: Anti-Nausea Rescue Medication measure: Anti-nausea rescue medication administered by post-operative day measure: Emesis (Yes/No) measure: Baxter Retching Faces score measure: Pain score measure: Headache (yes/no) measure: Flatus (yes/no) measure: Bowel Motility (yes/no) measure: Sensation of Itch measure: Treatment of emergent adverse events sex: ALL minimumAge: 8 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06357221 id: GLI.04.US.SL.035 briefTitle: A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients overallStatus: RECRUITING date: 2024-04-08 date: 2024-07-31 date: 2024-07-31 date: 2024-04-10 date: 2024-04-10 name: Galderma R&D class: INDUSTRY briefSummary: Subjects having mild-to-severe plaque psoriasis, with active target lesion plaques, and currently on or starting a prescription treatment for plaque psoriasis will apply a topical skincare regimen to one side of the body. Evaluations of the regimen's efficacy will be conducted at 2 weeks, 4 weeks, and 8 weeks post-baseline. conditions: Plaque Psoriasis conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Cetaphil measure: Change in psoriatic Body Surface Area compared to baseline measure: Change in target lesion severity compared to baseline measure: Change of Physician Global Assessment compared to baseline measure: Change in skin quality measured by macroscopic imaging measure: Subject treatment satisfaction measure: Incidence of psoratic irritation [tolerability assessment] measure: Subject Quality of Life Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southeast Dermatology Specialists, LLC status: NOT_YET_RECRUITING city: Columbus state: Georgia zip: 31904 country: United States name: George F Hougeir, MD role: CONTACT phone: 706-568-2700 email: hougeir@gmail.com name: Moriah Hibbard role: CONTACT email: mhibbard@sedsderm.com name: George F Hougeir, MD role: PRINCIPAL_INVESTIGATOR lat: 32.46098 lon: -84.98771 facility: Southeast Dermatology Specialists, LLC status: NOT_YET_RECRUITING city: Douglasville state: Georgia zip: 30135 country: United States name: George F Hougeir, MD role: CONTACT phone: 678-702-3376 email: hougeir@gmail.com name: Moriah Hibbard role: CONTACT email: mhibbard@sedsderm.com name: George F Hougeir, MD role: PRINCIPAL_INVESTIGATOR lat: 33.7515 lon: -84.74771 facility: Dermatology Consulting Services status: RECRUITING city: High Point state: North Carolina zip: 27262 country: United States name: Zoe D Draelos, MD role: CONTACT phone: 336-841-2040 email: zdraelos@northstate.net name: Crystal Williams role: CONTACT email: dcs11@northstate.net name: Zoe D Draelos, MD role: PRINCIPAL_INVESTIGATOR lat: 35.95569 lon: -80.00532 hasResults: False

 nctId: NCT06357208 id: 23-AOI-06 id: 2023-A02687-38 type: OTHER domain: ANSM briefTitle: IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION BREATH HOLD TO BREATH BETTER PROGRAM acronym: BHBB overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-10 date: 2024-04-10 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: we propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control conditions: Reproductive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Breathing Control and Retention measure: Rate of stressed patients measure: STAI Y-A (anxiety state) scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu de Nice city: Nice zip: 06003 country: France name: Valérie BENOIT role: CONTACT phone: 0492034702 email: benoit.v@chu-nice.fr name: marion causeret role: CONTACT phone: 0492034702 email: causeret.m@chu-nice.fr name: Valérie BENOIT role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 hasResults: False

 nctId: NCT06357195 id: 2024H0075 briefTitle: DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-04-10 date: 2024-04-10 name: Ohio State University class: OTHER briefSummary: The goal of this observational study is to learn about current practices for the acute neuropsychiatric management of older adults during emergency department (ED) visits. Researchers will compare current standard of care practices with implemented guideline practice to see if standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations. The main questions this study aims to answer are:

* How many older adults are receiving antipsychotics or benzodiazepines during emergency department visits?
* Why are older adults receiving antipsychotics or benzodiazepines during emergency department visits?
* How many older adults who receive antipsychotics or benzodiazepines during emergency department visits have an underlying cognitive or movement disorder?
* What effects does administration of antipsychotics or benzodiazepines during emergency department visits have on patient outcomes in older adults and adults with neurocognitive disorders?
* Does implementation of standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations? conditions: Emergency Psychiatric conditions: Cognition Disorder conditions: Movement Disorders conditions: Antipsychotics and Neuroleptics Toxicity conditions: Dementia With Lewy Bodies conditions: Alteration in Mental Status conditions: Behavior conditions: Aging studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED measure: Antipsychotic/Benzodiazepine measure: Clinical Indication measure: Length of Stay measure: Disposition measure: Code Status sex: ALL minimumAge: 54 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357182 id: STUDY00026136 id: NCI-2024-01262 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00026136 type: OTHER domain: OHSU Knight Cancer Institute briefTitle: Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2026-03-08 date: 2026-05-29 date: 2024-04-10 date: 2024-04-10 name: OHSU Knight Cancer Institute class: OTHER name: Oregon Health and Science University name: Oryzon Genomics S.A. briefSummary: This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy. conditions: Acute Myeloid Leukemia conditions: Myelodysplastic Syndrome/Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The treatment plan starts with a 7 day monotherapy lead-in (Cycle 0 \[C0\]) and then proceeds to combination therapy in 28 day cycles. Disease will be assessed pre-treatment (Screening/Baseline), at the end of monotherapy, in C1 (and C2, if response is not observed in C1), and at the end of alternating cycles, thereafter. A disease assessment will also be conducted within 30 days of the last dose of IADA. Participants that do not achieve response after up to 2 cycles of the triplet regimen will be taken off treatment. primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Azacitidine name: Biospecimen Collection name: Bone Marrow Biopsy name: Echocardiography name: Iadademstat name: Multigated Acquisition Scan name: Questionnaire Administration name: Venetoclax measure: Incidence of dose-limiting toxicities (DLTs) within specific iadademstat (IADA) dose levels measure: Percentage of efficacy-evaluable participants achieving composite complete remission (cCR) measure: Percentage of efficacy-evaluable participants achieving an overall response (ORR) measure: Incidence of treatment-emergent grade ≥ 3 adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHSU Knight Cancer Institute city: Portland state: Oregon zip: 97239 country: United States name: Curtis A. Lachowiez role: CONTACT phone: 503-494-5058 email: lachowie@ohsu.edu name: Curtis A. Lachowiez role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06357169 id: Venus Glow briefTitle: Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias overallStatus: COMPLETED date: 2023-01-13 date: 2023-06-30 date: 2024-01-13 date: 2024-04-10 date: 2024-04-10 name: University of Minnesota class: OTHER briefSummary: The objective of this study is to assess the effect of standardized scalp care, specifically mechanical cleansing with the Venus Glow™ Device and water, on the scalp microbiome. This study also seeks to characterize the microbiome of the normal, healthy scalp, thereby providing a baseline for which the scalp affected by hair and scalp disease can be compared. conditions: Lichen Planopilaris of Scalp conditions: Alopecia Areata studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ACTUAL name: Venus Glow measure: scalp microbiome composition measure: scalp health sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06357156 id: ORAD-621 briefTitle: Evaluating the Topographic and Quantitative Differences of the Mandibular Symphysis Area Between Males and Females Egyptians Using CBCT Scans: a Cross-sectional Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-01-30 date: 2025-03-30 date: 2024-04-10 date: 2024-04-10 name: Cairo University class: OTHER briefSummary: Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.

* Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).
* Images showing lower anterior mandibular teeth with 0.2 -0.4 voxel sizes will be reviewed.
* The topography and the quantity of the mandibular symphysis area will be assessed through the different planes: sagittal, coronal and axial cuts as well as assessing the prevalence of MIC and its distance from inferior border of the mandible if detected. Correlation of results according to gender and age (3 age sub-groups per gender:18-35, 36- 55, 56-75).
* CBCT images will be interpreted by oral and maxillofacial radiologist; blinded from demographic data of the patients.
* radiologist (Principle investigator) will evaluate the images for assessing the topography and quantity of bone in symphysial area through measuring dimensions of mandibular symphysis. Then will re-evaluate twice with a time lag of two weeks between the two reading sessions. The assistant supervisor will evaluate percentage of the scans. Any disagreement will be solved by consensus between the two observers.
* The measurements will be carried out by the principle observer (PY) and will be repeated 2 weeks later for intra-observer reliability assessment.
* Mandibular scans will be collected from planmeca machine, with 0.2-0.4 voxel size to be viewed on Romexis software to do the measurements of mandibular symphysis. Vertical height will be measured from the apices of anterior teeth to inferior border of the mandible from the sagittal and coronal cuts with the orientation lines parallel to the buccal cortical plate. Also, the sagittal cuts will be used to determine the depth of the labial bone, from the apices of anterior teeth the labial cortical plate with the orientation lines parallel to the buccal cortical plate (Safi, Yaser et al.,2021) Whilst horizontal dimension (width) will be measured along the outer surface of the labial cortical bone, which is determined from the inter-foraminal distance. 3D slicer software will be used for this curved measurement on the axial plane, since Romexis software can only do the linear and angular measurements (Lee , Kim et al, 2014).

Also, the sagittal reformatted cuts will be used for the determination of the topography of bone in symphysial area; either class I, II or III (Jussara Constantino, et al., 2018) Radiographs showing the different topographic types Radiograph A: Type I, B: Type II and C: Type III

• Through scrolling in sagittal, coronal cuts and the reformatted panoramic view the prevalence of mandibular incisive nerve will be detected (Borghesi, Andrea et al., 2022).

After collecting the whole data, statistically will be correlated to the age and gender. conditions: Mandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal, and CBCT studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 222 type: ESTIMATED name: CBCT measure: Effect of gender on the mean height of basal bone in the symphysial area measure: Effect of gender on quantity of the bone in symphysial area: *depth of the bone *width of the bone measure: Effect of gender on topography of the bone in symphysial area measure: Effect of age on quantity of the bone in the symphysial area measure: Effect of age on topography of the bone in symphysial area measure: Prevalence of mandibular incisive canal sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357143 id: REMOVE briefTitle: Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2026-06 date: 2027-12 date: 2024-04-10 date: 2024-04-10 name: University of Malaga class: OTHER briefSummary: The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients. conditions: Shoulder Fractures conditions: Prosthesis User studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: REMOVE name: CONTROL measure: Functionality measure: Muscle mass measure: Kinematics measure: Strength measure: Range of movement sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357130 id: CHUBX 2023/75 briefTitle: Gynaecological Care for Transgender People in France in 2024. acronym: GyneTrans overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-10 date: 2024-04-29 name: University Hospital, Bordeaux class: OTHER briefSummary: To date, the transgender population, still poorly characterized, tends to increase. The impact of gender-affirming hormone therapy (GAHT) in this population remains poorly understood, and few data are published on the gynecological repercussions of such therapy. A recent literature review by a French team suggests gynecological follow-up procedures for transgender people. conditions: Transgender Management Care studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Questionnaire measure: Percentage of people aware of gynaecological recommendations. measure: Percentage of people aware of cancer risks measure: Percentage of people aware of contraception in transgender male population measure: Percentage of people aware of fertility and the impact of hormone treatments measure: Percentage of people aware of gynaecological repercussions of masculinizing hormone treatment in transgender male population sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Haut-Lévêque city: Pessac zip: 33604 country: France name: Virginie GROUTHIER, MD role: CONTACT phone: 05.57.65.60.78 phoneExt: +33 email: virginie.grouthier@chu-bordeaux.fr name: Clara GUINARD role: CONTACT phone: 05.57.65.60.78 phoneExt: +33 email: clara.guinard@chu-bordeaux.fr lat: 44.81011 lon: -0.64129 hasResults: False

 nctId: NCT06357117 id: A01263 briefTitle: Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma overallStatus: COMPLETED date: 2018-04-13 date: 2021-12-22 date: 2021-12-22 date: 2024-04-10 date: 2024-04-11 name: Beijing Tsinghua Chang Gung Hospital class: OTHER briefSummary: The extent of intrahepatic infiltration of perihilar cholangiocarcinoma (PHCC) remains unclear. This research aimed to explore the pattern and extent of intrahepatic infiltration of PHCC to guide surgical treatment and pathological research. This prospective study included 62 participants diagnosed with PHCC who underwent major hepatectomy. A whole-mount digital liver pathology system (WDLPS) for hepatectomy specimens greater than 10 × 10 cm was used to panoramically assess the intrahepatic infiltration extent of PHCC. conditions: Perihilar Cholangiocarcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 62 type: ACTUAL measure: Relapse-free survival (RFS). measure: Overall survival (OS). sex: ALL minimumAge: 44 Years maximumAge: 81 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tsinghua Chang Gung Hospital city: Beijing state: Beijing zip: 102218 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06357104 id: SCI-CT-0001 briefTitle: Detoxification From the Lipid Tract overallStatus: COMPLETED date: 2024-02-26 date: 2024-03-14 date: 2024-03-20 date: 2024-04-10 date: 2024-04-10 name: Pachankis, Yang I., M.D. class: INDIV name: First Affiliated Hospital of Chongqing Medical University briefSummary: Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study. conditions: COVID-19 Vaccine Adverse Reaction studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1 type: ACTUAL name: electroencephalogram biofeedback name: electrical brain stimulation name: ultra-low frequency transcranial magnetic stimulation name: Sertraline Hydrochloride name: Clonazepam name: Alprazolam name: Metoprolol name: Olanzapine name: Pravastatin Sodium 20 MG name: Sacubitril Valsartan Sodium Hydrate measure: Changes in Leukocyte and Components' Quantities measure: Changes in Leukocyte Components' Ratios measure: Quantity Changes in Megakaryocyte-Erythroid Progenitor measure: Changes in Hemoglobin Distribution measure: Changes in Mean Corpuscular Hemoglobin measure: Changes in Hematocrit measure: Changes in Plateletcrit measure: Red cell Distribution Width Coefficient of Variation measure: Changes in Particulate Matter Sizes measure: Changes in Total Lipid Quantities measure: Changes in Apolipoproteina measure: Changes in Lipoprotein (a) measure: Blood Pressure Changes measure: Heart Rate Changes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Residential Address city: Chongqing state: Chongqing zip: 402762 country: China lat: 29.56278 lon: 106.55278 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2024-03-07 uploadDate: 2024-03-15T00:02 filename: Prot_ICF_000.pdf size: 479591 hasResults: False

 nctId: NCT06357091 id: 1097/2023 ACL-Shark Screw® briefTitle: ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2031-06-01 date: 2031-06-01 date: 2024-04-10 date: 2024-04-25 name: Bezirkskrankenhaus Schwaz class: OTHER briefSummary: The goal of this clinical trial is to compare the outcome of 2 different screws for Anterior cruciate ligament reconstruction. The main question is if the human allogeneic cortical bone screw reduces tunnel widening in comparison to conventional treatment with a biocomposite screw. Additional the re-rupture rate will be evaluated and knee scores will be recorded before surgery and after surgery. Participants will have MRI before and after surgery, 3, 6, 12, and 24 months after surgery and Computertomography after surgery, 3, 6 and 24 months after surgery. Questionnaires (Knee-scores) will be recorded before surgery, 6, 12, 24 months after surgery.

the investigators hope that with the human cortical bone screw the tunnel widening is reduced and the re-rupture rate is low conditions: Anterior Cruciate Ligament Rupture conditions: Anterior Cruciate Ligament Reconstruction conditions: Anterior Cruciate Ligament Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: ACL reconstruction with Shark Screw ACL® name: ACL reconstruction with biocomposite screw (Mecta) measure: bone tunnel widening will be measured by CT and/or MRI and measured in mm measure: International Knee Documentation Committee (IKDC) Scores measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores measure: Lysholm Knee Score measure: Tegner Activity Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H. city: Schwaz state: Tirol zip: 6130 country: Austria name: Alexander Rofner-Moretti, MD role: CONTACT phone: +435242 phoneExt: 600 email: alexander.rofner-moretti@kh-schwaz.at name: Markus Reichkendler, MD role: CONTACT phone: +435242 phoneExt: 600 email: markus.reichkendler@kh-schwaz.at lat: 47.35169 lon: 11.71014 facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H city: Schwaz state: Tirol zip: 6130 country: Austria name: Alexander Rofner-Moretti, MD role: CONTACT phone: +435242600 email: alexander.rofner-moretti@kh-schwaz.at name: Markus Reichkendler, MD role: CONTACT phone: +435242600 email: markus.reichkendler@kh-schwaz.at name: Alexander Rofner-Moretti, MD role: PRINCIPAL_INVESTIGATOR name: Markus Reichkendler, MD role: SUB_INVESTIGATOR name: Boris Tirala, MD role: SUB_INVESTIGATOR name: Martin Wallner, MD role: SUB_INVESTIGATOR name: Lukas Pöhl, MD role: SUB_INVESTIGATOR name: Samuel Dolling, MD role: SUB_INVESTIGATOR name: Edith Reches, MD role: SUB_INVESTIGATOR name: Clemens Lottersberger, MD role: SUB_INVESTIGATOR lat: 47.35169 lon: 11.71014 hasResults: False

 nctId: NCT06357078 id: AmasyaU-NU-679 briefTitle: Art Therapy and Caregivers Stress overallStatus: RECRUITING date: 2024-01-02 date: 2024-06-28 date: 2024-07-31 date: 2024-04-10 date: 2024-04-16 name: Amasya University class: OTHER briefSummary: This research will be conducted to determine the effect of art therapy on the stress, anxiety and well-being of caregivers in the palliative care service. conditions: Caregiver Stress Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 52 type: ESTIMATED name: Art Therapy measure: Distress Thermometer measure: The State Anxiety Inventory measure: Personal Well-Being Index sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neşe Uysal status: RECRUITING city: Amasya zip: 0500 country: Turkey name: Neşe Uysal role: CONTACT phone: (90)3582181767 email: uysaln2007@hotmail.com lat: 40.65333 lon: 35.83306 hasResults: False

 nctId: NCT06357065 id: UCatolicaMaule id: 11240343 type: OTHER_GRANT domain: ANID Chile briefTitle: Active Transport Educational Program Based on the Ecological Model on Improving the Physical and Mental Health: MOV-ES Project acronym: MOV-ES overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-20 date: 2026-12-20 date: 2024-04-10 date: 2024-04-10 name: Universidad Católica del Maule class: OTHER briefSummary: The epidemic of physical inactivity affects the entire world and is responsible for more than 5 million deaths per year. The call of the United Nations, through the 2030 Agenda and the Sustainable Development Goals, encourages the creation of favorable environments for physical activity based on the ecological model of physical activity. Given this context, active transportation can be an accessible, economical, and sustainable method to increase daily physical activity. The rate of school children who use active transport has decreased, being replaced by motorized transport, causing congestion and high levels of pollution in cities. In the Chilean context, there are studies of active transportation in the Chilean population; however, they are scarce in the school population and none of them is an intervention study, demonstrating the incipient development of this area in the country. The benefits of promoting active transportation not only favor the lifestyles of school children but also include additional co-benefits such as the improvement of mental health and better academic performance, in addition to the reduction of exhaust and greenhouse gas emissions.

Objectives. This proposal consists of three phases with the following objectives: Phase I: i) to synthesize the evidence about interventions aimed at estimating the effect on health of active transport in the secondary students; and ii), using qualitative techniques, to explore, from the basis of grounded theory, barriers and facilitators perceived by professors, students and parents about the development and implementation of the MOV-ES intervention. Phase II. Pilot and feasibility trial: a) to test the effect of MOV-ES intervention on improving body composition (body fat percentage and muscle mass), physical fitness (aerobic capacity and muscular strength), executive function and mental fitness (mood disorders, cognitive functioning) in the secondary students; and b), to examine the acceptability by professors, parents and students of the intervention by using ad hoc questionnaires. Phase III: to test the effectiveness of the MOV-ES intervention on physical activity, physical fitness, cognition and mental health through a cluster randomized controlled trial.

Expected results: This project will give rise to the following master\&#39;s and doctoral theses, with their corresponding articles of high scientific impact: 1) Barriers and facilitators of teachers, parents and students for active transport from a qualitative approach; 2) Association between the built environment, urban features, and active transportation in high school students, 3) Effectiveness of an active transportation educational intervention on physical fitness and body composition, 4) Effectiveness of an active transportation educational intervention on the cognition of schoolchildren. It is expected that the results of the MOV-ES Project will transcend the physical health of schoolchildren and will have an impact on the school community, especially by decongesting the school environment. Through these results, the Ministry of Education, regional DAEM, municipalities, and educational establishments will be able to propose public policies that favor the practice of physical activity and the acquisition of healthy habits at school age. All of the above is based on quality indicators proposed by the Education Quality Agency. conditions: Physical Inactivity in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Study design, setting: This is a cluster randomized field trial aimed to evaluate the previously tested MOV-ES intervention.

Population: First year of high school students in a city in south-central Chile. Three secondary schools in the urban area of Talca (1 public, 1 private subsidized, and 1 private non-subsidized) with at least three classes per school year will be randomly selected. This methodological option was adopted because, in Chile, school administration is associated with the socioeconomic level of families. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Randomization and blinding procedures: We invited 6 first-year high school classes to participate and, using a computer-generated procedure, will be randomized to the IG and to CG. The participants will be informed of the result of randomization after they agreed to participate in the study. The nature of the intervention makes its blinding infeasible. whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: Active transport educational program based on the ecological model measure: Body composition change (fat mass) by bioimpedance at 16 weeks measure: Change from Body Composition (fat-free mass) by bioimpedance at 16 weeks measure: Changes in Executive Function (inhibition) at 16 weeks measure: Changes in Executive Function (cognitive flexibility) at 16 weeks measure: Changes in executive function (working memory) at 16 weeks measure: Change from Anthropometric measurements at 16 weeks measure: Changes in objective physical activity at 16 week measure: Change from Physical Fitness (Aptitud cardiorrespiratoria (VO2 máx) at 16 weeks measure: Change from Physical Fitness (lower body strength) at 16 weeks measure: Change from Physical-Functional Fitness (strenght on the upper body) at 16 weeks measure: Change from mental health (depression) at 16 weeks measure: Change from mental health (Anxiety) at 16 weeks measure: Change from mental health (Stress) at 16 weeks measure: Changes in overall academic performance once the intervention is completed measure: Changes in health-related quality of life at 16 weeks measure: Changes in the Perception of urban environmental characteristics at 16 weeks measure: Changes in physical activity barriers at 16 weeks measure: Changes in adherence to physical activity at 16 weeks measure: Changes in the form of Transportation to and from School (Active Transportation) at 16 weeks. measure: Sociodemographic evaluations of parents measure: Parents' perception of urban environmental characteristics measure: Parents' perception of physical fitness sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06357052 id: 2701 briefTitle: The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) acronym: LINA overallStatus: COMPLETED date: 2019-07-19 date: 2022-04-30 date: 2022-11-30 date: 2024-04-10 date: 2024-04-10 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation. conditions: NAFLD conditions: Urinary Lithiasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 42 type: ACTUAL measure: the analysis of the correlation between the degree of severity of NAFLD And urinary lithogenic profilecharacterized by reduced urinary magnesium and altered urinary ammonium excretion. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico A.Gemelli IRCCS city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06357039 id: 09.2023.422 id: 2220124 type: OTHER_GRANT domain: Scientific and Technological Research Council of Türkiye (TÜBİTAK) id: 1065371 type: OTHER_GRANT domain: Small and Medium Enterprises Development Organization (KOSGEB) briefTitle: Validation Study of Sleep Tracking Devices overallStatus: COMPLETED date: 2023-03-21 date: 2023-05-31 date: 2023-07-17 date: 2024-04-10 date: 2024-04-25 name: PNAPS Health Informatics and Space Technologies Inc. class: OTHER name: Analog Devices briefSummary: In this study, a two-part recursive convolutional neural networks model was developed, extracting features for each epoch window independently from before and after sleep onset (epoch encoder), and then trained in the context of long-term relationships in the sleep process (sequence encoder), using an approach similar to human expert classification based on information from single-channel forehead EEG and PPG (IR, Green, Red). The classification is based on guidelines from the American Academy of Sleep Medicine and calculated six parameters: total sleep duration (TST), wake (W), N1, N2, N3, and REM.

The validation study of the developed model and the device was conducted at the Sleep Disorders Centre of the Istanbul Medical Faculty using concurrent polysomnographic data from 305 male and female patients aged 18 to 65 years. conditions: Sleep conditions: Sleep Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 305 type: ACTUAL name: Sleep tracking device measure: Sleep Stages Classification Accuracy measure: Interoception analysis from PPG data collected from facial skin sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pnaps Health Informatics and Space Technologies Inc city: Istanbul state: Başıbüyük, Maltepe zip: 34854 country: Turkey lat: 41.01384 lon: 28.94966 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-03-09 uploadDate: 2024-04-04T08:32 filename: Prot_000.pdf size: 55944 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-03-09 uploadDate: 2024-04-04T04:55 filename: ICF_001.pdf size: 78393 hasResults: False

 nctId: NCT06357026 id: Phitys I -2024 briefTitle: Phitys I™ Percutaneous Left Ventricular Assist System Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-01 date: 2026-04-01 date: 2024-04-10 date: 2024-04-10 name: Shanghai NewMed Medical Co., Ltd. class: INDUSTRY name: Shanghai Phigine Medical Technology Co., Ltd. briefSummary: The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 344 type: ESTIMATED name: Percutaneous Ventricular Assist System（Phigine Medical） name: intra-aortic balloon pump (IABP) measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) measure: Incidence of death measure: Incidence of myocardial infarction measure: Incidence of stroke measure: Incidence of target vessel revascularization measure: Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia measure: Incidence of acute kidney injury measure: Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion measure: Incidence of increasing in aortic insufficiency by more than one grade measure: Incidence of severe hypotension measure: Incidence of failure to achieve angiographic success measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) measure: Hemodynamic support success rate during PCI procedure measure: Technical success rate measure: Procedural success rate measure: Change in LVEF compared to baseline measure: Improvement in cardiac function measure: Evaluation of Experimental device performance sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Hospital of Jilin University city: Jilin state: Changchun country: China name: Bin Liu role: CONTACT lat: 43.85083 lon: 126.56028 facility: The First Affiliated Hospital of Harbin Medical University city: Harbin state: Heilongjiang country: China name: Yue Li role: CONTACT lat: 45.75 lon: 126.65 facility: Henan Provincial Chest Hospital city: Zhengzhou state: Henan country: China name: Yiqiang Yuan role: CONTACT lat: 34.75778 lon: 113.64861 facility: Renmin Hospital of Wuhan University city: Wuhan state: Hubei country: China name: Hong Jiang role: CONTACT lat: 30.58333 lon: 114.26667 facility: The Second Xiangya Hospital of Central South University city: Changsha state: Hunan country: China name: Shenghua Zhou role: CONTACT lat: 28.19874 lon: 112.97087 facility: General Hospital of Northern Theater Command city: Shenyang state: Liaoning country: China name: Yaling Han role: CONTACT lat: 41.79222 lon: 123.43278 facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine city: Shanghai state: Shanghai country: China name: Li Zhang role: CONTACT lat: 31.22222 lon: 121.45806 facility: West China Hospital, Sichuan University city: Chengdu state: Sichuan country: China name: Mao Chen role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06357013 id: 2023-40 briefTitle: Postoperative Analgesia in Bilateral Knee Arthroplasties overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-05-01 date: 2024-05-30 date: 2024-04-10 date: 2024-04-10 name: Kocaeli City Hospital class: OTHER_GOV briefSummary: To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period. conditions: Knee Arthroplasty, Total conditions: Peripheral Nerve Block conditions: Pain, Postoperative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Bilateral Suprainguinal fascia iliaca compartment block name: Local infiltration analgesia measure: Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli City Hospital city: Kocaeli country: Turkey lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06357000 id: Time from PCI to surgery briefTitle: Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes overallStatus: COMPLETED date: 2008-01-01 date: 2018-12-31 date: 2018-12-31 date: 2024-04-10 date: 2024-04-10 name: Samsung Medical Center class: OTHER briefSummary: To evaluate the association between time from PCI to cancer surgery and cardiovascular and oncologic outcomes in early-stage cancer patients, A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database. conditions: Coronary Artery Disease conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3621 type: ACTUAL measure: Occurence of Bleeding measure: Occurence of Spontaneous myocardial infarction measure: Occurence of Repeat revascularization measure: Occurence of Cancer recurrence measure: Occurence of All cause death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356987 id: 0002 briefTitle: Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children acronym: Herniotomy overallStatus: COMPLETED date: 2021-06-01 date: 2021-12-31 date: 2021-12-31 date: 2024-04-10 date: 2024-04-12 name: King Edward Medical University class: OTHER briefSummary: All patients of age 6 month to 12 years with inguinal hernia were included in study.

Data was collected on detailed proforma regarding age, sex, side ,operative time, cosmesis , and postoperative complications conditions: Inguinal Hernia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 66 patients with inguinal hernia were randomly divided into two groups (A and B) primaryPurpose: TREATMENT masking: NONE maskingDescription: 66 patients (33 patients in each group) of laparoscopic extraperitoneal closure and open herniotomy each count: 66 type: ACTUAL name: Herniotomy measure: Operative time measure: Recurrence sex: ALL minimumAge: 6 Months maximumAge: 12 Years stdAges: CHILD facility: Muhammad Sharif city: Lahore state: Punjab zip: 53711 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06356974 id: STROgHAT briefTitle: Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT) acronym: STROgHAT overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2026-12-30 date: 2027-12-30 date: 2024-04-10 date: 2024-04-10 name: Drugs for Neglected Diseases class: OTHER name: Institute of Tropical Medicine, Belgium name: Institut de Recherche pour le Developpement name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo name: Ministry of Public Health, Democratic Republic of the Congo briefSummary: This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested clinical study aimed at generating further evidence on safety of acoziborole in gambiense human African trypanosomiasis (gHAT) seropositives individuals. The overall coordinator will be ITM. ITM will be fully responsible for the epidemiological study (study Part A), including cost effectiveness and evaluation of diagnostic tests. DNDi will be the legal sponsor of the nested safety clinical study (study Part B) and will ensure compliance with regulatory requirements and good clinical practices (GCP) for this part of the study.

The investigators hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, that it will be able to arrive at a zero prevalence over a three-year period.

The objectives are to evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b.gambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative. conditions: Human African Trypanosomiasis studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: one-arm, open label, non-randomized, multicentre, phase IIIb study primaryPurpose: TREATMENT masking: NONE count: 2500 type: ESTIMATED name: Treatment of seropositive individuals (positive serology test, but parasitology not confirmed) measure: Interruption of transmission of T.b. gambiense measure: Assessment of safety measure: Economic evaluation measure: assessment of the performance of several diagnostic tests sex: ALL minimumAge: 11 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356961 id: 2022Z4BB82 id: 2022Z4BB82 type: OTHER_GRANT domain: Decreto Direttoriale n. 901 SH4(MUR-PRIN 2022) briefTitle: Routine Outcome Monitoring and Feedback Informed Therapy in Italy acronym: FIT-ITALY overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-10-05 date: 2024-04-10 date: 2024-04-10 name: University of Bergamo class: OTHER name: University of Palermo name: Politecnico di Milano name: Leiden University name: University of Ottawa name: University of Sheffield name: Brigham Young University briefSummary: The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy.

The following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan.

Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following:

I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.

Recruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https://www.miur.it/ElencoSSPWeb/).

Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables. conditions: Feedback, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ESTIMATED name: (Feedback Informed Therapy) with Clinical Support Tools and ah hoc training name: Feedback and ROM (basic) measure: Change from baseline in Symptom severity (GAD7-PHQ9) in OPM-F,OPM and TAU conditions at T2 (up to 6 months), and follow up (3 months) measure: Clinical Outcomes in Routine Evaluation-10 (Change in Session by session) measure: Working Alliance Inventory-Short Revised-Client (Change in session by session) measure: Impact of Usability of MINDY platform with Post-Study System Usability Questionnaire (PSSUQ) and Net Promoter Score (NPS) on patient outcomes measure: Change from baseline of The Reflective Functioning Questionnaire (RFQ)-7 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bergamo (DSUS) city: Bergamo state: Ita (bg) zip: 24125 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False

 nctId: NCT06356948 id: H23-02918 briefTitle: Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study. acronym: RateTXA overallStatus: RECRUITING date: 2024-03-30 date: 2027-07-30 date: 2027-12-30 date: 2024-04-10 date: 2024-04-10 name: University of British Columbia class: OTHER briefSummary: Tranexamic acid is a well-established treatment for post-partum hemorrhage. This study aims to examine the effect of tranexamic acid administration rates on blood pressure changes over 1 minute compared to 10 minutes in healthy pregnant patients scheduled for cesarean delivery. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, randomized, double-blind, non-inferiority trial.

Arm 1: Intravenous infusion of TXA 1g (10 mL) administered over 1 minute. Arm 2: Intravenous infusion of TXA 1g (10 mL) administered over 10 minutes primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: An anesthesiologist or anesthesia assistant not involved in the study will draw up TXA and labelling them based on the randomization. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: Tranexamic Acid (TXA) measure: Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups. measure: Incidence of nausea measure: Incidence of vomiting measure: Incidence of hypotension measure: Incidence of hypertension measure: Incidence of central nervous system side effects sex: FEMALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BC Women's Hospital status: RECRUITING city: Vancouver state: British Columbia zip: V6H3N1 country: Canada name: Aislynn Sharrock, BA (Hons.) role: CONTACT phone: 604-875-2158 phoneExt: 6335 email: aislynn.sharrock@cw.bc.ca name: Anton Chau, MD MMSc role: PRINCIPAL_INVESTIGATOR name: Simon Wydall, MBBS MSc role: SUB_INVESTIGATOR name: Juliana Barrera, MD MSc role: SUB_INVESTIGATOR lat: 49.24966 lon: -123.11934 hasResults: False

 nctId: NCT06356935 id: HP2024 briefTitle: Effects of Heavy-load Resistance Training overallStatus: COMPLETED date: 2023-03-17 date: 2023-08-03 date: 2023-08-03 date: 2024-04-10 date: 2024-04-10 name: University of Southern Denmark class: OTHER name: Team Denmark briefSummary: The study aims to investigate effects of 8-weeks of heavy-load resistance training on mechanical muscle function and functional performance in elite female team handball players from the Danish Women's Handball League. Players will be randomly assigned to either a resistance training group (RT) or serves as training-as-usual controls (CON). conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: RT name: CON measure: Explosive muscle strength measure: Acceleration capacity measure: Agility performance measure: Jump ability sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of Southern Denmark city: Odense zip: 5230 country: Denmark lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06356922 id: RC20_0123 briefTitle: Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia. acronym: PENTILULA overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2027-05-15 date: 2027-05-15 date: 2024-04-10 date: 2024-04-11 name: Nantes University Hospital class: OTHER briefSummary: CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Radiolabeled CXCR4 ligands have been developed for PET imaging (68Ga-PentixaFor; INN: Gallium (68Ga) boclatixafortide) and radioligand therapy (RLT) (\[177Lu\]Lu-PentixaTher/\[90Y\]Y-PentixaTher). \[177Lu\]Lu and \[90Y\]Y-PentixaTher have been tested in three multiple myeloma patients in named-patient use with a remarkable efficacy in 2 patients (Herrmann, 2016). Moreover, feasibility of CXCR4 PET imaging in AML was reported, providing a framework for future theranostic approaches targeting the CXCR4/CXCL12-defined leukemia-initiating cell niche (Herhaus, 2016).

Here a Phase I/II study to determine maximal tolerated dose (MTD) of a RLT using \[177Lu\]Lu-PentixaTher in relapsed/refractory AL was designed. This will be a standard phase I/II 3+3 dose escalation study. Five dose levels will be tested, so 6 to 21 patients have to be included in the study. conditions: Acute Leukemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Experimental drug [177Lu]Lu-PentixaTher measure: Safety of RLT using one injection of [177Lu]Lu-PentixaTher measure: Tolerance measure: Overall response rate measure: Complete response rate measure: Overall survival measure: Leukemia-free survival measure: Minimal residual disease measure: Whole-body biodistribution measure: Serum uptake measure: Radiation dosimetry measure: Renal safety measure: Renal safety measure: Renal safety measure: Renal safety measure: Correlation between different cytokines and toxicity measure: Factors associated response measure: Exploratory outcome measure = Identification of biological biomarkers sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Bordeaux city: Bordeaux state: Gironde zip: 33604 country: France name: DUMAS Pierre-Yves role: CONTACT name: pierre-yves.dumas@chu-bordeaux.fr role: CONTACT lat: 44.84044 lon: -0.5805 facility: CHU de Nantes city: Nantes state: Loire-Atlantique zip: 44000 country: France name: Patrice CHEVALLIER role: CONTACT phone: 00332 40 08 39 94 email: patrice.chevallier@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU d'Angers city: Angers state: Maine Et Loire zip: 49100 country: France name: HUNAULT Mathilde role: CONTACT email: mahunault@chu-angers.fr lat: 47.46667 lon: -0.55 facility: CHU de Clermont-Ferrand city: Clermont-Ferrand state: Puy De Dôme zip: 63000 country: France name: MOLUCON Cécile role: CONTACT email: cecile.chabrot@chu-clermontferrand.fr lat: 45.77966 lon: 3.08628 hasResults: False

 nctId: NCT06356909 id: SUPREMEneo briefTitle: Study of PREMEdication Before Laryngoscopy in Neonates in France acronym: SUPREMEneo overallStatus: RECRUITING date: 2024-03-11 date: 2024-04-07 date: 2024-04-07 date: 2024-04-10 date: 2024-04-10 name: Centre Hospitalier Intercommunal Creteil class: OTHER briefSummary: This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety) conditions: Neonatal Respiratory Distress studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 900 type: ESTIMATED name: Survey of sedo-analgesia practices before laryngoscopy measure: Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement measure: Molecules used for sedo-analgesia measure: Cumulative doses of sedo-analgesia used measure: Questionnaire for the operator describing reasons for non-compliance with best practice guidelines measure: Numeric rating scale for pain (by operator and assistant) measure: TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment) measure: Side effects related to the premedication sex: ALL minimumAge: 20 Weeks maximumAge: 44 Weeks stdAges: CHILD facility: Centre Hospitalier Intercommunal de Creteil status: RECRUITING city: Creteil zip: 94000 country: France name: Manon TAUZIN, MD role: CONTACT phone: 0157023458 email: manon.tauzin@chicreteil.fr lat: 48.78333 lon: 2.46667 hasResults: False

 nctId: NCT06356896 id: 2023/034 briefTitle: The Effect of Diaphragmatic Breathing Exercise on Symptom Severity, Sleep Quality and Anxiety in CABG Patients. overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2024-09-01 date: 2024-04-10 date: 2024-04-10 name: KTO Karatay University class: OTHER briefSummary: Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the patients' heart muscle. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit patients' daily activities, negatively affect their quality of life, and make the rehabilitation process difficult. Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency. Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties. Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up. At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation. This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery. conditions: Coronary Artery conditions: Anxiety conditions: Symptom conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adult patients will be divided into two groups: experimental and control groups. Diaphragmatic breathing exercise will be explained to the patients in the experimental group in the preoperative period. In the preoperative period, the sleep, anxiety and symptom levels of the experimental and control groups will be evaluated.In the post-operative period, the experimental group was reminded to do diaphragmatic breathing exercises on the 2nd, 3rd and 4th days.On the 5th post-operative day, sleep, anxiety and symptom severity of the experimental and control groups will be evaluated. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Single (Participant) Single Blinded whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: diaphragmatic breathing exercise measure: cardiovascular surgery symptom inventory measure: richards champbell sleep quality scale measure: state anxiety inventory measure: Personal information form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Konya City Hospital status: RECRUITING city: Konya state: Karatay zip: 42020 country: Turkey name: Serap SAYAR, PhD role: CONTACT phone: 05059102994 email: oranserap@gmail.com name: Havva Nur YALICI, Nurse role: CONTACT phone: 05413386593 email: havvanur.yalici2017@gmail.com lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06356883 id: 2024-4938 briefTitle: Intraarterial Carboplatin + Caelyx Compared to Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma overallStatus: RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-04-10 date: 2024-04-10 name: Université de Sherbrooke class: OTHER briefSummary: The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action.

Study design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m\^2) + IA Cealyx (30 mg/m\^2) or IA carboplatin (400 mg/m\^2) + IA etoposide phosphate (400 mg/m\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered.

Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC).

Putting together these data will allow to correlate clinical and radiological response to QOL and NC. conditions: Glioblastoma Multiforme conditions: Relapse studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: IA Carboplatin + IA Caelyx name: IA Carboplatin + IA Etoposide Phosphate measure: Tumor Response on MRI using the RANO Criteria measure: Progression-free Survival measure: Median overall survival measure: Treatment-related toxicity measure: Per treatment quality of life assessment measure: Incidence of treatment related Neurocognitive decline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHUS status: RECRUITING city: Sherbrooke state: Quebec zip: J1H 5N4 country: Canada name: David Fortin, MD role: CONTACT phone: 819-346-1110 phoneExt: 13895 email: david.fortin@usherbrooke.ca name: Marie-Andrée Roy, Nurse role: CONTACT phone: 819-346-1110 phoneExt: 13895 email: marie-andree.roy.s-inf.ciussse-chus@ssss.gouv.qc.ca lat: 45.40008 lon: -71.89908 hasResults: False

 nctId: NCT06356870 id: BUE briefTitle: Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone. acronym: BMAC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2026-06-01 date: 2024-04-10 date: 2024-04-10 name: Cairo University class: OTHER briefSummary: radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting conditions: Alveolar Cleft Grafting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: BMAC MIXED WITH ALLOGRAFT name: Cancellous bone from anterior iliac crest measure: bone density measure: Bone gain measure: Postoperative donor site morbidity sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06356857 id: H-23070312 briefTitle: Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging acronym: Heart-Wave overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-04-10 date: 2024-04-11 name: Peter Hovind class: OTHER briefSummary: This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with \[O15\]H2O-PET-MPI. conditions: Myocardial Blood Flow studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT measure: [O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bispebjerg Hospital city: Copenhagen state: RegionH zip: 2400 country: Denmark name: Laila Seidelin, MD role: CONTACT phone: +4520353008 email: laila.seidelin.01@regionh.dk name: Martin Krakauer, MD, Phd. role: CONTACT email: martin.krakauer@regionh.dk name: Laila Seidelin, MD role: SUB_INVESTIGATOR name: Martin Krakauer, MD, P.hd role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06356844 id: 27.02.2023-E.142568 briefTitle: The Effect of Resolvins on the Resolve of Inflammatory Low Back Pain overallStatus: RECRUITING date: 2024-02-27 date: 2024-04 date: 2024-12 date: 2024-04-10 date: 2024-04-10 name: Bezmialem Vakif University class: OTHER briefSummary: Brief Summary: Inflammatory back pain is a chronic condition localized in the axial spine and sacroiliac joints.1 It often accompanies mechanical issues like lumbar disc herniation. While non-surgical interventions such as medication, physiotherapy, and epidural steroid injections are typically the initial approach, surgical options may be considered if these prove ineffective.2 Resolvins, derived from omega-3 fatty acids, have shown promise in reducing inflammation and pain. They help to resolve inflammatory responses, promote tissue repair, and decrease disc size, potentially reducing the need for surgery.3,4 This clinical trial aims to evaluate the efficacy of adding oral resolvins to transforaminal epidural steroid injections for treating lumbar disc herniation (LDH) The control group (Group C: n=25) will receive epidural steroids, while the study group (Group R: n=25) will receive both oral omega-3 supplementation and epidural steroids on the same day. Additionally, the study group will continue taking oral omega-3 supplements for six months.

The primary outcome measure will be changes in protruded/extruded disc size assessed via MRI, with secondary outcomes including pain levels measured by the Numeric Rating Scale (NRS) and serum cytokine levels (IL-6, IL-17, IL-1 beta, TNF-alpha) over the study period.

Discussion: This trial anticipates that combining the anti-inflammatory properties of resolvins with epidural steroid injection will provide a beneficial treatment for patients suffering from inflammatory low back pain. conditions: Low Back Pain conditions: Inflammatory Response conditions: Lumbar Disc Herniation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Resolvin supplement measure: changes in protruded/extruded disc size measure: Pain intensity score measure: Cytokine markers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aylin Ceren Şanlı status: RECRUITING city: Istanbul country: Turkey name: Aylin C Sanli, Asist Dr role: CONTACT phone: +0905496522412 email: aylincerensanli@hotmail.com lat: 41.01384 lon: 28.94966 facility: Aylin Ceren status: COMPLETED city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06356831 id: Endomecryo briefTitle: National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis acronym: Endomercyo overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-07-31 date: 2028-01-31 date: 2024-04-10 date: 2024-04-10 name: Centre Hospitalier Intercommunal Creteil class: OTHER briefSummary: National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team conditions: Endometriosis conditions: Cryotherapy Effect conditions: Surgical conditions: Radiology studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis measure: Characterize the epidemiology of parietal endometriosis nodules measure: Characterize the epidemiology of parietal endometriosis nodules measure: To assess the impact of hormone treatment on parietal endometriosis measure: Assess the demographic distribution of parietal endometriosis measure: Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis measure: Evaluate the aesthetic impact of the treatments measure: Assess the complication rate between the two groups measure: Assess the Severity of Complications according to Society (SIR) of Interventional Radiology or Cardiovascular and Interventional Radiological Society of Europe ( CIRSE) for Radiologists measure: Assess the Severity of Complications according to Clavien Dindo for the surgeon measure: Assess the recidivism rate at 3 years measure: Assess the quality of life between the two groups with PGIC-7 questionnaire measure: Assess the quality of life between the two groups with asses EHP-5 questionnaire measure: Assess the quality of life between the two groups with asses EVA questionnaire measure: Evaluate signal and morphology changes on imaging MRI of parietal endometriosis nodules after cryoablation treatment measure: Evaluate signal and morphology changes on ultrasound imaging of parietal endometriosis nodules after cryoablation treatment sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Tivoli city: Bordeaux country: France name: Horace ROMAN role: CONTACT email: Horace.roman@gmail.com lat: 44.84044 lon: -0.5805 facility: CHU bordeaux city: Bordeau country: France lat: 48.32158 lon: 3.20107 facility: CHU Clermont Ferrand city: Clermont-Ferrand country: France name: Benoit Chauveau role: CONTACT email: b_chauveau@chu-clermontferrand.fr name: Michel CANIS role: CONTACT email: mcanis@chu-clermontferrand.fr lat: 45.77966 lon: 3.08628 facility: CHI Creteil city: Créteil country: France name: Leo RAZAKAMANANTSOA role: CONTACT email: eo.razakamanantsoa@chicreteil.fr name: Yann SALHI role: CONTACT email: yann.salhi@chicreteil.fr lat: 48.78333 lon: 2.46667 facility: CHU de Lyon city: Lyon country: France name: Ana GJORGJIEVSKA-DELOV role: CONTACT email: ana.gjorgjievska-delov@chu-lyon.fr name: Gautier CHENE role: CONTACT email: Gautier.chene@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: APHP Marseille city: Marseill country: France lat: 43.29551 lon: 5.38958 facility: CHU Montpellier city: Montpellier country: France name: Cécile VERHEYDEN role: CONTACT email: c-verheyden@chu-montpellier.fr name: Claire VINCENS role: CONTACT email: c-vincens@chu-montpellier.fr lat: 43.61092 lon: 3.87723 facility: CHU Nime city: Nîmes zip: 30000 country: France lat: 43.83333 lon: 4.35 facility: AP-HP - Tenon city: Paris country: France name: Milan NAJDAW role: CONTACT email: milan.najdawi@aphp.fr name: Yohann DABI role: CONTACT email: Yohann.dabi@aphp.fr lat: 48.85341 lon: 2.3488 facility: AP-HP Hôpital Européen Georges Pompidou city: Paris country: France name: Tom BOEKEN role: CONTACT email: tom.boeken@aphp.fr name: Henri AZAIS role: CONTACT email: henri.azais@aphp.fr lat: 48.85341 lon: 2.3488 facility: APHP Cochin-Port Royal city: Paris country: France name: Maxime BARAT role: CONTACT email: maxime.barat@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU Strasbourg city: Strasbourg country: France name: Afshin GANGI role: CONTACT email: Afshin.gangi@chru-strasbourg.fr name: Emilie FALLER role: CONTACT email: Emilie.faller@chru-strasbourg.fr lat: 48.58392 lon: 7.74553 facility: CHU Toulouse city: Toulouse country: France name: Marie FARUCH role: CONTACT email: Faruch.m@chu-toulouse.fr name: Elodie CHANTALAT role: CONTACT email: Chantalat.e@chu-toulouse.fr lat: 43.60426 lon: 1.44367 facility: CH Valencienne city: Valenciennes country: France name: Thibault POCLET role: CONTACT email: Poclet-t@ch-valenciennes.fr name: Vassili FAGUE role: CONTACT email: fague-v@ch-valenciennes.fr lat: 50.35 lon: 3.53333 hasResults: False

 nctId: NCT06356818 id: E-74555795-050.04-941155 briefTitle: Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-09 date: 2024-04-10 date: 2024-04-10 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: In this study, the effects of different treatment methods for ankle instability patients are being compared aiming to find the optimal treatment. Via comparing virtual reality, motor imagery, and classic rehabilitation programs to clarify their effects on ankle static and dynamic balance, proprioception, range of motion, muscle strength, pain, function and patient satisfaction. conditions: Ankle Sprains studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: three groups with a conventional therapy control group. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Conventional physiotherapy program name: Virtual reality (VR) name: Motor imagery (MI) measure: Visual Analog Scale (VAS) measure: Pressure Pain Threshold (PPT) measure: Star Excursion Balance Test (SEBT) measure: Single Leg Balance Test (SLBT) measure: Joint position sense (JPS) measure: Range of Motion (ROM) measure: Muscle strength measure: Cumberland ankle instability questionnaire (CAIT) measure: Patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Istanbul University-Cerrahpasa (IUC) city: Istanbul country: Turkey name: Doaa HAKAM, PT role: CONTACT phone: +905345456224 email: d.hakam@ogr.iuc.edu.tr name: YILDIZ AKBABA, Assoc. Prof. role: CONTACT email: yildizanalay@iuc.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06356805 id: rTMS in Fibromyalgia briefTitle: rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia acronym: rTMS overallStatus: COMPLETED date: 2023-01-10 date: 2024-01-30 date: 2024-02-20 date: 2024-04-10 date: 2024-04-10 name: Assiut University class: OTHER name: Tanta University briefSummary: the aim of this work was to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. Fibromyalgia Impact Questionnaire (FIQ), Hamilton depression and Anxiety scale and different cognitive rating scales were evaluated pre-1 month post sessions and pre -post 3 months later. all eligible patients with fibromyalgia (FM) were randomized to have 20 sessions of active or sham rTMS over right DLPFC. The improvement changes in groups were compared in each rating scale. conditions: Treatment Resistant Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ACTUAL name: repetitive transcranial magnetic stimulation measure: 1- Assessment of Fibromyalgia Impact Questionnaire (FIQ) measure: 1-Assessment of Hamilton depression (HDRS) and Hamilton Anxiety scales (HARS) (pre- post sessions and pre post three months) measure: Assessment of different cognitive rating scales (Montreal cognitive Assessment scale (MoCa), and Rey Auditory Verbal Learning Test [RAVLT], sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Eman Khedr city: Assiut zip: 11517 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06356792 id: Obstetrics outcome in Abortion briefTitle: Obstetrics , Prenatal Outcomes in Recurrent Miscarriage acronym: OBPORPL overallStatus: RECRUITING date: 2024-04-21 date: 2025-03-21 date: 2025-03-21 date: 2024-04-10 date: 2024-04-10 name: Assiut University class: OTHER briefSummary: The effect of recurrent miscarriage on the outcome of the current pregnancy and if there's a relation between it and adverse out come conditions: Recurrent Miscarriage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 102 type: ESTIMATED measure: If there's relation between recurrent abortion and having a medical disorder during current pregnancy sex: FEMALE minimumAge: 17 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut University status: RECRUITING city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06356779 id: H-23066725 briefTitle: Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease acronym: OLIGO-DK overallStatus: RECRUITING date: 2024-04-15 date: 2030-12-31 date: 2035-12-31 date: 2024-04-10 date: 2024-04-16 name: Gitte Fredberg Persson MD PhD class: OTHER briefSummary: This prospective national multicenter observational and interventional study aims to assess the longitudinal disease trajectory of patients with oligometastatic disease (OMD) who receive local metastasis-directed therapy. Patients with any category of OMD from any non-hematological cancer are eligible for inclusion. Local ablative therapy (LAT) includes surgical metastasectomy, radiotherapy, thermal ablation, and electroporations.

The primary objective is to assess the time to failure of LAT strategy in patients with OMD from any primary cancer treated with all LAT modalities. conditions: Oligometastatic Disease conditions: Metastases conditions: Ablation Techniques conditions: Radiotherapy conditions: Stereotactic Radiation conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1200 type: ESTIMATED name: Local ablative therapy (LAT) measure: Time to failure of local ablative therapy (LAT) strategy measure: Progression-free survival measure: Time to widespread progression measure: Freedom from systemic treatment measure: Overall survival measure: Time to progression measure: Time to local progression measure: Local lesion control rate at 1- and 3-years post-local ablative therapy measure: Time to distant progression measure: Investigator reported grade 3-5 CTCAE (v.5.0) LAT related toxicity measure: Harms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University Hospital Rigshospitalet status: NOT_YET_RECRUITING city: Copenhagen state: Capital Region Of Denmark zip: 2100 country: Denmark name: Mette Pøhl, MD PhD role: CONTACT name: Mette Pøhl, MD PhD role: PRINCIPAL_INVESTIGATOR name: Maja Maraldo, MD PhD role: SUB_INVESTIGATOR name: Morten Suppli, MD PhD role: SUB_INVESTIGATOR name: Rene H Petersen, MD PhD role: SUB_INVESTIGATOR name: Hans-Christian Pommergaard, MD PhD role: SUB_INVESTIGATOR name: Søren Møller, MD PhD role: SUB_INVESTIGATOR name: Michael Achiam, MD PhD role: SUB_INVESTIGATOR name: Mikkel Rosendahl, MD PhD role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Copenhagen University Hospital Herlev and Gentofte status: RECRUITING city: Herlev state: Capital Region Of Denmark zip: 2730 country: Denmark name: Michael RT Laursen, MD role: CONTACT phone: +453868 9202 email: michael.ruben.teindl.laursen@regionh.dk name: Mette Felter, MD PhD role: SUB_INVESTIGATOR name: Henriette Lindberg, MD PhD role: PRINCIPAL_INVESTIGATOR name: Eva Serup-Hansen, MD PhD role: SUB_INVESTIGATOR name: Sebastian Krog, MD role: SUB_INVESTIGATOR name: Jesper Palshof, MD PhD role: SUB_INVESTIGATOR name: Bodil Engelmann, MD PhD role: SUB_INVESTIGATOR name: Eva Ellebæk, MD PhD role: SUB_INVESTIGATOR name: Lisbet Hölmich, MD PhD role: SUB_INVESTIGATOR lat: 55.72366 lon: 12.43998 facility: Hillerød Hospital status: NOT_YET_RECRUITING city: Hillerød state: Capital Region Of Denmark zip: 3400 country: Denmark name: Maria Lendorf role: CONTACT name: Maria Lendorf, MD PD role: PRINCIPAL_INVESTIGATOR lat: 55.92791 lon: 12.30081 facility: Aarhus University Hospital status: NOT_YET_RECRUITING city: Aarhus state: Central Denmark Region zip: 8200 country: Denmark name: Mette Marie Fode, MD PhD role: CONTACT email: mettfode@rm.dk name: Mette Marie Fode, MD PhD role: PRINCIPAL_INVESTIGATOR name: Azza Khalil, MD PhD role: SUB_INVESTIGATOR name: Thomas Decker Christensen, MD PhD role: SUB_INVESTIGATOR name: Ole Graumann, MD PhD role: SUB_INVESTIGATOR name: Jørgen Bjerggaard Jensen, MD PhD role: SUB_INVESTIGATOR lat: 56.15674 lon: 10.21076 facility: Gødstrup Hospital status: NOT_YET_RECRUITING city: Herning state: Central Denmark Region zip: 7400 country: Denmark name: Trine Øllegaard role: CONTACT name: Trine Øllegaard, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 56.13932 lon: 8.97378 facility: Danish Center for Particle Therapy status: NOT_YET_RECRUITING city: Aarhus state: Central Region Denmark zip: 8200 country: Denmark name: Britte Weber, MD PhD role: CONTACT name: Britta Weber, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 56.15674 lon: 10.21076 facility: Aalborg University Hospital status: NOT_YET_RECRUITING city: Aalborg state: Northern Region Of Denmark zip: 9000 country: Denmark name: Jimmy Søndergaard, MD PhD role: CONTACT name: Laurids Ø Poulsen, MD PhD role: CONTACT name: Jimmi Søndergaard, MD PhD role: PRINCIPAL_INVESTIGATOR name: Laurids Ø Poulsen, MD PhD role: SUB_INVESTIGATOR name: Hella Sand, MSc role: SUB_INVESTIGATOR lat: 57.048 lon: 9.9187 facility: Odense University Hospital status: NOT_YET_RECRUITING city: Odense state: Southern Denmark Region zip: 5000 country: Denmark name: Tine Schytte, MD PhD role: CONTACT name: Tine Schytte, MD PhD role: PRINCIPAL_INVESTIGATOR name: Jørgen Johansen, MD PhD role: SUB_INVESTIGATOR name: Christina Nyborg, MD PhD role: SUB_INVESTIGATOR lat: 55.39594 lon: 10.38831 facility: Sønderborg Hospital status: NOT_YET_RECRUITING city: Sønderborg state: Southern Denmark Region zip: 6400 country: Denmark lat: 54.90896 lon: 9.78924 facility: Vejle Hospital status: NOT_YET_RECRUITING city: Vejle state: Southern Denmark Region zip: 7100 country: Denmark name: Charlotte Kristiansen, MD role: CONTACT name: Charlotte Kristiansen, MD role: PRINCIPAL_INVESTIGATOR name: Lars Fokdal, MD PhD role: SUB_INVESTIGATOR name: Lise Bentzen, MD PhD role: SUB_INVESTIGATOR lat: 55.70927 lon: 9.5357 facility: Zealand University Hospital, Roskilde and Næstved status: NOT_YET_RECRUITING city: Roskilde state: Zealand Region zip: 4000 country: Denmark name: Julie Gehl, MD DMSc role: CONTACT name: Julie Gehl, MD DMSc role: PRINCIPAL_INVESTIGATOR lat: 55.64152 lon: 12.08035 hasResults: False

 nctId: NCT06356766 id: 30.01.2024/009 briefTitle: Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-10-08 date: 2025-04-08 date: 2024-04-10 date: 2024-04-16 name: Istanbul University class: OTHER briefSummary: The treatment process following Zone 2 flexor tendon injuries, which are particularly controversial for hand surgery, is challenging. There are various rehabilitation methods for Zone 2 flexor tendon injuries, one of which is the Modified Duran Protocol. Disruptions in the physiotherapy process lead to joint contractures, tendon adhesions, and limitations in daily life activities for patients. Due to global issues such as socioeconomic factors, physical barriers, distance, and pandemics, patients who cannot actively participate in physiotherapy miss out on the rehabilitation process.

The aim of the present study is to investigate the effectiveness of the Modified Duran protocol applied through telerehabilitation following Zone 2 flexor tendon repair. Between April and October 2024, a total of 42 adults aged 18-55 who underwent Zone 2 flexor tendon repair at Istanbul University Istanbul Faculty of Medicine will be recruited, with 21 participants in face-to-face clinic group and 21 in telerehabilitation group. Rehabilitation process will be followed for 12 weeks. The telerehabilitation group will receive exercise training on the third day. After the first training session, patients will be discharged and called to the clinic once a week for dressing changes, monitoring, exercises and if necessary, revision of the protective splint. Patients will be contacted three times a week to implement the planned program using telerehabilitation.

The face-to-face rehabilitation group will receive face-to-face clinic rehabilitation three times a week under the supervision of a physiotherapist for the first 12 weeks.

Patients will be evaluated at the end of the 5th, 6th, and 12th weeks. Data collection tools will include a 'Sociodemographic Form', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Visual Analog Scale (VAS)', 'Jamar Hand Dynamometer', and 'Goniometer (Joint Range of Motion)'.

SPSS (Statistical Package for the Social Sciences) Statistics will be used for the statistical analysis of all data, with a significance level of p \<0.05 considered significant in all assessments, and accepted as two-tailed. conditions: Zone 2 Flexor Tendon Injuries of the Hand studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Telerehabilitation name: Face-to-face rehabilitation measure: Range of Motion measure: DASH measure: Pain of the affected hand measure: Muscle Strength sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06356753 id: RC19_0203 briefTitle: EndoxOmics : Exposome, Endometriosis and Fertility acronym: EndoxOmics overallStatus: COMPLETED date: 2019-09-01 date: 2021-03-31 date: 2021-03-31 date: 2024-04-10 date: 2024-04-10 name: Nantes University Hospital class: OTHER briefSummary: For several years, the effects of environmental pollution on human health have been a growing concern for the scientific community and public authorities. Among the many known chemical contaminants, persistent organic pollutants (POPs) are of particular concern because of their properties as endocrine disrupters, bioaccumulation and biomagnification. The associations between environmental pollutants, endometriosis and infertility remains poorly understood. The objective of this exploratory non interventional monocentric study conducted in the University Hospital of Nantes, is to identify endogenous molecular profiles associated with endometriosis and related infertility. This project implements an exploratory approach combining exposure and metabolomics approaches based on high-resolution mass spectrometry to identify exposure and metabolomics profiles associated with infertility, and biomarkers for potential prognostic application. conditions: Endometriosis conditions: Infertility, Female studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 87 type: ACTUAL measure: Identify endogenous molecular profiles of patients with infertile endometriosis measure: Characterize the internal chemical exposure profiles and metabolomic profiles in the different groups. measure: Compare the distribution of contaminant concentration levels and metabolomic profiles according to the media measured. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Nantes University Hospital city: Nantes state: Loire-Atlantique zip: 44093 country: France lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06356740 id: 69HCL22_0878 id: 2023-508611-22-00 type: CTIS briefTitle: Efficacy and Tolerance of Abacavir/Lamivudine Treatment in Patients With Systemic Lupus Erythematosus acronym: PENCIL overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-11-01 date: 2029-06-01 date: 2024-04-10 date: 2024-04-10 name: Hospices Civils de Lyon class: OTHER briefSummary: Systemic lupus (SL) is a rare chronic autoimmune disease characterized by the production of autoantibodies directed against nuclear antigens, particularly native double-stranded deoxyribonucleic acid (DNA), and excessive production of antiviral cytokines: type I interferons, particularly interferon alpha (IFN-α). IFN-α production results from the excessive detection of nucleic acids (DNA or Ribonucleic Acid (RNA)) by endosomal or intracytoplasmic receptors that are capable of inducing interferon production. The precise mechanisms of cytoplasmic sensor activation remain unknown; however, recent work in the field of interferonopathies suggests a role for human endogenous retroviruses (HERVs). HERVs are remnants of ancient infections caused by exogenous retroviruses integrated into the genome during evolution and represent 8% of the human genome.Several studies have suggested a role for HERVs in the development and maintenance of an excessive immune response in lupus patients and other autoimmune diseases by affecting the type I interferons (I IFN) signalling pathway.

To date, none of the approved immunosuppressive drugs for Systemic Lupus Erythematosus (SLE) have been shown to be effective in the background treatment of SL or in preventing relapse. Consequently, there is an urgent need to identify new molecules and therapeutic avenues for disease-modifying therapies.

In this study, an innovative therapeutic strategy using a combination of nucleoside reverse transcriptase inhibitors (NRTIs), abacavir/lamivudine, is proposed to treat SLE. Thus, we propose a pilot Phase II, randomized, open-label study using NRTIs in patients with SL in remission or with low clinical activity, and evaluating a biological endpoint (IFN signature), which is a direct proxy for the drug's expected effect.

The main objective is to compare the addition of Abacavir/Lamivudine (Add-on) to standard care for 6 months, on the value of the interferon (IFN) transcriptomic signature of patients with systemic lupus with low activity as defined by the Lupus Low Disease Activity State (LLDAS). conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open-label randomized, controlled study with 2 parallel arms (Add-on treatment versus standard of care treatment) primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Blood sample name: Treatment :Abacavir 600 mg/lamivudine 300 mg name: Lupus Impact Tracker questionnaire measure: Absolute variation in interferon signature (IFN) measure: percentage of patients maintaining LLDAS criteria measure: number of relapses measure: anti-native double-stranded DNA quantification measure: anti-extractable nuclear antigens (anti-ENA) quantification measure: interferon-α production quantification measure: Number of successful patients measure: Cumulative dose of intravenous (IV) corticosteroids measure: Lupus Impact Tracker questionnaire score measure: number of missed treatment measure: number of adverse event (AE) measure: number of serious adverse event (SAE) measure: HERVs transcription quantification sex: ALL minimumAge: 12 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Groupe Hospitalier Pellegrin-CHU de Bordeaux city: Bordeaux zip: 33076 country: France name: Christophe RICHEZ, MD, PhD role: CONTACT phone: 05 56 79 56 79 phoneExt: +33 email: christophe.richez@chu-bordeaux.fr name: Christophe RICHEZ, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: Hôpital Femme-Mère-Enfant (HCL) city: Bron zip: 69677 country: France name: Alexandre BELOT, MD, PhD role: CONTACT phone: 04 27 85 61 26 phoneExt: +33 email: Alexandre.belot@chu-lyon.fr name: Alexandre BELOT, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: CHU de Clermont-Ferrand - Hôpital Gabriel Montpied city: Clermont-Ferrand zip: 63003 country: France name: Marc ANDRE, MD, PhD role: CONTACT phone: 0473751440 phoneExt: +33 email: mandre@chu-clermontferrand.fr name: Marc ANDRE, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: CHU Nord de Grenoble - Albert Michallon city: Grenoble zip: 38043 country: France name: Laurence BOUILLET, MD, PhD role: CONTACT phone: 04 76 76 76 40 phoneExt: +33 email: lbouillet@chu-grenoble.fr name: Laurence BOUILLET, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.16667 lon: 5.71667 facility: Hôpital Claude Huriez city: Lille zip: 59037 country: France name: Éric HACHULLA, MD, PhD role: CONTACT phone: 03 20 44 56 50 phoneExt: +33 email: eric.hachulla@chru-lille.fr name: Éric HACHULLA, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Hôpital de la Croix-Rousse (HCL) city: Lyon zip: 69004 country: France name: Yvan JAMILLOUX, MD, PhD role: CONTACT phone: 0426732636 phoneExt: +33 email: yvan.jamilloux@chu-lyon.fr name: Yvan JAMILLOUX, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Hôpital Edouard Herriot (HCL) city: Lyon zip: 69437 country: France name: Thomas BARBA, MD role: CONTACT phone: 0472119583 phoneExt: +33 email: thomas.barba@chu-lyon.fr name: Thomas BARBA, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Hôpital Necker-Enfants malades city: Paris zip: 75015 country: France name: Brigitte BADER-MEUNIER, MD role: CONTACT phone: 0144494332 phoneExt: +33 email: brigitte.bader-meunier@aphp.fr name: Brigitte BADER-MEUNIER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Pitié-Salpêtrière city: Paris zip: 75651 country: France name: Zahir AMOURA, MD, PhD role: CONTACT phone: 01 42 17 80 01 phoneExt: +33 email: zahir.amoura@aphp.fr name: Zahir AMOURA, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Lyon Sud (HCL) city: Pierre-Bénite zip: 69310 country: France name: Mael Richard, MD role: CONTACT phone: 0478861352 phoneExt: +33 email: mael.richard@chu-lyon.fr name: Mael Richard, MD role: PRINCIPAL_INVESTIGATOR lat: 45.7009 lon: 4.82511 facility: CHU de Saint-Etienne - Hôpital Nord city: Saint-Priest-en-Jarez zip: 42270 country: France name: Martin KILLIAN, MD, PhD role: CONTACT phone: 04 77 82 91 79 phoneExt: +33 email: martin.killian@chu-st-etienne.fr name: Martin KILLIAN, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.47501 lon: 4.37614 hasResults: False

 nctId: NCT06356727 id: 121CET-MICROREV-DCM briefTitle: Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling acronym: MICROREV overallStatus: RECRUITING date: 2024-01-03 date: 2026-01-31 date: 2030-01-31 date: 2024-04-10 date: 2024-04-10 name: Azienda Ospedaliera Universitaria Integrata Verona class: OTHER name: Abbott Medical Devices briefSummary: Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \<40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance. conditions: Heart Failure conditions: Left Ventricular Dysfunction conditions: Idiopathic Dilated Cardiomyopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective multicenter single-arm experimental study. The study aims to perform a functional study of the coronary microcirculation with pressure guides, in patients with new diagnoses of dilated cardiomyopathy and clinical indication for coronary angiography. Following this, a multiparametric imaging study with transthoracic echo cardiography will be performed. 12 months after the optimization of medical therapy, the patient will receive a clinical, laboratory and instrumental re-evaluation of transthoracic cardiac color Doppler. The primary endpoint is the recovery of left ventricular function on cardiac imaging. Follow up will continue up to 5 years from enrollment through telephone contacts, outpatient visits and review of clinical data. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 190 type: ESTIMATED name: Thermodilution based assessment of coronary microcirculation measure: Rate of Left ventricular reverse remodeling (LVRR) measure: Adverse clinical events measure: Rate of LVRR at cardiac magnetic resonance measure: Changes in functional capacity at cardiopulmonary exercise test measure: Prevalence of different CMD endotypes and their correlation with the severity of adverse cardiac remodeling. measure: Left ventricle adverse cardiac remodeling at cardiovascular magnetic resonance. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Universitaria di Ferrara status: NOT_YET_RECRUITING city: Ferrara country: Italy name: Gianluca Campo role: CONTACT name: Elisabetta Tonet role: CONTACT lat: 44.83804 lon: 11.62057 facility: Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino status: NOT_YET_RECRUITING city: Genova country: Italy name: Italo Porto role: CONTACT lat: 44.40478 lon: 8.94438 facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele status: NOT_YET_RECRUITING city: Milan country: Italy name: Matteo Montorfano role: CONTACT name: Marco Ancona role: CONTACT lat: 45.46427 lon: 9.18951 facility: Ospedale Galeazzi di Sant'Ambrogio IRCCS status: NOT_YET_RECRUITING city: Milan country: Italy name: Giovanni Monizzi role: CONTACT lat: 45.46427 lon: 9.18951 facility: University of Naples Federico II status: NOT_YET_RECRUITING city: Naples country: Italy name: Giovanni Esposito role: CONTACT name: Luigi Di Serafino role: CONTACT lat: 40.85216 lon: 14.26811 facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: NOT_YET_RECRUITING city: Roma country: Italy name: Cristina Aurigemma role: CONTACT name: Francesco Burzotta role: CONTACT name: Antonio M Leone role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Sant'Andrea status: NOT_YET_RECRUITING city: Rome country: Italy name: Emanuele Barbato role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino status: NOT_YET_RECRUITING city: Torino country: Italy name: Fabrizio D'Ascenzo role: CONTACT lat: 45.07049 lon: 7.68682 facility: Azienda Ospedaliera Universitaria di Verona status: RECRUITING city: Verona zip: 37126 country: Italy name: Flavio Ribichini role: CONTACT phone: 0039 0458122320 email: flavio.ribichini@univr.it lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06356714 id: 13914704179 briefTitle: Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD Status overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-08-01 date: 2024-04-10 date: 2024-04-10 name: Sun Jing class: OTHER briefSummary: Evaluate the efficacy and safety of Nocardia rubra cell wall skeleton in combination with prior second- or third-line regimens for the treatment of potentially hazardous colorectal cancer SD(Stable Disease) status in the real world. conditions: Colorectal Cancer conditions: Colorectal Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens measure: Progression-free survival(PFS) measure: Overall survival (OS) measure: Objective remission rate (ORR) measure: Disease Control Rate (DCR) measure: Incidence and extent of major security incidents measure: Quality of Life Score (QoL) for tumor patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356701 id: dongyandl briefTitle: Tumor Nutritional Therapy in the First-line Treatment of Stage IV NSCLC overallStatus: RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: The First Affiliated Hospital of Dalian Medical University class: OTHER briefSummary: A Single-center, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Tumor Nutritional Therapy Combined With Immune Checkpoint Inhibitors and Chemotherapy in the First-line Treatment of Stage IV NSCLC Without Driver Gene Mutations conditions: Long-Term Effects Secondary to Cancer Therapy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules) measure: PFS measure: Assessment of global disorders in patients with cancer measure: ORR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: DongYan status: RECRUITING city: Dalian City state: Liaoning zip: 116000 country: China name: DongYan Dong role: CONTACT phone: 18098876750 email: dongyan979828@hotmail.com hasResults: False

 nctId: NCT06356688 id: 13914704178 briefTitle: A Clinical Study on the Efficacy and Safety of Paclitaxel Polymer Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-04-20 date: 2025-06-20 date: 2024-04-10 date: 2024-04-10 name: Sun Jing class: OTHER briefSummary: The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (cadonilimab) in combination with platinum-containing chemotherapy (paclitaxel polymer micelles combined with cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with cadonilimab combined with chemotherapy. conditions: Locally Advanced Esophageal Squamous Cell Carcinoma conditions: Neoadjuvant Therapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: paclitaxel polymer micelles and cisplatin combined with Camrelizumab primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: paclitaxel polymer micelles and cisplatin combined with Cadonilimab measure: Pathological complete response (pCR) rates measure: Objective Rate of Effectiveness (ORR) measure: R0 Removal Rate measure: 2-year overall survival rate measure: 2-year disease free survival rate measure: major pathological response (MPR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356675 id: A single-arm pilot briefTitle: A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-07-01 date: 2028-07-01 date: 2024-04-10 date: 2024-04-10 name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine class: OTHER briefSummary: Immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。Targeted angiogenesis therapy has always been the focus of research on the treatment of NSCLC patients with progressive disease after immunotherapy. From the mechanism of action, angiogenesis and immunosuppression are interrelated processes. conditions: Advanced NSCLC studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Tislelizumab name: Anlotinib measure: objective response rate measure: progression free survival time measure: over survival time measure: disease control rate measure: safety including any grade adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356662 id: KY-2023-198 briefTitle: Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease overallStatus: RECRUITING date: 2024-01-23 date: 2024-08-31 date: 2024-12-31 date: 2024-04-10 date: 2024-04-10 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: To evaluate the efficacy and safety of tenofovir disoproxil fumarate in the treatment of Parkinson's disease. The changes of motor symptoms and the occurrence of adverse reactions in early Parkinson's disease patients who took tenofovir disoproxil fumarate and did not take Tenofovir disoproxil fumarate at different time points were compared. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Tenofovir Disoproxil Fumarate measure: UPDRS III（Unified Parkinson's Disease Rating Scale part 3） measure: Non-Motor Symptom Scale（NMSS） measure: creatinine(μmoI/L) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guohua Zhao status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Zhao Guohua, Doctor role: CONTACT phone: +86 13777812308 email: gzhao@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06356649 id: ESOGU2 briefTitle: Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes During Extubation overallStatus: COMPLETED date: 2023-03-15 date: 2024-01-15 date: 2024-01-20 date: 2024-04-10 date: 2024-04-10 name: Eskisehir Osmangazi University class: OTHER briefSummary: Controlled ventilation is applied to patients intubated for general anesthesia. Additionally, positive end-expiratory pressure (PEEP) and pressure support are mechanical ventilation modes that have been used in general anesthesia practice for many years. When the recovery-extubation phase is reached, intermittent bag-mask ventilation is usually used and the patient is allowed to breathe spontaneously and is extubated when an adequate respiratory level is reached. It has been shown in previous studies that the use of intermittent mask ventilation causes postoperative atelectasis. Different methods have been used to prevent postoperative atelectasis. In our study, we aimed to observe the effect of terminating general anesthesia at the end of the operation and using PEEP and pressure-supported ventilation during the extubation phase on early complications. conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 199 type: ACTUAL name: extubation measure: Complications developing during recovery-extubation measure: hemodynamic changes measure: hemodynamic data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eskisehir Osmangazi University Medical Faculty city: Eskisehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False

 nctId: NCT06356636 id: P1216/2022 briefTitle: Impact of the Financial Inclusion Improves Sanitation and Health acronym: FINISH overallStatus: RECRUITING date: 2022-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: Amref Health Africa class: OTHER briefSummary: The goal of this interventional study is to evaluate the impacts of Financial Inclusion improvement sanitation and Health (FINISH) interventions in Kenya's Homa Bay County and Uganda's Kamwenge District among children under five. The main questions it aims to answer are:

1. What is the estimated impact of the FINISH model on health outcomes (diarrhoea occurrence and hygienic behaviour) as well as social (school attendance and sanitation) in the intervention groups?
2. What are the perspectives, attitudes, and practices of various stakeholders (communities, governments, entrepreneurs, and financiers) regarding the FINISH model?
3. What is the cost-effectiveness of the FINISH model, including the amount of leverage funds generated?

The FINISH model postulates that countries will be supported to improve the enabling business environment for sanitation, markets to offer improved safely managed services and products at an affordable price, and formal and informal financial institutions will offer more funding to businesses and households for satiation and hygiene.

Researchers will then compare intervention areas (Homa Bay in Kenya and Kamwenge in Uganda) with control areas (Siaya and Bushenyi in Kenya and Uganda, respectively) to see if the FINISH intervention leads to improved sanitation, health outcomes, and economic benefits. conditions: Health Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants are divided into two or more groups, with each group receiving a different intervention or a control condition. The outcomes of each group are compared at the end of the study to assess the effectiveness of the intervention. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE maskingDescription: to be updated whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1090 type: ESTIMATED name: Financial Inclusion Improves Sanitation and Health measure: Health outcome, measured as, Proportion of households with diarrhoea occurrence in children under five years, and social outcome measured as proportion of households whose children missed school due to diarrhoea occurrence sex: ALL minimumAge: 0 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Homa Bay county status: RECRUITING city: Homa Bay country: Kenya name: Martin Dr Muchangi, PhD role: CONTACT phone: 0721453712 email: martin.muchangi@amref.org lat: -0.52731 lon: 34.45714 hasResults: False

 nctId: NCT06356623 id: SHDC2202020401 briefTitle: A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2024-08-05 date: 2024-08-06 date: 2024-04-10 date: 2024-04-10 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: PONV management has been recommended as a necessary part of enhanced recovery protocols during the perioperative period, and PONV risk assessment is, therefore, a necessary first step in determining the number of medications or strategies for prophylaxis and treatment by considering the number of modifiable and non-modifiable risk factors. However, the external validity of two commonly-used PONV prediction models for patients undergoing liver surgery is unsatisfied, and need to be updated for liver cancer populations to better inform personalized perioperative care regime and individualized decision-making in clinical practice. conditions: Nausea and Vomiting, Postoperative conditions: Liver Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 476 type: ESTIMATED name: 1 measure: Postoperative nausea and vomiting sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356610 id: ALCS-REG-23-08-HT briefTitle: Pharmacokinetic and Subjective Effects of Heated Tobacco Products overallStatus: RECRUITING date: 2024-02-06 date: 2024-09 date: 2025-06 date: 2024-04-10 date: 2024-04-10 name: Altria Client Services LLC class: INDUSTRY name: Celerion briefSummary: This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK (pharmacokinetic) and subjective effects of HTPs (Heated Tobacco Products) comprised of 2 menthol varieties and 2 tobacco flavor varieties (Ploom® HTPs, Japan Tobacco Inc.) in adult menthol and non-menthol combustible cigarette smokers (males and females between the ages of 22 and 65). The study will include participants' UBCC (Usual Brand Combustible Cigarette) and a nicotine gum (Nicorette®) as high and low abuse liability reference products, respectively, to the HTP. Study participation is expected to last up to 34 days, including a 28-day screening period (that includes a 5-day at-home HTP product trial period), and a 6-day in-clinic confinement period (from Check-in \[Day -1\] through the end-of-study \[EOS\] visit on Day 6). conditions: Tobacco Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK and subjective effects of HTPs (2 menthol varieties, Products A and B; 2 tobacco flavor varieties, Products C and D). The study will include participants' UBCC (Product F) and a nicotine gum (Product E) as high and low abuse liability reference products. Sponsor will prepare the randomization schedule. On Day -1 participants will be randomized at 1:1:1:1:1:1 ratio into 1 of 6 sequences as listed below. At least 60 participants will be randomized to ensure approximately 48 completed participants, with approximately 24 menthol and 24 non-menthol cigarette smokers. Participants will be stratified by sex and cigarette type for each of the sequences. A 6x6 Latin Square with the following sequences will be used for the randomization: Sequence 1 = ABFCED Sequence 2 = BCADFE Sequence 3 = CDBEAF Sequence 4 = DECFBA Sequence 5 = EFDACB Sequence 6 = FAEBDC. primaryPurpose: OTHER masking: SINGLE maskingDescription: Study participants will know when they are using their UBCC (usual brand combustible cigarette) and the nicotine gum. However, participants will not be informed of which Ploom® HTS (heated tobacco stick) product they are using. Participants will not see the stick or device packaging. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Test Product A name: Test Product B name: Test Product C name: Test Product D name: Reference Product E name: Reference Product F measure: Plasma Nicotine Concentration Pharmacokinetic (PK) Measurement measure: Product Liking of Heated Tobacco Products (HTP) measure: Tobacco Nicotine Withdrawal Questionnaire measure: Direct Effects of Product Questionnaire measure: Use the Product Again Questionnaire measure: Modified Cigarette Evaluation Questionnaire (mCEQ) - Cigarette measure: Modified Cigarette Evaluation Questionnaire - HTP measure: Modified Cigarette Evaluation Questionnaire-NRT measure: Product Use for HTP-Units Dispensed measure: Product Use for UBCC-Units Dispensed measure: Product Use for Nicotine Gum-Units Dispensed measure: Product Use for HTP-Puff Count measure: Product Use for UBCC-Puff Count measure: Physiological Heart Rate (HR) Assessment-HTP measure: Physiological Heart Rate (HR) Assessment-UBCC measure: Physiological Heart Rate (HR) Assessment-Nicotine Gum sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: Lexington state: Kentucky zip: 40509 country: United States name: Mark Adams, MD role: CONTACT phone: 859-264-8999 email: Mark.adams@amrllc.com lat: 37.98869 lon: -84.47772 facility: QPS Bio-Kinetic status: RECRUITING city: Springfield state: Missouri zip: 65802 country: United States name: Donald W Burkindine, DO role: CONTACT phone: 417-893-6161 email: donald.burkindine@qps.com lat: 37.21533 lon: -93.29824 facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: Knoxville state: Tennessee zip: 37920 country: United States name: William Smith, MD role: CONTACT phone: 865-305-9100 email: william.smith@amrllc.com lat: 35.96064 lon: -83.92074 hasResults: False

 nctId: NCT06356597 id: KY2024-004-A briefTitle: Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-12 date: 2027-12-12 date: 2024-04-10 date: 2024-04-10 name: Jing-yuan Fang, MD, Ph. D class: OTHER briefSummary: The aim of this study is to evaluate the efficacy and safety of Tislelizumab with Fruquintinib, Metronidazole treatment in MSS/MSI-L advanced colorectal cancer patients with high abundance of Fusobacterium nucleatum in a single arm Phase II clinical. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Tislelizumab with Fruquintinib, Metronidazole measure: objective response rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai First People's Hospital status: RECRUITING city: Shanghai country: China name: Qi Li role: CONTACT lat: 31.22222 lon: 121.45806 facility: Shanghai Ninth People's Hospital status: NOT_YET_RECRUITING city: Shanghai country: China name: Yanjie Zhang role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06356584 id: SDZLEC2024-078-01 briefTitle: Sintilimab Combined With Fruquintinib/Regorafenib ± Radiotherapy for Third-line Treatment of Advanced Metastatic Colorectal Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2026-10-01 date: 2024-04-10 date: 2024-04-10 name: Shandong Cancer Hospital and Institute class: OTHER briefSummary: Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. Despite advancements in first- and second-line treatments, third-line therapies for advanced CRC remain limited, emphasizing the need for novel strategies. This prospective study evaluates the efficacy of combined therapy involving Sintilimab, Fruquintinib/Regorafenib, and radiotherapy in advanced CRC. The study cohort comprises patients with non-liver metastatic advanced CRC and those with liver metastases, each receiving tailored treatment protocols. The primary objectives are to assess progression-free survival (PFS), overall survival (OS), and treatment response rates. Subgroup analyses will focus on liver metastases to delineate their impact on treatment outcomes. The rationale for this study stems from the intricate interplay between immunotherapy, targeted therapy, and radiotherapy in CRC management. Previous data suggest a negative correlation between liver metastases and immunotherapy efficacy, necessitating a comprehensive approach integrating multiple treatment modalities. Radiotherapy, particularly stereotactic body radiation therapy (SBRT), has shown promise in controlling liver tumors and modulating the tumor microenvironment, potentially enhancing immunotherapy responses. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for advanced CRC by elucidating the efficacy and safety of this combined treatment approach. The findings may pave the way for personalized treatment strategies tailored to individual patient characteristics, ultimately improving clinical outcomes in this challenging disease setting. conditions: Colorectal Cancer conditions: Immunotherapy conditions: Radiotherapy conditions: Targeted Therapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 141 type: ESTIMATED name: Sintilimab measure: Progression-free survival (PFS) measure: Overall response rate (ORR) measure: Disease control rate (DCR) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinbo Yue status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: Jin Bo Yue role: CONTACT phone: 0531-67626442 phoneExt: 0531-67626442 email: Len.Xu@hotmail.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06356571 id: LPS18183 id: U1111-1298-7348 type: OTHER domain: WHO ICTRP briefTitle: A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma acronym: SubQSA overallStatus: NOT_YET_RECRUITING date: 2024-06-11 date: 2027-01-08 date: 2027-07-15 date: 2024-04-10 date: 2024-04-17 name: Sanofi class: INDUSTRY briefSummary: The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy. conditions: Plasma Cell Myeloma Refractory studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Isatuximab SC-OBDS name: Montelukast name: Dexamethasone name: Acetaminophen name: Diphenhydramine name: Methylprednisolone name: Carfilzomib measure: Overall response rate (ORR) measure: Number of participants with infusion reactions (IRs) measure: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable) measure: Number of participants with injection site reactions (ISRs) measure: CR or better measure: VGPR or better measure: Duration of response (DOR) measure: Time to first response (TT1R) measure: Time to best response (TTBR) measure: Patient experience and Satisfaction Questionnaire v2 (PESQ v2) measure: Positivity titer of anti-drug antibodies (ADA) in a subset of 15 participants measure: Maximum observed concentration (Cmax) of isatuximab in a subset of 15 participants measure: Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of 15 participants sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356558 id: IRB-300010279 id: R01CA271303 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA271303 briefTitle: Adapting Enhanced Recovery Programs for Low Health Literacy Patients overallStatus: NOT_YET_RECRUITING date: 2026-05 date: 2027-08 date: 2028-05 date: 2024-04-10 date: 2024-04-10 name: University of Alabama at Birmingham class: OTHER name: National Cancer Institute (NCI) briefSummary: Low health literacy patients are a vulnerable population at high-risk for surgical disparities including longer hospital stays, more complications, and more readmissions. This study will adapt enhanced recovery programs (ERPs) to low health literacy patients with a multilevel, health literacy-based implementation strategy (called VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) to improve ERP fidelity and thereby outcomes. In the final aim of this project (Specific Aim 3), the VISACT intervention will be tested in a pilot trial. Findings from this study will lay the foundation for a multi-institutional stepped-wedge trial and establish key principles for adapting interventions to eliminate disparities. conditions: Surgery conditions: Health Knowledge, Attitudes, Practice conditions: Colorectal Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This pilot study will be a pre-post trial of the intervention (VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) at 2 sites. This design was selected because the intervention is an implementation strategy and it will not be possible to randomize patients to a non-intervention arm once the VISACT is delivered to a facility. All patients, providers, and organizational units will be subject to downstream effects of VISACT once implemented. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1050 type: ESTIMATED name: Educational intervention (VISACT) measure: Reach - the primary outcome will be to assess the reach of the intervention (VISACT) on patients and providers. measure: Efficacy - Length-of-stay of index surgical hospitalization measure: Adoption - Completion rate of the intervention (VISACT) by participants per month measure: Implementation - Fidelity rate of patients with components of the Enhanced Recovery Program measure: Maintenance - Long-term adoption rate of the intervention (VISACT) per year measure: Efficacy - Readmission rate measure: Efficacy - Complications rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356545 id: OMICS_CODE_01 briefTitle: Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-04-10 date: 2024-04-10 name: Children's Hospital of Fudan University class: OTHER briefSummary: This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model. conditions: Diarrhea Infantile studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Clinical phenotype of congenital diarrhea and enteropathy in China measure: Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features measure: Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning sex: ALL minimumAge: 1 Month maximumAge: 3 Years stdAges: CHILD hasResults: False

 nctId: NCT06356532 id: 202312197544 briefTitle: the Intensive Care Unit Diary for Liver Transplant Recipients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: Chang Gung Memorial Hospital class: OTHER briefSummary: the purpose of this study is to assess the effectiveness of the intensive care unit diary for intensive care unit liver transplant recipients. conditions: Liver Transplant Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants in the control group received the routine care including communication and companionship provided by the nurses of the intensive care unit.

The participants in the intervention group received the intensive care unit diary writing and reading. Participants are required to write at least one sentence daily. The primary writers will be the patients themselves, and in cases where patients are unable to write, their family members will write on their behalf. After completion, the diary will be handed over to the patients to review its contents for at least 10 minutes before bedtime, allowing them to write down their immediate reflections and thoughts on when they read. This process will continue until the 14th day post-operation. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Outcomes Assessor is blinded to the group assignments of the patients. She is tasked with collecting the measured outcomes from the patients. Data collection will be conducted by co-principal investigator of the research team. She will distribute the questionnaires at enrollment, and on the 7th and 14th days post-operation. Once notified by the researchers, data collector will distribute and collect the questionnaires. Upon completion, the questionnaires will be sealed in envelopes by the data collectors. whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: intensive care unit diary measure: change from baseline in depression on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 measure: change from baseline in anxiety on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 measure: change from baseline in stress on the Depression-Anxiety-Stress scale at post operation day 7 and day 14 measure: change from baseline in sense of coherence on the Sense of Coherence Scale at post operation day 7 and day 14 measure: change from baseline in emotional stress on the Brief Symptom Rating Scale at post operation day 7 and day 14 measure: change from baseline in delirium on the intensive care delirium screening checklist at post operation day 1 and day 14 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356519 id: YOUNGBC-29 briefTitle: Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-10 date: 2024-04-10 name: Fudan University class: OTHER briefSummary: The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Sacituzumab Govitecan measure: PFS measure: ORR measure: OS measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Biyun Wang role: CONTACT phone: 18017312387 email: pro_wangbiyun@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06356506 id: 2022-P2-338-01 briefTitle: A Study on Factors of Biochemical Response in Autoimmune Hepatitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2034-05-01 date: 2034-05-01 date: 2024-04-10 date: 2024-04-19 name: Beijing Friendship Hospital class: OTHER briefSummary: The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:

Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up. conditions: Autoimmune Hepatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 630 type: ESTIMATED measure: Alanine aminotransferase (ALT) recovery measure: Aspartate transaminase (AST) recovery measure: Immunoglobulin G (IgG) recovery measure: Death measure: Liver transplantaiton measure: Progression to hepatocellular carcinoma (HCC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06356493 id: OBIIA CMNT briefTitle: Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD overallStatus: COMPLETED date: 2020-01-02 date: 2022-12-31 date: 2022-12-31 date: 2024-04-10 date: 2024-04-10 name: Tunis University class: OTHER briefSummary: The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons.

The aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders. conditions: Hemorrhage conditions: Placenta Accreta Spectrum conditions: Cesarean Section Complications studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 38 type: ACTUAL name: caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries name: caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries measure: calculated blood loss measure: Transfusion peroperatively measure: Duration of surgery measure: Postoperative hospital stay measure: Postoperative transfer to the intensive care unit measure: Morbidity sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Haithem Aloui city: Manouba state: Nabeul zip: 2010 country: Tunisia lat: 36.80803 lon: 10.09721 facility: Haithem Aloui city: Tunis state: Nabeul zip: 2010 country: Tunisia lat: 36.81897 lon: 10.16579 hasResults: False

 nctId: NCT06356480 id: 266 briefTitle: 1% Acetic Acid vs Normal Saline Dressing inManagement of Diabetic Foot overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-04 date: 2024-04 date: 2024-04-10 date: 2024-04-10 name: Dr. Muhammad Naeem class: OTHER briefSummary: Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic diabetic wounds conditions: Granulation of Chronic Diabetic Wounds conditions: Diabetic Wounds studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 74 type: ACTUAL name: 1% Acetic acid dressing measure: Early epithelialization and granulation sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pak Emirates military hospital city: Rawalpindi state: Punjab country: Pakistan lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06356467 id: FARINET briefTitle: Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs acronym: FARINET overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-21 date: 2024-12-31 date: 2024-12-31 date: 2024-04-10 date: 2024-04-12 name: IRCCS San Raffaele class: OTHER briefSummary: Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated. conditions: Neuroendocrine Tumors conditions: GEP-NET studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 450 type: ESTIMATED measure: Global Progression Free Survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS OSpedale San Raffaele city: Milan zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06356454 id: KAPCON-CR briefTitle: Knowledge, Attitudes and Practices of Paediatric Cardiologists About Cardiac Rehabilitation in Children With Congenital Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-02 date: 2025-06-02 date: 2025-12-02 date: 2024-04-10 date: 2024-04-15 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Despite significant clinical benefits and recommendations of clinical practice guidelines to refer patients for exercise and physical activity counselling in the capacity of cardiac rehabilitation (CR), CR is largely underutilised and not implemented effectively. Studies have reported that the reasons for the low implementation of CR are multifactorial at the healthcare system, physician and patient levels. Therefore, the aim of this study was to investigate the knowledge, attitudes and practical applications of paediatric cardiologists regarding cardiac rehabilitation and specifically exercise and physical activity in children with congenital heart disease (CHD). conditions: Physician's Role studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease measure: The score of Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease sex: ALL minimumAge: 32 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356441 id: B2024-039-01 briefTitle: Artificial Intelligence-supported Reading Versus Standard Double Reading for the Interpretation of Magnetic Resonance Imaging in the Detection of Local Recurrence for Nasopharyngeal Carcinoma: a Randomised Controlled Multicenter Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-10 date: 2024-04-10 name: Sun Yat-sen University class: OTHER briefSummary: The aim of this randomized controlled study is to investigate whether the previously developed artificial intelligence model can triage post-radiotherapy magnetic resonance images of patients with nasopharyngeal carcinoma and assist radiologists in their interpretation. conditions: Artificial Intelligence Supported Image Reviewing studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10400 type: ESTIMATED name: AI measure: sensitivity measure: specificity measure: positive predictive value measure: negative predictive value measure: total time of interpretation for all the MR images measure: the rate of discussion with a third radiologist measure: the detection rate of local recurrence in the AI-supported reading group measure: the sensitivity in the subgroups of different rT-stage measure: the incidence of cases whose recurrent risks and contours cannot be provided by the AI model sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China name: Fang-Yun Xie role: CONTACT phone: +8602087342926 email: xiefy@sysucc.org.cn name: Pu-Yun OuYang role: CONTACT phone: +8602087342926 email: ouyangpy@sysucc.org.cn name: Fang-Yun Xie role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06356428 id: KARYÖN-DR briefTitle: Psychometric Properties and Cross-cultural Adaptation of the Turkish Version of Physcian Attitudes Toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R) overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2025-05-13 date: 2025-08-13 date: 2024-04-10 date: 2024-04-15 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Research has reported that the reasons for low implementation of CR are multifactorial at the health system, physician and patient levels. It has also been found that patients are more likely to initiate CR if physicians strongly and positively promote the importance of CR participation. Unfortunately, there are insufficient and ineffective data on CR, referral to CR and both clinical and cost-effectiveness outcomes of CR in Turkey. In this context, it is important to examine more objectively from the perspective of physicians who play a key role in referring patients to CR. However, in our country, there is no relatively objective measurement tool to evaluate physicians' attitudes towards CR. Therefore, this study aims to adapt the original "Physician Attitudes towards Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R)" into Turkish and to examine its psychometric properties. conditions: Physician's Role studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Physcian Attitudes toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R) measure: Physician Attitudes toward Cardiac Rehabilitation and Referral (PACRR)-Revised Scale Score sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356415 id: Dex Dex in infraclavicular briefTitle: Infraclavicular Brachial Plexus Block With Bupivacaine Alone or With Both Dexmedetomidine and Dexamethasone overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-30 date: 2024-09-30 date: 2024-04-10 date: 2024-04-10 name: Suez Canal University class: OTHER briefSummary: Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects. conditions: Upper Extremity Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The sealed-envelope technique will be used. An assistant who is not involved in patient care will make and combine bupivacaine, whether it contains adjuvants or not. Thus, all patients, operators, and outcome assessors remain blinded to the nature of the perineural adjuvant whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Bupivacaine injection name: Bupivacaine+ Dexamethasone+ Dexmedetomidine measure: Onset of sensory block sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356402 id: 8510224SMCPD briefTitle: An Investigation of the Efficacy of OHEM for Improving Oral Hygiene in Children overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-12 date: 2024-04-10 date: 2024-04-10 name: Ziauddin University class: OTHER name: Universiti Sains Malaysia briefSummary: This pilot study evaluates the feasibility of conducting a larger Randomized Controlled Trial to compare three oral health education delivery methods to a control group. Except for the control group, mothers in the three intervention groups will receive the same oral health education based on the OHEM module but differ in the delivery methods, namely lecture, exhibition, and demonstration. All groups will receive a booklet and oral hygiene kits and be instructed to educate their children at home. Pre- and post-intervention assessments include the satisfaction of participants, the researchers' evaluation and cost of the trial, oral hygiene status, and the knowledge of the parents and children. conditions: Dental Plaque conditions: Gingivitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 540 type: ESTIMATED name: Oral Health Educational Module for Mothers (OHEM) lecture name: Oral Health Educational Module for Mothers (OHEM) exhibition name: Oral Health Educational Module for Mothers (OHEM) demonstration measure: Satisfaction of participants: measure: Recruitment and participation of participants in the study measure: Cost of the trial measure: Dental plaque scores measure: Gingival scores measure: Oral health KAP scores measure: Oral health behaviors measure: Oral health-related quality of life using Oral health impact profile-14 sex: ALL minimumAge: 12 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Primary Healthcare Center Gulshan-e-Sikandarabad Shireen Jinnah Colony city: Karachi country: Pakistan name: Sidra Mohiuddin, MDS role: PRINCIPAL_INVESTIGATOR lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06356389 id: JX11502MA-Ib-II briefTitle: A Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of JX11502MA Capsule in Patients With Schizophrenia. overallStatus: COMPLETED date: 2022-03-02 date: 2022-12-27 date: 2023-01-28 date: 2024-04-10 date: 2024-04-10 name: Zhejiang Jingxin Pharmaceutical Co., Ltd. class: INDUSTRY name: Shanghai Mental Health Center briefSummary: A multicenter, randomized, double-blind, placebo-controlled, dose-increasing phase Ib/II clinical trial to evaluate the safety, tolerance and pharmacokinetic characteristics of JX11502MA capsules administered multiple times in patients with schizophrenia conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double-Blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: JX11502MA name: Placebo measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 28 measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Day 28 measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Day 28 measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 measure: Tmax measure: Css_min measure: Css_max measure: Css_av measure: AUC0-t,ss measure: AUC0-∞,ss measure: AUCtau,ss measure: t1/2 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Shanghai Mental Health Center city: Shanghai state: Shanghai zip: 201109 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06356376 id: UAarhus_AGK_MNG_2 briefTitle: The Effects of Pain and Pain Relief on Peripheral Nerve Excitability overallStatus: RECRUITING date: 2023-12-20 date: 2024-04-30 date: 2024-04-30 date: 2024-04-10 date: 2024-04-10 name: University of Aarhus class: OTHER name: Lundbeck Foundation briefSummary: This study will assess changes in nerve excitability of C-fibers, and changes in sympathetic or parasympathetic tone, when the subject experiences pain and pain relief.

The investigators will continuously measure blood pressure, heart rate, respiration rate, gastric motility, sympathetic skin response and C-fiber excitability while using thermal stimuli before and after an analgesic. conditions: Analgesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Heat Stimulation measure: C-fiber excitability measure: Action potential duration (ms) measure: Action potential amplitude (V) measure: Heart-rate variability (ms) measure: Blood pressure variability (mmHg) measure: Sympathetic Skin Response (V) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danish Pain Research Center status: RECRUITING city: Aarhus N zip: 8200 country: Denmark name: Alexander G Kristensen, MD,PhD role: CONTACT phone: +45 93 52 28 64 email: alexgramm@clin.au.dk lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06356363 id: 2023_RIPH_005_OncoPREMs briefTitle: Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway (Onco-PREMs) acronym: OncoPREMs overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-11-01 date: 2025-11-01 date: 2024-04-10 date: 2024-04-10 name: Institut Jean-Godinot class: OTHER name: Université de Reims Champagne-Ardenne briefSummary: Healthcare systems are evolving, giving increasing prominence to the patient-centered model, accompanied by objective and perceived outcomes.

PREMs (Patient Reported Experience Measures) are used to assess how patients feel about their experience of care. PREMs enable patients to take an active role in their own care, and enable healthcare establishments to identify areas for improvement that can be incorporated into their quality processes.

In oncology, the collection of patient-perceived quality regarding their care pathway would enable better coordination of their care. While a few initiatives have emerged in the field of PREMs, the development of a reliable questionnaire assessing patient perception of their care pathway in oncology remains a challenge. conditions: Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: Data collection measure: Psychometric validation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356350 id: IUC_jia_scoliosis_gait briefTitle: Exercise Programs on Gait in Children With Scoliosis Diagnosed JIA overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-11-01 date: 2024-04-10 date: 2024-04-19 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk (1). These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA (2, 3). All these situations can lead to scoliosis, which we often encounter in children with JIA. Current studies describing various 3-dimension (3D) exercise methods (SEAS, Schroth, Dobomed, BSPTS, Side-shift, Lyon, etc.) effective on scoliosis (4). However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children with scoliosis diagnosed JIA. conditions: Scoliosis Idiopathic conditions: Juvenile Idiopathic Arthritis conditions: Gait, Frontal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Conventional exercises name: 3D exercises measure: ATR measure: Cobb angle measure: Maximum Loading measure: Center of mass displacement measure: Walking speed sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Istanbul University-Cerrahpasa status: RECRUITING city: Istanbul country: Turkey name: Gökçe Leblebici role: CONTACT phone: 05397395718 email: leblebicigokce@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06356337 id: STUDY-22-01199 briefTitle: A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1 overallStatus: RECRUITING date: 2024-02-22 date: 2024-08-31 date: 2025-08-31 date: 2024-04-10 date: 2024-04-10 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: The purpose of this research study is to investigate the relationship between light and circadian rhythms. Twenty healthy older adults will be recruited to participate in a randomized, cross-over study, where an active lighting intervention designed to maintain entrainment and a control intervention designed not to entrain will be tested. conditions: Alzheimer's Disease conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Light goggles name: Orange glasses measure: Saliva samples for melatonin levels measure: Light exposure using the Speck measure: Sleep time using actigraphy sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Light and Health Research Center status: RECRUITING city: Menands state: New York zip: 12204 country: United States name: Barbara Plitnick role: CONTACT phone: 518-242-4603 email: barbara.plitnick@mountsinai.org name: Mariana Figueiro role: PRINCIPAL_INVESTIGATOR lat: 42.69202 lon: -73.72456 hasResults: False

 nctId: NCT06356324 id: 2021-13347 briefTitle: The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery overallStatus: COMPLETED date: 2021-10-18 date: 2024-01-31 date: 2024-04-01 date: 2024-04-10 date: 2024-04-10 name: Montefiore Medical Center class: OTHER briefSummary: This study investigates whether television viewing or music listening can reduce pre-operative anxiety and improve surgical outcomes for patients undergoing cataract surgery. It aims to determine the effectiveness of these interventions compared to a control group and assess their impact on physiological markers of anxiety as well as the incidence of intra-operative hypertensive events.

The key questions that are to be answered are:

1. Does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?
2. Does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients? conditions: Anxiety conditions: Intraoperative Hypertension conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants assigned to one of three groups: music listening, tv viewing, or control (waiting with ambient noise) primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 650 type: ACTUAL name: Music Intervention name: Television Intervention measure: Intraoperative hypertensive event measure: Change in VAS-A measurements for Anxiety measure: Change in Heart Rate measurements for Anxiety measure: Change in Blood pressure measurements for Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Medical Center city: New York state: New York zip: 10467 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06356311 id: 2870-015 id: 2023-505423-31 type: REGISTRY domain: EU CT id: U1111-1291-7109 type: OTHER domain: UTN id: MK-2870-015 type: OTHER domain: Merck Id briefTitle: A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2027-01-04 date: 2028-05-05 date: 2024-04-10 date: 2024-04-29 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS). conditions: Gastroesophageal Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Sacituzumab tirumotecan name: Trifluridine-Tipiracil name: Irinotecan name: Paclitaxel name: Docetaxel measure: Overall Survival (OS) measure: Progression-free survival (PFS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Number of Participants Who Experience an Adverse Event (AE) measure: Number of Participants Who Discontinue Study Intervention Due to an AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356298 id: MCHH_004 briefTitle: Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy overallStatus: COMPLETED date: 2023-08-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-10 date: 2024-04-24 name: Maternal and Child Health Hospital of Hubei Province class: OTHER briefSummary: The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy.

Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia .

The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA. conditions: Anesthesia Intubation Complication conditions: Airway conditions: Adenotonsillectomy conditions: Children studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: Airway Management: Flexible Reinforced Laryngeal Mask Airway name: Airway Management: Endotracheal Tube measure: Peak airway pressure measure: Petco2 measure: Ventilation leakage or not measure: Mean arterial pressure (MAP) measure: Heart rate (HR) measure: Recovery time measure: Extubation time measure: Dosage of anesthetic measure: Success of FLMA or ETT measure: Surgeon satisfaction measure: Adverse events sex: ALL minimumAge: 2 Years maximumAge: 10 Years stdAges: CHILD facility: Maternal and Child Health Hospital of Hubei Province city: Wuhan state: Hubei zip: 430000 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06356285 id: 6995049 briefTitle: Testing New Ways to Name Antimicrobial Resistance overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-06-01 date: 2024-06-01 date: 2024-04-10 date: 2024-04-10 name: Imperial College London class: OTHER name: The Behavioural Insights Team briefSummary: This study aims to investigate the public's views on antibiotics and the impact of different ways to name the potential consequences of antibiotics not working in the future. It is known that current ways to name this don't resonate well with the public, and the study team have worked with members of the public through focus groups and community workshops to develop new ways of describing this in a process of co-design. This study aims to test four different ways of presenting this potential crisis to the public, some of which are new communication strategies designed by the public themselves, to evaluate which are the most memorable and investigate the impact on behaviour change.

Adults aged over 18, living in the United Kingdom, who have already signed up to a market panel research company will be eligible to participate in this study.

Participants will be invited to complete a short online survey (this should take around five minutes), advertised to them by the market research panel they have already signed up to. This survey is completely anonymous, and contains some multiple-choice questions, and some that require a short free text response. At the start of the survey one of the four ways to name AMR will be presented to participants in the form of a poster.

This study aims to result in an improved understanding regarding the general public's understanding of antibiotic use and investigate the impact of communication on behaviour change. The data from this study may be used to inform future public health campaigns on this topic and improve the use of antibiotics.

This study will be conducted online using the Predictiv platform, an online platform built by the Behavioural Insights Team. The study is being run in collaboration between the Behavioural Insights Team and the Institute of Global Health Innovation at Imperial College London.

Is it anticipated that the survey will open in April 2024 and be open until recruitment of 4000 participants is complete. This is expected to take 4-6 weeks. conditions: Antimicrobial Resistance conditions: Attitude to Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study has been designed as a four-armed online randomised control trial (RCT). This will be conducted using Predictiv, an online platform for running behavioural experiments built by the Behavioural Insights Team The 4,000 participants will be randomised in a 1:1:1:1 ratio to one of four trial arms. primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants will be blinded to the study arm that they have been assigned to. whoMasked: PARTICIPANT count: 4000 type: ESTIMATED name: Presentation of Antimicrobial Resistance measure: Attitudes towards Antimicrobial Resistance (Sentiment) measure: Comprehension measure: Intent measure: Recall measure: Impact on population sub-groups sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356272 id: 19-006036 id: NCI-2024-00965 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19-006036 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Oropharynx (OPX) Biomarker Trial overallStatus: RECRUITING date: 2019-11-15 date: 2024-12-15 date: 2025-12-15 date: 2024-04-10 date: 2024-04-10 name: Mayo Clinic class: OTHER briefSummary: The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent. conditions: Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 conditions: Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 conditions: Metastatic Oropharyngeal Squamous Cell Carcinoma conditions: Oropharyngeal Squamous Cell Carcinoma conditions: Recurrent Oropharyngeal Squamous Cell Carcinoma conditions: Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 conditions: Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Non-Interventional Study measure: Change in biomarkers measure: Oncologic outcomes associated with biomarkers measure: Genetic alterations measure: Immunologic biomarkers for predicting progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Diane Vogen role: CONTACT phone: 507-266-1247 email: Vogen.Diane2@mayo.edu name: Kathryn M. Van Abel, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06356259 id: IMMUNRX-01 id: 2023-503917-31 type: EUDRACT_NUMBER briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants overallStatus: RECRUITING date: 2023-06-07 date: 2025-01-22 date: 2025-01-22 date: 2024-04-10 date: 2024-04-15 name: ImmunoRx Pharma Inc. class: INDUSTRY briefSummary: The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics with intravenous(IV) administration of IRX-010 in Healthy Participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 81 type: ESTIMATED name: IRX-010 name: Placebo measure: Number of participants with Serious Adverse Events measure: Number of participants with Treatment-Emergent Adverse Events measure: Pharmacokinetics(PK): Area under Curve(AUC) measure: Pharmacokinetics(PK): Maximum Concentration (Cmax) measure: Pharmacokinetics(PK): Half-Life (t½) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ICON status: RECRUITING city: Groningen zip: 9728 country: Netherlands name: Renger Tiessen role: CONTACT name: Renger Tiessen role: PRINCIPAL_INVESTIGATOR lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06356246 id: APHP240363 briefTitle: Oral Health Status of Cystic Fibrosis Patients. An Online Survey in Collaboration With the Vaincre la Mucoviscidose Patient Association. acronym: E-MUCODENT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-08-01 date: 2024-04-10 date: 2024-04-10 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Vaincre la Mucoviscidose briefSummary: Cystic Fibrosis (CF) is a rare hereditary disease with autosomal recessive transmission, affecting 1 in 4700 births in France. Numerous studies have explored the links between oral health and CF, predominantly focusing on a children population. These studies reveal hyposalivation, a risk of dental erosion, an increased prevalence of enamel structural defects, but a reduced prevalence of dental caries in CF children, potentially explained by better oral hygiene. Periodontal disease does not appear to be increased in this population, while the oral quality of life of CF patients has been insufficiently studied.

Today, emerging challenges arise due to the increased life expectancy of CF patients, attributed to the rise of modulators such as Kaftrio®, resulting in an adult-majority population in France. The study of periodontal diseases, associated with oral dysbiosis, becomes relevant as they represent bacterial reservoirs that could impact respiratory complications in CF patients.

To deepen understanding of the links between oral health and CF, as well as to improve oral health of these patients, it is crucial to update the specific oral profile of this population. A cross-sectional survey using a questionnaire is proposed to include a large number of CF patients in France, aiming for real-life data. This questionnaire is constructed around internationally recognized tools for comparative analysis with normative data. Collaboration with the Patients Association "Vaincre la Mucoviscidose" (VLM) facilitates questionnaire creation, dissemination, and interpretation of results. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED measure: Periodontal Risk Screening Score PESS measure: Assess the adherence to good oral hygiene practices and dental follow-up in adult CF patients according to French Union for Oral Health (UFSBD) 2021 measure: Evaluate the risk of dental caries and tooth wear measure: Assess the oral quality of life measure: Evaluate oral dryness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marjolaine GOSSET city: Ivry-sur-Seine state: Ile-de-France zip: 94270 country: France name: Marjolaine GOSSET, MD, PhD role: CONTACT phone: +33 (0)1 49 59 48 20 email: marjolaine.gosset@aphp.fr name: Anne Sophie Duflos, Vaincre La Mucoviscidose role: CONTACT phone: +33 (0)1 40 78 91 97 email: asduflos@vaincrelamuco.org lat: 48.81568 lon: 2.38487 hasResults: False

 nctId: NCT06356233 id: FIMBEX briefTitle: Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy acronym: FIMBEX overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-10-01 date: 2027-12-31 date: 2024-04-10 date: 2024-04-10 name: Fundación Iniciativa para las Neurociencias (FINCE) class: OTHER briefSummary: This is a prospective observational study to evaluate the phenotype of 10 patients under 10 years of age with developmental epileptic encephalopathy due to mutation of the STXBP1 gene. The study will consist of a clinical and neurodevelopmental evaluation, magnetic resonance imaging, prolonged electroencephalogram, cardiological study, and analysis of biomarkers in cerebrospinal fluid. These patients will be followed up for 3 years. The aim of the study is, knowing the baseline phenotype, to analyse the response to commonly used drugs and to anticipate the response to different drugs available on the market in this group of patients based on clinical and biomarker assessment (EEG, MRI and study of specific proteins and neurotransmitters in plasma, urine and CSF). conditions: STXBP1 Encephalopathy With Epilepsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: No intervention will be performed measure: CSF biomarkers measure: EEG markers measure: MRI markers measure: Clinical phenotype sex: ALL minimumAge: 1 Month maximumAge: 10 Years stdAges: CHILD facility: Hospital Ruber Internacional city: Madrid zip: 28034 country: Spain name: Alvaro Beltran Corbellini, MD role: CONTACT phone: +34913875250 email: info@neurologiaclinica.es name: Antonio Gil-Nagel, MD, PhD role: CONTACT name: Antonio Gil-Nagel, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06356220 id: IRB-P00046867 briefTitle: GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health) acronym: GF-NOURISH overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-01 date: 2026-07 date: 2024-04-10 date: 2024-04-10 name: Boston Children's Hospital class: OTHER briefSummary: We propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. We hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits conditions: Celiac Disease in Children conditions: Nutrition Disorder, Child studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. Study Design: Prospective randomized controlled trial.
2. Study population: Children (N=120) with newly diagnosed CeD
3. Intervention: Gluten-Free Food Guide, a nutritional education program focused on minimizing ultra-processed foods in gluten-free die(GFFG), OR a conventional GFD nutritional education class. The nutrition educational program will be based on validated GFD education program. We will use a randomized control trial to assess improvement of overall diet quality, changes in body composition, and minimize toxic and nutrient metal exposures associated with processed gluten-free foods. primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Gluten-Free Diet Education measure: To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass measure: To compare the effect of GFFG vs conventional GFD class on diet quality measure: To compare the effect of GFFG versus conventional GFD on arsenic exposure sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Lauren Robertson role: CONTACT name: Nan Du, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06356207 id: 113-2023 briefTitle: Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study acronym: SALT-TILT overallStatus: RECRUITING date: 2024-03-20 date: 2026-03 date: 2027-03 date: 2024-04-10 date: 2024-04-11 name: Azienda Ospedaliera di Bolzano class: OTHER briefSummary: Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope. However, despite careful selection, a substantial proportion of patients treated with pacemakers suffer recurrences of syncope. It is thought that a pronounced vasodepressor component may hinder the efficacy of pacing in patients, preventing adequate cerebral perfusion during the reflex, thus relativizing the anti-bradycardia function of the pacemaker to prevent syncope. It is hypothesised that the time elapsed from the actual loss of consciousness to the asystole recorded on the ECG during Tilt Table Test may be predictive in terms of response to pacemaker therapy, so this parameter becomes the subject of the present study. conditions: Syncope conditions: Pacemaker conditions: Asystole conditions: Neurally Mediated Syncope studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: Tilt Table Test measure: SALT (Syncope-Asystole Latency Time) measure: Recurrence of syncope measure: Recurrence of syncope sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Sanitaria di Bolzano status: RECRUITING city: Bolzano zip: 39100 country: Italy name: Marco Tomaino, Dr. role: CONTACT lat: 46.49067 lon: 11.33982 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-06 uploadDate: 2024-04-04T15:15 filename: Prot_SAP_000.pdf size: 334779 hasResults: False

 nctId: NCT06356194 id: AT-01B-006 briefTitle: Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-30 date: 2024-05-30 date: 2024-04-10 date: 2024-04-10 name: Atea Pharmaceuticals, Inc. class: INDUSTRY briefSummary: Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir conditions: Healthy Volunteer Study studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK name: Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. measure: PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR). measure: To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Atea Study Site city: Québec state: Montreal country: Canada name: Atea Study Site role: CONTACT phone: 888-481-1607 email: ateaclinicaltrials@ateapharma.com lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06356181 id: Pro00135143 briefTitle: Training Adaptations With and Without Ventilatory Training Device overallStatus: RECRUITING date: 2024-03-18 date: 2024-09-01 date: 2024-09-01 date: 2024-04-10 date: 2024-04-10 name: University of South Carolina class: OTHER name: MAXIMUS briefSummary: This project aims to assess the effectiveness of using a Respiratory Muscle Training (RMT) device during high-intensity functional training (HIFT) to improve fitness and ventilatory parameters. Primary outcome measures include aerobic, anaerobic, and HIFT measures. Secondary measures include sleep, affect, and mood state questionnaires. Participants will be randomized into one of two groups: with the RMT device and without the RMT device. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Respiratory Maximus Training Device name: No Respiratory Training Device measure: Changes in spirometry measure: Changes in aerobic capacity measure: Changes in peak power measure: Changes in ventilatory threshold measure: Changes in countermovement jump measure: Changes in anaerobic capacity measure: Changes in high-intensity functional training test measure: Changes in heart rate at ventilatory threshold measure: Changes in body composition measure: Changes in sleep quality measure: Changes in total mood disturbances measure: Changes in positive mood and emotion measure: Change in blood lactate responses measure: Changes in negative mood and emotion sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of South Carolina Sport Science Lab status: RECRUITING city: Columbia state: South Carolina zip: 29208 country: United States name: Shawn M. Arent, PhD role: CONTACT phone: 803-576-8394 email: sarent@mailbox.sc.edu name: Sten O Stray-Gundersen, PhD role: CONTACT email: sten@mailbox.sc.edu lat: 34.00071 lon: -81.03481 hasResults: False

 nctId: NCT06356168 id: SVR/IVR briefTitle: Virtual Reality in End Stage Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-01-31 date: 2024-04-10 date: 2024-04-15 name: University of Pennsylvania class: OTHER briefSummary: The goal of this clinical trial to compare the social virtual reality and individual virtual reality in patients with end stage kidney disease who are hemodialysis. The main aim is to determine if there are differences in symptoms between the groups. Participants will use virtual reality glasses for 30-45 minutes during dialysis sessions for 4 weeks. conditions: End Stage Kidney Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Social Virtual Reality name: Individual Virtual Reality measure: De Jong Gierveld Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356155 id: UMCC 2023.011 briefTitle: Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer acronym: NEPTUNE overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2027-07 date: 2027-07 date: 2024-04-10 date: 2024-04-10 name: University of Michigan Rogel Cancer Center class: OTHER briefSummary: This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab. conditions: Urothelial Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Enfortumab vedotin name: Pembrolizumab measure: Efficacy of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in cisplatin-eligible patients based off pathological response measure: Assess the safety and toxicity of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in UTUC measure: Assess whether patients who receive the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy have increased surgical complications. measure: Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring RECIST v1.1 measurable disease. measure: Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year recurrence-free survival (RFS). measure: Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year overall survival (OS). measure: Estimate the number of patients who are able to complete neoadjuvant combination enfortumab vedotin and pembrolizumab and safely complete definitive surgery. measure: Assess comprehensive profiling of tumor and host characteristics (including genomics and assessment of tumor mutational burden) as predictors of response to treatment. measure: Explore circulating biomarkers as early detectors of cancer recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan Comprehensive Cancer Center city: Ann Arbor state: Michigan zip: 48109 country: United States name: Irene Tsung, M.D. role: CONTACT phone: 734-936-4385 email: itsung@umich.edu name: Irene Tsung, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06356142 id: UMMC-IRB-2023-317 briefTitle: The Effects of Palmar Cooling on Repeated Sprinting Ability overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2025-03-01 date: 2025-03-01 date: 2024-04-10 date: 2024-04-10 name: University of Mississippi Medical Center class: OTHER briefSummary: Repeated sprinting ability is key for athletic performance in a variety of sport settings. Significant degradations in work output (i.e. fatigue) have been shown to develop after just one sprinting bout1. This pilot study aims to investigate the effects that noninvasive transient temperature manipulation has on an individual's ability to perform repeated sprints. The investigators aim to enroll 90 healthy individuals, 18-30 years of age. Participants will be randomized into two groups (Group A, and B). All groups will perform a ten-minute warm-up followed by two minutes of rest. Following the warm-up and rest period, all groups will participate in a series of five sprints, 60 meters in total length with two 180 degree changes in direction. Between sprints, participants will have 10 seconds rest. After the first series of five sprints participants will be given a 2-minute rest interval. Then participants will perform another series of five sprints followed by another 2-minute rest interval. During each rest interval, Group A will utilize a palmar cooling device. Group B will utilize a placebo version of the palmar cooling device. All sprints will be timed. Heart rate recovery will be measured during all rest breaks, and a rating of perceived exertion will be measured at the beginning and end of each resting interval. Delayed onset muscle soreness will be assessed 48 hours post sprinting, utilizing a visual analog scale. conditions: Exercise Induced Fatigue studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Palmar Cooling name: Placebo Palmar Cooling measure: Participants Sprinting times measure: Participants Heart Rate Recovery measure: Participants Rating of Perceived exertion measure: Participants Reported Delayed Onset Muscle Soreness sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: University of Mississippi Medical Center city: Jackson state: Mississippi zip: 39216 country: United States name: Jacob Daniels, DPT, EdD role: CONTACT phone: 601-815-4038 email: jbdaniels@umc.edu lat: 32.29876 lon: -90.18481 hasResults: False

 nctId: NCT06356129 id: CA073-1020 id: 2023-510178-15 type: REGISTRY domain: EU CT Number id: U1111-1300-8493 type: REGISTRY domain: UTN briefTitle: Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma acronym: GOLSEEK-1 overallStatus: NOT_YET_RECRUITING date: 2024-06-24 date: 2028-08-14 date: 2029-11-20 date: 2024-04-10 date: 2024-04-10 name: Celgene class: INDUSTRY briefSummary: The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL). conditions: Large B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 850 type: ESTIMATED name: Golcadomide name: Placebo name: Rituximab name: Cyclophosphamide name: Doxorubicin name: Vincristine name: Prednisone measure: Progression-free survival (PFS) assessed by the Investigator measure: Overall survival (OS) measure: Event-free survival (EFS) measure: Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC) measure: Minimal residual disease (MRD) negativity rate measure: Progression-free survival (PFS) assessed by the IRAC measure: Objective response (OR) assessed by the Investigator measure: Complete metabolic response (CMR) assessed by the Investigator measure: PFS24 assessed by the Investigator 24 months after randomization measure: Duration of response (DoR) measure: Second progression-free survival (PFS2) assessed by the Investigator measure: Relative dose intensity (%) measure: Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire measure: Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire measure: Mean change from baseline in the EORTC QLQ-C30 measure: Mean change from baseline in the FACT-LymS measure: Number of participants with Adverse Events (AEs) measure: Number of participants with treatment-emergent adverse events (TEAEs) measure: Number of participants with laboratory abnormalities measure: Number of participants with vital sign abnormalities sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Local Institution - 0014 city: Mobile state: Alabama zip: 36604 country: United States name: Site 0014 role: CONTACT lat: 30.69436 lon: -88.04305 facility: Local Institution - 0342 city: San Francisco state: California zip: 94143 country: United States name: Site 0342 role: CONTACT lat: 37.77493 lon: -122.41942 facility: Local Institution - 0287 city: Jacksonville state: Florida zip: 32224 country: United States name: Site 0287 role: CONTACT lat: 30.33218 lon: -81.65565 facility: Local Institution - 0415 city: Margate state: Florida zip: 33063 country: United States name: Site 0415 role: CONTACT lat: 26.24453 lon: -80.20644 facility: Local Institution - 0012 city: Pensacola state: Florida zip: 32504 country: United States name: Site 0012 role: CONTACT lat: 30.42131 lon: -87.21691 facility: Local Institution - 0414 city: Tampa state: Florida zip: 33612 country: United States name: Site 0414 role: CONTACT lat: 27.94752 lon: -82.45843 facility: Local Institution - 0303 city: Atlanta state: Georgia zip: 30322 country: United States name: Site 0303 role: CONTACT lat: 33.749 lon: -84.38798 facility: Local Institution - 0182 city: Chicago state: Illinois zip: 60611 country: United States name: Site 0182 role: CONTACT lat: 41.85003 lon: -87.65005 facility: Local Institution - 0048 city: Skokie state: Illinois zip: 60077 country: United States name: Site 0048 role: CONTACT lat: 42.03336 lon: -87.73339 facility: Local Institution - 0461 city: Des Moines state: Iowa zip: 50309 country: United States name: Site 0461 role: CONTACT lat: 41.60054 lon: -93.60911 facility: Local Institution - 0031 city: Fairway state: Kansas zip: 66205 country: United States name: Site 0031 role: CONTACT lat: 39.02223 lon: -94.6319 facility: Local Institution - 0436 city: Edgewood state: Kentucky zip: 41017 country: United States name: Site 0436 role: CONTACT lat: 39.01867 lon: -84.58189 facility: Local Institution - 0408 city: Baton Rouge state: Louisiana zip: 70809 country: United States name: Site 0408 role: CONTACT lat: 30.45075 lon: -91.15455 facility: Local Institution - 0067 city: Minneapolis state: Minnesota zip: 55407 country: United States name: Site 0067 role: CONTACT lat: 44.97997 lon: -93.26384 facility: Local Institution - 0203 city: Rochester state: Minnesota zip: 55905 country: United States name: Site 0203 role: CONTACT lat: 44.02163 lon: -92.4699 facility: Local Institution - 0437 city: Kansas City state: Missouri zip: 64132 country: United States name: Site 0437 role: CONTACT lat: 39.09973 lon: -94.57857 facility: Local Institution - 0466 city: Reno state: Nevada zip: 89511 country: United States name: Site 0466 role: CONTACT lat: 39.52963 lon: -119.8138 facility: Local Institution - 0049 city: Morristown state: New Jersey zip: 07960 country: United States name: Site 0049 role: CONTACT lat: 40.79677 lon: -74.48154 facility: Local Institution - 0190 city: Buffalo state: New York zip: 14263 country: United States name: Site 0190 role: CONTACT lat: 42.88645 lon: -78.87837 facility: Local Institution - 0369 city: New York state: New York zip: 10028 country: United States name: Site 0369 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Local Institution - 0176 city: New York state: New York zip: 10029 country: United States name: Site 0176 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Local Institution - 0174 city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Site 0174 role: CONTACT lat: 35.9132 lon: -79.05584 facility: Local Institution - 0066 city: Massillon state: Ohio zip: 44646 country: United States name: Site 0066 role: CONTACT lat: 40.79672 lon: -81.52151 facility: Local Institution - 0179 city: Portland state: Oregon zip: 97239 country: United States name: Site 0179 role: CONTACT lat: 45.52345 lon: -122.67621 facility: Local Institution - 0009 city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Site 0009 role: CONTACT lat: 40.44062 lon: -79.99589 facility: Local Institution - 0419 city: York state: Pennsylvania zip: 17403 country: United States name: Site 0419 role: CONTACT lat: 39.9626 lon: -76.72774 facility: Local Institution - 0435 city: Fort Sam Houston state: Texas zip: 78234 country: United States name: Site 0435 role: CONTACT lat: 29.45746 lon: -98.4472 facility: Local Institution - 0046 city: Houston state: Texas zip: 77030 country: United States name: Site 0046 role: CONTACT lat: 29.76328 lon: -95.36327 facility: Local Institution - 0424 city: Houston state: Texas zip: 77030 country: United States name: Site 0424 role: CONTACT lat: 29.76328 lon: -95.36327 facility: Local Institution - 0293 city: Richmond state: Virginia zip: 23219 country: United States name: Site 0293 role: CONTACT lat: 37.55376 lon: -77.46026 facility: Local Institution - 0113 city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1118AAT country: Argentina name: Site 0113 role: CONTACT lat: -34.61315 lon: -58.37723 facility: Local Institution - 0421 city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1417DTB country: Argentina name: Site 0421 role: CONTACT lat: -34.61315 lon: -58.37723 facility: Local Institution - 0112 city: Buenos Aires zip: 1426 country: Argentina name: Site 0112 role: CONTACT lat: -34.61315 lon: -58.37723 facility: Local Institution - 0136 city: Buenos Aires zip: C1431FWO country: Argentina name: Site 0136 role: CONTACT lat: -34.61315 lon: -58.37723 facility: Local Institution - 0119 city: Ciudad Autónoma de Buenos Aires zip: C1426ANZ country: Argentina name: Site 0119 role: CONTACT lat: -34.61315 lon: -58.37723 facility: Local Institution - 0111 city: Córdoba zip: 5016 country: Argentina name: Site 0111 role: CONTACT lat: -31.4135 lon: -64.18105 facility: Local Institution - 0357 city: Gosford state: New South Wales zip: 2250 country: Australia name: Site 0357 role: CONTACT lat: -33.4244 lon: 151.34399 facility: Local Institution - 0361 city: Sydney state: New South Wales zip: 2560 country: Australia name: Site 0361 role: CONTACT lat: -33.86785 lon: 151.20732 facility: Local Institution - 0358 city: Westmead state: New South Wales zip: 2145 country: Australia name: Site 0358 role: CONTACT lat: -33.80383 lon: 150.98768 facility: Local Institution - 0363 city: Tiwi state: Northern Territory zip: 0810 country: Australia name: Site 0363 role: CONTACT lat: -12.35876 lon: 130.878 facility: Local Institution - 0356 city: Birtinya state: Queensland zip: 4575 country: Australia name: Site 0356 role: CONTACT lat: -26.74322 lon: 153.11913 facility: Local Institution - 0360 city: Southport state: Queensland zip: 4215 country: Australia name: Site 0360 role: CONTACT lat: -27.96724 lon: 153.39796 facility: Local Institution - 0365 city: Frankston state: Victoria zip: 3195 country: Australia name: Site 0365 role: CONTACT lat: -38.14458 lon: 145.12291 facility: Local Institution - 0362 city: Heidelberg state: Victoria zip: 3084 country: Australia name: Site 0362 role: CONTACT lat: -37.75 lon: 145.06667 facility: Local Institution - 0359 city: St Albans state: Victoria zip: 3021 country: Australia name: Site 0359 role: CONTACT lat: -37.73901 lon: 144.80024 facility: Local Institution - 0364 city: Warrnambool state: Victoria zip: 3280 country: Australia name: Site 0364 role: CONTACT lat: -38.38176 lon: 142.48799 facility: Local Institution - 0385 city: Wels state: Oberösterreich zip: 4600 country: Austria name: Site 0385 role: CONTACT lat: 48.16667 lon: 14.03333 facility: Local Institution - 0387 city: Linz zip: 4021 country: Austria name: Site 0387 role: CONTACT lat: 48.30639 lon: 14.28611 facility: Local Institution - 0386 city: Vienna zip: 1140 country: Austria name: Site 0386 role: CONTACT lat: 48.20849 lon: 16.37208 facility: Local Institution - 0255 city: Fortaleza state: Ceará zip: 60115-281 country: Brazil name: Site 0255 role: CONTACT lat: -3.71722 lon: -38.54306 facility: Local Institution - 0297 city: Lago sul state: Distrito Federal zip: 71635580 country: Brazil name: Site 0297 role: CONTACT lat: -15.90603 lon: -47.86366 facility: Local Institution - 0256 city: Goiania state: Goiás zip: 74605-020 country: Brazil name: Site 0256 role: CONTACT lat: -16.67861 lon: -49.25389 facility: Local Institution - 0302 city: Curitiba state: Paraná zip: 81520-060 country: Brazil name: Site 0302 role: CONTACT lat: -25.42778 lon: -49.27306 facility: Local Institution - 0296 city: Niteroi state: Rio De Janeiro zip: 24020-096 country: Brazil name: Site 0296 role: CONTACT lat: -22.88333 lon: -43.10361 facility: Local Institution - 0304 city: Natal state: Rio Grande Do Norte zip: 59075-740 country: Brazil name: Site 0304 role: CONTACT lat: -5.795 lon: -35.20944 facility: Local Institution - 0253 city: Porto Alegre state: Rio Grande Do Sul zip: 90110-270 country: Brazil name: Site 0253 role: CONTACT lat: -30.03306 lon: -51.23 facility: Local Institution - 0246 city: Chapecó state: Santa Catarina zip: 89812-211 country: Brazil name: Site 0246 role: CONTACT lat: -27.09639 lon: -52.61833 facility: Local Institution - 0247 city: Joinville state: Santa Catarina zip: 89201260 country: Brazil name: Site 0247 role: CONTACT lat: -26.30444 lon: -48.84556 facility: Local Institution - 0250 city: Barretos state: São Paulo zip: 14784400 country: Brazil name: Site 0250 role: CONTACT lat: -20.55722 lon: -48.56778 facility: Local Institution - 0249 city: Jaú state: São Paulo zip: 17210-120 country: Brazil name: Site 0249 role: CONTACT lat: -22.29639 lon: -48.55778 facility: Local Institution - 0248 city: Sao Paulo state: São Paulo zip: 01323-903 country: Brazil name: Site 0248 role: CONTACT lat: -23.5475 lon: -46.63611 facility: Local Institution - 0316 city: Sao Paulo state: São Paulo zip: 01509-010 country: Brazil name: Site 0316 role: CONTACT lat: -23.5475 lon: -46.63611 facility: Local Institution - 0252 city: Sao Paulo state: São Paulo zip: 04543-000 country: Brazil name: Site 0252 role: CONTACT lat: -23.5475 lon: -46.63611 facility: Local Institution - 0301 city: São José do Rio Preto state: São Paulo zip: 15090000 country: Brazil name: Site 0301 role: CONTACT lat: -20.81972 lon: -49.37944 facility: Local Institution - 0298 city: Rio de Janeiro zip: 22061-080 country: Brazil name: Site 0298 role: CONTACT lat: -22.90278 lon: -43.2075 facility: Local Institution - 0294 city: São Paulo zip: 01409-902 country: Brazil name: Site 0294 role: CONTACT lat: -23.5475 lon: -46.63611 facility: Local Institution - 0251 city: São Paulo zip: 05652-900 country: Brazil name: Site 0251 role: CONTACT lat: -23.5475 lon: -46.63611 facility: Local Institution - 0394 city: Sofia state: Sofia (stolitsa) zip: 1431 country: Bulgaria name: Site 0394 role: CONTACT lat: 42.69751 lon: 23.32415 facility: Local Institution - 0393 city: Plovdiv zip: 4002 country: Bulgaria name: Site 0393 role: CONTACT lat: 42.15 lon: 24.75 facility: Local Institution - 0392 city: Sofia zip: 1407 country: Bulgaria name: Site 0392 role: CONTACT lat: 42.69751 lon: 23.32415 facility: Local Institution - 0091 city: Victoria state: British Columbia zip: V8R 6V5 country: Canada name: Site 0091 role: CONTACT lat: 48.43294 lon: -123.3693 facility: Local Institution - 0153 city: Montreal state: Quebec zip: H3T 1M5 country: Canada name: Site 0153 role: CONTACT lat: 45.50884 lon: -73.58781 facility: Local Institution - 0073 city: Montreal state: Quebec zip: H4J 1C5 country: Canada name: Site 0073 role: CONTACT lat: 45.50884 lon: -73.58781 facility: Local Institution - 0004 city: Sherbrooke state: Quebec zip: J1H 5N4 country: Canada name: Site 0004 role: CONTACT lat: 45.40008 lon: -71.89908 facility: Local Institution - 0109 city: Chile state: Región Metropolitana De Santiago zip: 8380455 country: Chile name: Site 0109 role: CONTACT facility: Local Institution - 0106 city: Santiago state: Región Metropolitana De Santiago zip: 7500921 country: Chile name: Site 0106 role: CONTACT lat: -33.45694 lon: -70.64827 facility: Local Institution - 0107 city: Santiago state: Región Metropolitana De Santiago zip: 7580206 country: Chile name: Site 0107 role: CONTACT lat: -33.45694 lon: -70.64827 facility: Local Institution - 0110 city: Santiago state: Región Metropolitana De Santiago zip: 8320325 country: Chile name: Site 0110 role: CONTACT lat: -33.45694 lon: -70.64827 facility: Local Institution - 0108 city: Santiago state: Región Metropolitana De Santiago zip: 8330032 country: Chile name: Site 0108 role: CONTACT lat: -33.45694 lon: -70.64827 facility: Local Institution - 0164 city: Viña del Mar state: Valparaíso zip: 0 country: Chile name: Site 0164 role: CONTACT lat: -33.02457 lon: -71.55183 facility: Local Institution - 0195 city: Beijing state: Beijing zip: 100091 country: China name: Site 0195 role: CONTACT lat: 39.9075 lon: 116.39723 facility: Local Institution - 0236 city: Chongqing state: Chongqing zip: 400016 country: China name: Site 0236 role: CONTACT lat: 29.56278 lon: 106.55278 facility: Local Institution - 0196 city: Chongqing state: Chongqing zip: 400030 country: China name: Site 0196 role: CONTACT lat: 29.56278 lon: 106.55278 facility: Local Institution - 0274 city: Fuzhou state: Fujian zip: 350014 country: China name: Site 0274 role: CONTACT lat: 26.06139 lon: 119.30611 facility: Local Institution - 0157 city: Xiamen state: Fujian zip: 361003 country: China name: Site 0157 role: CONTACT lat: 24.47979 lon: 118.08187 facility: Local Institution - 0133 city: Guangzhou state: Guangdong zip: 510515 country: China name: Site 0133 role: CONTACT lat: 23.11667 lon: 113.25 facility: Local Institution - 0240 city: Guangzhou state: Guangdong zip: 510555 country: China name: Site 0240 role: CONTACT lat: 23.11667 lon: 113.25 facility: Local Institution - 0338 city: Nanning state: Guangxi zip: 530021 country: China name: Site 0338 role: CONTACT lat: 22.81667 lon: 108.31667 facility: Local Institution - 0239 city: Harbin state: Heilongjiang zip: 150081 country: China name: Site 0239 role: CONTACT lat: 45.75 lon: 126.65 facility: Local Institution - 0238 city: Zhengzhou state: Henan zip: 450008 country: China name: Site 0238 role: CONTACT lat: 34.75778 lon: 113.64861 facility: Local Institution - 0346 city: Wuhan state: Hubei zip: 430022 country: China name: Site 0346 role: CONTACT lat: 30.58333 lon: 114.26667 facility: Local Institution - 0214 city: Wuhan state: Hubei zip: 430030 country: China name: Site 0214 role: CONTACT lat: 30.58333 lon: 114.26667 facility: Local Institution - 0275 city: Changsha state: Hunan zip: 410013 country: China name: Site 0275 role: CONTACT lat: 28.19874 lon: 112.97087 facility: Local Institution - 0156 city: Suzhou state: Jiangsu zip: 215006 country: China name: Site 0156 role: CONTACT lat: 31.30408 lon: 120.59538 facility: Local Institution - 0237 city: Nanchang state: Jiangxi zip: 330006 country: China name: Site 0237 role: CONTACT lat: 28.68396 lon: 115.85306 facility: Local Institution - 0241 city: Nanchang state: Jiangxi zip: 330029 country: China name: Site 0241 role: CONTACT lat: 28.68396 lon: 115.85306 facility: Local Institution - 0291 city: Changchun state: Jilin zip: 130021 country: China name: Site 0291 role: CONTACT lat: 43.88 lon: 125.32278 facility: Local Institution - 0334 city: Shenyang state: Liaoning zip: 110004 country: China name: Site 0334 role: CONTACT lat: 41.79222 lon: 123.43278 facility: Local Institution - 0169 city: Shenyang state: Liaoning zip: 110015 country: China name: Site 0169 role: CONTACT lat: 41.79222 lon: 123.43278 facility: Local Institution - 0242 city: Jinan state: Shandong zip: 250012 country: China name: Site 0242 role: CONTACT lat: 36.66833 lon: 116.99722 facility: Local Institution - 0344 city: Jinan state: Shandong zip: 250117 country: China name: Site 0344 role: CONTACT lat: 36.66833 lon: 116.99722 facility: Local Institution - 0132 city: Shanghai state: Shanghai zip: 200025 country: China name: Site 0132 role: CONTACT lat: 31.22222 lon: 121.45806 facility: Local Institution - 0339 city: Shanghai state: Shanghai zip: 200032 country: China name: Site 0339 role: CONTACT lat: 31.22222 lon: 121.45806 facility: Local Institution - 0234 city: Taiyuan state: Shanxi zip: 030032 country: China name: Site 0234 role: CONTACT lat: 37.86944 lon: 112.56028 facility: Local Institution - 0141 city: Cheng Du state: Sichuan zip: 610041 country: China name: Site 0141 role: CONTACT facility: Local Institution - 0289 city: Tianjin state: Tianjin zip: 300020 country: China name: Site 0289 role: CONTACT lat: 39.14222 lon: 117.17667 facility: Local Institution - 0155 city: Urumchi state: Xinjiang zip: 830054 country: China name: Site 0155 role: CONTACT facility: Local Institution - 0197 city: Hangzhou state: Zhejiang zip: 310003 country: China name: Site 0197 role: CONTACT lat: 30.29365 lon: 120.16142 facility: Local Institution - 0457 city: Wenzhou state: Zhejiang zip: 325000 country: China name: Site 0457 role: CONTACT lat: 27.99942 lon: 120.66682 facility: Local Institution - 0130 city: Bogota state: Cundinamarca zip: 111151 country: Colombia name: Site 0130 role: CONTACT lat: 4.60971 lon: -74.08175 facility: Local Institution - 0129 city: Bogotá state: Distrito Capital De Bogotá zip: 110131 country: Colombia name: Site 0129 role: CONTACT lat: 4.60971 lon: -74.08175 facility: Local Institution - 0390 city: Zagreb state: Grad Zagreb zip: 10000 country: Croatia name: Site 0390 role: CONTACT lat: 45.81444 lon: 15.97798 facility: Local Institution - 0440 city: Osijek zip: 31000 country: Croatia name: Site 0440 role: CONTACT lat: 45.55111 lon: 18.69389 facility: Local Institution - 0105 city: Brno state: Brno-město zip: 625 00 country: Czechia name: Site 0105 role: CONTACT lat: 49.19522 lon: 16.60796 facility: Local Institution - 0104 city: Hradec Kralove state: Hradec Králové zip: 500 05 country: Czechia name: Site 0104 role: CONTACT lat: 50.20923 lon: 15.83277 facility: Local Institution - 0102 city: Olomouc state: Olomoucký Kraj zip: 779 00 country: Czechia name: Site 0102 role: CONTACT lat: 49.59552 lon: 17.25175 facility: Local Institution - 0120 city: Pilsen state: Plzeňský Kraj zip: 305 99 country: Czechia name: Site 0120 role: CONTACT lat: 49.74747 lon: 13.37759 facility: Local Institution - 0103 city: PRague state: Praha 10 zip: 100 34 country: Czechia name: Site 0103 role: CONTACT lat: 50.08804 lon: 14.42076 facility: Local Institution - 0243 city: Praha 2 zip: 12808 country: Czechia name: Site 0243 role: CONTACT lat: 50.08804 lon: 14.42076 facility: Local Institution - 0285 city: Aarhus state: Midtjylland zip: 8200 country: Denmark name: Site 0285 role: CONTACT lat: 56.15674 lon: 10.21076 facility: Local Institution - 0284 city: Odense state: Syddanmark zip: 5000 country: Denmark name: Site 0284 role: CONTACT lat: 55.39594 lon: 10.38831 facility: Local Institution - 0281 city: Oulu state: Pohjois-Pohjanmaa zip: 90220 country: Finland name: Site 0281 role: CONTACT lat: 65.01236 lon: 25.46816 facility: Local Institution - 0283 city: Kuopio state: Pohjois-Savo zip: 70210 country: Finland name: Site 0283 role: CONTACT lat: 62.89238 lon: 27.67703 facility: Local Institution - 0282 city: Turku state: Varsinais-Suomi zip: 20521 country: Finland name: Site 0282 role: CONTACT lat: 60.45148 lon: 22.26869 facility: Local Institution - 0280 city: Helsinki zip: 00029 country: Finland name: Site 0280 role: CONTACT lat: 60.16952 lon: 24.93545 facility: Local Institution - 0083 city: Nice state: Alpes-Maritimes zip: 06202 country: France name: Site 0083 role: CONTACT lat: 43.70313 lon: 7.26608 facility: Local Institution - 0084 city: Strasbourg state: Alsace zip: 67033 country: France name: Site 0084 role: CONTACT lat: 48.58392 lon: 7.74553 facility: Local Institution - 0090 city: Bordeaux state: Aquitaine zip: 33076 country: France name: Site 0090 role: CONTACT lat: 44.84044 lon: -0.5805 facility: Local Institution - 0324 city: Pessac state: Aquitaine zip: 33600 country: France name: Site 0324 role: CONTACT lat: 44.81011 lon: -0.64129 facility: Local Institution - 0087 city: Marseille state: Bouches-du-Rhône zip: 13273 country: France name: Site 0087 role: CONTACT lat: 43.29551 lon: 5.38958 facility: Local Institution - 0292 city: Dijon state: Côte-d'Or zip: 21000 country: France name: Site 0292 role: CONTACT lat: 47.31667 lon: 5.01667 facility: Local Institution - 0332 city: Brest state: Finistère zip: 29609 country: France name: Site 0332 role: CONTACT lat: 48.3903 lon: -4.48628 facility: Local Institution - 0335 city: Saint-Cloud state: Hauts-de-Seine zip: 92210 country: France name: Site 0335 role: CONTACT lat: 48.84598 lon: 2.20289 facility: Local Institution - 0079 city: Tours state: Indre-et-Loire zip: 37032 country: France name: Site 0079 role: CONTACT lat: 47.38333 lon: 0.68333 facility: Local Institution - 0321 city: Saint Priest en Jarez state: Loire zip: 42271 country: France name: Site 0321 role: CONTACT lat: 45.47501 lon: 4.37614 facility: Local Institution - 0081 city: Lille state: Nord zip: 59000 country: France name: Site 0081 role: CONTACT lat: 50.63297 lon: 3.05858 facility: Local Institution - 0325 city: Nantes state: Pays-de-la-Loire zip: 44000 country: France name: Site 0325 role: CONTACT lat: 47.21725 lon: -1.55336 facility: Local Institution - 0089 city: Pierre-Bénite state: Rhône zip: 69310 country: France name: Site 0089 role: CONTACT lat: 45.7009 lon: 4.82511 facility: Local Institution - 0200 city: Creteil state: Val-de-Marne zip: 94010 country: France name: Site 0200 role: CONTACT lat: 48.78333 lon: 2.46667 facility: Local Institution - 0076 city: Villejuif state: Val-de-Marne zip: 94805 country: France name: Site 0076 role: CONTACT lat: 48.7939 lon: 2.35992 facility: Local Institution - 0306 city: Poitiers state: Vienne zip: 86021 country: France name: Site 0306 role: CONTACT lat: 46.58333 lon: 0.33333 facility: Local Institution - 0244 city: Bayonne zip: 64109 country: France name: Site 0244 role: CONTACT lat: 43.48333 lon: -1.48333 facility: Local Institution - 0315 city: Caen zip: 14033 country: France name: Site 0315 role: CONTACT lat: 49.18585 lon: -0.35912 facility: Local Institution - 0202 city: Lille zip: 59020 country: France name: Site 0202 role: CONTACT lat: 50.63297 lon: 3.05858 facility: Local Institution - 0077 city: Paris zip: 75010 country: France name: Site 0077 role: CONTACT lat: 48.85341 lon: 2.3488 facility: Local Institution - 0323 city: Saint-Pierre zip: 97448 country: France name: Site 0323 role: CONTACT facility: Local Institution - 0383 city: Augsburg state: Bayern zip: 86156 country: Germany name: Site 0383 role: CONTACT lat: 48.37154 lon: 10.89851 facility: Local Institution - 0384 city: Koblenz state: Rheinland-Pfalz zip: 56068 country: Germany name: Site 0384 role: CONTACT lat: 50.35357 lon: 7.57883 facility: Local Institution - 0370 city: Essen zip: 45122 country: Germany name: Site 0370 role: CONTACT lat: 51.45657 lon: 7.01228 facility: Local Institution - 0399 city: Athens state: Attikí zip: 106 76 country: Greece name: Site 0399 role: CONTACT lat: 37.97945 lon: 23.71622 facility: Local Institution - 0396 city: Athens state: Attikí zip: 11527 country: Greece name: Site 0396 role: CONTACT lat: 37.97945 lon: 23.71622 facility: Local Institution - 0397 city: Chaidari state: Attikí zip: 12462 country: Greece name: Site 0397 role: CONTACT lat: 38.01135 lon: 23.66597 facility: Local Institution - 0398 city: Alexandroupolis zip: 08100 country: Greece name: Site 0398 role: CONTACT lat: 40.84995 lon: 25.87644 facility: Local Institution - 0395 city: Ioannina state: Ípeiros zip: 455 00 country: Greece name: Site 0395 role: CONTACT lat: 39.66486 lon: 20.85189 facility: Local Institution - 0160 city: Budapest state: Pest zip: 1122 country: Hungary name: Site 0160 role: CONTACT lat: 47.49801 lon: 19.03991 facility: Local Institution - 0162 city: Kaposvár state: Somogy zip: 7400 country: Hungary name: Site 0162 role: CONTACT lat: 46.36667 lon: 17.8 facility: Local Institution - 0353 city: Nyiregyhaza state: Szabolcs-Szatmár-Bereg zip: 4400 country: Hungary name: Site 0353 role: CONTACT lat: 47.95539 lon: 21.71671 facility: Local Institution - 0161 city: Szombathely state: Vas zip: 9700 country: Hungary name: Site 0161 role: CONTACT lat: 47.23088 lon: 16.62155 facility: Local Institution - 0163 city: Budapest zip: 1088 country: Hungary name: Site 0163 role: CONTACT lat: 47.49801 lon: 19.03991 facility: Local Institution - 0266 city: Debrecen zip: 4032 country: Hungary name: Site 0266 role: CONTACT lat: 47.53333 lon: 21.63333 facility: Local Institution - 0276 city: Anjo state: Aichi zip: 446-8602 country: Japan name: Site 0276 role: CONTACT lat: 34.95828 lon: 137.08054 facility: Local Institution - 0371 city: Nagoya state: Aichi zip: 466-8560 country: Japan name: Site 0371 role: CONTACT lat: 35.18147 lon: 136.90641 facility: Local Institution - 0168 city: Kashiwa state: Chiba zip: 277-8577 country: Japan name: Site 0168 role: CONTACT lat: 35.86224 lon: 139.97732 facility: Local Institution - 0271 city: Ogaki state: Gifu zip: 503-0864 country: Japan name: Site 0271 role: CONTACT lat: 35.35 lon: 136.61667 facility: Local Institution - 0368 city: Sapporo state: Hokkaido zip: 0608648 country: Japan name: Site 0368 role: CONTACT lat: 43.06667 lon: 141.35 facility: Local Institution - 0327 city: Sapporo state: Hokkaido zip: 064-0804 country: Japan name: Site 0327 role: CONTACT lat: 43.06667 lon: 141.35 facility: Local Institution - 0273 city: Amagasaki state: Hyogo zip: 660-8550 country: Japan name: Site 0273 role: CONTACT lat: 34.71667 lon: 135.41667 facility: Local Institution - 0328 city: Himeji state: Hyogo zip: 670-8540 country: Japan name: Site 0328 role: CONTACT lat: 34.81667 lon: 134.7 facility: Local Institution - 0270 city: Kanazawa state: Ishikawa zip: 920-8530 country: Japan name: Site 0270 role: CONTACT lat: 36.6 lon: 136.61667 facility: Local Institution - 0343 city: Morioka state: Iwate zip: 020-0066 country: Japan name: Site 0343 role: CONTACT lat: 39.7 lon: 141.15 facility: Local Institution - 0170 city: Isehara state: Kanagawa zip: 259-1193 country: Japan name: Site 0170 role: CONTACT lat: 35.39932 lon: 139.31019 facility: Local Institution - 0333 city: Yokohama state: Kanagawa zip: 221-0855 country: Japan name: Site 0333 role: CONTACT lat: 35.43333 lon: 139.65 facility: Local Institution - 0320 city: Sendai-shi state: Miyagi zip: 980-8574 country: Japan name: Site 0320 role: CONTACT lat: 38.26667 lon: 140.86667 facility: Local Institution - 0166 city: Osaka-sayama state: Osaka zip: 589-8511 country: Japan name: Site 0166 role: CONTACT lat: 34.69374 lon: 135.50218 facility: Local Institution - 0269 city: Hidaka state: Saitama zip: 350-1298 country: Japan name: Site 0269 role: CONTACT facility: Local Institution - 0288 city: Nagaizumi-cho,Sunto-gun state: Shizuoka zip: 411-8777 country: Japan name: Site 0288 role: CONTACT facility: Local Institution - 0350 city: Bunkyo-ku state: Tokyo zip: 113-8431 country: Japan name: Site 0350 role: CONTACT lat: 35.37517 lon: 139.92991 facility: Local Institution - 0268 city: Itabashiku state: Tokyo zip: 173-8610 country: Japan name: Site 0268 role: CONTACT facility: Local Institution - 0331 city: Chuo state: Yamanashi zip: 409-3898 country: Japan name: Site 0331 role: CONTACT lat: 35.57779 lon: 139.71685 facility: Local Institution - 0348 city: Fukuoka zip: 810-8563 country: Japan name: Site 0348 role: CONTACT lat: 33.6 lon: 130.41667 facility: Local Institution - 0319 city: Fukuoka zip: 811-1395 country: Japan name: Site 0319 role: CONTACT lat: 33.6 lon: 130.41667 facility: Local Institution - 0313 city: Fukuoka zip: 812-8582 country: Japan name: Site 0313 role: CONTACT lat: 33.6 lon: 130.41667 facility: Local Institution - 0272 city: Hiroshima zip: 734-8551 country: Japan name: Site 0272 role: CONTACT lat: 34.4 lon: 132.45 facility: Local Institution - 0171 city: Kumamoto zip: 860-0008 country: Japan name: Site 0171 role: CONTACT lat: 32.80589 lon: 130.69182 facility: Local Institution - 0215 city: Kyoto zip: 602-8566 country: Japan name: Site 0215 role: CONTACT lat: 35.02107 lon: 135.75385 facility: Local Institution - 0329 city: Okayama zip: 700-8558 country: Japan name: Site 0329 role: CONTACT lat: 34.65 lon: 133.93333 facility: Local Institution - 0322 city: Osaka zip: 543-8555 country: Japan name: Site 0322 role: CONTACT lat: 34.69374 lon: 135.50218 facility: Local Institution - 0347 city: Osaka zip: 545-8586 country: Japan name: Site 0347 role: CONTACT lat: 34.69374 lon: 135.50218 facility: Local Institution - 0167 city: Yamagata zip: 990-9585 country: Japan name: Site 0167 role: CONTACT lat: 38.23333 lon: 140.36667 facility: Local Institution - 0149 city: Goyang-si state: Kyǒnggi-do zip: 10408 country: Korea, Republic of name: Site 0149 role: CONTACT lat: 37.65639 lon: 126.835 facility: Local Institution - 0117 city: Seongnam state: Kyǒnggi-do zip: 13620 country: Korea, Republic of name: Site 0117 role: CONTACT lat: 37.43861 lon: 127.13778 facility: Local Institution - 0233 city: Suwon-si state: Kyǒnggi-do zip: 16499 country: Korea, Republic of name: Site 0233 role: CONTACT lat: 37.29111 lon: 127.00889 facility: Local Institution - 0115 city: Busan state: Pusan-Kwangyǒkshi zip: 49201 country: Korea, Republic of name: Site 0115 role: CONTACT lat: 35.10278 lon: 129.04028 facility: Local Institution - 0114 city: Busan state: Pusan-Kwangyǒkshi zip: 49241 country: Korea, Republic of name: Site 0114 role: CONTACT lat: 35.10278 lon: 129.04028 facility: Local Institution - 0131 city: Busan state: Pusan-Kwangyǒkshi zip: 49267 country: Korea, Republic of name: Site 0131 role: CONTACT lat: 35.10278 lon: 129.04028 facility: Local Institution - 0143 city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 02841 country: Korea, Republic of name: Site 0143 role: CONTACT lat: 37.566 lon: 126.9784 facility: Local Institution - 0069 city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 03080 country: Korea, Republic of name: Site 0069 role: CONTACT lat: 37.566 lon: 126.9784 facility: Local Institution - 0100 city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 05505 country: Korea, Republic of name: Site 0100 role: CONTACT lat: 37.566 lon: 126.9784 facility: Local Institution - 0068 city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 06351 country: Korea, Republic of name: Site 0068 role: CONTACT lat: 37.566 lon: 126.9784 facility: Local Institution - 0070 city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 06591 country: Korea, Republic of name: Site 0070 role: CONTACT lat: 37.566 lon: 126.9784 facility: Local Institution - 0118 city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 07345 country: Korea, Republic of name: Site 0118 role: CONTACT lat: 37.566 lon: 126.9784 facility: Local Institution - 0442 city: Daegu state: Taegu-Kwangyǒkshi zip: 41404 country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: Local Institution - 0116 city: Deagu state: Taegu-Kwangyǒkshi zip: 41404 country: Korea, Republic of facility: Local Institution - 0455 city: Seongnam zip: 463-707 country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: Local Institution - 0432 city: George Town state: Pulau Pinang zip: 10990 country: Malaysia name: Site 0432 role: CONTACT lat: 5.41123 lon: 100.33543 facility: Local Institution - 0431 city: Kuching state: Sarawak zip: 93586 country: Malaysia name: Site 0431 role: CONTACT lat: 1.54999 lon: 110.33333 facility: Local Institution - 0126 city: Cdmx state: Distrito Federal zip: 14080 country: Mexico name: Site 0126 role: CONTACT facility: Local Institution - 0122 city: Ciudad de México state: Distrito Federal zip: 03100 country: Mexico name: Site 0122 role: CONTACT lat: 19.42847 lon: -99.12766 facility: Local Institution - 0121 city: Mexico City state: Distrito Federal zip: 14080 country: Mexico name: Site 0121 role: CONTACT lat: 19.42847 lon: -99.12766 facility: Local Institution - 0128 city: México state: Distrito Federal zip: 06720 country: Mexico name: Site 0128 role: CONTACT lat: 19.42847 lon: -99.12766 facility: Local Institution - 0127 city: Morelia state: Michoacán zip: 58260 country: Mexico name: Site 0127 role: CONTACT lat: 19.70078 lon: -101.18443 facility: Local Institution - 0139 city: Monterrey state: Nuevo León zip: 66460 country: Mexico name: Site 0139 role: CONTACT lat: 25.67507 lon: -100.31847 facility: Local Institution - 0125 city: Oaxaca de Juarez state: Oaxaca zip: 68020 country: Mexico name: Site 0125 role: CONTACT lat: 17.06542 lon: -96.72365 facility: Local Institution - 0444 city: Hermosillo state: Sonora zip: 83106 country: Mexico name: Site 0444 role: CONTACT lat: 29.1026 lon: -110.97732 facility: Local Institution - 0463 city: Hermosillo state: Sonora zip: 83106 country: Mexico lat: 29.1026 lon: -110.97732 facility: Local Institution - 0123 city: Huixquilucan zip: 52787 country: Mexico name: Site 0123 role: CONTACT lat: 19.35985 lon: -99.35016 facility: Local Institution - 0124 city: Puebla zip: 72424 country: Mexico name: Site 0124 role: CONTACT lat: 19.03793 lon: -98.20346 facility: Local Institution - 0367 city: Dunedin state: Otago zip: 9016 country: New Zealand name: Site 0367 role: CONTACT lat: -45.87416 lon: 170.50361 facility: Local Institution - 0366 city: Hamilton state: Waikato zip: 3240 country: New Zealand name: Site 0366 role: CONTACT lat: -37.78333 lon: 175.28333 facility: Local Institution - 0391 city: Oslo zip: 0310 country: Norway name: Site 0391 role: CONTACT lat: 59.91273 lon: 10.74609 facility: Local Institution - 0336 city: Bydgoszcz state: Kujawsko-pomorskie zip: 85-168 country: Poland name: Site 0336 role: CONTACT lat: 53.1235 lon: 18.00762 facility: Local Institution - 0337 city: Lublin state: Lubelskie zip: 20-090 country: Poland name: Site 0337 role: CONTACT lat: 51.25 lon: 22.56667 facility: Local Institution - 0443 city: Warszawa state: Mazowieckie zip: 02-781 country: Poland name: Site 0443 role: CONTACT lat: 52.22977 lon: 21.01178 facility: Local Institution - 0201 city: Kraków state: Małopolskie zip: 30-727 country: Poland name: Site 0201 role: CONTACT lat: 50.06143 lon: 19.93658 facility: Local Institution - 0388 city: Poznan state: Wielkopolskie zip: 60-175 country: Poland name: Site 0388 role: CONTACT lat: 52.40692 lon: 16.92993 facility: Local Institution - 0330 city: Katowice state: Śląskie zip: 40-027 country: Poland name: Site 0330 role: CONTACT lat: 50.25841 lon: 19.02754 facility: Local Institution - 0286 city: Lisboa zip: 1500-650 country: Portugal name: Site 0286 role: CONTACT lat: 38.71667 lon: -9.13333 facility: Local Institution - 0098 city: Porto zip: 4200-072 country: Portugal name: Site 0098 role: CONTACT lat: 41.14961 lon: -8.61099 facility: Local Institution - 0372 city: San Juan zip: 00909 country: Puerto Rico name: Site 0372 role: CONTACT lat: 18.46633 lon: -66.10572 facility: Local Institution - 0375 city: Bucuresti state: București zip: 022328 country: Romania name: Site 0375 role: CONTACT lat: 44.42802 lon: 26.09665 facility: Local Institution - 0381 city: Bucuresti state: București zip: 022328 country: Romania name: Site 0381 role: CONTACT lat: 44.42802 lon: 26.09665 facility: Local Institution - 0417 city: Tg.Mures state: Mureș zip: 540136 country: Romania name: Site 0417 role: CONTACT facility: Local Institution - 0380 city: Brasov zip: 500052 country: Romania name: Site 0380 role: CONTACT lat: 45.64861 lon: 25.60613 facility: Local Institution - 0374 city: București zip: 022238 country: Romania name: Site 0374 role: CONTACT lat: 44.42802 lon: 26.09665 facility: Local Institution - 0377 city: București zip: 030171 country: Romania name: Site 0377 role: CONTACT lat: 44.42802 lon: 26.09665 facility: Local Institution - 0382 city: București zip: 030171 country: Romania name: Site 0382 role: CONTACT lat: 44.42802 lon: 26.09665 facility: Local Institution - 0378 city: București zip: 050098 country: Romania name: Site 0378 role: CONTACT lat: 44.42802 lon: 26.09665 facility: Local Institution - 0423 city: Cluj zip: 400015 country: Romania name: Site 0423 role: CONTACT lat: 46.76667 lon: 23.6 facility: Local Institution - 0379 city: Iași zip: 700483 country: Romania name: Site 0379 role: CONTACT lat: 47.16667 lon: 27.6 facility: Local Institution - 0376 city: Sibiu zip: 550245 country: Romania name: Site 0376 role: CONTACT lat: 45.8 lon: 24.15 facility: Local Institution - 0439 city: Dammam state: Ash Sharqīyah zip: 31444 country: Saudi Arabia name: Site 0439 role: CONTACT lat: 26.43442 lon: 50.10326 facility: Local Institution - 0416 city: Riyadh zip: 12713 country: Saudi Arabia name: Site 0416 role: CONTACT lat: 24.68773 lon: 46.72185 facility: Local Institution - 0427 city: Singapore state: Central Singapore zip: 169608 country: Singapore name: Site 0427 role: CONTACT lat: 1.28967 lon: 103.85007 facility: Local Institution - 0355 city: Banska Bystrica state: Banskobystrický Kraj zip: 97517 country: Slovakia name: Site 0355 role: CONTACT lat: 48.73946 lon: 19.15349 facility: Local Institution - 0204 city: Bratislava zip: 83101 country: Slovakia name: Site 0204 role: CONTACT lat: 48.14816 lon: 17.10674 facility: Local Institution - 0412 city: A Coruña state: A Coruña [La Coruña] zip: 15006 country: Spain name: Site 0412 role: CONTACT lat: 43.37135 lon: -8.396 facility: Local Institution - 0071 city: L'Hospitalet Del Llobregat state: Barcelona [Barcelona] zip: 08908 country: Spain name: Site 0071 role: CONTACT facility: Local Institution - 0389 city: Barakaldo state: Bizkaia zip: 48903 country: Spain name: Site 0389 role: CONTACT lat: 43.29639 lon: -2.98813 facility: Local Institution - 0172 city: Santa Cruz de Tenerife state: Canarias zip: 38010 country: Spain name: Site 0172 role: CONTACT lat: 28.46824 lon: -16.25462 facility: Local Institution - 0314 city: San Sebastian state: Gipuzkoa zip: 20014 country: Spain name: Site 0314 role: CONTACT lat: 43.31283 lon: -1.97499 facility: Local Institution - 0096 city: Majadahonda state: Madrid, Comunidad De zip: 28222 country: Spain name: Site 0096 role: CONTACT lat: 40.47353 lon: -3.87182 facility: Local Institution - 0409 city: El Palmar, Murcia state: Murcia, Región De zip: 30120 country: Spain name: Site 0409 role: CONTACT facility: Local Institution - 0092 city: Malaga state: Málaga zip: 29010 country: Spain name: Site 0092 role: CONTACT lat: 36.72016 lon: -4.42034 facility: Local Institution - 0095 city: Cáceres zip: 10003 country: Spain name: Site 0095 role: CONTACT lat: 39.47649 lon: -6.37224 facility: Local Institution - 0072 city: Madrid zip: 28006 country: Spain name: Site 0072 role: CONTACT lat: 40.4165 lon: -3.70256 facility: Local Institution - 0093 city: Salamanca zip: 37007 country: Spain name: Site 0093 role: CONTACT lat: 40.96882 lon: -5.66388 facility: Local Institution - 0277 city: Uppsala state: Uppsala Län [se-03] zip: 751 85 country: Sweden name: Site 0277 role: CONTACT lat: 59.85882 lon: 17.63889 facility: Local Institution - 0278 city: Linköping state: Östergötlands Län [se-05] zip: 581 85 country: Sweden name: Site 0278 role: CONTACT lat: 58.41086 lon: 15.62157 facility: Local Institution - 0142 city: Chiayi City state: Chiayi zip: 613 country: Taiwan name: Site 0142 role: CONTACT lat: 23.47917 lon: 120.44889 facility: Local Institution - 0146 city: Tainan City state: Tainan zip: 71004 country: Taiwan name: Site 0146 role: CONTACT lat: 22.99083 lon: 120.21333 facility: Local Institution - 0159 city: Kaohsiung zip: 83301 country: Taiwan name: Site 0159 role: CONTACT lat: 22.61626 lon: 120.31333 facility: Local Institution - 0135 city: Taichung zip: 40447 country: Taiwan name: Site 0135 role: CONTACT lat: 24.1469 lon: 120.6839 facility: Local Institution - 0145 city: Taichung zip: 407 country: Taiwan name: Site 0145 role: CONTACT lat: 24.1469 lon: 120.6839 facility: Local Institution - 0134 city: Taipei zip: 10002 country: Taiwan name: Site 0134 role: CONTACT lat: 25.04776 lon: 121.53185 facility: Local Institution - 0147 city: Taipei zip: 112 country: Taiwan name: Site 0147 role: CONTACT lat: 25.04776 lon: 121.53185 facility: Local Institution - 0158 city: Taoyuan zip: 333 country: Taiwan name: Site 0158 role: CONTACT lat: 24.95233 lon: 121.20193 facility: Local Institution - 0434 city: Bangkok state: Krung Thep Maha Nakhon zip: 10330 country: Thailand name: Site 0434 role: CONTACT lat: 13.75398 lon: 100.50144 facility: Local Institution - 0426 city: Bangkok state: Krung Thep Maha Nakhon zip: 10700 country: Thailand name: Site 0426 role: CONTACT lat: 13.75398 lon: 100.50144 facility: Local Institution - 0428 city: Chiang Mai zip: 50200 country: Thailand name: Site 0428 role: CONTACT lat: 18.79038 lon: 98.98468 facility: Local Institution - 0400 city: Ankara zip: 06100 country: Turkey name: Site 0400 role: CONTACT lat: 39.91987 lon: 32.85427 facility: Local Institution - 0405 city: Ankara zip: 06100 country: Turkey name: Site 0405 role: CONTACT lat: 39.91987 lon: 32.85427 facility: Local Institution - 0422 city: Ankara zip: 06170 country: Turkey name: Site 0422 role: CONTACT lat: 39.91987 lon: 32.85427 facility: Local Institution - 0401 city: Ankara zip: 06200 country: Turkey name: Site 0401 role: CONTACT lat: 39.91987 lon: 32.85427 facility: Local Institution - 0406 city: İzmir zip: 35100 country: Turkey name: Site 0406 role: CONTACT lat: 38.41273 lon: 27.13838 facility: Local Institution - 0403 city: Mersin zip: 33343 country: Turkey name: Site 0403 role: CONTACT lat: 36.79526 lon: 34.61792 facility: Local Institution - 0407 city: Samsun zip: 55270 country: Turkey name: Site 0407 role: CONTACT lat: 41.27976 lon: 36.3361 facility: Local Institution - 0402 city: Trabzon zip: 61080 country: Turkey name: Site 0402 role: CONTACT lat: 41.005 lon: 39.72694 hasResults: False

 nctId: NCT06356116 id: CMUH111-REC3-029 briefTitle: Rehabilitation After Direct Anterior Approach for Total Hip Arthroplasty overallStatus: RECRUITING date: 2023-11-14 date: 2024-10-31 date: 2024-12-31 date: 2024-04-10 date: 2024-04-11 name: China Medical University Hospital class: OTHER briefSummary: The causes for total hip arthroplasty (THA) in Taiwan include ischemic necrosis of the femoral head and degenerative osteoarthritis. Contemporary, the surgical approach for total hip replacement mostly adopts the lateral approach. However, the direct anterior approach (DAA) has gained attention gradually due to its characteristics such as muscle preservation, small surgical incision length, and few surgical complications. Nevertheless, literature lacks detailed exploration or long-term follow-up on the recovery of physical functions related to fall occurrence after this type of surgery. It limits the establishment and design of suitable post-operative rehabilitation plans. Therefore, this study aims to explore and follow-up the functional recovery in patients who undergo the DAA for hip replacement using current usual care and new-designed accelerated rehabilitation program. The proposed method involves recruiting 30 patients who will undergo the DAA for total hip replacement, who will receive the current usual care plan; and another 30 patients will receive the accelerated rehabilitation program. The assessments will be conducted before the surgery and at 2, 4, 8, and 12 weeks after the operation, evaluating hip joint function, hip abduction and flexion muscle strength, balance function, and gait performance. The statistical analysis will utilize mixed-model two-factor ANOVA, comparing the preoperative and postoperative recovery of patients undergoing the DAA with different intervention programs and at different time points. The expected outcome of this study is to enhance the understanding of the functional recovery of patients undergoing the DAA for total hip replacement in terms of hip joint function, muscle strength, balance function, and gait performance after surgery. This information will help establish the targeted DAA postoperative treatment plans, which will be practically applied to patients and compared with the current usual care to assess its effectiveness, ultimately contributing to more efficient rehabilitation plans in the future. conditions: Total Hip Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Usual care name: Accelerated rehabilitation measure: Functional recovery questionaire measure: Maximum muscle strength measure: Quality of Life questionaire measure: Balance function measure: Gait performance measure: Walking speed sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China Medical University Hospital status: RECRUITING city: Taichung zip: 404 country: Taiwan name: Hsiu-Chen Lin, PhD role: CONTACT phone: +886-4-22053366 phoneExt: 7303 email: hclin@mail.cmu.edu.tw lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06356103 id: 0107060 briefTitle: Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula On Undernourished Neurologically Impaired Children overallStatus: COMPLETED date: 2022-06-01 date: 2022-12-31 date: 2023-07-15 date: 2024-04-10 date: 2024-04-10 name: Alexandria University class: OTHER briefSummary: Purpose: Undernutrition is common in neurologically impaired children. It increases the burden of comorbidities and affects the quality of life of these children. It must be recognized and treated as early as possible. This study aimed primarily to compare the efficacy of high-caloric whey-based partially hydrolyzed formula (HC-WPHF) versus standard feeding on the nutritional status reflected by growth parameters and feeding tolerance in undernourished children with neurological impairment (NI). The secondary aim was to compare the change in these parameters after using HC-WPHF for 3 and 6 months. conditions: Nutrition Disorder, Child conditions: Neurologic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Controlled Study primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 100 type: ACTUAL name: High Caloric Whey-Based Partially Hydrolyzed Formula name: nutritional feeding according to ESPGHAN guidelines measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI). measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in centimeter in undernourished children with neurological impairment (NI). measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the body mass index (BMI) in children with neurological impairment (NI). measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in centimeter in undernourished children with neurological impairment (NI) measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI) for 3 and 6 months measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus on the body mass index in undernourished children with neurological impairment (NI) for 3 and 6 months measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: Alexandria University Children Hospital city: Alexandria zip: 23445 country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06356090 id: 2023.0322 - NL84369.018.23 briefTitle: SPACE: a Parent-based Treatment for Pediatric OCD overallStatus: RECRUITING date: 2023-11-23 date: 2025-03-31 date: 2025-03-31 date: 2024-04-10 date: 2024-04-10 name: Chaim Huijser class: OTHER name: Levvel briefSummary: This study will investigate the parent-based treatment SPACE: Supportive Parenting for Anxious Childhood Emotions. The aim of this study is to investigate whether SPACE is effective in reducing family accommodation (FA) and OCD symptoms in children with a complex obsessive-compulsive disorder (OCD), that did not or cannot benefit from first line treatment. conditions: Obsessive-Compulsive Disorder conditions: Obsessive-Compulsive Disorder in Children conditions: Obsessive-Compulsive Disorder in Adolescence conditions: Anxiety Disorders and Symptoms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single case experimental design (SCED) with multiple baselines primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Supportive Parenting for Anxious Childhood Emotions (SPACE) measure: (Change in) OCD severity measure: (Change in) family accommodation (parent report) measure: (Change in) Family accommodation (child report) measure: Daily (change in) OCD symptoms measure: Daily (change in) family accommodation measure: Symptoms of child anxiety measure: Symptoms of child depression measure: Symptoms of autism measure: Quality of life (parent-report) measure: Quality of life (child-report) measure: Clinical impression of outcome measure: Treatment progress measure: Session experience measure: Treatment adherence measure: Demographic variables measure: Psychiatric DSM-5 diagnosis of the child measure: Parenting burden measure: Psychopathology and adaptive functioning of parents measure: Child Behavior Checklist (CBCL, parent-report) measure: Youth Self-report (YSR) (child-report) measure: Teacher Report Form Emotional- and behavioral problems of the child (teacher- report) measure: Treatment satisfaction sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Amsterdam UMC / Levvel (Academic centre for child & adolescent psychiatry) status: RECRUITING city: Amsterdam country: Netherlands name: J.D.K. Veeger role: CONTACT name: C. Huijser, Dr. role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06356077 id: OBPM_HTN2024 briefTitle: Evaluation of the Satisfaction of a Hypertensive Population in Their Use of the Aktiia 24/7 Blood Pressure Monitor acronym: OBPM_HTN2024 overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-12 date: 2027-12 date: 2024-04-10 date: 2024-04-10 name: Aktiia SA class: INDUSTRY briefSummary: OBPM_HTN2024 study was designed by AKTIIA SA to evaluate how a hypertensive population, reflective of the United States and encompassing a range of phenotypes, perceives the Aktiia 24/7 device (Aktiia G1) during their first 3 months of use. conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED measure: Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor measure: Frequency of Aktiia app use measure: Frequency of use of Aktiia device as compared to previously use other blood pressure monitors measure: Evaluation of subject's experience in using the Aktiia App measure: Evaluation of the most valuable data on the Aktiia Mobile App by subjects sex: ALL minimumAge: 21 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356064 id: E2-23-3834 briefTitle: Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei overallStatus: COMPLETED date: 2023-05-15 date: 2023-12-15 date: 2024-01-15 date: 2024-04-10 date: 2024-04-22 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.

Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up. conditions: Spur, Heel studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 112 type: ACTUAL name: Extracorporeal shock wave therapy measure: Visual Analog Scale measure: Functional Foot Index measure: Radiographic assesment, epin size sex: ALL minimumAge: 18 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Özge TEZEN city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06356051 id: Gbuyukyilmaz briefTitle: Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-01 date: 2023-09-01 date: 2024-04-10 date: 2024-04-10 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Epicardial fat thickness, carotid intima-media thickness, and augmentation index from arterial stiffness indicators are increased in children with T1DM compared to the healthy control group. These results support the idea that children with T1DM present significant changes in important subclinical indicators for the development of cardiovascular disease. conditions: Type 1 Diabetes studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 202 type: ACTUAL name: Echocardiography measure: Epicardial fat thickness measure: carotid intima-media thickness measure: arterial stiffness parameters such as pulse wave velocity, augmentation index sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ankara Bilkent City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-01-04 uploadDate: 2024-03-30T05:04 filename: Prot_SAP_000.pdf size: 347934 hasResults: False

 nctId: NCT06356038 id: Prot. n. 76 SA/2022 briefTitle: Phrenic Nerve Infiltration: Pulmonary Expansion and Pain Control overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-09 date: 2025-01-02 date: 2025-01-02 date: 2024-04-10 date: 2024-04-10 name: Azienda Ospedaliera "Sant'Andrea" class: OTHER briefSummary: Between January 2021-2023, 65 consecutive patients at risk for PAL (defined in accordance to "2019 Society of Thoracic Surgery score-criteria of PAL") underwent lung resection (lobectomy or sublobar resection) for malignancy. 5 patients were lost. The remaining have been assigned with a 1:2 randomization into: group A (22 patients), received intra-operative phrenic nerve infiltration with Ropivacaine 10 mg/ml in the peri-neurotic fat on the pericardium and group B (38 patients), did not receive infiltration. Data on hemidiaphragm elevation, air leaks, pain at 24 and 72 hours post-surgery, shoulder pain, length of hospital stay, length of chest tube permanence, were retrospectively collected and compared.The aim of the study is to investigate the effect of intra-operative phrenic nerve infiltration with long acting anesthetic in patients at high risk for PAL, improving pulmonary expansion after surgery, and reducing air leaks, while controlling post-operative pain. conditions: Prolonged Air Leak conditions: Post-operative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 66 type: ACTUAL name: intra-operative phrenic nerve infiltration measure: rate of pulmonary expansion due by phrenic nerve intra-operative local anaesthetic infiltration measure: rate of post-operative pain control after intra-operative phrenic nerve infiltration with local anaesthetic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera "Sant'Andrea" city: Roma country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06356025 id: 52082 id: 2024-512546-42 type: EUDRACT_NUMBER briefTitle: Botulinum Toxin Injection in the UES for R-CPD acronym: BOTUS R-CPD overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-10 date: 2024-04-10 name: AZ Delta class: OTHER name: KU Leuven briefSummary: The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection).

This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label. conditions: Retrograde Cricopharyngeus Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: botulinum toxin type A name: Sodium Chloride 0.9% Inj measure: Change of at least 50% of 'inability to belch' using the symptom questionnaire at week 12. measure: Change in associated gastrointestinal symptoms: abdominal bloating/discomfort measure: Change in associated gastrointestinal symptoms: abdominal/chest pain measure: Change in associated gastrointestinal symptoms: flatulence measure: Change in associated gastrointestinal symptoms: gurgling noises from the chest/lower neck measure: Change of at least 50% of 'inability to belch' during long term follow-up at week 20, and at 48 weeks. measure: Overall treatment effect (OTE) measure: Overall symptom severity (OSS) measure: EuroQol-5D (EQ-5D) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06356012 id: 71163523.1.0000.5437 briefTitle: Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated With Imiquimod overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2026-12-31 date: 2028-12-31 date: 2024-04-10 date: 2024-04-10 name: Barretos Cancer Hospital class: OTHER name: Fundação de Amparo à Pesquisa do Estado de São Paulo name: Farmoquimica S.A. name: Hospital de Cancer de Barretos - Fundacao Pio XII briefSummary: The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod. Participants will be divided in 3 groups: CIN 3 who will use 16 doses of imiquimod in the uterine cervix, applied twice a week and will be treated with LEEP procedure; 2) patients with CIN 3 who will undergo standard treatment with LEEP procedure; 3) patients with negative cytology and HPV (human papillomavirus) test. Blood and cervicovaginal lavage collections will be performed at different times, for comparisons between cellular response profiles to imiquimod during treatment and baseline levels in healthy patients. conditions: HSIL, High-Grade Squamous Intraepithelial Lesions conditions: Vaginal Microbiome conditions: Biomarkers studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Imiquimod name: Loop Electrosurgical Excision Procedure measure: Number of participants with histological regression of High-grade squamous intraepithelial lesion (HSIL) measure: Identification of immune response in vaginal and plasma collection measure: Correlation between vaginal microbiome and immunological response sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06355999 id: 2007p000646-F briefTitle: Levari Exp.20: 2D - Partial Feedback overallStatus: COMPLETED date: 2021-05-01 date: 2021-06-01 date: 2021-06-01 date: 2024-04-10 date: 2024-04-10 name: Brigham and Women's Hospital class: OTHER briefSummary: Suppose that observers are trying to classify a spot on the skin as normal or abnormal and suppose that the two attributes that are important are the color and shape of the spot. The investigators have found that perceptual decisions of this short are shaped by the prevalence of the target abnormality and by the feedback that observers (Os) receive. If abnormal spots are rare (low prevalence), Os will tend to become more conservative about calling spots abnormal. In this experiment, Os see items defined by color and shape. They are looking for one combination (bumpy green). Bumpy green targets can be common (50% prevalence) or rare (10%). Os in one group will get feedback about their responses based on color. The other group will receive feedback based on shape. The investigators will look for effects of prevalence and of the type of feedback. The goal is to better understand perceptual decisions in settings like clinical evaluation of skin lesions. conditions: Form Perception conditions: Color Perception conditions: Decision Making studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups, each receiving different feedback primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Observers are naive as to the purpose of the experiment until after participation whoMasked: PARTICIPANT count: 55 type: ACTUAL name: Feedback measure: Participant naming of visual stimuli sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Visual Attention Lab / Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06355986 id: 39039039AFL4016 briefTitle: Computerized Decision Support to Prevent Stroke in Atrial Fibrillation acronym: AF-ALERT3 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-30 date: 2026-07-30 date: 2024-04-10 date: 2024-04-10 name: Brigham and Women's Hospital class: OTHER name: Janssen, LP briefSummary: Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the Mass General Brigham (MGB) health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Two single academic medical center randomized controlled trials demonstrated success for increasing adherence to guideline recommendations for stroke prevention in AF. To address the feasibility and impact of a computerized decision support (CDS) strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management. conditions: Atrial Fibrillation conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2500-patient U.S. multicenter, community-based Quality Improvement Initiative in the form of a cluster-randomized controlled trial. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Assignment to a particular cluster (ALERT or NO ALERT) will be masked to the patient participant, investigator, and outcomes assessor. Since the intervention is a computer alert to the provider of record, he/she will be aware of whether or not a notification is provided. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2500 type: ESTIMATED name: Alert-based computerized decision support measure: Frequency of prescription of anticoagulation at 90 days in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention at the time of study enrollment measure: Frequency of major bleeding at 6 months from enrollment. measure: Frequency of failure to prescribe anticoagulation because of perceived risk of bleeding in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation at the time of study enrollment and are assigned to the alert group measure: Frequency of a composite of major adverse cardiovascular events, defined as cerebrovascular accident, systemic embolism, any MI, symptomatic VTE, or all-cause mortality at 6 months from enrollment measure: Frequency of referral for left atrial appendage occlusion among patients with high bleeding risk at 6 months will be reported measure: Frequency of clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding at 6 months. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Elizabeth Health city: Edgewood state: Kentucky zip: 41017 country: United States name: Benjamin Peterson, MD role: CONTACT phone: 617-987-1046 email: benjamin.peterson@stelizabeth.com lat: 39.01867 lon: -84.58189 facility: Mass General Brigham city: Boston state: Massachusetts zip: 02115 country: United States name: Gregory Piazza, MD, MS role: CONTACT phone: 781-956-5525 email: gregorypiazza@hotmail.com lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06355973 id: 2024-01-061 briefTitle: A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12-31 date: 2024-12-31 date: 2024-04-10 date: 2024-04-10 name: MinYoung Kim, MD, PhD class: OTHER briefSummary: This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.

It is for the prevention and treatment of dementia in the future. randomized, Pilot Study. conditions: Patients With Mild Cognitive Impairment (MCI) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Using tablets and workbooks cognitive function. name: self-programming of physical function training. measure: Montreal Cognitive Assessment (MoCA) measure: Korean-Mini Mental Status Examination (K-MMSE) measure: Clinical Dementia Rating (CDR) measure: Clinical Global Impressions of Change (CGIC) measure: Instrumental Activities of Daily Living (I-ADL) measure: Berg Balance Scale (BBS) measure: Geriatric Quality of Life-Dementia (GQOL-D) measure: Geriatric Depression Scale (GDSd) measure: Global Deterioration Scale (GDS) measure: Electroencephalography sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355960 id: 2024-853 briefTitle: Effect of Dexmedetomidine on Oxygenation and Lung Mechanics overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-10 date: 2024-04-10 name: Cairo University class: OTHER briefSummary: Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation conditions: Drug Use conditions: Dexmedetomidine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: GROUP Dexmedetomidine name: GROUP B name: GROUP C measure: Oxygenation by the end study measure: Intraoperative dynamic lung compliance measure: Intraoperative static lung compliance measure: Physiological dead space sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo university city: Cairo zip: 11562 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06355947 id: 103-7445B briefTitle: Cycling and Treadmill With Dual Task for Parkinson's Disease Improvement overallStatus: COMPLETED date: 2015-12-07 date: 2017-09-11 date: 2018-07-31 date: 2024-04-10 date: 2024-04-10 name: Chang Gung University class: OTHER briefSummary: Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.

Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.

Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.

The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.

The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.

The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability. conditions: Parkinson Disease(PD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: Cognitive cycling training name: Cognitive treadmill training measure: Walking Speed measure: Step Length measure: Step Time measure: Power Spectral Density (PSD) measure: Task Accuracy measure: Reaction Time measure: Balance Performance measure: Double Support Time measure: Single Support Time measure: Swing Time measure: Stance Time measure: Cadence measure: Heart rate sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University city: Taoyuan zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06355934 id: D8450R00004 briefTitle: OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis acronym: OverTTuRe overallStatus: RECRUITING date: 2023-08-21 date: 2026-09-30 date: 2026-09-30 date: 2024-04-10 date: 2024-04-29 name: AstraZeneca class: INDUSTRY briefSummary: The overall aim of this observational study is to generate real-world evidence on the pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes (for example Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments) in patients with ATTR amyloidosis, and to better understand how the disease is presented. conditions: ATTR Amyloidosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 55000 type: ESTIMATED name: no intervention measure: Health Care Resource Utilization (HCRU) - Outpatient visits measure: Health Care Resource Utilization (HCRU) - Outpatient visits by specialty measure: Health Care Resource Utilization (HCRU) - Emergency department visits measure: Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay measure: Health Care Resource Utilization (HCRU) - Hospitalizations measure: Health Care Resource Utilization (HCRU) - Health care cost measure: Cardiac transplant measure: All cause mortality measure: Liver transplant measure: Heart Failure Hospitalization measure: New ATTR amyloidosis clinical manifestation measure: Hospitalization (any cause) measure: Neuropathy Impairment Score (NIS) measure: Neuropathy Impairment Score Lower Limbs (NIS-LL) measure: Neuropathy Impairment Score +7 (NIS+7) measure: Neuropathy Impairment Score modified +7 (mNIS+7) measure: Neuropathy symptoms and change (NCS) score measure: PND (Polyneuropathy Disability) measure: Other relevant clinical measurement of ATTR amyloidosis functional status measure: Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QoL-DN) Score measure: Health Care Resource Utilization (HCRU) - Outpatient visits measure: Health Care Resource Utilization (HCRU) - Outpatient visits by specialty measure: Health Care Resource Utilization (HCRU) - Emergency department visits measure: Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay measure: Health Care Resource Utilization (HCRU) - Hospitalizations measure: Health Care Resource Utilization (HCRU) - Health care cost sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: COMPLETED city: Eden Prairie state: Minnesota zip: 55344 country: United States lat: 44.85469 lon: -93.47079 facility: Research Site status: RECRUITING city: Horsens country: Denmark lat: 55.86066 lon: 9.85034 facility: Research Site status: COMPLETED city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Research Site status: RECRUITING city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06355921 id: RFAdesmoid briefTitle: A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors acronym: RFAdesmoid overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-01 date: 2028-05-01 date: 2024-04-10 date: 2024-04-10 name: Blokhin's Russian Cancer Research Center class: OTHER briefSummary: This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors.

In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month.

In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months. conditions: Desmoid Tumor conditions: Desmoid Fibromatosis conditions: Desmoid studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: radiofrequency ablation measure: Comparison of safety assessment. measure: Overall Response Rate measure: Duration of responce measure: Comparison of tumor necrosis based on MRI/CT sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO) city: Moscow state: MO zip: 115522 country: Russian Federation name: Artem Galustov role: CONTACT phone: 9169117818 email: artem115583@mail.ru name: Aslan Valiev, PhD role: PRINCIPAL_INVESTIGATOR name: Denis Sofronov, PhD role: SUB_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06355908 id: TT002 briefTitle: IL13Rα2 CAR-T for Patients With r/r Glioma acronym: ENHANCING overallStatus: RECRUITING date: 2024-03-21 date: 2026-05-01 date: 2027-05-01 date: 2024-04-10 date: 2024-04-10 name: Yang Zhang class: OTHER name: TCRCure Biopharma Ltd. briefSummary: This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma. conditions: Glioma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: IL13Rα2 CAR-T measure: Safety of IL13Rα2 CAR-T measure: Overall Response Rate (ORR) measure: Duration of Response (DOR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Overall Survival (OS) at 6 months (OS6) measure: Overall Survival (OS) at 12 months (OS12) measure: The levels of IL13Rα2 CAR-T cell and IL13Rα2 CAR in the CSF and peripheral blood measure: The levels of cytokines in the CSF and peripheral blood measure: The Exploratory Indicators sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing country: China name: Yang Zhang, MD, phD role: CONTACT phone: +861059976516 email: zhangyang8025@yeah.net lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06355895 id: HCC 23-104 briefTitle: Liver Volume Variation Effect on SBRT Planning and Delivery for Upper Abdominal Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-10 date: 2024-04-10 name: University of Pittsburgh class: OTHER name: American College of Radiation Oncology briefSummary: Standard planning constraints for liver SBRT incorporate strict dose-volume limits for normal liver parenchyma to minimize the risk of radiation-induced liver disease. The presence of diurnal and fasting/fed variations in liver volume therefore carry substantial potential for introducing errors into estimates of dose-volume distribution within normal liver tissue, as well as affecting day-to-day setup fidelity and organ alignment for treatment. This prospective study will examine how diurnal and fast-fed variations in liver volume affect treatment planning for abdominal SBRT. conditions: Upper Abdominal Malignancies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 17 type: ESTIMATED name: Standardized high-carbohydrate meal measure: Diurnal Difference in Liver Volumes measure: Difference in total liver volume measure: Percentage diurnal difference in liver mean dose at V5 Gy measure: Percentage diurnal difference in liver mean dose at V15Gy measure: Difference in liver mean dose at V15 Gy measure: Difference in liver dose at V15 Gy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC Hillman Cancer Center city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Samantha Demko role: CONTACT name: Brieanna Marino role: CONTACT name: Susannah Ellsworth, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06355882 id: LCOSDental briefTitle: Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia overallStatus: RECRUITING date: 2023-08-08 date: 2024-12-01 date: 2024-12-01 date: 2024-04-10 date: 2024-04-22 name: University of Sao Paulo General Hospital class: OTHER name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. briefSummary: Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed conditions: Low Cardiac Output Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 29 type: ESTIMATED name: Anesthetic infiltration measure: Amount ventricular and supraventricular arrhythmia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coração HCFMUSP status: RECRUITING city: São Paulo zip: 05403000 country: Brazil name: Itamara LI Neves, PhD role: CONTACT phone: 1126615229 email: itamara@incor.usp.br name: Mariana DC Dias role: CONTACT phone: 19996614440 email: mariana2497@gmail.com name: Itamara LI Neves, PhD role: PRINCIPAL_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06355869 id: s65337 briefTitle: Repeatability of Gait Deviations in Children With Cerebral Palsy overallStatus: COMPLETED date: 2021-08-17 date: 2023-05-31 date: 2023-05-31 date: 2024-04-10 date: 2024-04-15 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. This study aimed to define the inter-trial (intrinsic) and inter-session (extrinsic) repeatability in gait analysis data of children with CP who were walking in four conditions, namely barefoot or with ankle-foot orthosis, and overground or treadmill. conditions: Spastic Cerebral Palsy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 10 type: ACTUAL name: repeated 3D gait-analysis measure: The standard error of measurement (SEM) of the continuous kinematic gait waveforms measure: The intra-class correlation (ICC) of the gait indices measure: The standard error of measurement (SEM) of the continuous kinetic gait waveforms measure: The standard error of measurement (SEM) of the gait indices sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: UZ Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06355856 id: ACH-PNT-04(01/22) briefTitle: Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss acronym: CAPELLI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-05 date: 2024-04-10 date: 2024-04-10 name: Ache Laboratorios Farmaceuticos S.A. class: INDUSTRY briefSummary: Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss. conditions: Alopecia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 196 type: ESTIMATED name: DNN.22.17.036 name: 10573048700 measure: Percentage variation of hairs in the hair loss phase sex: MALE minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06355843 id: SXY briefTitle: Clinical Applications of Integrated PET/MR and PET/CT in the Diagnosis and Treatment of Prostate Cancer. overallStatus: SUSPENDED date: 2022-04-28 date: 2023-09-30 date: 2027-03-31 date: 2024-04-09 date: 2024-04-09 name: The First Affiliated Hospital of Anhui Medical University class: OTHER name: National Natural Science Foundation of China briefSummary: The goal of this study type: observational study (prospective study) is to study prostate cancer occurrence and recurrence, to specifically identify and localize tumor foci at the molecular level at an early stage, to evaluate the prognosis of patients, and to accurately stage not only intermediate- and high-risk prostate cancer patients with a primary diagnosis, but also detect recurrent foci in patients with biochemical recurrence, to restage those who have developed metastases, to assess tumor load, and to ultimately assist in determining the personalized treatment plans. The main question it aims to answer is whether 68Ga-PSMA PET/CT (PET/MR) examination is beneficial for assessing the

* Accurate staging of patients with intermediate- and high-risk prostate cancer at first diagnosis;
* Detecting recurrent lesions in patients with recurrent tumors for re-staging;
* Assessment of tumor load;
* Assessment of patient prognosis. Participants will sign an informed consent form, undergo 68Ga-PSMA PET/CT (PET/MR) before surgery or biopsy, and have regular follow-up after obtaining pathological results of surgical resection or puncture biopsy, 6 weeks after surgery or biopsy, and then every 3 months; the follow-up will include: blood PSA, whole-body bone imaging, etc. conditions: Prostate Cancer conditions: Pet-ct studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: 68Ga-PSMA measure: Measuring the value of 68Ga-PSMA PET/MRI in the diagnosis and staging of primary prostate cancer and comparing it with mp-MRI and PET/CT measure: Exploring whether 68Ga-PSMA PET/MRI can be used as a method for diagnostic efficacy sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First affiliated hospital of anhui university city: Hefei state: Anhui zip: 230032 country: China lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06355830 id: RETimaging4iAMD briefTitle: Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study acronym: Imaging4iAMD overallStatus: RECRUITING date: 2019-01-02 date: 2025-06 date: 2026-06 date: 2024-04-09 date: 2024-04-09 name: Universidade Nova de Lisboa class: OTHER name: iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL name: Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal name: Centro Hospitalar Universitário de São João, Porto, Portugal briefSummary: Study: observational prospective clinical study. Study population: Subjects over 55 years old with drusen secondary to intermediate AMD.

Recruitment: at the Medical Retinal Consultation from the Ophthalmology Department of CHULC.

Primary outcome: Identifying imaging predictors of iAMD progression. conditions: Age-Related Macular Degeneration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Orthoptic assessment (Outcome measure) measure: Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline measure: Change in Drusen morphology from baseline measure: Change in Subfoveal drusen area from baseline measure: Change in other drusen area from baseline measure: Change in Drusen reflectivity from baseline measure: Change in other Drusen homogeneity from baseline measure: Change in ellipsoid zone disruption from baseline measure: Change in Drusen homogeneity from baseline measure: Change in hyperreflective foci from baseline measure: Change in hyperreflective foci location (within 500-μm disc area) from baseline measure: Change in hyperreflective foci association to drusen from baseline measure: Progression to Moderate Vision Loss measure: Geographic Atrophy (GA) Growth Rate measure: Progression to Advanced AMD according to international classification/grading system sex: ALL minimumAge: 55 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE status: RECRUITING city: Lisbon zip: 1150-199 country: Portugal name: Rita Flores, MD role: CONTACT phone: 00351218841000 phoneExt: 21355 email: ritamariaflores@gmail.com lat: 38.71667 lon: -9.13333 hasResults: False

 nctId: NCT06355817 id: HS25941 briefTitle: Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration overallStatus: COMPLETED date: 2023-09-21 date: 2024-03-19 date: 2024-03-19 date: 2024-04-09 date: 2024-04-22 name: University of Manitoba class: OTHER name: Winnipeg Regional Health Authority briefSummary: To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections. conditions: Anesthetics, Local conditions: Blepharoplasty conditions: Age-Related Ptosis conditions: Adult conditions: Humans conditions: Lidocaine conditions: Ophthalmologic Surgical Procedure conditions: Vibration conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each patient will receive both interventions and serve as their own comparator. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The participant and surgeon was not made aware of which intervention the participant would receive first until the time of the procedure. Randomization was made at the time of the procedure. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 80 type: ACTUAL name: Vibration name: Tapping measure: Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia measure: Difference in Pain Reduction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Misericordia Health Centre city: Winnipeg state: Manitoba zip: R3C 1A2 country: Canada lat: 49.8844 lon: -97.14704 hasResults: False

 nctId: NCT06355804 id: STUDY2023-1565 briefTitle: Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-22 date: 2025-04-22 date: 2024-04-09 date: 2024-04-09 name: University of Illinois at Chicago class: OTHER briefSummary: The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years).

Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention.

Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Physical activity condition name: Waitlist condition measure: Physical Activity Behavior measure: Physical Activity Behavior measure: Physical Activity Level (Light physical activity) measure: Physical Activity Level (Moderate-to-vigorous physical activity) measure: Physical Activity Level (Daily step count) measure: Health-related quality of Life measure: Health-related Quality of Life measure: Fatigue Severity measure: Depressive Symptoms measure: Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355791 id: PDPROJ-4-TP-001-23 briefTitle: The Stability Study acronym: STABILITY overallStatus: ENROLLING_BY_INVITATION date: 2024-04-15 date: 2025-04-30 date: 2025-09-30 date: 2024-04-09 date: 2024-04-09 name: Spinal Simplicity LLC class: INDUSTRY briefSummary: The studied indication is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.

The purpose of this study is to evaluate the effectiveness and safety of instrumented posterior arthrodesis using the Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. conditions: Lumbar Spinal Stenosis conditions: Spondylolisthesis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 150 type: ESTIMATED name: Minuteman G5 measure: NRS Back and Leg measure: ODI measure: PROMIS 29 2.0 measure: 12 Month Fusion Assessment sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kansas University Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 hasResults: False

 nctId: NCT06355778 id: HUM00234185 id: 1R01DA056415 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA056415 briefTitle: Adversity, Brain and Opioid Use Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-04 date: 2024-04-09 date: 2024-04-09 name: University of Michigan class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The way people process and remember information may be related to adverse childhood experiences and Opioid Use Disorder symptoms. The purpose of this project is to examine brain function and performance during learning and memory tasks in adults. The study will compare measures of learning and memory across three groups of participants: those with an Opioid Use Disorder (OUD) that take buprenorphine for opioid replacement therapy, adults without an Opioid Use Disorder taking buprenorphine, and healthy adults that do not have an Opioid Use Disorder and are not taking buprenorphine. conditions: Opioid Use Disorder conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 315 type: ESTIMATED name: Magnetic Resonance Imaging (MRI) name: Computer Tasks measure: Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus measure: Differences in Hippocampal (Hpc) volume measure: Differences in hippocampal circuit connectivity measure: Differences in performance measure: Differences in performance measure: Differences in threat reactivity measured via skin conductance response (SCR) measure: Differences in threat reactivity measured via skin conductance response (SCR) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Mariya Churina role: CONTACT email: AdversityBrainOUD@med.umich.edu name: Elizabeth Duval, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06355765 id: CITIZ_001 briefTitle: Citicoline & Antioxidants in Glaucoma overallStatus: COMPLETED date: 2022-01-10 date: 2022-12-10 date: 2022-12-10 date: 2024-04-09 date: 2024-04-17 name: University of Naples class: OTHER briefSummary: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters. conditions: Glaucoma, Open-Angle studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ACTUAL name: Citicoline blackcurrant supplement measure: Evaluation of Ganglionar cells complex (GCC) measure: Evaluation of Retinal nerve fiber layer (RNFL) sex: ALL minimumAge: 30 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Naples Federico II city: NAples zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06355752 id: 0018-N-23 briefTitle: Biomarkers of Pain and Stress Perception and Dry Needling Technique Application overallStatus: RECRUITING date: 2024-04-12 date: 2024-07-15 date: 2024-07-15 date: 2024-04-09 date: 2024-04-16 name: University of Alcala class: OTHER briefSummary: The use of the dry needling technique has become widespread in recent years for the treatment of musculoskeletal pain. Although dry needling has been shown to be effective in the treatment of shoulder pain, elbow pain, headache, etc., we do not yet have a clear understanding of the mechanisms of action that justify its beneficial effects.

In this study, we propose to analyse the biochemical markers of pain generated by the application of a dry needling technique on the lumbar musculature in patients with mechanical lumbar pain of non-specific origin.

The aim of this study will be to evaluate the effects of dry needling technique on the plasmatic concentration of biochemical markers.Furthermore, the test subjects will be randomly distributed into two groups.

An experimental group where the subjects will receive a real dry needling technique.

Another group will be treated with a sham technique. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Dry needling of lumbar iliocostalis muscle name: Sham dry needling lumbar iliocostalis muscle measure: Extracting Blood Samples and Obtaining Serum/Plasma sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Investigación Fisioterapia y Dolor status: RECRUITING city: Alcalá De Henares state: Madrid zip: 28805 country: Spain name: Patricia Martinez-Merinero, PhD role: CONTACT phone: 683378391 email: info@institutofisioterapiaydolor.es name: Laura Cabellos role: CONTACT phone: 683378391 email: clinica.fisio@fgua.es lat: 40.48205 lon: -3.35996 hasResults: False

 nctId: NCT06355739 id: BIC-19GG, BIC-2019,BIC-2219 briefTitle: CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+ overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-01 date: 2027-01-15 date: 2024-04-09 date: 2024-04-09 name: Zhu Xiaofan class: OTHER briefSummary: To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children conditions: B Lymphocytic Leukemia conditions: B Lymphoblastic Lymphoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: CAR T cell injection measure: Overall survival and event-free survival measure: Overall remission rate measure: Adverse events sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Tianjin state: Tianjin zip: 300020 country: China name: Xiaofan Zhu, MD role: CONTACT phone: 86-21-23909001 email: xfzhu@ihcams.ac.cn name: Jingliao Zhang, MD role: SUB_INVESTIGATOR lat: 39.14222 lon: 117.17667 facility: InstituteHBDH status: NOT_YET_RECRUITING city: Tianjin state: Tianjin zip: 300020 country: China name: Zhu Xiaofan role: CONTACT phone: 86-21-23909001 email: xfzhu@ihcams.ac.cn name: Guo Ye role: PRINCIPAL_INVESTIGATOR name: Yang Wenyu role: PRINCIPAL_INVESTIGATOR name: Chen Xiaojuan role: PRINCIPAL_INVESTIGATOR name: Chen Yumei role: PRINCIPAL_INVESTIGATOR name: Ruan Min role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06355726 id: ILBS-Alcoholic Hepatitis-03 briefTitle: Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-28 date: 2025-02-28 date: 2024-04-09 date: 2024-04-09 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.\[1\] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.\[2,8\] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation. conditions: Alcoholic Hepatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Plasma Exchange name: Standard Medical Treatment measure: Liver transplant free survival at 28 days, 90 days and 180 days. measure: Change in total bilirubin and INR as measured by Discriminant Functions measure: Number of patients with change in Model for End Stage Liver Disease (MELD) measure: Number of patients with change in CTP measure: Number of patients with change in LSM,SSM measure: Mortality in both groups measure: clinical improvement in the form of jaundice as measured by total bilirubin measure: clinical improvement in the form of hepatic encephalopathy as measured by west haven criteria measure: clinical improvement in the form of ascites as measured by ICA criteria. measure: Frequency of decompensation events on follow up period measure: Adverse events during plasma exchange sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Institute of Liver & Biliary Sciences (ILBS) city: New Delhi state: Delhi zip: 110070 country: India lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06355713 id: 69HCL23_0899 id: 2023-A02010-45 type: OTHER domain: ID-RCB briefTitle: Improvement of Symptoms After Removal of the Essure® Contraceptive Implant acronym: ABLES overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2031-08-01 date: 2036-06-01 date: 2024-04-09 date: 2024-04-09 name: Hospices Civils de Lyon class: OTHER briefSummary: ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy. Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and extra-gynecological symptoms. Studies with small numbers and short-term follow-up have shown a significant improvement in these symptoms after implant explantation. This constitutes a real public health problem since according to the report of the EPI-PHARE Scientific Interest Group, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted, knowing that explantation of ESSURE® implants is recommended only in symptomatic patients. A large number of these patients, presenting symptoms, have not yet been treated for an explant.

The physiopathological mechanism(s) is (are) not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory and/or allergic and/or autoimmune phenomena.

Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients, determine the most appropriate surgical techniques, and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers. From a surgical point of view, there is a real risk of fracture of implants whatever the type of intervention performed: study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation. From a biological point of view, the dosage of the metallic elements constituting ESSURE® implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body. Analysis of pro-inflammatory cytokines, micro-RNAs (miRNA), quantitative analysis of inflammatory pathway messenger ribonucleic acid (mRNAs) (NanoString technology) and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms. This study responds to a significant request from patient associations. conditions: Implant Complication conditions: Contraceptive Device; Complications studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 444 type: ESTIMATED name: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination name: blood sample name: urine collection name: Collection of a lock of hair name: questionnaire measure: Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms measure: Percentage of patients with improvement in symptoms measure: Short Form 12 (SF-12) score measure: Fibromyalgia Impact Questionnaire (FIQ) score measure: Hospital Anxiety and Depression scale (HADS) score measure: Multidimensional Fatigue Inventory (MFI)-20 score measure: Visual analog scale (VAS) score measure: Questionnaire Douleur St-Antoine (QDSA) score measure: Female Sexual Function Index (FSFI) score measure: Higham questionnaires measure: visual analog scale (VAS) score measure: Duration of the procedure measure: Complications measure: characterization of the mechanical behavior of the implant measure: determination of the associated mechanical stress levels determination of the associated mechanical stress levels measure: quantification of the factors influencing these levels of mechanical stress measure: thermal resistance measure: risk of degradation measure: Concentrations of titanium constituting the Essure® implant measure: Concentrations of nickel constituting the Essure® implant measure: Concentrations of chromium constituting the Essure® implant measure: Concentrations of tin constituting the Essure® implant measure: Concentrations of platinum constituting the Essure® implant measure: Concentrations of iridium constituting the Essure® implant measure: Concentrations of molybdenum constituting the Essure® implant measure: Concentrations of manganese constituting the Essure® implant measure: Concentrations of tungsten constituting the Essure® implant measure: Concentrations of silver constituting the Essure® implant measure: Concentrations of iron constituting the Essure® implant measure: concentration of pro-inflammatory cytokines measure: expression profile of miRNAs measure: activated T lymphocyte profile measure: analysis of inflammatory pathway mRNAs measure: Percentage of detection of Human Leukocyte Antigen measure: Functional brain functions sex: FEMALE minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Angers city: Angers zip: 49933 country: France name: Guillaume Legendre, PU,PH role: CONTACT phone: 0241354635 phoneExt: +33 email: guillaume.legendre@chu-angers.fr name: Guillaume Legendre, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 47.46667 lon: -0.55 facility: Hôpital Femme Mère Enfant (Hospices Civils de Lyon) city: Bron zip: 69677 country: France name: Gautier Chene, PU,PH role: CONTACT phone: 0472355870 phoneExt: +33 email: gautier.chene@chu-lyon.fr name: Gautier Chene, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Hôpital Bicêtre city: Le Kremlin-Bicêtre zip: 94275 country: France name: Perrine CAPMAS, PU,PH role: CONTACT phone: 0145217714 phoneExt: +33 email: perrine.capmas@aphp.fr name: Perrine CAPMAS, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 48.81471 lon: 2.36073 facility: Hôpital Jeanne de Flandres city: Lille zip: 59037 country: France name: Victoire Delporte, PU,PH role: CONTACT phone: 0320446641 phoneExt: +33 email: victoire.delporte@chu-lille.fr name: Victoire Delporte, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Hôpital de La Conception city: Marseille zip: 13005 country: France name: Aubert Agostini, PU,PH role: CONTACT phone: 0491383702 phoneExt: +33 email: Aubert.AGOSTINI@ap-hm.fr name: Aubert Agostini, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Institut Mère Enfant Alix de Champagne, CHU Reims city: Reims zip: 51092 country: France name: Olivier Graesslin, PU,PH role: CONTACT phone: 0326783517 phoneExt: +33 email: ograesslin@chu-reims.fr name: Olivier Graesslin, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 49.25 lon: 4.03333 facility: CHU de Rouen city: Rouen zip: 76000 country: France name: Patrice Crochet, PU,PH role: CONTACT phone: 0232881054 phoneExt: +33 email: patrice.crochet@chu-rouen.fr name: Patrice Crochet, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 49.44313 lon: 1.09932 facility: Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg city: Strasbourg zip: 67200 country: France name: Thomas Boisrame, PU,PH role: CONTACT phone: 0388127458 phoneExt: +33 email: thomas.boisrame@chru-strasbourg.fr name: Thomas Boisrame, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Hôpital Paule de Viguier, CHU de Toulouse city: Toulouse zip: 31059 country: France name: Yann Tanguy Le Gac, PU,PH role: CONTACT phone: 0567771105 phoneExt: +33 email: tanguylegac.y@chu-toulouse.fr name: Yann Tanguy Le Gac, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Hôpital André Mignot, Centre Hospitalier de Versailles city: Versailles zip: 78157 country: France name: Pierre Panel, PU,PH role: CONTACT phone: 0139638936 phoneExt: +33 email: ppanel@ch-versailles.fr name: Pierre Panel, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 48.8 lon: 2.13333 hasResults: False

 nctId: NCT06355700 id: 5476 briefTitle: Hepatocellular Carcinoma Liver Organoids acronym: HELIO overallStatus: RECRUITING date: 2023-06-15 date: 2025-03 date: 2025-03 date: 2024-04-09 date: 2024-04-09 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of this interventional study is to create hepatocellular carcinoma organoids from liver bioptic samples of individuals with hepatocellular carcinoma. The main questions it aims to answer are:

* the feasibility of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells
* the molecular pattern of the organoid tumor microenvironment
* the in vitro therapeutic response of hepatocellular carcinoma organoids conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Liver biopsy measure: Success rate of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells measure: Analysis of hepatocellular carcinoma organoid transcriptome distribution within a reference set from The Cancer Genome Atlas measure: Evaluation of the concordance of somatic genetic mutations between the organoid and the original tumor measure: Correlation between gut microbiota community profiling and growth rate of hepatocellular carcinoma organoids measure: Treatment response evaluation in vitro sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Agostino Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Francesca Ponziani, MD role: CONTACT phone: +390630156018 email: comitato.etico@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06355687 id: FMASU MD304/2023 briefTitle: Melatonin in Obese Patients in Laparoscopic Cholecystectomy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-09 date: 2024-04-09 name: Ain Shams University class: OTHER briefSummary: Opioid free anesthesia (OFA) means a technique in which no intraoperative opioid is administered through any route. Perioperative pain management in an obese patient is challenging. The incidence of respiratory depression is higher in obese patients and is exaggerated with opioids, so the investigators are searching for a drug that has analgesic effect without any effect on respiratory function. In this study, the investigators will add melatonin to OFA in obese patients undergoing laparoscopic cholecystectomy. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Melatonin name: Vitamin Supplement measure: Postoperative Pain. measure: Postoperative Pain. measure: Analgesics usage. measure: Postoperative nausea and vomiting. measure: Recovery time. measure: Number of participants with hemodynamic instability. measure: Number of participants with hemodynamic instability. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06355674 id: HRÜ/23.21.12 briefTitle: Adolescent Mother and Breastfeeding Education overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-09-15 date: 2024-10-15 date: 2024-04-09 date: 2024-04-09 name: Adiyaman University class: OTHER briefSummary: In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. 10% of adolescents under the age of 15 in the world are forced to have sexual intercourse and as a result, unwanted teenage pregnancies occur. In high-income countries like Latin America, there is a high prevalence of adolescent non-marital pregnancies. When considering the fertility, health, and social outcomes of adolescence, it emerges as a significant issue. Adolescent motherhood carries numerous adverse effects from both demographic and social perspectives.

In pregnancies occurring during adolescence, both maternal and infant mortality rates are two to three times higher compared to pregnancies at later ages. Many infant and child deaths occur due to preventable causes. Breastfeeding is a significant factor in reducing infant and child mortality. Since infants born to adolescent mothers are at higher risk of death and illness, breastfeeding these infants becomes even more important. However, one of the significant challenges adolescent mothers face during the postpartum period is initiating and maintaining lactation. Research has shown that maternal age plays a significant role in initiating and sustaining breastfeeding, with a strong positive correlation between maternal age and duration of breastfeeding. This study was designed as a randomized controlled trial to examine the effect of breastfeeding education provided to adolescent mothers on maternal breastfeeding self-efficacy, mother-infant attachment, and infant anthropometric measurements. conditions: Adolescent Mother studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Breastfeeding education provided with Lactation Simulation Model measure: Postnatal Breastfeeding Self-Efficacy Scale-Short Form measure: Maternal-Infant Attachment Scale sex: FEMALE minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06355661 id: HP/231102/PA/URTI briefTitle: A Study for Assessing the Efficacy and Safety ParActin® in Individuals With Upper Respiratory Tract Infections overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-05-15 date: 2024-06-01 date: 2024-04-09 date: 2024-04-09 name: Vedic Lifesciences Pvt. Ltd. class: INDUSTRY briefSummary: The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 60 completed participants after accounting for a dropout/withdrawal rate of 20percent. The intervention duration for all the study participants is 7 days conditions: Upper Respiratory Tract Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Double-blind, Randomized, Placebo-Controlled primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule name: MCC: 400 mg (± 10%) per Capsule measure: To evaluate the effect of investigational products on participant's severity of common cold like symptoms measure: To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms measure: To evaluate the effect of investigational products on Percentage of participants with unresolved common cold symptoms measure: To evaluate the effect of investigational products on Percentage of population with minimal important difference of ≥ 10.3 as per change in Wisconsin Upper Respiratory Symptom Survey-21 total score. (daily score will be analysed in study) measure: To evaluate the effect of investigational products on Number of days taken to be afebrile (temp < 100 oF/< 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline- as assessed by 10-point visual analogue scale. measure: To evaluate the effect of investigational products on Percentage population with fever during the study. measure: To evaluate the effect of investigational products on Quality of life as assessed by Wisconsin Upper Respiratory Symptom Survey Quality of Life sex: ALL minimumAge: 16 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Biswas health care & Diagnostic Centre city: Nainital state: Uttaranchal country: India name: Dr Bijay Biswas, MBBS,MD role: CONTACT phone: 919760010003 email: biswasclinic058@gmail.com lat: 29.39743 lon: 79.44686 hasResults: False

 nctId: NCT06355648 id: IRAS 337181 briefTitle: Advanced Clinical Practitioners in the ED overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-10-01 date: 2025-03-01 date: 2024-04-09 date: 2024-04-09 name: King's College London class: OTHER briefSummary: No patient data is involved in the study. This study is designed to understand better how Emergency Care Advanced Clinical Practitioners (EC-ACPs) work in emergency departments (EDs). The main research question is:

1) What is the EC-ACP's perception of assimilation into emergency care teams, what tensions are created due to the role, and what system adaptations are required to facilitate integration?

With secondary aims :

1. What are the common organisational factors that affect the implementation of the EC-ACP workforce, and what recommendations can be made to improve Trust-wide implementation?
2. How are EC-ACPs deployed in two contrasting emergency departments, what differences can be identified in their Work-As-Done (WAD), and how does this compare to the Work-As-Imagined (WAI) of the role?

Participants will all be staff members who work in the hospital. Patient data is not being collected or processed. This is a mixed-method study using two approaches to collect data:

1. Observation of the EC-ACPs at work - noting how they interact with colleagues and how they are deployed in the ED.
2. Interviews with various staff who work with the EC-ACPs clinically or in various managerial or director roles.

Background

In the UK, a health care role has been developed called Advanced Clinical Practitioners (ACPs). ACPs work in various clinical settings, but this study focuses on those in Emergency Care. While non-medical practitioners have worked in Emergency Departments (EDs) for over 20 years, the ACP role is relatively new. Most ACPs in ED are from a nursing or paramedical background, but they can also be from other allied health professions like physiotherapy. After the base qualification, ACPs undertake a three-year master\&#39;s degree with clinical portfolios. Once qualified, the goal is to create clinicians who work alongside doctors, seeing, treating, and discharging patients. Unlike previous practitioner roles, EC-ACPs treat the whole spectrum of ED patients, from minor injuries and illnesses to the sickest patients needing the highest level of care.

These roles were heavily supported by local and political desires to create blended workforces to meet increasing patient demands. The problem with implementing ACP roles is that initially, little consultation was held with stakeholders in EDs. This has resulted in various trade-offs. For example, trainee doctors often feel displaced by trainee ACPs seeking to learn the same or similar skills.

Previous research on advanced roles in ED has focused on direct clinical comparisons between doctors and practitioners. Researchers have investigated which professional (doctors vs. nurse practitioners) triages patients quickest or who is more accurate at interpreting X-rays. There are several problems with these approaches. The first is that they can create a professional rivalry. The second problem is that these approaches oversimplify what is a more complex system of care. conditions: Healthy Volunteers studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Narrative data measure: Narrative data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355635 id: JohannesGUVA briefTitle: Application and Monitoring of Vasoactive and Inotrope Drugs acronym: Vasin overallStatus: RECRUITING date: 2024-04-04 date: 2024-06-01 date: 2024-11-01 date: 2024-04-09 date: 2024-04-09 name: Johannes Gutenberg University Mainz class: OTHER briefSummary: The investigators aimed to establish current practice of application and monitoring of vasoactive and inotrope Drugs in non-cardiac surgery patients. conditions: Hemodynamic Instability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Choice and Monitoring measure: current practice of correct application and monitoring of vasoactive and inotrope Drugs sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anaesthesiology; status: RECRUITING city: Mainz state: Rhineland-Palatinate zip: D55131 country: Germany name: Marc Kriege, MD role: CONTACT phone: 00496131170 email: MaKriege@uni-mainz.de lat: 49.98419 lon: 8.2791 hasResults: False

 nctId: NCT06355622 id: 3717 briefTitle: Prevalence and Characterization of Pain in RASopathies acronym: 3717 overallStatus: RECRUITING date: 2021-01-27 date: 2024-01-30 date: 2024-06-30 date: 2024-04-09 date: 2024-04-09 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: RASopathies are a group of syndromes caused by variants in genes belonging to the RAS/MAPK pathway. Pain is a neglected topic in RASopathies but it is frequently complained by affected individuals. conditions: RASopathy conditions: Costello Syndrome conditions: Cardio-Facio-Cutaneous Syndrome conditions: Noonan Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Characterization of pain measure: Prevalence of pain in verbal patients with RASopathies measure: Prevalence of Pain in no-communitating patients with RASopathies measure: Characterization of pain in RASopathies sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Chiara Leoni, MD, PhD role: CONTACT phone: 0039063381344 email: chiara.leoni@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06355609 id: DZ2023EI004-RW briefTitle: Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW acronym: WUKONG-32-RW overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-12-30 date: 2027-12-30 date: 2024-04-09 date: 2024-04-09 name: Hunan Province Tumor Hospital class: OTHER briefSummary: This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: sunvozertinib in combination with Anlotinib measure: Progression-free survival (PFS) measure: Objective Response Rate (ORR) measure: Overall survival (OS) measure: Duration of Response (DoR) measure: Adverse events (AEs) according to CTCAE 5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410013 country: China lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06355596 id: 20IC6361 briefTitle: Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills overallStatus: COMPLETED date: 2022-03-11 date: 2022-04-08 date: 2022-04-08 date: 2024-04-09 date: 2024-04-09 name: Imperial College London class: OTHER briefSummary: The goal of this observational study is to develop and evaluate a virtual teaching method for minimally invasive surgery (MIS) skills among novice learners, using widely available technology and incorporating objective assessments of proficiency. The main questions it aims to answer are:

Can MIS skills be effectively taught to novice learners through a virtual platform using widely available technology? How do virtual and face-to-face (F2F) teaching methods compare in terms of effectiveness, measured by performance in MIS tasks and cognitive workload parameters?

Participants in this study will:

Be randomly allocated to either F2F or virtual teaching groups. Undergo training and evaluation using validated laparoscopic assessments, namely the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task and the European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment.

Have their performance and cognitive workload parameters (SURG-TLX score, heart rate, and pupil metrics) evaluated during the tasks. conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Participants are randomly allocated to either face-to-face or virtual teaching groups primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Virtual teaching measure: McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score measure: European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score measure: SURG-TLX score measure: Heart rate measure: Pupil metrics sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Mary's Hospital city: London zip: W2 1NY country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06355583 id: C/42/2022 id: 2022-003617-10 type: EUDRACT_NUMBER briefTitle: Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial acronym: MAST overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-02-01 date: 2027-05-01 date: 2024-04-09 date: 2024-04-09 name: Imperial College London class: OTHER briefSummary: The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant.

The main questions it aims to answer are:

* Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires
* Changes in gut microbiome diversity across all timepoints
* Markers of general health, infective/microbiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured.

Participants will be asked at their routine follow up visits to,

* Provide stool, urine and blood samples at the scheduled study visits
* Complete questionnaires at selected visits
* Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+/-3 days)

Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity. conditions: Acute Lymphoblastic Leukaemia conditions: Acute Leukemia of Ambiguous Lineage conditions: Chronic Myeloid Leukemia conditions: Chronic Myelomonocytic Leukemia conditions: Myelodysplastic Syndrome conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: EBX-102 name: Placebo measure: Change in gut microbiota diversity using Inverse Simpsons Index measure: Gut Microbiome Diversity - Alpha diversity measure: Alpha Diversity - Chao1 Index measure: Alpha Diversity - Shannon Index measure: Alpha Diversity - Faiths Phylogenetic Diversity (Faiths PD) measure: Beta Diversity - Aitchison Distance measure: Gut Microbiome Taxonomic Composition measure: Markers of general health - ITU Admission measure: Quality of life EQ-5D-5L measure: Quality of Life EORTC-QLQ-C30 measure: Infective Haematological Outcomes - Fever Occurrence measure: Infective Haematological Outcomes - Fever CTCAE Grade measure: Infective Haematological Outcomes - Infection measure: Infective Haematological Outcomes - Multi drug Resistant Bacterial Colonisation (MDROs) measure: Infective Haematological Outcomes - Antibiotic Use measure: Markers of General Health - Severity of Mucositis measure: Markers of General Health -Occurrence of Severe Acute Kidney Injury (AKI) measure: Markers of General Health - Occurrence of Severe liver dysfunction measure: Markers of general health - Use of Parenteral Nutrition measure: Neutrophil and platelet engraftment data measure: Recovery of T-cell Chimaerisms, measure: Haematological Outcomes - Non-relapsed mortality measure: Haematological Outcomes - Occurrence Graft vs Host Disease measure: Haematological Outcomes - Severity of graft vs Host Disease measure: Overall Survival measure: Graft-versus disease-free relapse-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Birmingham NHS Foundation Trust city: Birmingham state: England zip: B15 2WB country: United Kingdom name: Senior Haematology Research Sister role: CONTACT phone: 01213714351 email: HaematologyCancerResearch@uhb.nhs.uk name: Francesca Kinsella role: PRINCIPAL_INVESTIGATOR lat: 52.48142 lon: -1.89983 facility: Leeds Teaching Hospital NHS Trust city: Leeds state: England zip: LS9 7TF country: United Kingdom name: Principal Investigator role: CONTACT phone: 01132068561 email: anjum.khan@nhs.net lat: 53.79648 lon: -1.54785 facility: University College London Hospitals NHS Trust city: London state: England zip: NW1 2BU country: United Kingdom name: BMT Trials role: CONTACT email: uclh.bmttrials@nhs.net name: Panagiotis Kottaridis role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Kings College NHS Foundation Trust city: London state: England zip: SE5 9RS country: United Kingdom name: Principal Investigator role: CONTACT email: p.krishnamurthy@nhs.net name: Pramila Krishnamurthy role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust city: London state: England zip: W12 0NN country: United Kingdom name: Senior Research Operations Manager role: CONTACT phone: 02037048452 email: Eleni.Vourvou@nhs.net lat: 51.50853 lon: -0.12574 facility: Royal Mardsen Hostpital city: London zip: SW3 6JJ country: United Kingdom name: Haemato-Oncology Department role: CONTACT phone: 0208915 6187 email: Emma.Nicholson@rmh.nhs.uk name: Emma Nicholson role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06355570 id: 331314 id: RFPR2324_29 type: OTHER_GRANT domain: Imperial Health Charity id: 24/YH/0011 type: OTHER domain: UK Health Research Authority (Research Ethics Committee) briefTitle: Delirium After Cardiac Surgery in Intensive Care Units acronym: DaCsi-ICU overallStatus: RECRUITING date: 2024-03-20 date: 2024-12-31 date: 2025-03-20 date: 2024-04-09 date: 2024-04-11 name: Imperial College Healthcare NHS Trust class: OTHER briefSummary: STUDY SUMMARY

STUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit (ICU) at Hammersmith Hospital, Imperial College Healthcare NHS Trust (ICHT). This study is a mixed methods research design that includes the collection of data through qualitative interviews, quality-of-life questionnaires and patients' medical records.

AIMS

* Determine the incidence of ICU delirium in ICHT following cardiac surgery
* Explore the compliance of outcome measures that diagnose ICU delirium
* Implement a family-focused sensory stimulation programme in the ICU
* Evaluate its useability and potential impact on patients, families and ICU staff

STUDY POPULATION 30 study participants (12 patients, 12 family members/friends and 6 ICU nurses)

ELIGIBILITY Study eligibility criteria are specific for each care group (patients, family members/friends and ICU nurses).

DURATION 12 months at Hammersmith Hospital, ICHT conditions: Intensive Care Unit Delirium conditions: Cardiac Surgery conditions: Post Operative Delirium studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 12-patient participants will be submitted to the study intervention. primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Personal Pictures name: Family Videos name: Family Videos - Intervention as required measure: Feasibility of implementing the study intervention measure: Practicalities of introducing the study intervention measure: Acceptability of implementing the study intervention measure: Short-term delirium outcomes post-ICU discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London zip: W12 0HS country: United Kingdom name: Maria Reguenga, BSN role: CONTACT phone: +442033131703 email: maria.reguenga@nhs.net name: Sanooj Soni, PhD role: CONTACT phone: 07714329708 email: sanooj.soni@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06355557 id: DSRB 2023/00640 briefTitle: Human vs Machine: a RCT Comparing Traditional In-person Instruction, AI Versus VR for Learning Basic CCE overallStatus: RECRUITING date: 2024-04-04 date: 2024-12-31 date: 2025-01 date: 2024-04-09 date: 2024-04-09 name: Tan Tock Seng Hospital class: OTHER briefSummary: The aim of the study is to investigate if hands-on training for basic CCE with virtual reality simulators or guided by artificial intelligence is non-inferior to training by an experienced instructor. conditions: Ultrasound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3-arm prospective randomised controlled trial. primaryPurpose: OTHER masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: AI enabled ultrasound system for self-directed learning name: Simulator for self-directed learning name: traditional with human instructors measure: Improvement in image acquisition and structure identification at the end of 3 months. sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tan Tock Seng Hospital status: RECRUITING city: Singapore zip: 319581 country: Singapore name: Yie H Lau role: CONTACT phone: 6563577771 email: yie_hui_lau@ttsh.com.sg name: Yie H Lau role: PRINCIPAL_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06355544 id: PINEAPPL2023 id: 2023-A02494-41 type: OTHER domain: Agence nationale de sécurité du médicament et des produits de santé briefTitle: Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk acronym: PINEAPPL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05-30 date: 2026-06-30 date: 2024-04-09 date: 2024-04-09 name: Integrative Phenomics class: INDUSTRY name: Assistance Publique - Hôpitaux de Paris name: Assistance Publique Hopitaux De Marseille name: University Hospital, Bordeaux name: Centre Hospitalier Universitaire Dijon name: Institut Pasteur de Lille name: Hopitaux Civils de Colmar briefSummary: The goal of this observational study is to learn about low-grade inflammation in healthy individuals and individuals with overweight or obesity.

The main questions it aims to answer are:

* Whether it is possible to predict low-grade inflammation
* What are the medical, biological, and lifestyle variables related to low-grade inflammation?

Participants will be asked to:

1. Attend a general medical visit to collect vital signs, anthropometric measurements, and collect blood samples.
2. Complete questionnaires and collect a stool sample at home. conditions: Overweight conditions: Obesity conditions: Metabolic Syndrome conditions: Healthy conditions: Low-grade Inflammation conditions: Normal Weight Adults conditions: Risk Factor, Cardiovascular conditions: Hypertension conditions: Hypercholesterolemia conditions: Abdominal Obesity conditions: Metabolically Healthy Controls studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 3000 type: ESTIMATED measure: Low-grade inflammation measure: Gut microbiome metabolites measure: Fasting glucose measure: Stool microbiome composition measure: Stool microbiome functional pathways measure: Systolic blood pressure measure: Resting heart rate measure: Serum glycated hemoglobin (HbA1c) measure: Diastolic blood pressure measure: Height measure: Waist circumference measure: Neck circumference measure: Hip circumference measure: Body fat mass measure: Water body mass measure: Lean body mass measure: Serum fasting low-density lipoprotein measure: Fasting serum high-density lipoprotein measure: Fasting total serum cholesterol measure: Consumption of dietary macronutrients measure: Consumption of dietary micronutrients measure: Consumption of dietary metabolites measure: Food item consumption measure: Food group consumption measure: Body weight measure: Serum Alanine Transaminase (ALT) measure: Serum Aspartate Aminotransferase (ALT) measure: Serum gamma-glutamyl transferase (GGT) measure: Fasting serum triglycerides measure: Fasting serum uric acid measure: Fasting serum creatinine measure: Fasting serum insulin measure: Blood hemoglobin measure: Blood hematocrit measure: Red blood cells measure: Red blood cell volume measure: Hemoglobin relative red blood cell size measure: Mean cell hemoglobin (MCH) measure: Blood platelets measure: White blood cells measure: Perceived quality of life measure: Eating behavior measure: Physical activity measure: Stool consistency measure: Stress measure: Deprivation measure: Sleep measure: Sleep apnea sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355531 id: FNP223-CT-2301 briefTitle: A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-11 date: 2026-11 date: 2024-04-09 date: 2024-04-09 name: Ferrer Internacional S.A. class: INDUSTRY briefSummary: PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks and to assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP. conditions: Progressive Supranuclear Palsy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 220 type: ESTIMATED name: FNP-223 name: Placebo measure: Change From Baseline to Week 52 in the PSPRS Outcome measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) measure: Number of Participants Experiencing Serious Adverse Events (SAEs) measure: Change From Baseline to Week 52 in Clinical Global Impression of Severity Scale (CGI-S) measure: Change From Baseline to Week 52 Participant Global Impression of Severity Scale (PGI-S) measure: Change From Baseline to Week 52 in Caregiver Global Impression of Severity Scale (CaGI-S) measure: Slope of Decline in PSPRS measure: Change From Baseline to Week 52 in Individual Subitems of PSPRS measure: Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale measure: Change From Baseline to Week 52 in PSP Clinical Deficits Scale (PSP-CDS) measure: Change From Baseline to Week 52 in Montreal Cognitive Assessment (MoCA) measure: Change From Baseline to Week 52 in PSP Quality of Life Scale (PSP-QoL) measure: Pharmacokinetic characterization of FNP-223 sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355518 id: INu-RC briefTitle: Pre-operative Immuno-Nutrition in Radical Cystectomy acronym: INu-RC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2026-09 date: 2024-04-09 date: 2024-04-09 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER name: IRCCS Ospedale San Raffaele briefSummary: This study will evaluate the effect of preoperative oral immunonutrition on postoperative complications in patients undergoing radical cystectomy for bladder cancer. Patients receiving preoperative immunonutrition will be compared to controls receiving a standard high-calorie, high-protein oral nutritional supplement. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 260 type: ESTIMATED name: Immunonutrition name: Standard Oral Nutritional Supplement measure: 30-day complications measure: 30-day severe complications measure: 90-day severe complications measure: 30-day and 90-day infectious complications measure: 30-day and 90-day occurrence of other medical conditions measure: Time to recovery of bowel function measure: Time to postoperative mobilization measure: Muscular strength modifications measure: Weight modifications measure: Biochemical nutritional indexes modifications measure: Need of blood transfusions measure: Length of stay measure: Readmission rate measure: 30-day and 90-day mortality measure: Compliance measure: Tolerability (gastrointestinal symptoms related to nutritional supplement) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele city: Milan zip: 20132 country: Italy name: Bettiga Arianna role: CONTACT email: bettiga.arianna@hsr.it name: Marco Moschini, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS Policlinico San Matteo city: Pavia zip: 27100 country: Italy name: Ferrari Alessandra, PharmD role: CONTACT phone: +390382503689 email: alessandra.ferrari@smatteo.pv.it name: Valentina Da Prat, MD role: PRINCIPAL_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06355505 id: PREPS-21-0098 briefTitle: Process of Emergence and Implementation of Advanced Practice Nursing in France acronym: PEIPA overallStatus: RECRUITING date: 2024-03-01 date: 2028-01-01 date: 2028-03-01 date: 2024-04-09 date: 2024-04-09 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Longitudinal, observational research with a mixed quantitative (by questionnaires) and qualitative (by interviews and observations) approach, multidisciplinary, among Advanced Practice Nurses (APNs) already graduated and 3 consecutive classes of advanced practice students who will be followed annually during their implementation as APN until the last year of the study. The questionnaires will focus on APN scope of practice evolution, economical analysis and geographical distribution of APN. The ethnographical approach will assess APN settlements and relation with healthcare colleagues and patients. conditions: Nurse's Role studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1600 type: ESTIMATED measure: Factors influencing the effective implementation of advanced practice nursing in France in primary care and health facilities measure: Mapping of APNs in France with socio-demographic data measure: Definition by the APN of its role and missions measure: Implementation and dissemination of the APN practice in the territory according to the context of practice (community care, hospital) measure: Identification of potential impact dimensions of Advanced Practice Nursing sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beaujon hospital status: RECRUITING city: Clichy zip: 92110 country: France name: Julie Devictor, PhD role: CONTACT phone: 06 64 71 26 75 email: julie.devictor@aphp.fr name: Anne Leclercq, PhD role: CONTACT phone: 0033 7 62 70 58 05 email: anne.leclercq2@aphp.fr lat: 48.90018 lon: 2.30952 hasResults: False

 nctId: NCT06355492 id: 2090/10/30 briefTitle: Virtual Reality Distraction in Pediatric Patients. overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06 date: 2025-07 date: 2024-04-09 date: 2024-04-09 name: Tanta University class: OTHER briefSummary: The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients. conditions: Virtual Reality conditions: Distraction conditions: Infiltration Anesthesia conditions: Pediatric Patients studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Virtual reality goggles (VR ) name: regular screen measure: Assessment of pain during virtual reality distraction sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Rokia Abdelrhman Saad Elfaramawy city: Tanta state: El-Gharbia zip: 31527 country: Egypt name: Rokia A Elfaramawy, BDS role: CONTACT phone: 01069823221 email: Rokiaabdelrahman94@gmail.com name: Fatma A Elhendawy, Professor role: SUB_INVESTIGATOR name: Nura I Abozena, Lecturer role: SUB_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06355479 id: HY1001-2022-P3 briefTitle: A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia overallStatus: COMPLETED date: 2023-04-10 date: 2023-11-22 date: 2023-12-12 date: 2024-04-09 date: 2024-04-09 name: Healthgen Biotechnology Corp. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia.

Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients.

Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively. conditions: Hypoalbuminemia conditions: Hepatic Cirrhosis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 328 type: ACTUAL name: OsrHSA name: Plasbumin®-20 measure: To evaluate the efficacy of OsrHSA on elevating the serum albumin level. measure: To estimate the time to reach 35 g/L or more in serum albumin measure: To estimate the change from baseline in serum albumin measure: To estimate the change from baseline in colloid osmotic pressure measure: To estimate the change from baseline in body weight measure: To estimate the change from baseline in abdominal circumference, and ascites severity measure: To estimate the change from baseline in ascites severity sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Beijing Youan Hospital, Capital Medical University city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Chongqing University Three Gorges Hospital city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: The Second Affiliated Hospital of Chongqing Medical University city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: Mengchao Hepatobiliary Hospital of Fujian Medical University city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 facility: The First Affiliated Hospital of Fujian Medical University city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 facility: Nanfang Hospital city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital, Sun Yat-Sen University city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Huizhou Central People's Hospital city: Huizhou state: Guangdong country: China lat: 23.11147 lon: 114.41523 facility: Affiliated Hospital of Guilin Medical University city: Guilin state: Guangxi country: China lat: 25.28194 lon: 110.28639 facility: Liuzhou Worker's Hospital city: Liuzhou state: Guangxi country: China facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi country: China lat: 22.81667 lon: 108.31667 facility: Affiliated Hospital Of Zunyi Medical University city: Zunyi state: Guizhou country: China lat: 27.68667 lon: 106.90722 facility: The Fourth Affiliated Hospital, Harbin Medical University city: Harbin state: Heilongjiang country: China lat: 45.75 lon: 126.65 facility: Luoyang Central Hospital city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Zhengzhou University city: Zhengzhou state: Henan country: China lat: 34.75778 lon: 113.64861 facility: The Sixth People's Hospital of Zhengzhou city: Zhengzhou state: Henan country: China lat: 34.75778 lon: 113.64861 facility: Jingzhou Central Hospital city: Jingzhou state: Hubei country: China lat: 30.35028 lon: 112.19028 facility: TaiHe Hospital city: Shiyan state: Hubei country: China lat: 32.6475 lon: 110.77806 facility: The Central Hospital of Wuhan city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Wuhan Jinyintan Hospital city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Yichang Central People's Hospital city: Yichang state: Hubei country: China lat: 30.71444 lon: 111.28472 facility: Yueyang Central Hospital city: Yueyang state: Hunan country: China lat: 29.37455 lon: 113.09481 facility: The Third People's Hospital of Zhenjiang city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: First Affiliated Hospital of Gannan Medical University city: Ganzhou state: Jiangxi country: China facility: The First Affiliated Hospital of Nanchang University city: Nanchang state: Jiangxi country: China lat: 28.68396 lon: 115.85306 facility: Pingxiang People's Hospital city: Pingxiang state: Jiangxi country: China lat: 27.61672 lon: 113.85353 facility: Yichun People's Hospital city: Yichun state: Jiangxi country: China lat: 47.72143 lon: 128.87529 facility: Hepatobiliary Hospital Of Jilin city: Chang chun state: Jilin country: China lat: 42.74694 lon: 126.24667 facility: The First Hospital of Jilin University city: Chang chun state: Jilin country: China lat: 42.74694 lon: 126.24667 facility: The Sixth People's Hospital of Shenyang city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: The People's Hospital of Qinghai city: Xining state: Qinghai country: China lat: 36.62554 lon: 101.75739 facility: Shandong Public Health Clinical Center city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 facility: West China Hospital, Sichuan University city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 facility: The Second Affiliated Hospital of Kunming Medical University city: Kunming state: Yunnan country: China lat: 25.03889 lon: 102.71833 facility: Ruian People's Hospital city: Rui'an state: Zhejiang country: China facility: The First School of Medicine, School of Information and Engineering, The First Affiliated Hospital of Wenzhou Medical University city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06355466 id: 51-112334 briefTitle: Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors overallStatus: COMPLETED date: 2022-01-09 date: 2023-08-11 date: 2023-08-28 date: 2024-04-09 date: 2024-04-09 name: Golestan University of Medical sciences class: OTHER briefSummary: In this prospective cross-sectional study, patients with ESRD unfit for AVF/AVG were scheduled for a right or left trans-jugular tunneled catheter placement. All patients were asked about their catheters' function one year after its implantation and the presumed affecting factors on catheters' patency were evaluated. conditions: Vascular Access Devices studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 156 type: ACTUAL measure: one year patency rate of hemodialysis catheters measure: one year patency rate of hemodialysis catheters in age subgroups measure: one year patency rate of hemodialysis catheters in diabetic patients measure: one year patency rate of hemodialysis catheters in hypertensive patients measure: one year patency rate of hemodialysis catheters in patients on antiplatelet drugs measure: one year patency rate of hemodialysis catheters in sex subgroups sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Golestan University of Medical Sciences, faculty of medicine city: Gorgan state: Golestan zip: 4918936316 country: Iran, Islamic Republic of lat: 36.8427 lon: 54.44391 hasResults: False

 nctId: NCT06355453 id: 2023-090-MIC-GES briefTitle: Evaluation of the Goldcrest Patch Performance overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-08-30 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: GE Healthcare class: INDUSTRY briefSummary: The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.

The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity. conditions: Fetal Monitoring studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Goldcrest Patch and Three Patch Coupons name: Goldcrest Patch and Novii Patch measure: Primary Objective measure: Primary Objective measure: Secondary Objective measure: Secondary Objective measure: Incidence of Treatment-Emergent Adverse Events Objective sex: FEMALE minimumAge: 22 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355440 id: 2312288-16 briefTitle: Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China overallStatus: RECRUITING date: 2024-03-18 date: 2024-06-30 date: 2024-06-30 date: 2024-04-09 date: 2024-04-09 name: Fudan University class: OTHER briefSummary: The goal of this pilot study is to access the feasibility and impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.

The main questions it aims to answer are:

* Is the intervention feasible and acceptable among participants?
* Does the intervention enhance participants' cost-related health literacy?
* Does the intervention reduce participants' financial toxicity?

Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.

Participants will receive comprehensive information support, including:

* Strategies on patient-physician costs discussion
* Skills for inquiring and tracking treatment-related costs
* Basic knowledge about health insurance
* Guidance on accessing and applying for financial assistance
* Suggestions for returning to normal life and work
* Strategies for holding a financial-related family meeting conditions: Breast Neoplasm Female conditions: Financial Toxicity conditions: Financial Navigation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Financial Navigation name: Usual Care measure: Eligibility rate measure: Consent rate measure: Retention rate measure: Adherence rate measure: Patient-reported satisfaction measure: Qualitative assessment of the intervention measure: Cost-related health literacy measure: Financial toxicity measure: Material domain of financial toxicity measure: Behavioral domain of financial toxicity sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Xiaoyi Yuan, Master role: CONTACT phone: (+86) 18918305439 email: 22211170009@m.fudan.edu.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06355427 id: 2023-507938-24-00 briefTitle: The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma acronym: FAPIChol overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-09-01 date: 2028-02-01 date: 2024-04-09 date: 2024-04-09 name: Mara Veenstra, MD class: OTHER name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) name: UMC Utrecht briefSummary: Background

Bile duct cancer (cholangiocarcinoma) represents the second most common type of hepatobiliary cancer worldwide with an incidence of 0.35 to 2 per 100.000 annually. Currently, surgical resection is the only curative option. However, patients are not eligible for surgery if the tumor cannot be resected or the cancer has spread. For this group of patients, palliative chemotherapy is the most suited treatment option. To find out if a patient is suited for surgery, CT and MRI are performed. These imaging techniques, however, struggle to correctly identify small cancer spreads that are smaller than 1 cm. Therefore, cancer that has already spread can be found during surgery. In these cases, the tumor cannot be removed and the surgery therefore has not been of any benefit for the patient. These surgeries could be avoided by implementing a diagnostic tool with significantly higher accuracy than those currently used. Single center studies have shown that fibroblast activation protein inhibitor (FAPI) PET-CT is a very promising technique for determining metastases in tumors with prominent desmoplastic reactions, like cholangiocarcinoma. The investigators predict that implementation of preoperative FAPI PET-CT could prevent futile surgery for at least half of patients in whom intra-operative metastasized disease is found using the current work-up.

Patient population

Patients ≥18 years with potentially curable proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma) who are planned to undergo surgery based on imaging using CT thorax/abdomen and MRI of the upper abdomen. Exclusion criteria are previous abdominal surgery or chemotherapy, known pregnancy or lactation and indication for FDG PET-CT.

Participation in this study

Participation would mean to undergo FAPI PET-CT prior to the scheduled surgery. This will take up about half a day of the participant's time. Afterwards, participants receive questionnaires about quality of life and use of healthcare services over a period of six months in order for the researchers to be able to calculate the cost-effectiveness of additional FAPI PET-CT.

Risks and benefits of participation

Patients may benefit directly from \[18F\]F-FAPI PET-CT by allowing for more targeted treatment, possibly avoiding futile surgery and receiving chemotherapy or best clinical support instead, minimizing treatment delay. Avoiding futile surgery will also prevent patients from being exposed to the risks and discomfort associated with surgery: hospital stay, possibility of intraoperative or postoperative complications, postoperative pain and recovery, and mortality.

Potential risks and burdens associated with this study are an extra hospital visit and a time burden of approximately half a day. Risks associated with administering FAPI are (re)bleed and infection. Both risks have a minimal probability of onset and can usually easily be treated. As \[18F\]F-FAPI is a sub-pharmacologically micro-dosed diagnostic tracer, the risk of allergic reactions is expected to be minimal and no tissue damage is expected. The burden associated with undergoing a PET-CT may be laying still for a certain time, and possible experience of claustrophobia. Possible metastases of the cancer will have to be confirmed when suspicious findings are seen on FAPI PET-CT. This could mean that participants will have to undergo additional testing such as imaging (CT or MRI) or biopsy. Undergoing FAPI PET-CT prior to surgery will result in a surgical delay when compared with the current clinical practice. The investigators do not expect this delay to influence the patient's prognosis. Follow-up will result in a time burden for patients to answer questionnaires on a two-weekly or monthly basis. conditions: Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 81 type: ESTIMATED name: [18F]F-FAPI PET-CT measure: Diagnostic accuracy of [18F]F-FAPI PET-CT measure: Change of treatment measure: Cost-effectiveness measure: Number of additional significant findings using [18F]F-FAPI PET-CT measure: Number of times nuclear medicine specialists' [18F]F-FAPI PET-CT conclusions differed from one another measure: Number of lesions found on [18F]F-FAPI PET-CT measure: Number of days between [18F]F-FAPI PET-CT and exploratory surgery measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 measure: Number of participants in which dynamic [18F]F-FAPI PET-CT followed by conventional [18F]F-FAPI PET-CT was able to distinguish benign lesions from malignant lesions measure: Change in volume of interest (cm3) using dynamic [18F]F-FAPI PET-CT measure: Difference in SUVmax between dynamic and conventional [18F]F-FAPI PET-CT measure: Difference in SUVmean between dynamic and conventional [18F]F-FAPI PET-CT measure: Difference in transport rate (k1 to k2) on dynamic [18F]F-FAPI PET-CT between participants with malignant lesions and particpants with benign lesions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355414 id: IRB00385932 id: R33AT012317 type: NIH link: https://reporter.nih.gov/quickSearch/R33AT012317 briefTitle: Psilocybin in Chronic Low Back Pain and Depression overallStatus: RECRUITING date: 2024-04-22 date: 2026-07-30 date: 2026-08-30 date: 2024-04-09 date: 2024-04-23 name: Johns Hopkins University class: OTHER name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D).

Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects. conditions: Chronic Low-back Pain conditions: Depression studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, active control study comparing the effects of psilocybin (25mg fixed dose) and methylphenidate (40mg fixed dose) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: This is a double-blind trial, and efforts will be made to mask the study drug (psilocybin) and the active control (methylphenidate) from participants, guides, and study staff. Participants will be debriefed about their randomly assigned drug condition after the completion of the final follow-up assessment, or after discontinuation/withdrawal, whichever comes first. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Psilocybin name: Methylphenidate measure: Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing) measure: Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA) measure: Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing) measure: Pain as assessed by discrete pain items assessed via EMA measure: Dynamic association between affect and pain using micro-longitudinal EMA data of affective variables (positive, negative affect outcomes) and pain outcomes measure: Changes in mood as measured by a selection of discrete items derived from the Positive and Negative Affect Schedule- Expanded Form (PANAS-X). measure: Changes in self-reported Pain Impact as measured by Pain intensity (P), interference with Enjoyment of life (E), and interference with General activity (G) Scale (PEG) measure: Changes in Pressure Pain Threshold (Quantitative Sensory Testing) measure: Changes in Conditioned Pain Modulation (Quantitative Sensory Testing) measure: Chronic Pain Exacerbation as measured by the Graded Chronic Pain Scale- Revised (GCPS-R) measure: Changes in neuropathic pain features as assessed by the painDETECT questionnaire (PDQ) measure: Changes in CLBP-related disability as measured by the Oswestry Disability Index (ODI) measure: Change in Emotion Regulation as assessed by the Difficulties in Emotion Regulation Scale (DERS) measure: Pain intensity and related dimensions of health (i.e., sleep) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.0). measure: Psychological Inflexibility in Pain as measured by the Psychological Inflexibility in Pain Scale (PIPS) measure: Personal values and the degree of success in following those values as measured by the Chronic Pain Values Inventory (CPVI). measure: Dispositional tendencies to feel positive emotions towards others in daily life as measured by the Dispositional Positive Emotion Scale (DPES) measure: Mindfulness as measured by the Five Facet Mindfulness Questionnaire (FFMQ-15) measure: Subjective experiences: Awe Experience Scale (AWE-S) measure: Subjective experiences: Mystical Experience Questionnaire (MEQ30) measure: Subjective experiences: Challenging Experience Questionnaire (CEQ) measure: Subjective experiences: Altered States of Consciousness Questionnaire (5D-ASC) measure: Subjective experiences: Psychological Insight Questionnaire (PIQ) measure: Changes in basic beliefs about the world as measured by the Primals Inventory (PI-6) sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins University School of Medicine status: RECRUITING city: Baltimore state: Maryland zip: 21224 country: United States name: David Yaden, PhD role: CONTACT phone: 410-550-5250 phoneExt: 0-5250 email: dyaden1@jhmi.edu name: David Yaden, PhD role: PRINCIPAL_INVESTIGATOR name: Patrick Finan, PhD role: SUB_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06355401 id: Soh-Med-24-03--06PD briefTitle: Maintenance Hormonal Therapy and DLBCL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2029-03 date: 2024-04-09 date: 2024-04-09 name: Sohag University class: OTHER briefSummary: the study aims to detect the benefit of maintenance tamoxifen after achieving CR with conventional immuno-chemotherapy and/or radiotherapy in patients with DLDCL conditions: Diffuse Large B Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Tamoxifen 20mg measure: disease free survival measure: overall survival measure: side effects sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355388 id: TRAGUSHF briefTitle: TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure acronym: TRAGUS-HF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2027-05-01 date: 2024-04-09 date: 2024-04-09 name: Fondazione Toscana Gabriele Monasterio class: OTHER name: Azienda Ospedaliera Città della Salute e della Scienza di Torino briefSummary: To verify the efficacy of transcutaneous vagus nerve stimulation (tVNS) on and autonomic balance in patients with chronic heart failure and reduced (HFrEF) or mildly reduced (HFmrEF) left ventricular ejection fraction. The study hypothesis is that tVNS increases baroreflex gain, with consequent benefits on sympathovagal balance (at short- and mid-term), and on quality of life and bio-humoral parameters (at mid-term). conditions: Heart Failure conditions: Heart Failure With Reduced Ejection Fraction conditions: Heart Failure With Midrange Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: In order to maintain the 'double-blind,' at the end of the experimental protocol, the data acquired in each phase (baseline, active tVNS, placebo tVNS) will be saved in three different files, made unrecognizable by one of the investigators not involved in the tabulation and data analysis. A second investigator, unaware of the stimulation phases, will proceed with the tabulation of the data for each individual recording (three per patient). Only at the end of the study (or after recruiting 50% of patients for any interim analyses), will the investigators responsible for data analysis be revealed the corresponding phase for each recording. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 24 type: ESTIMATED name: Active tVNS name: Sham tVNS measure: Mean change in baroreflex gain (ms/mmHg) measure: Mean change in baroreflex gain (ms/mmHg) measure: Mean change in MSNA burst incidence (bursts/100 heartbeats) measure: Mean change in peak O2 consumption (mL/Kg/min) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Michele Emdin city: Pisa state: Pi zip: 56120 country: Italy name: Michele Emdin, MD, PhD role: CONTACT email: emdin@ftgm.it name: Francesco Gentile, MD role: SUB_INVESTIGATOR name: Claudio Passino, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06355375 id: 02.24 briefTitle: Exercise in Pregnancy and Risk of Postpartum Depression overallStatus: RECRUITING date: 2024-03-22 date: 2025-01-01 date: 2025-12-01 date: 2024-04-09 date: 2024-04-09 name: Federico II University class: OTHER briefSummary: The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day conditions: Depression conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Exercise during pregnancy primaryPurpose: PREVENTION masking: NONE count: 398 type: ESTIMATED name: exercise in pregnancy measure: edinburgh depression scale measure: Postpartum depression measure: preterm birth sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Gabriele Saccone status: RECRUITING city: Naples zip: 80100 country: Italy name: Gabriele Saccone role: CONTACT phone: 0817461111 email: gabriele.saccone.1990@gmail.com lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06355362 id: HeCoMo briefTitle: Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality acronym: HeCoMo overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-06-30 date: 2024-04-09 date: 2024-04-22 name: Kliniken Essen-Mitte class: OTHER briefSummary: Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature.

The aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic.

In the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study.

In addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities. conditions: High-risk Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Incidence of postoperative complications measure: Incidence of postoperative mortalities measure: Implementation rate of preoperative factors impacting postoperative outcome measure: Intraoperative hemodynamic characteristics measure: Postoperative haemodynamic characteristics measure: Co-morbidities of patients measure: Transfusion of blood components and administration of coagulation factors measure: Score of the physical/pathological activity status of the patients measure: Clinical frailty scale measure: Characteristics of perioperative care, time in perioperative units and the hospital measure: Characteristics of provision of anesthesia and type of pain therapy measure: Implementation rate of items perioperatively impacting outcome within an Enhanced-Recovery-After-Surgery pathway description sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355349 id: JW22101 briefTitle: To Evaluate the Safety and PK Characteristics in Healthy Volunteers overallStatus: COMPLETED date: 2023-04-28 date: 2023-07-10 date: 2023-07-17 date: 2024-04-09 date: 2024-04-09 name: JW Pharmaceutical class: INDUSTRY briefSummary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 46 type: ACTUAL name: Reference Drug or Test Drug measure: AUCt measure: Cmax sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Clinical Trial Center, Jeonbuk National University Hospital city: Jeonju country: Korea, Republic of lat: 35.82194 lon: 127.14889 hasResults: False

 nctId: NCT06355336 id: CCA/IRN-24-001 briefTitle: Real World Prostate Cancer Registry acronym: RWPCR overallStatus: RECRUITING date: 2024-03-18 date: 2034-03-18 date: 2034-03-18 date: 2024-04-09 date: 2024-04-09 name: Cincinnati Cancer Advisors class: NETWORK briefSummary: Prostate cancer is the most common cancer diagnosed in men in the USA with 268,490 cases diagnosed in 2022 constituting 27% of male cancers and 34,500 deaths (11%) occurred in same year.1 Prostate cancer is a very heterogeneous disease that has different presentations, molecular and pathological features, stages, and disease biology. The treatment options are dependent on the disease stage, its features, and the patient's condition and preferences. The disease outcome also varies significantly due to the previous heterogeneity of the features in addition to other social determinants of health.

Therefore, it is critical to obtain real-world data that reflects the actual patterns of prostate cancer presentation, work up, management, and outcome. Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: To determine practice patterns for prostate cancer in the region. measure: To determine progression free survival and overall survival of patients. measure: Prevalence of long term complications of prostate cancer treatment. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cincinnati Cancer Advisors status: RECRUITING city: Cincinnati state: Ohio zip: 45212 country: United States name: Dr. Jazieh role: CONTACT phone: 513-731-2273 email: a.jazieh@cincinnaticanceradvisors.org name: Amy Barber role: CONTACT phone: 5137312273 email: ctcoordinator@iresearchnetwork.com name: Abdul R Jazieh, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 hasResults: False

 nctId: NCT06355323 id: PT22020 briefTitle: Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France acronym: PREDDICHA overallStatus: RECRUITING date: 2022-11-28 date: 2025-11-28 date: 2025-11-28 date: 2024-04-09 date: 2024-04-09 name: CHU de Reims class: OTHER briefSummary: Primary humoral immunodeficiency (PHID), such as common variable immunodefiency, are the most common symptomatic primary immunodeficiency in adults, in France. Patients are more prone to infections (particularly bacterial upper and lower respiratory tract infections), auto-immunity and atopic manifestations. Morbidity and mortality in PHID are mainly linked to the presence of bronchiectasis, which can lead to infections and to chronic respiratory failure. However, bronchiectasis in these patients can be asymptomatic for a long time. There is no known predictive factors to identify patients more susceptible to develop bronchiectasis and notably, there was no link between the number of previous infectious episodes and bronchiectasis. A marked IgM deficiency and switched memory B cell deficiency might be associated with bronchiectasis.

Thoracic CT-scan is recommended at PHID diagnosis but there is no guideline for follow-up, thus leading to bronchiectasis being under-diagnosis or leading to delayed diagnosis conditions: Primary Immunodeficiency conditions: Common Variable Immunodeficiency conditions: Igg Subclass Deficiency conditions: Selective IgM Deficiency studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 75 type: ESTIMATED name: Blood test name: chest CT scan measure: Thoracic CTscan measure: Pulmonary Function Test measure: Pulmonary Function Test measure: Pulmonary Function Test measure: Pulmonary Function Test measure: Pulmonary Function Test measure: Pulmonary Function Test measure: 6 minutes walking test measure: 6 minutes walking test measure: 6 minutes walking test measure: 6 minutes walking test measure: Quality of life questionnaires measure: Quality of life questionnaires measure: Immunophenotyping measure: Biochemical factors : desmosine seric concentration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damien JOLLY status: RECRUITING city: Reims country: France name: Amélie SERVETTAZ role: CONTACT phone: 03 26 83 27 68 9 phoneExt: 0033 email: aservettaz@chu-reims.fr name: Ailsa ROBBINS role: CONTACT phone: 03 26 83 27 68 phoneExt: 0033 email: arobbins@chu-reims.fr lat: 49.25 lon: 4.03333 hasResults: False

 nctId: NCT06355310 id: IRB 2023-6429 briefTitle: Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease acronym: SHIELD overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2028-12-31 date: 2028-12-31 date: 2024-04-09 date: 2024-04-09 name: Ann & Robert H Lurie Children's Hospital of Chicago class: OTHER briefSummary: This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity. conditions: Non-Alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 randomization primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: double blind placebo control whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Empagliflozin 10 MG name: Placebo Oral Tablet measure: Hepatic Fat measure: Body mass index sex: ALL minimumAge: 16 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06355297 id: 124CER19. briefTitle: Educational Intervention Related to Pelvic Floor Care in Females in Sport: ACTITUD acronym: ACTITUD overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-09 date: 2024-05-22 date: 2024-06-20 date: 2024-04-09 date: 2024-04-23 name: University of the Balearic Islands class: OTHER briefSummary: Pelvic floor dysfunctions (PFD) are especially prevalent among females who practice and compete in sport. One of the main reason is the great physical effort required to achieve the maximal sports performance. As conservational management, increasing the females' information is an important research line. However, gender stereotypes, embarrassment and normalization among females make it difficult to seek professional care. In this situation, prevention or management of PFD is limited.

New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational intervention compounded by three sessions (60 min of duration) with one week apart, about PFD, habits related with it, and existing gender stereotypes.

To this end, all female who practice and compete in any sport in Spain will be invited to attend an educational online intervention with theoretical-practical content about PFD. As eligibility criteria, participants should train and compete in any sport, and have federative license from regional or national sports federation at the moment of the start of the study. Participants should have at least 16 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational intervention. Before the educational intervention, all females will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD self-reported diagnosis. One month later, this questionnaire will be sent to females (both athletes who attended the educational intervention or not) to describe changes after attending the online educational intervention and compared to those females who did not attend it. The main outcomes will be the level of knowledge about PF, the number of habits potentially related to PFD, and score of gender stereotyped beliefs. As an additional outcome, it will be considered the PFD self-reported symptomatology. conditions: Pelvic Floor Disorders studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group. primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: Education about pelvic floor measure: Knowledge about pelvic floor measure: Habits related to pelvic floor dysfunctions measure: Gender stereotypes beliefs measure: Occurrence of symptoms related to pelvic floor dysfunctions sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of the Balearic Islands city: Palma De Mallorca state: Balearic Islands zip: 07122 country: Spain lat: 39.56939 lon: 2.65024 hasResults: False

 nctId: NCT06355284 id: D5150-P briefTitle: Overcontrol and Suicide in PTSD acronym: OSP overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-02-27 date: 2026-04-30 date: 2024-04-09 date: 2024-04-09 name: VA Office of Research and Development class: FED briefSummary: High standards and self-discipline are prized in military culture, but drawbacks of overcontrol are often ignored. Overcontrol is characterized by over-regulated behavior and cognitive rigidity, driven by an intense need for perfection and control. It is frequently observed in people with obsessive-compulsive (OC) spectrum disorders, especially OC Personality Disorder (OCPD). Their inclination to set high expectations for others can strain social bonds. When grappling with mental health challenges, overcontrolled individuals often do so with limited social support, and as a result, tend to be at greater risk of developing more severe mental health symptoms, or suicidal thoughts and behaviors, over time.

New treatments are needed to improve social functioning in these vulnerable Veterans. Adding brain stimulation to psychotherapy is one method that might speed learning of social skills discussed in therapy. However, before this technology can be developed and tested more broadly, the investigators must make sure that the methods used to measure social functioning and related brain circuits are acceptable to most potential patients and can be used consistently.

In this pilot project, the investigators aim to recruit trauma-exposed Veterans with overcontrolled traits and study the feasibility and acceptability of:

1. Our recruitment strategy and social functioning and mental health symptom assessments
2. A three-session, weekly fMRI protocol.
3. A three-week online protocol for remote monitoring of social and emotional functioning. conditions: Compulsive Personality Disorder conditions: Stress Disorders, Post-Traumatic studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 74 type: ESTIMATED name: Functional MRI measure: Number of potential participants screened per month meeting the overcontrol criterion. measure: Percentage of sessions completed by participants receiving MRI. measure: Percentage of remote questionnaires completed. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Providence VA Medical Center, Providence, RI city: Providence state: Rhode Island zip: 02908-4734 country: United States name: Jennifer L Barredo role: CONTACT phone: 401-273-7100 phoneExt: 6290 email: Jennifer.Barredo@va.gov name: Jennifer L Barredo role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 hasResults: False

 nctId: NCT06355271 id: 2024-00019 briefTitle: Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery acronym: MoFe overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-08-31 date: 2025-09-01 date: 2024-04-09 date: 2024-04-10 name: Ente Ospedaliero Cantonale, Bellinzona class: OTHER briefSummary: Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery conditions: Obstetric Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program. The identification code will be present on the data collection form (where the patient's name, surname or date of birth will not appear to ensure blinding of the study).

Personnel not directly involved with patient care, present during the randomization process, will sterilely prepare anesthesia solution while maintaining a total volume of 3,1 ml. This will allow blinding of patients, care providers and data collectors. The procedure will take place as a common clinical practice in our center. When performing spinal anesthesia, sterility is of fundamental importance, so it will not be possible to have the syringe used tagged. In the kit all materials will be sterile whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 63 type: ESTIMATED name: Fentanyl 1 name: Fentanyl2 name: Fentanyl 3 measure: Patient Controlled Analgesia morphine consumption measure: obstetric quality of recovery score measure: Visual Analogue Scale measure: pruritus measure: nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity measure: intraoperative hypotension measure: intraoperative opioids measure: satisfaction rate measure: intraoperative pain sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355258 id: 20230817LX001 briefTitle: A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients overallStatus: RECRUITING date: 2023-09-15 date: 2024-09 date: 2025-03 date: 2024-04-09 date: 2024-04-09 name: Westlake University class: OTHER name: Shaoxing Central Hospital briefSummary: The goal of this clinical trial is to learn if troxerutin works to prevent thrombotic events in mild or severe COVID-19 patients. It will also learn about the safety of troxerutin. The main questions it aims to answer are:

* Does troxerutin lower the number of thrombotic events in participants?
* What medical problems do participants have when taking troxerutin? Researchers will compare troxerutin to a placebo (a look-alike substance that contains no drug) to see if troxerutin works to prevent thrombotic events in COVID-19 patients.

Participants will:

* Take troxerutin or a placebo every day for 7 days.
* Visit the clinic at the first, fourth, seventh and 28th days after enrollment for checkups and tests
* Keep a diary of their symptoms and the number of times of thrombotic events, bleeding events and type II HIT-related thrombocytopenia conditions: COVID 19 Associated Coagulopathy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: According to the inclusion criteria, participants will be randomly divided into mild patients and severe patients, and then patients with severe disease were randomly assigned to placebo + low molecular weight heparin group or troxerutin + low molecular weight heparin group, and patients with mild disease were randomly assigned to placebo group or troxerutin group primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Troxerutin name: Placebo name: placebo + low molecular weight heparin name: troxerutin + low molecular weight heparin measure: Overall number of thrombotic events through 28 days measure: Tolerability of anticoagulation therapy measure: Time to clinical improvement in patients through 28 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shaoxing central hospital status: RECRUITING city: Shaoxing state: Zhejiang country: China name: Xu Li, Doctor role: CONTACT phone: 13811635032 email: lixu@westlake.edu.cn lat: 30.00237 lon: 120.57864 hasResults: False

 nctId: NCT06355245 id: 2017/2160-31/1 briefTitle: MEDECA - Markers in Early Detection of Cancer acronym: MEDECA overallStatus: RECRUITING date: 2018-03-01 date: 2026-12 date: 2026-12 date: 2024-04-09 date: 2024-04-09 name: Danderyd Hospital class: OTHER briefSummary: Early diagnosis of cancer is key for improving patient outcomes, but cancers are difficult to diagnose if patients present with unspecific symptoms. The principal objective of the MEDECA (Markers in Early Detection of Cancer) study is to identify a multi-analyte blood test that can detect and map occult cancer within a mixed population of patients presenting with serious but unspecific symptoms. The study will include 1500 patients referred to the Diagnostic Center at Danderyd Hospital (DC DS), a multidisciplinary diagnostic center referral pathway for patients with radiological findings suggestive of metastasis without known primary tumor or suspicion of serious but unspecific symptoms. Blood samples are collected prior to a standardized and extensive cancer diagnostic work-up, including an expanded panel of biochemical analyses and extensive imaging such as computed tomography or magnetic resonance investigations. In collaboration with world-leading international scientists, the blood samples will be analyzed for a panel of novel and established blood biomarkers predictive of an underlying cancer, including markers of neutrophil extracellular traps, circulating tumor DNA, platelet mRNA profiling, affinity-based proteomics and nuclear magnetic resonance metabolomics. The diagnostic accuracy of the blood biomarkers with respect to cancer detection during the diagnostic work-up will be analyzed through machine learning. conditions: Cancer conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: Blood sampling measure: Cancer diagnosis measure: Other diagnosis measure: Mortality measure: Cancer diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danderyd Hospital status: RECRUITING city: Stockholm country: Sweden name: Charlotte Thålin, M.D., Ph.D. role: CONTACT phone: +46709565120 email: charlotte.thalin@regionstockholm.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06355232 id: Vaxine-2301 briefTitle: Covid-19 and Influenza Oral Vaccine Study overallStatus: NOT_YET_RECRUITING date: 2024-04-21 date: 2024-04-21 date: 2025-04-21 date: 2024-04-09 date: 2024-04-09 name: Vaxine Pty Ltd class: INDUSTRY name: Australian Respiratory and Sleep Medicine Institute Ltd briefSummary: The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines. conditions: covid19 Infection conditions: Influenza, Human studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomised, controlled cross-over study primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: A comparator vaccine (influenza) with an identical appearance will be used as the control. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Covid-19 vaccine name: Influenza vaccine measure: SARS-CoV-2 Seroconversion measure: Influenza Seroconversion measure: SARS-CoV-2 Seroprotection measure: Influenza Seroprotection measure: SARS-CoV-2 Geometric mean titer fold change measure: Influenza geometric mean titer fold change measure: Safety assessment 1 measure: Safety assessment 2 measure: SARS-CoV-2 infection measure: Influenza infection measure: Antibody durability measure: Seroconversion in participants with and without evidence of past infection measure: Antibody GMT in participants with and without evidence of past infection measure: Antibody correlates of protection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ARASMI city: Adelaide state: South Australia zip: 5042 country: Australia lat: -34.92866 lon: 138.59863 hasResults: False

 nctId: NCT06355219 id: IRB #19-066 briefTitle: Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines acronym: M6 overallStatus: ACTIVE_NOT_RECRUITING date: 2010-01-01 date: 2022-12-31 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: Ali Aminian class: OTHER briefSummary: The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths. conditions: Type 2 Diabetes Mellitus conditions: Obesity conditions: Microvascular Disease conditions: Macrovascular Disease conditions: Major Adverse Cardiovascular Events conditions: Nephropathy conditions: Retinopathy conditions: Heart Failure conditions: All Cause Mortality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3932 type: ACTUAL measure: All-cause Mortality Rate measure: Incidence of MACE measure: Incidence of Nephropathy measure: Incidence of Retinopathy measure: Incidence of Components of MACE Separately measure: Change in weight percentage measure: Change HBA1c percentage measure: Trends of prescription and dispenses of medications for T2DM and cardio-vascular conditions measure: Progression of Chronic Kidney Disease (CKD) in Patients with CKD stages 3 and 4 at baseline measure: Cost-effectiveness of Metabolic Surgery vs GLP-1RAs measure: Incidence of Adverse Events After Metabolic Surgery sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355206 id: NACRE20230306 briefTitle: Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis acronym: NACRE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2034-12 date: 2034-12 date: 2024-04-09 date: 2024-04-09 name: Changhai Hospital class: OTHER briefSummary: The goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. The main question it aims to answer is:

Does endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? What are the risk factors affecting the recurrence of acute pancreatitis?

Patients will be closely followed and clinical information will be recorded. conditions: Cohort Study conditions: Recurrent Acute Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: endoscopic intervention, surgery or conservative treatment measure: Recurrence rate of acute pancreatitis measure: Proportion of patients with different treatment measure: Characteristics of acute pancreatitis measure: Proportion of patients wtih pain in RAP patients measure: Proportion of patients with chronic pancreatitis measure: Evaluation of quality of life measure: Evaluation of psychological condition sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355193 id: MZhou briefTitle: The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study overallStatus: COMPLETED date: 2022-11-01 date: 2022-12-30 date: 2022-12-31 date: 2024-04-09 date: 2024-04-09 name: Central South University class: OTHER briefSummary: This study has significant implications for research, as it provides a basis for further studies on the antiviral effects of LGLQ Oral Liquid, encouraging more extensive clinical studies in larger populations and diverse age groups to validate these findings. For medical practice, the findings suggest that LGLQ can be considered an alternative treatment option for mild cases of COVID-19, especially in managing symptoms like fatigue, potentially broadening the range of effective treatments available to healthcare practitioners. In terms of policy, the demonstrated efficacy of LGLQ could lead to its inclusion in treatment guidelines for COVID-19 and other viral infections, fostering a more integrated approach combining Western medicine and Traditional Chinese Medicine in the global fight against pandemics. The insights from this study might prompt health policymakers to reassess the potential of herbal formulations in managing and treating infectious diseases and consider them in the development of future healthcare strategies and policies. conditions: Treatment of Mild Cases of COVID-19 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 253 type: ACTUAL name: Langenlianqiao name: LianhuaQingWen name: placebo control group measure: Treatment and symptomatic improvement effects of LGLQ sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changde Hospital city: Changde state: Hunan country: China lat: 29.04638 lon: 111.6783 hasResults: False

 nctId: NCT06355180 id: Shoudufazhan2024-1-2122 briefTitle: Esketamine Treatment for Depressive Episodes With Suicidal Ideation in Mood Disorders overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-09 date: 2024-04-09 name: Capital Medical University class: OTHER name: Wuhu Fourth People's Hospital name: The Second People's Hospital of Dali Bai Autonomous Prefecture name: Inner Mongolia Autonomous Region Mental Health Center name: Beijing Chaoyang District Third Hospital name: Beijing Daxing District Xinkang Hospital name: Capital's Funds for Health Improvement and Research briefSummary: This study is a multicenter, non-inferiority, randomized, parallel-group, open-label clinical trial aimed at evaluating the effectiveness of esketamine versus modified electroconvulsive therapy (MECT) in treating suicidal ideation during depressive episodes of mood disorders. Additionally, it seeks to explore the potential mechanisms of esketamine's anti-suicidal effects. conditions: Mood Disorders conditions: Suicidal Ideation conditions: Depressive Episode studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients will be randomized to either the esketamine group or the MECT group, but due to the differences in treatment modalities, it will not be possible to blind the subjects and investigators. To ensure the objectivity of the measurements, independent assessors will be established. These assessors are psychiatrists trained in the consistency of the scales and will remain blinded to the group allocation of the subjects throughout the entire assessment process. whoMasked: OUTCOMES_ASSESSOR count: 340 type: ESTIMATED name: Subanesthetic dose intravenous esketamine name: Modified electroconvulsive therapy measure: Suicide remission rate based on the Scale for Suicidal Ideation (SSI) measure: Quick Inventory of Depressive Symptoms Self Report (QIDS-SR) measure: Columbia Suicide Severity Rating Scale (CSSR-S) measure: Montgomery Asberg Depression Rating Scale (MADRS) measure: Clinical Global Impressions(CGI) measure: Short Form 12 Health Survey(SF-12) measure: Sheehan Disability Scale(SDS) measure: Digital Span Test(DST) measure: Digit Symbol Substitution Test(DSST) measure: Perceived Deficit Questionnaire for Depression 5-item(PDQ-D-5) measure: Young Mania Rating Scale (YMRS) measure: Clinician Administered Dissociative States Scale(CADSS) measure: Adverse event sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355167 id: Bacoxy_I briefTitle: Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress acronym: Bacoxy_I overallStatus: COMPLETED date: 2022-03-15 date: 2022-05-25 date: 2022-09-30 date: 2024-04-09 date: 2024-04-10 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress. conditions: Oxidative Stress conditions: Cardiovascular Diseases conditions: Bacopaside II conditions: Bacopa Monnieri conditions: Endothelial Dysfunction conditions: Aquaporin 1 conditions: AQP1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group A (n=10): 400mg/d of Bacopa monnieri Broup B (n=10): 800 mg/d of Bacopa monnieri primaryPurpose: PREVENTION masking: NONE count: 20 type: ACTUAL name: Bacopa monnieri measure: Ex vivo DCFDA test on red blood cells (RBCs) measure: Plasma lipid peroxydes measure: Methemoglobin in red blood cells measure: Nitrosylated hemoglobin (HbNO) in red blood cells measure: haemoglobin measure: haematocrit measure: Red blood cells count measure: Sodium measure: Potassium measure: Bicarbonate measure: Total cholesterol measure: High-Density Lipoprotein (HDL) cholesterol measure: Low-Density Lipoprotein (LDL) cholesterol measure: Triglycerides measure: aspartate aminotransferase (ASAT), (U/L) measure: alanine aminotransferase (ALAT) (U/L) measure: gamma-glutamyl-transferase (GGT) level measure: Creatinine measure: Glomerular filtration rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique universitaires saint luc city: Brussels zip: 1200 country: Belgium lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06355154 id: 069823- HMO-CTIL briefTitle: Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-02-01 date: 2024-04-09 date: 2024-04-09 name: Hadassah Medical Organization class: OTHER briefSummary: Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, ≤120g/day) versus SCD improves glycemic control and alters metabolomic profiles in pregnant individuals on IIT.

Aims: To compare the efficacy and safety of a SCD versus MCD on glycemic control, metabolomic signatures, and pregnancy outcomes in pregnant individuals on IIT. conditions: Diabetes in Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open label, randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Nutritional intervention measure: Time in range measure: Time above range sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06355141 id: E-15189967-050.04-494458 briefTitle: Oral Structural and Functional Problems in Children With Autism overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2024-05-13 date: 2024-08-12 date: 2024-04-09 date: 2024-04-09 name: Hacettepe University class: OTHER briefSummary: This study aims to examine oral structural and functional problems in children with autism. conditions: Autism Spectrum Disorder conditions: Chewing Problem conditions: Drooling studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: oral assessment measure: Demographic Information Form measure: Time to achieve Oromotor skills measure: Oral structural assessment measure: Chewing evaluation measure: Drooling of saliva evaluation measure: Tongue thrust evaluation sex: ALL minimumAge: 5 Years maximumAge: 15 Years stdAges: CHILD hasResults: False

 nctId: NCT06355128 id: 20240307 briefTitle: A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-02-18 date: 2024-04-30 date: 2024-04-09 date: 2024-04-09 name: Zhongnan Hospital class: OTHER name: Qichun People's Hospital briefSummary: To investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022 conditions: COVID-19 conditions: Ocular Surface Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 16000 type: ACTUAL name: NOT measure: Questionnaire data were collected and statistically analyzed. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongnan Hospital of Wuhan University city: Wuhan state: Hubei zip: 430071 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06355115 id: 400/218/K.3/302/2023 briefTitle: Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation acronym: PACE-PRO overallStatus: RECRUITING date: 2023-09-01 date: 2024-09-01 date: 2024-09-01 date: 2024-04-09 date: 2024-04-09 name: University of Brawijaya class: OTHER name: Saiful Anwar Hospital briefSummary: The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection. Therefore, administering prophylactic antibiotics to prevent infections before they occur, is a useful strategy to lower the risk of such infections.

Nonetheless, the optimal duration of prophylactic antibiotics for PPM remains uncertain. Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use. Accordingly, the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations.

The main questions it aims to answer are:

1. What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations?
2. What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications?

Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections.

Participants will:

* Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations.
* Visit the clinic for follow-ups and tests. conditions: Pacemaker Complication studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Cefazolin 1000 MG Injection measure: Number of participants with early pocket infection (EPI) measure: Number of participants with late pocket infection (LPI) measure: Number of participants with infective endocarditis (IE) measure: Number of participants who underwent pacemaker revision measure: Level of C-reactive protein (mg/dl) measure: Level of procalcitonin (mcg/dl) measure: Erythrocyte sedimentation rate (ESR) (mm/hour) measure: Neutrophil-to-leukocyte ratio (NLR) measure: Neutrophil count (cells/mm3) measure: Leukocyte count (cells/mm3) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RSUD Dr. Saiful Anwar status: RECRUITING city: Malang state: Jawa Timur zip: 65112 country: Indonesia name: RSUD Dr. Saiful Anwar role: CONTACT phone: 0341-362101 email: staf-rsu-drsaifulanwar@jatimprov.go.id lat: -7.9797 lon: 112.6304 hasResults: False

 nctId: NCT06355102 id: 2024-SR-116 briefTitle: The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-31 date: 2026-03-31 date: 2024-04-09 date: 2024-04-09 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The goal of this clinical trial is to investigate the factors and mechanisms underlying tinnitus generation and chronification in patients with sudden sensorineural hearing loss (SSNHL) . The main questions it aims to answer are:

* What are the peripheral and central influencing factors that contribute to tinnitus in patients with SSNHL?
* Can serum metabolic biomarkers be identified to predict and monitor tinnitus prognosis in these patients?

Participants in this study will include patients with SSNHL and tinnitus, patients with SSNHL without tinnitus, and healthy subjects. They will be asked to undergo a series of assessments, including audiological tests, vestibular function examinations, and functional magnetic resonance imaging (fMRI). Additionally, blood samples will be collected for metabolomics analysis.

Investigators will compare the brain functional states and serum metabolite profiles of patients with SSNHL and tinnitus to those without tinnitus. Morever, tinnitus symptom characteristics, audiological outcomes, and brain functional states will be assessed during time. conditions: Sudden Sensorineural Hearing Loss conditions: Tinnitus studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Brain function states measure: Serum metabolomics sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355089 id: VAR-MIKRO briefTitle: Intestinal Microbiota: Immunity, Recovery and Metabolic Health acronym: VAR-MIKRO overallStatus: COMPLETED date: 2023-01-09 date: 2023-09-07 date: 2023-09-07 date: 2024-04-09 date: 2024-04-09 name: University of Turku class: OTHER name: Government Body Funding briefSummary: The aim of this intervention study is to investigate the effect of a specific postbiotic (Lacticaseibacillus rhamnosus GG = LGG) and whey protein on immunity, recovery, and weight management in young adults. The objective is based on previous knowledge about the health-promoting effects of these factors. A new goal is to study the combined effect of the postbiotic and whey protein. The results of the study can be utilized to promote the health of the young adults. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ACTUAL name: Placebo Comparator name: Whey protein hydrolysate milk product name: Postbiotic and whey protein hydrolysate milk product measure: Concentrations of inflammatory markers from the blood samples measure: Gut microbiota composition in feces measure: Weight of the participant measure: Waist circumference of the participant measure: Infections during the intervention measure: Development of physical fitness measure: Sleep quality measure: Recovery measure: Blood pressure measure: BMI sex: ALL minimumAge: 17 Years maximumAge: 28 Years stdAges: CHILD stdAges: ADULT facility: University of Turku city: Turku country: Finland lat: 60.45148 lon: 22.26869 hasResults: False

 nctId: NCT06355076 id: CSZ03 briefTitle: New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection overallStatus: RECRUITING date: 2023-02-05 date: 2026-06 date: 2026-06 date: 2024-04-09 date: 2024-04-09 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are:

Is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? The researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation.

Participants will:

The intervention group adopted the new reconstruction proposed by our team; End-to-end anastomosis was performed in non-intervention group. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group received a new urethral reconstruction technique, which involves suturing the levator ani muscle with the lateral striated muscle of the urethra, the dorsal median ridge (MDR), and the Di's fascia together for continuous suturing before performing bladder urethral anastomosis. After the reconstruction is completed, the end to end anastomosis of the bladder urethra is performed primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients in the experimental or control group, as well as their family members, are unaware whoMasked: PARTICIPANT count: 94 type: ESTIMATED name: New urethral reconstruction measure: Recovery of urinary incontinence measure: complication measure: PSA measure: recurrence sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu hospital status: RECRUITING city: Jinan state: Shandong zip: 276600 country: China name: shouzhen chen role: CONTACT phone: 18560089085 email: 201900412102@mail.sdu.edu.cn lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06355063 id: NP-PCF-037 briefTitle: CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-08-31 date: 2025-10-31 date: 2024-04-09 date: 2024-04-09 name: Pulse Biosciences, Inc. class: INDUSTRY briefSummary: This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure. conditions: Atrial Fibrillation conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is a prospective, multicenter, single arm, non-randomized, feasibility study. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CellFX® nsPFA™ Cardiac Surgery System measure: Rate of acute major adverse events (MAEs) measure: Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial free wall. measure: Proportion of Participants with one or more SAEs measure: Number of Participants with Long-Term Technical Success sex: ALL minimumAge: 22 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Academic Medical Center city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 facility: Maastricht University Medical Center city: Maastricht country: Netherlands lat: 50.84833 lon: 5.68889 facility: St. Antonius Hospital city: Nieuwegein country: Netherlands lat: 52.02917 lon: 5.08056 hasResults: False

 nctId: NCT06355050 id: UKJ-ultraHART briefTitle: Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer acronym: ultraHART overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-09-30 date: 2031-09-30 date: 2024-04-09 date: 2024-04-09 name: Jena University Hospital class: OTHER name: University Hospital Schleswig-Holstein name: Klinikum Stuttgart briefSummary: In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered with by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively. conditions: Prostate Cancer conditions: Adaptive Radiotherapy conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Toxicity (CTCAE v5.0) measure: Quality of Life (EPIC 26) measure: Planning parameters measure: Dose constraints measure: Conformity indices measure: Quality of adaptive planning measure: PSA-value measure: Overall survival measure: Recurrence free survival sex: MALE minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Radiotherapy and Radiation Oncology, Jena University Hospital city: Jena country: Germany name: Klaus Pietschmann, MD role: CONTACT email: klaus.pietschmann@med.uni-jena.de name: Georg Wurschi, MD role: PRINCIPAL_INVESTIGATOR lat: 50.92878 lon: 11.5899 hasResults: False

 nctId: NCT06355037 id: B2024.1.30 briefTitle: Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2025-01-31 date: 2024-04-09 date: 2024-04-09 name: Fudan University class: OTHER briefSummary: This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of dasatinib, quercetin with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy. conditions: Triple-negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Quercetin name: Dasatinib name: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Progression Free Survival (PFS) measure: Safety and treatment-related AEs measure: Biomarker analysis1 measure: Biomarker analysis2 sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355024 id: A2024.1.30 briefTitle: Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2025-01-31 date: 2024-04-09 date: 2024-04-09 name: Fudan University class: OTHER briefSummary: This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of Inosine with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy. conditions: Triple-negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Inosine name: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Progression Free Survival (PFS) measure: Biomarker analysis1 measure: Safety and treatment-related AEs sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06355011 id: 7016194 briefTitle: Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data overallStatus: COMPLETED date: 2024-03-01 date: 2024-04-02 date: 2024-04-02 date: 2024-04-09 date: 2024-04-09 name: University of Manchester class: OTHER name: The National Joint Registry name: The Royal College of Surgeons of England name: John Charnley Trust name: University of Bristol briefSummary: The goal of this observational registry study is to provide detailed descriptions of the patients who are receiving primary total elbow replacement surgery in England. The main questions it aims to answer are:

* Who are receiving primary total elbow replacement surgery?
* Where and by whom is the total elbow replacement surgery is being performed?
* What the current surgical practices for total elbow replacement?

Pseudonymous data from the National Joint Registry NJR of all patients with total elbow replacement will be used. conditions: Total Elbow Replacement studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3891 type: ACTUAL name: Total Elbow Replacement measure: The incidence of total elbow replacement (TER) in England measure: Serious adverse events or re-admissions measure: Duration of elective wait measure: Post-operative duration of stay measure: Surgeon volume measure: Hospital volume measure: Patient characteristics (Age) measure: Body mass index measure: Hand dominance measure: American Society of Anaesthesiologists (ASA) grade measure: Indication for total elbow replacement measure: Socioeconomic status measure: Ethnicity measure: Co-morbidities measure: Charlson Comorbidity Index measure: Implant classification measure: Fixation type measure: Implant type measure: If radial head replacement was used measure: Grade of primary surgeon measure: Funding measure: Elective admission type sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre city: Manchester zip: M13 9PT country: United Kingdom lat: 53.48095 lon: -2.23743 hasResults: False

 nctId: NCT06354998 id: mRNA-1273-P401 briefTitle: A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults overallStatus: RECRUITING date: 2024-04-08 date: 2024-06-01 date: 2024-06-01 date: 2024-04-09 date: 2024-04-22 name: ModernaTX, Inc. class: INDUSTRY briefSummary: To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). conditions: SARS-CoV-2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Investigational mRNA-1273.815 name: Licensed Spikevax Vaccine measure: Geometric Mean of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15 measure: Number of Participants with Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study measure: Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain at Day 15 measure: Geometric Mean Ratio of nAb Against the SARS-CoV-2-specific Strain for Investigational mRNA-1273.815 Over the Licensed Spikevax Vaccine at Day 15 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Paratus Canberra status: RECRUITING city: Canberra state: Australian Capital Territory zip: 2617 country: Australia lat: -35.28346 lon: 149.12807 facility: Holdsworth House status: RECRUITING city: Darlinghurst state: New South Wales zip: 2010 country: Australia lat: -33.87939 lon: 151.21925 facility: Paratus Brisbane status: RECRUITING city: Brisbane state: Queensland zip: 2617 country: Australia lat: -27.46794 lon: 153.02809 facility: USC Morayfield status: NOT_YET_RECRUITING city: Morayfield state: Queensland zip: 4506 country: Australia lat: -27.10876 lon: 152.94907 facility: University of the Sunshine Coast, South Bank status: RECRUITING city: South Brisbane state: Queensland zip: 4101 country: Australia lat: -27.48034 lon: 153.02049 facility: Emeritus Melbourne status: RECRUITING city: Camberwell state: Victoria zip: 3124 country: Australia lat: -37.84205 lon: 145.0694 facility: AusTrials Sunshine Hospital status: RECRUITING city: Melbourne state: Victoria zip: 3021 country: Australia lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06354985 id: 23-5996 id: MODEX2023 type: OTHER domain: Clinical Trial Protocol Number id: FRN:183960 type: OTHER_GRANT domain: CIHR id: CTO Project ID: 4701 type: OTHER domain: Clinical Trials Ontario briefTitle: Modafinil and Exercise for Post Stroke Fatigue acronym: MODEX overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2027-09 date: 2027-09 date: 2024-04-09 date: 2024-04-09 name: University Health Network, Toronto class: OTHER briefSummary: A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke.

Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has two main aims:

1. Test if Exercise Program One is better than Exercise Program Two
2. Test if Modafinil is better than a Sugar Pill

As another aim, the investigators will also look at if combining Modafinil with exercise has any benefits.

This study will take place at 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels.

Participants will be assigned at random (like flipping a coin) to 1 of 4 groups:

1. Sugar Pill plus Exercise Program One
2. Sugar Pill plus Exercise Program Two
3. Modafinil plus Exercise Program One
4. Modafinil plus Exercise Program Two

The treatment will last 8 weeks. The Modafinil or Sugar Pill will be taken once a day. The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week. Change in fatigue, quality of life, and other outcomes will be measured over 6 months.

The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke. conditions: Stroke conditions: Fatigue conditions: Modafinil conditions: Exercise studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All members of the research team and the participants will be blinded to medication group allocation, but cannot be blinded to exercise group allocation. Evaluators and the study statistician will be blinded to the exercise group allocation. The study statistician and the rest of the Data Safety Monitoring Board will have access to the medication assignment if needed (e.g. adverse drug reaction). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 224 type: ESTIMATED name: Modafinil 200mg name: Placebo name: Exercise Program One name: Exercise Program Two measure: Severity of Fatigue Symptoms measure: Severity of Fatigue Symptoms measure: Impact on Quality of Life measure: Walking Recovery measure: Leg Strength and Coordination measure: 3-Day Physical Activity Assessment measure: Mood and Anxiety measure: Attention measure: Cognition measure: Health Resource Utilization measure: Quality Adjusted Life Years sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354972 id: SASP Turin briefTitle: Impact of SASP in the GCF on the Outcomes of Periodontal Regeneration overallStatus: COMPLETED date: 2022-01-02 date: 2022-11-02 date: 2024-01-02 date: 2024-04-09 date: 2024-04-09 name: University of Turin, Italy class: OTHER briefSummary: Objectives: To test the impact of clinical inflammation and molecular expression profile (senescence-associated secretory phenotype; SASP) in the gingival crevicular fluid (GCF) on the outcomes of minimally-invasive periodontal regeneration in intra-bony defects.

Methods: Sites associated with intrabony defects ≥ 3 mm requiring periodontal regeneration through minimally-invasive surgical technique were included. Pre-operatively, GCF was sampled for inflammatory biomarker analysis related to SASP \[interleukin (IL)-1β, IL-6 and IL-12; matrix-metalloproteinases (MMP)-8 and -9\]. Correlation analyses and logistic regression models were performed to assess the impact of predictors on clinical and radiographic outcomes. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Minimally invasive surgical procedure measure: Clinical attachment level change measure: Achievement of composite outcome measure measure: Radiographic bone level change measure: Probing pocket depth change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CIR Dental School city: Turin zip: 10126 country: Italy lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06354959 id: 1030020 briefTitle: Prehab for Lung and Esophageal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-01-01 date: 2024-04-09 date: 2024-04-09 name: Nova Scotia Health Authority class: OTHER name: Dalhousie University briefSummary: Research indicates that individuals diagnosed with lung or esophageal cancer who enter treatment with higher functional capacities, improved body composition, and better nutrition status tend to experience better outcomes and a higher quality of life. The primary objective of a prehabilitation health coaching program is to enhance the overall health and well-being of patients before they undergo major surgery.This personalized 8-week program encompasses elements such as nutrition, smoking cessation, sleep hygiene, and movement, equipping participants with the knowledge and tools needed to adopt healthier lifestyles. conditions: Neoplasm of Lung conditions: Neoplasms conditions: Exercise conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 25 type: ESTIMATED name: Prehabilitation measure: Feasibility- Recruitment measure: Feasibility- Participant fidelity measure: Feasibility - Safety measure: Feasibility - Retention/Attrition measure: Feasibility - Participant Experience measure: Feasibility- Attendance measure: Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E) measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) measure: 5x chair stand measure: Stair climb test measure: Grip strength measure: Resting Heart rate measure: Resting blood pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Victoria General Hospital city: Halifax state: Nova Scotia country: Canada name: Jodi Langley role: CONTACT email: jodi.langley@dal.ca lat: 44.64533 lon: -63.57239 hasResults: False

 nctId: NCT06354946 id: SCORE 4C briefTitle: External Validation of Simplified 4C Mortality Score by Deleting CRP acronym: 4Cs overallStatus: COMPLETED date: 2020-01-01 date: 2022-11-30 date: 2022-12-30 date: 2024-04-09 date: 2024-04-09 name: University of Monastir class: OTHER briefSummary: The (Coronavirus Clinical Characterisation Consortoum) 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (Glasgow Coma Scale), urea or blood urea nitrogen (BUN) level, and C reactive protein (CRP). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability. A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use. we aim to validate a modified 4C score. conditions: COVID-19 Pandemic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ACTUAL measure: The primary outcome was all-cause in-hospital mortality rate The primary outcome was all-cause in-hospital mortality rate measure: Number of patients admitted to the ICU sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: EPS Fattouma Bourguiba University hospital city: Monastir zip: 5020 country: Tunisia lat: 35.77799 lon: 10.82617 hasResults: False

 nctId: NCT06354933 id: DemeNSS (3785) briefTitle: Neurological Soft Signs in Neurodegenerative Dementias acronym: DemeNSS overallStatus: COMPLETED date: 2022-04-01 date: 2023-11-30 date: 2024-02-01 date: 2024-04-09 date: 2024-04-15 name: University of Milano Bicocca class: OTHER briefSummary: The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are:

* Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls?
* Are NSS associated with neuropsychiatric alterations in dementia patients?
* Do NSS correlate with cognitive screening tools?
* Do NSS increase over time in patients with neurodegenerative dementias?

Participants will undergo assessments including:

* Evaluation of NSS using the Heidelberg scale
* Neuropsychiatric assessments
* Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB)

Researchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored. conditions: Alzheimer Disease conditions: Dementia With Lewy Bodies conditions: Frontotemporal Dementia conditions: Corticobasal Degeneration studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 186 type: ACTUAL name: Neurological Soft Signs measure: Difference in NSS measure: Association between NSS and Neuropsychiatric Inventory (NPI) scores measure: Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE) measure: Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB) measure: Longitudinal changes in NSS scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS San Gerardo dei Tintori city: Monza state: Lombardia zip: 20900 country: Italy lat: 45.58005 lon: 9.27246 hasResults: False

 nctId: NCT06354920 id: HUM00247781 id: R18HS028963 type: AHRQ link: https://reporter.nih.gov/quickSearch/R18HS028963 briefTitle: M-Well Bonding Bundle to Improve Patient-Physician Relationships overallStatus: RECRUITING date: 2024-04-08 date: 2026-06 date: 2026-06 date: 2024-04-09 date: 2024-04-10 name: University of Michigan class: OTHER name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: The goal of this clinical trial is to learn more about the interaction between a patient in the hospital and their treating doctor. A good relationship between patients and their doctors can help improve patient care. Doctors will be asked to use strategies to improve their interactions with patients in the hospital. The main questions it aims to answer are:

* Will using the intervention strategies improve doctors' empathy towards their patients?
* Will using the intervention strategies lead to improved scores in patient views of doctors' empathy?

There will be 2 study arms. One group of doctors will be asked to use the intervention strategies. The other group of doctors will provide care as they would normally.

Researchers will compare the doctors in the intervention arm to those in the control arm.

Doctors are the primary subjects for this study. The doctors in both study arms will be asked to do the following:

1. Allow study staff to observe the interaction between them and their patients.
2. Complete a brief survey at the end of their 2-week work rotation.

Doctors who are in the intervention arm will be asked to use suggested strategies when visiting with patients in the hospital.

Patients are secondary subjects for this study. Patients of participating doctors may be asked to do the following:

1. Allow study staff to observe the interaction between them and their doctors.
2. Complete a brief survey after meeting with their doctor. conditions: Physician-Patient Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Quasi-experimental randomized controlled trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 3624 type: ESTIMATED name: Bonding Bundle measure: Jefferson Scale of Empathy (JSE) measure: Jefferson Scale of Patient's Perceptions of Physician Empathy (JSPPPE) measure: Communication Assessment Tool measure: Frequency of use of intervention methods measure: Perceived duration of interaction measure: Wake Forest Physician Trust Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Sanjay Saint, MD, MPH role: CONTACT phone: 734-615-8341 email: Saint@umich.edu name: Karen Fowler, MPH role: CONTACT phone: 734-845-3611 email: Karen.Fowler@va.gov name: Sanjay Saint, MD, MPH role: PRINCIPAL_INVESTIGATOR name: Christopher Smith, MD role: SUB_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: VA Ann Arbor Healthcare System status: NOT_YET_RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Nathan Houchens, MD role: CONTACT phone: 734-845-5922 email: nathanho@med.umich.edu name: Karen Fowler, MPH role: CONTACT phone: 734-845-3611 email: Karen.Fowler@va.gov name: Nathan Houchens, MD role: PRINCIPAL_INVESTIGATOR name: Sanjay Saint, MD, MPH role: SUB_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06354907 id: HUM00150780 briefTitle: Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP) acronym: KEP overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-03 date: 2024-10-02 date: 2024-10-02 date: 2024-04-09 date: 2024-04-12 name: University of Michigan class: OTHER briefSummary: Depression and anxiety are major challenges to American children's optimal mental health, with already high rates exacerbated by the Covid-19 pandemic. Yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. Without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. The current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. The mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the Kids' Empowerment Program (KEP) and a comparison group that participates in the program after the second evaluation. Once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the State of Michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life. conditions: Child Mental Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of children and their parent will be compared and evaluated twice (twelve weeks apart). The first group (approximately half of the sample) will participate in the Kids' Empowerment Program in their classroom and their parent will complete assessments online. The second group will complete both assessments and then receive the program in their classroom after the 12 week interval. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: To minimize the possibility of a breach in confidentiality, each child's and parent's information is protected with a code number that will be associated with all of their study materials instead of their name. All identifying information is stored in a separate locked cabinet in the office of Dr. Graham-Bermann. All other study materials (without names) will be kept in a locked cabinet in the research laboratory of Dr. Graham-Bermann to maintain privacy. whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: The Kids' Empowerment Program measure: Revised Children's Anxiety and Depression Scale measure: Strengths and Difficulties Questionnaire measure: Cognitive Emotion Regulation Questionnaire measure: EPOCH Questionnaire sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06354894 id: MACOXS id: 133/2020/U type: REGISTRY domain: MACOXS briefTitle: Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures overallStatus: RECRUITING date: 2020-11-01 date: 2024-11-01 date: 2024-11-01 date: 2024-04-09 date: 2024-04-09 name: University of Turin, Italy class: OTHER briefSummary: The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws. conditions: Proximal Humeral Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Proximal humeral fracture fixation measure: Oxford Shoulder Score (OSS) measure: Quick Disabilities of the arm, shoulder and hand (DASH) score measure: Subjective Shoulder Value (SSV) measure: Radiographic outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Luigi Gonzaga Hospital status: RECRUITING city: Orbassano state: Turin zip: 10043 country: Italy name: Enrico Bellato, MD role: CONTACT phone: +393406429207 email: enrico.bellato@unito.it lat: 45.00547 lon: 7.53813 hasResults: False

 nctId: NCT06354881 id: 0967 id: TM61008S3 type: OTHER_GRANT domain: British Heart Foundation briefTitle: The Relationship Between Controlling Risk Factors and Cerebral Haemodynamics in Lacunar Stroke acronym: LACUNAR_CA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03 date: 2026-03 date: 2024-04-09 date: 2024-04-09 name: University of Leicester class: OTHER name: British Heart Foundation name: University Hospitals, Leicester briefSummary: The goal of this observational study is to look at differences in brain blood flow before and after management of risk factors such as high blood pressure and diabetes in patients with lacunar stroke. Participants will be asked to undergo a simple brain blood flow assessment at their initial appointment, whereby they will be asked to sit and stand twice. The patients will then be asked for a follow-up assessment 4 weeks after, identical to the first. This will allow us to look at any changes in brain blood flow from before management of risk factors and 4 weeks after management of risk factors. conditions: Lacunar Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED name: Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres measure: Cerebral blood velocity measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. measure: Arterial blood pressure measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. measure: Heart rate measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. measure: End-tidal carbon dioxide measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. measure: Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(CA). measure: Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed. (VMR). measure: Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(ARI). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals of Leicester NHS Trust city: Leicester state: Leicestershire zip: LE1 5WW country: United Kingdom name: Amit Mistri role: CONTACT email: amit.mistri@uhl-tr.nhs.uk lat: 52.6386 lon: -1.13169 hasResults: False

 nctId: NCT06354868 id: NNBioEP004 briefTitle: A Study to Assess utiLity of BIoEP as an Early Prognostic Indicator for Predicting Anti-Seizure Medication (ASM) Efficacy acronym: ECLIPSE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2027-06 date: 2024-04-09 date: 2024-04-12 name: Neuronostics Ltd class: INDUSTRY name: Cornwall Partnership NHS Foundation Trust briefSummary: This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy conditions: Epilepsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 158 type: ESTIMATED measure: The relationship between BioEP and seizure frequency. measure: Association between the 12-month change from baseline in BioEP result and the patients reported global impression of change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354855 id: NEU-FTR-FE-04 briefTitle: "Which Type of Exercise is More Effective in Chronic Constipation? overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-10 date: 2024-12 date: 2024-04-09 date: 2024-04-09 name: Necmettin Erbakan University class: OTHER briefSummary: In this study, it will be investigated whether a daily 30-minute walk or abdominal breathing exercise is more effective on chronic constipation. conditions: Chronic Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups with a conventional therapy control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The assignment of people to groups will be done by a statistician, apart from the research using a computer program. Randomization will be determined by entering the total number of cases through the program whose URL address is https://www.randomizer.org. whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Group is doing breathing exercises while watching videos name: Medium pace walking group measure: Visual Analog Scale (VAS) measure: Constipation Severity Scale (CSS) measure: Chronic Constipation Quality of Life Scale sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nezahat Keleşoğlu Health Sciences Necmettin Erbakan University city: Konya state: Meram zip: 42000 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06354842 id: 12345678 briefTitle: Measurement of Sweat Sodium Concentration in Patients With Chronic Kidney Disease overallStatus: COMPLETED date: 2018-10-05 date: 2020-12-11 date: 2020-12-11 date: 2024-04-09 date: 2024-04-09 name: Medical University of Vienna class: OTHER briefSummary: It has been shown that excretion of sodium and water through the skin in the form of sweat represents a regulatory mechanism of electrolyte- and fluid balance. Since patients with chronic kidney disease (CKD) exhibit increased skin sodium content, we investigated the feasibility of sweat testing as a novel experimental tool to a more complete assessment of fluid- and sodium homeostasis.

In this cross-sectional feasibility study, we applied pilocarpine iontophoresis to induce sweat testing in 58 patients across various stages of CKD including patients after kidney transplantation as well as a healthy control cohort (n=6) to investigate possible effects of CKD and transplantation status on sweat rate and sodium concentration. Due to non-linear relationships, we modeled our data using polynomial regression.

Decline of kidney function showed a significant association with lower sweat rates: adj R²= 0.2278, F(2, 61) = 10.29, p = 0.000141. Sweat sodium concentrations were increased in moderate CKD, however this effect was lost in end stage renal disease: adj R² = 0.3701, F(4, 59) = 10.26, p = 2.261e-06. We observed higher sweat weight in males compared to females.

Diagnostic sweat analysis represents an innovative and promising noninvasive option for more thorough investigation of sodium- and fluid homeostasis in CKD patients. Lower sweat rates and higher sweat sodium concentrations represent a unique feature of CKD patients with potential therapeutic implications. conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 64 type: ACTUAL name: pilocarpine iontopheresis measure: Sweat sodium concentration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Vienna city: Vienna zip: 1090 country: Austria lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06354829 id: MEDICALBUM briefTitle: Medical Images Collection Research acronym: MEDICALBUM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2049-04 date: 2049-04 date: 2024-04-09 date: 2024-04-09 name: Mario Negri Institute for Pharmacological Research class: OTHER name: Papa Giovanni XXIII Hospital briefSummary: This is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only. conditions: Kidney Diseases conditions: Brain Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Medical imaging procedures measure: Creation of a medical images collection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò city: Ranica state: BG zip: 24020 country: Italy name: Anna Caroli, PhD role: CONTACT phone: +3903545351 email: anna.caroli@marionegri.it lat: 45.72328 lon: 9.71335 hasResults: False

 nctId: NCT06354816 id: V 2.0, 07Feb2024 briefTitle: VENLID: The Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults acronym: VENLID overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-05 date: 2024-05 date: 2024-04-09 date: 2024-04-09 name: Krankenhaus Barmherzige Schwestern Linz class: OTHER briefSummary: Volunteers are invited to undergo 4 insertions of a peripheral intra-venous 18-gauge catheter (PIVC); 2 insertions at the the start of the study on the plantar side of the hand/vessel at the dorsum manus, 2 insertions after 2-10 hours into the forearm/cubita with and without application of a 10-% lidocaine spray (5 hubs of xylocaine 10%-pump spray; AstraZeneca BV, Zoetermeer, The Netherlands) prior to the insertion of the PIVC. conditions: Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: prospective, randomized, double-blind, controlled trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Xylocaine 10% pump spray name: Saline solution isotonic 0.9% NaCl measure: To demonstrate a reduction of pain caused by PIVC rated by Numerical Rating Scale (NRS), after application of a 10% lidocaine spray- Separately measured for the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita measure: To measure pain caused by PIVC rated by NRS in the dominant vs. non-dominant arm measure: To measure pain caused by PIVC rated by NRS at the plantar side of the hand/vessel at the dorsum manus vs. at the forearm/cubita measure: To measure the correlation between pain caused by PIVC rated by NRS and the anticipated pain rated by NRS measure: To measure the correlation between pain caused by PIVC rated by NRS and the anticipated difficulty by the operator to insert the PIVC measure: To measure pain rated by NRS depending on success measure: To describe success rates and compare it measure: To measure the correlation between PCS and pain caused by PIVC rated by NRS sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06354803 id: KafrelsheikhU 30 briefTitle: Effect of Pezzi Ball on Balance in Pregnant Women overallStatus: COMPLETED date: 2023-03-02 date: 2024-02-02 date: 2024-03-03 date: 2024-04-09 date: 2024-04-09 name: Kafrelsheikh University class: OTHER briefSummary: The effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum conditions: Postural Stability studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 45 participants with gestational age below 28 weeks primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE maskingDescription: The drawing procedure was conducted by a researcher without disclosure to the participants, ensuring unbiased allocation. Moreover, both the assessor and statistician remained blinded throughout the assessment period, unaware of the group assignments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ACTUAL name: proprioceptive training measure: change of postural stability sex: FEMALE minimumAge: 25 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of physical therapy kafrelshiekh university city: Kafr Ash Shaykh state: Kafrelshiekh zip: 6850001 country: Egypt lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06354790 id: NatHis LAMA2 briefTitle: Natural History Study of Children With LAMA2-related Dystrophies acronym: LAMA2 overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2027-06-14 date: 2027-12-31 date: 2024-04-09 date: 2024-04-09 name: Institut de Myologie, France class: OTHER name: Association Française contre les Myopathies (AFM), Paris briefSummary: The goal of this natural history study is to characterize the disease course, characteristics in paediatric population of LAMA2-RD (related dystrophies) patients.

The aim of the study is to establish a well-described cohort of patients in France with LAMA2-RD for prospective follow-up and recruitment for future clinical trials.

Participants will be follow up during a two years period regarding exhaustive aspects of the pathology:

* Muscular function
* Respiratory function
* Cognitive phenotyping
* Quality of life
* Growth parameters
* Biomarkers conditions: Merosin Deficient Congenital Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Motor evaluations name: Cognitive assessment name: Pulmonary function test name: Cardiac evaluation name: Quality of life name: Spine X Ray name: Muscular MRI name: Biomarkers collection and analysis measure: Change in Motor function Measurement (MFM32) score measure: Change in Motor Milestone Checklist measure: Change in Revised Upper Limb Module (RULM) score measure: Change in grip strength measured by dynamometer tool measure: Change in pinch strength measured by dynamometer tool measure: Change in arm flexion/extension strength measured by dynamometer tool measure: Change in 6 Minutes Walking Test measure: Change in 4 Stairs Climbing Test (4SCT) measure: Change in 10m Walking Test measure: Change in Rise from Floor Test measure: Change in patient's Forced Vital Capacity (FVC) results measure: Change in patient's Peak Cough Flow (PCF) results measure: Change in patient's Maximum Expiratory Pressure (MEP) results measure: Change in patient's Maximal Inspiratory Pressure (MIP) results measure: Change in patient's Sniff Nasal Inspiratory Pressure (SNIP) results measure: Change in patient's muscle fat replacement measured by Magnetic Nuclear Resonance measure: Change in patient's cross-sectional area of the residual muscle measured by MNR measure: Change in Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV) results measure: Change in Wechsler Intelligence Scale for Children-V (WISC-V) results measure: Change in PedsQL questionnaire results measure: Change in CGI-S questionnaire results measure: Change in CGI-I questionnaire results measure: Change in Faces pain rating scale results measure: Change in Fatigue Severity Scale results measure: Change in ACTIVLIM questionnaire results measure: Change in Egen Klassifikation Scale Version 2 (EK2) results measure: Change in Caregiver burden questionnaire (LMDIS) results sex: ALL minimumAge: 2 Years maximumAge: 15 Years stdAges: CHILD facility: Centre de Référence GNMH, Pédiatrie Hôpital Raymond-Poincaré city: Garches country: France name: Isabelle BOSSARD role: CONTACT name: Marta GOMEZ, MD role: PRINCIPAL_INVESTIGATOR lat: 48.84226 lon: 2.18232 facility: Service de MPR pédiatrique L'Escale - HCL city: Lyon country: France name: Manel SAIDI role: CONTACT name: Carole VUILLEROT, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Département de neuropédiatrie Pôle Femme Mère Enfant CHU de Montpellier - Hôpital Gui de Chauliac city: Montpellier country: France name: Léa THEVENET role: CONTACT name: Ulrike WALTHER-LOUVIER, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: Plateforme d'essais cliniques pédiatriques iMotion city: Paris country: France name: Dominique DUCHENE role: CONTACT name: Andreea SEFERIAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06354777 id: EVERCOOL AF briefTitle: REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry acronym: EVERCOOL AF overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-11-30 date: 2024-12-30 date: 2024-04-09 date: 2024-04-09 name: Heart Rhythm Clinical and Research Solutions, LLC class: OTHER name: Attune Medical briefSummary: This is a multi-center sub-study examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 312 type: ESTIMATED name: Ablation Procedure measure: To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling. measure: To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling. measure: To measure long term safety after atrial fibrillation in patients treated with active esophageal cooling. measure: Patient reported outcomes in patients treated with active esophageal cooling. measure: Physician reported outcome post procedure with active esophageal cooling. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354764 id: 8780-UC1 briefTitle: Propensity to Hospitalize Patients From the ED in European Centers. acronym: eCREAM-UC1 overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2026-09 date: 2024-04-09 date: 2024-04-11 name: Mario Negri Institute for Pharmacological Research class: OTHER name: Astir S.r.l. name: Centre Hospitalier Universitaire Vaudois name: Orobix Life S.r.l. name: Fondazione Bruno Kessler briefSummary: The peer-to-peer comparison means center-to-center comparison, which requires adjusting for possible differences among centers to be fair and convincing. The first step to reach this goal is to develop a predictive model that accurately estimates each patient's probability of being admitted, starting from clinical conditions and boundary variables. Such a model would make it possible to calculate, for each ED, the expected hospitalization rate; that is, the hospitalization rate that would have been observed if the ED had behaved like the average of the EDs that provided the data to build the model itself. Comparing the observed hospitalization rate in the single ED with the expected rate derived from the model provides a rigorous method of comparing the department with the average performance, taking into account the characteristics of the patients treated and the conditions under which the ED operated. In other words, the predictive model represents the benchmark against which each ED is evaluated. conditions: Emergency Medicine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 162000 type: ESTIMATED name: no intervention measure: Create two separate databases measure: Multivariable models measure: Adjusted comparison sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354751 id: 327236 briefTitle: Maternity Care Experiences of Asylum-seeking and Refugee Women in Scotland acronym: MACAWS overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-04-20 date: 2025-07-01 date: 2024-04-09 date: 2024-04-09 name: University of Aberdeen class: OTHER briefSummary: The International Organisation of Migration reports that over half (52.4%) of international migrants in Europe are women. Evidence suggests that women with immigrant backgrounds often struggle to access healthcare across the world. Among migrant women, asylum-seeking and refugee women face higher risks of poor pregnancy and birth outcomes, including babies with low birth weight, physical and/or mental health problems or death related to pregnancy and/or childbirth. Previous studies have focused on immigrant women's experiences of care during pregnancy and birth and did not differentiate between asylum seekers, refugees, and economic migrants. This can make it difficult to compare studies accurately. This PhD study focuses on asylum-seeking and refugee women, using the definitions provided by the United Nations. Asylum-seeking women refer to women who seek protection in a country other than their own and are waiting for a decision on their status. Asylum seekers become refugees once their application has been processed and accepted.

A scoping review was conducted to understand the experiences of asylum-seeking and refugee women accessing maternity care in the UK, with a focus on Scotland. The review found that all studies that focused on the experiences of asylum-seeking and refugee women accessing maternity care were mainly based in England. The review identified the presence of specialist migrant services in maternity settings in Scotland and across the UK, but there was no information on their implementation or impact on women's outcomes. Additionally, there is limited evidence in the UK on the perceptions of healthcare professionals providing care to asylum-seeking and refugee women.

This PhD aims to close this gap in research by exploring this area more deeply in Scotland through mixed-methods studies of surveys with asylum-seeking and refugee women and interviews with maternity care leaders, policymakers, maternity healthcare professionals, and asylum-seeking and refugee women. conditions: Refugee conditions: Asylum-seeking Women conditions: Maternity studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 300 type: ESTIMATED measure: Exploring and understanding asylum-seeking and refugee women's experiences of maternity care in Scotland. measure: Evidence of healthcare professionals' experiences of providing maternity care for asylum-seeking and refugee women in Scotland. measure: Identification of the successful components of specialist migrant maternity services in Scotland. measure: Identification of gaps between care pathways and practice (implementation gap) and how this affects the quality of maternity care and women's experiences of maternity services measure: Information for policymakers on approaches needed to improve maternity care for refugee and asylum-seeking women at local and national levels. sex: FEMALE minimumAge: 16 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06354738 id: S66928 briefTitle: Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment acronym: EUGENIE overallStatus: RECRUITING date: 2023-01-16 date: 2028-11-01 date: 2028-11-01 date: 2024-04-09 date: 2024-04-17 name: University Hospital, Gasthuisberg class: OTHER name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS name: University Medical Centre Maribor briefSummary: EUGENIE is a prospective multicentre interventional study, focused on improving endometrial cancer (EC) assessment by combining the new technique of genomic profiling with surgical extra uterine disease assessment. The investigators aim to correlate EC stage to each of the molecular subgroups of disease and thereby guide surgical treatment and staging of EC by determining the association between molecular classification and disease stage and evaluating if and how disease stage in each of the molecular subgroups associates with prognosis. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1000 type: ESTIMATED name: total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging measure: Endometrial cancer stage measure: Molecular type of endometrial cancer measure: Overall survival measure: Time to recurrence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Gasthuisberg, Katholieke Universiteit Leuven status: RECRUITING city: Leuven zip: 3000 country: Belgium name: Ayaka Wakatsuki role: CONTACT phone: +32 16 34 41 69 email: ayaka.wakatsuki@uzleuven.be name: Frédéric Amant, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06354725 id: 2vs4 briefTitle: Effect of Weekly Plyometric Training Frequency on Youth Female Basketball Players: A Comparison of Two vs. Four Sessions overallStatus: COMPLETED date: 2023-11-01 date: 2024-01-20 date: 2024-02-20 date: 2024-04-09 date: 2024-04-09 name: Bruno Figueira class: OTHER name: Vytautas Magnus University briefSummary: Players were randomly assigned to a two-times-a-week (2PLYO, n = 15) or four-times-a-week (4PLYO, n = 15) PT (Plyometric Training) group. Both groups performed the same weekly total volume of jumps during PT in addition to regular basketball training and competition. The 2PLYO group performed 240 jumps over two sessions (120 jumps per session), and the 4PLYO group performed 240 jumps over four sessions (60 jumps per session). After the eight-week intervention, all players underwent a one-week detraining period with no PT training while basketball training and competitions continued. Testing was performed at baseline (pre-test), after intervention (post-test), and after the detraining period. Players were assessed for lower body power using jump tests (countermovement jump \[CMJ\], drop-jump \[DJ\] from a 20-cm box, and horizontal jump \[HJ\]; change of direction ability using a planned agility test; and speed using a 20-m sprint and a 5-m split. conditions: Physical Performance studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Plyometric measure: Horizontal jump measure: CMJ measure: Drop Jump measure: Drop jump (RSI) measure: Linear sprint-5m measure: Linear sprint-20m measure: Change of direction sex: FEMALE minimumAge: 14 Years maximumAge: 16 Years stdAges: CHILD facility: Vytutas Magnus University city: Kaunas country: Lithuania lat: 54.90272 lon: 23.90961 hasResults: False

 nctId: NCT06354712 id: 2024-45 briefTitle: Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients. overallStatus: RECRUITING date: 2024-04-04 date: 2025-03-01 date: 2025-03-01 date: 2024-04-09 date: 2024-04-09 name: Mansoura University class: OTHER briefSummary: A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients. conditions: Oral Mucositis (Ulcerative) Due to Radiation studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: N-Acetyl-Cysteine with Institutional standard care name: Institutional standard care measure: Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis. measure: Time to develop oral mucositis with grade ≥ 2. measure: Duration of oral mucositis with grade ≥ 2. measure: Pain assessed by Visual Analog Scale (VAS). measure: Functional oral intake scale measure: Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Oncology and Nuclear Medicine of Mansoura University Hospital status: RECRUITING city: Mansoura country: Egypt name: Rasha Abd-Ellatif, Professor role: CONTACT lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06354699 id: RGS0000003993 briefTitle: A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children acronym: POPSICLE overallStatus: RECRUITING date: 2023-06-26 date: 2028-06 date: 2028-07 date: 2024-04-09 date: 2024-04-09 name: Telethon Kids Institute class: OTHER briefSummary: The purpose of this study is to investigate the prevalence, risk factors and consequences of chronic post-surgical pain in children aged 0-16 years through a number of questionnaires completed at various timepoints, from before surgery up to 1 year post surgery. conditions: Chronic Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED measure: The prevalence of chronic post-surgical pain after 10- 12 months. measure: Identifying potential risk factors for chronic post-surgical pain sex: ALL maximumAge: 16 Years stdAges: CHILD facility: Telethon Kids Institute status: RECRUITING city: Perth state: Western Australia country: Australia name: Natalie P Jowett role: CONTACT phone: 08 6456 4809 email: Natalie.Jowett@telethonkids.org.au name: Lliana Slevin role: CONTACT phone: 08 64564806 email: Lliana.slevin@telethonkids.org.au name: Britta von Ungern-Sternberg, Professor role: PRINCIPAL_INVESTIGATOR name: David Sommerfield, Associate role: PRINCIPAL_INVESTIGATOR lat: -31.95224 lon: 115.8614 hasResults: False

 nctId: NCT06354686 id: STUDY00004245 briefTitle: Characterizing the Scalp Tolerability of TMS overallStatus: RECRUITING date: 2024-02-12 date: 2026-05 date: 2027-05 date: 2024-04-09 date: 2024-04-09 name: Florida State University class: OTHER briefSummary: The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: TMS Tolerability measure: Tolerability of TMS - Scalp Location measure: Tolerability of TMS - Stimulation parameters (single pulse, 10 Hz, theta burst). measure: Tolerability of TMS (Knee Location) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florida State University status: RECRUITING city: Tallahassee state: Florida zip: 32306 country: United States name: Isabelle Taylor, MA role: CONTACT phone: 850-645-8882 email: imtaylor@fsu.edu lat: 30.43826 lon: -84.28073 hasResults: False

 nctId: NCT06354673 id: 278/1-April-2024 briefTitle: Stellate Ganglion Block Combined With Dexmedetomidine or Subanesthetic Ketamine Infusion for Treatment of Neurostorm. overallStatus: ENROLLING_BY_INVITATION date: 2024-04-04 date: 2024-09-04 date: 2024-10-04 date: 2024-04-09 date: 2024-04-10 name: Zagazig University class: OTHER_GOV briefSummary: Neurostorming is a sudden and exaggerated stress response as a result of damage to the brain. With appropriate treatment and time, there is hope for individuals to overcome storming, regain consciousness, and work towards successfully recovering from brain injury. Most treatments for neurostorming involve the use of medications only such as dexmedetomidine, opioids, gabapentin and propofol to address secondary complications like high blood pressure and fever. These medications focus on slowing the body's stress response or relaxing the body. Stellate ganglion block (SGB) is a promising therapy for paroxysmal sympathetic hyperactivity (PSH), overcoming the limitations of systemic medications and may serve to recalibrate aberrant autonomic states. Ketamine is a potent dissociative agent which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Its combination with stellate ganglion block is to oppose its sympathomimetic effect. Dexmedetomidine has analgesic and sedative effect which inhibits the sympathetic nerve activity through its action on the α2 receptor in the spinal cord. Hypothesis: Null hypothesis: There is no difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.Alternative hypothesis: There is a difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Aim of the work is achievement of effective treatment for the neurostorm after traumatic brain injury in critically ill patients with better outcomes and decrease intensive care unit (ICU) stay. conditions: Paroxysmal Sympathetic Hyperactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 205 type: ESTIMATED name: Stellate ganglion block name: Dexmedetomidine name: Ketamine measure: To compare the time of remission of neurostorm symptoms measure: To assess effect of stellate ganglion block combined with either dexmedetomidine or subanesthetic ketamine infusion on changes in glascow coma scale score. measure: ▪ To measure the duration of intensive care unit (ICU) stay. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zagazig university city: Zagazig country: Egypt lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06354660 id: 18804 id: J1I-MC-GZBY type: OTHER domain: Eli Lilly and Company briefTitle: Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-06 date: 2026-07 date: 2024-04-09 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits. conditions: Diabetes Type 2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 480 type: ESTIMATED name: Retatrutide name: Placebo measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%) measure: Percentage of Participants Who Achieve HbA1c < 7.0% measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% measure: Percentage of Participants Who Achieve HbA1c < 5.7% measure: Change from Baseline in Fasting Serum Glucose measure: Percent Change from Baseline in Body Weight measure: Change from Baseline in Body Weight measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15% measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction measure: Percent Change from Baseline in Triglycerides measure: Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol measure: Change from Baseline in Systolic Blood Pressure (SBP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scottsdale Clinical Trials city: Scottsdale state: Arizona zip: 85260 country: United States name: Ernest Lee role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Tucson Clinical Research Institute city: Tucson state: Arizona zip: 85712 country: United States name: Girish Karamchandani role: PRINCIPAL_INVESTIGATOR lat: 32.22174 lon: -110.92648 facility: San Fernando Valley Health Institute city: Canoga Park state: California zip: 91304 country: United States name: Jeffrey London role: PRINCIPAL_INVESTIGATOR lat: 34.20112 lon: -118.59814 facility: Ark Clinical Research city: Long Beach state: California zip: 90815 country: United States name: Martha Navarro role: PRINCIPAL_INVESTIGATOR lat: 33.76696 lon: -118.18923 facility: Northeast Research Institute (NERI) city: Fleming Island state: Florida zip: 32003 country: United States name: Senan Sultan role: PRINCIPAL_INVESTIGATOR lat: 30.0933 lon: -81.71898 facility: Ezy Medical Research city: Miami state: Florida zip: 33175 country: United States name: Manuel Fernandez role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Clinical Research of Central Florida city: Winter Haven state: Florida zip: 33880 country: United States name: Eduardo Torres role: PRINCIPAL_INVESTIGATOR lat: 28.02224 lon: -81.73286 facility: Trinity Research Centers city: Marietta state: Georgia zip: 30064 country: United States name: Jean Philippe role: PRINCIPAL_INVESTIGATOR lat: 33.9526 lon: -84.54993 facility: Cotton O'Neil Clinical Research Center - Central Office city: Topeka state: Kansas zip: 66606 country: United States name: Michael Cox role: PRINCIPAL_INVESTIGATOR lat: 39.04833 lon: -95.67804 facility: NECCR PrimaCare Research city: Fall River state: Massachusetts zip: 02721 country: United States name: Ehab Sorial role: PRINCIPAL_INVESTIGATOR lat: 41.70149 lon: -71.15505 facility: Clinical Research Professionals city: Chesterfield state: Missouri zip: 63005 country: United States name: Timothy Jennings role: PRINCIPAL_INVESTIGATOR lat: 38.66311 lon: -90.57707 facility: Boeson Research MSO city: Missoula state: Montana zip: 59804 country: United States name: Aubrey Remmers role: PRINCIPAL_INVESTIGATOR lat: 46.87215 lon: -113.994 facility: NJ MedCare & NJ Heart city: Linden state: New Jersey zip: 07036 country: United States name: Preet Randhawa role: PRINCIPAL_INVESTIGATOR lat: 40.62205 lon: -74.24459 facility: Accellacare - Wilmington - 1917 Tradd Court city: Wilmington state: North Carolina zip: 28401 country: United States name: John Parker role: PRINCIPAL_INVESTIGATOR lat: 34.22573 lon: -77.94471 facility: Providence Health Partners-Center for Clinical Research city: Dayton state: Ohio zip: 45439 country: United States name: Joni Koren role: PRINCIPAL_INVESTIGATOR lat: 39.75895 lon: -84.19161 facility: Clinical Research of Philadelphia city: Philadelphia state: Pennsylvania zip: 19114 country: United States name: Donna Gavarone role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Preferred Primary Care Physicians city: Uniontown state: Pennsylvania zip: 15401 country: United States name: Richard Cook II role: PRINCIPAL_INVESTIGATOR lat: 39.90008 lon: -79.71643 facility: Delricht Research - Tobias Gadson Boulevard - Charleston city: Charleston state: South Carolina zip: 29407 country: United States name: Edward Newton role: PRINCIPAL_INVESTIGATOR lat: 32.77657 lon: -79.93092 facility: Lifedoc Research - Lenox Park Drive city: Memphis state: Tennessee zip: 38115 country: United States name: Pedro Velasquez-Mieyer role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 facility: Clinical Research Associates Inc city: Nashville state: Tennessee zip: 37203 country: United States name: Stephan Sharp role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: Dallas Diabetes Research Center city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Prime Revival Research Institute city: Flower Mound state: Texas zip: 75028 country: United States name: WASIM HAQUE role: PRINCIPAL_INVESTIGATOR lat: 33.01457 lon: -97.09696 facility: Valley Institute of Research - Fort Worth city: Fort Worth state: Texas zip: 76164 country: United States name: alex guevara role: PRINCIPAL_INVESTIGATOR lat: 32.72541 lon: -97.32085 facility: Texas Valley Clinical Research city: Weslaco state: Texas zip: 78596 country: United States name: Eduardo Luna role: PRINCIPAL_INVESTIGATOR lat: 26.15952 lon: -97.99084 facility: Manassas Clinical Research Center city: Manassas state: Virginia zip: 20110 country: United States name: Nabil Andrawis role: PRINCIPAL_INVESTIGATOR lat: 38.75095 lon: -77.47527 facility: MultiCare Rockwood Cheney Clinic city: Cheney state: Washington zip: 99004 country: United States name: Jonathan Staben role: PRINCIPAL_INVESTIGATOR lat: 47.48739 lon: -117.57576 facility: Eastside Research Associates city: Redmond state: Washington zip: 98052 country: United States name: Chad Crystal role: PRINCIPAL_INVESTIGATOR lat: 47.67399 lon: -122.12151 facility: All India Institute of Medical Sciences city: Raipur state: Chhattisgarh zip: 492099 country: India name: Amritava Ghosh role: PRINCIPAL_INVESTIGATOR lat: 21.23333 lon: 81.63333 facility: Gujarat Endocrin Pvt Ltd city: Ahmedabad state: Gujarat zip: 380052 country: India name: parag Shah role: PRINCIPAL_INVESTIGATOR lat: 23.02579 lon: 72.58727 facility: Nirmal Hospital city: Surat state: Gujarat zip: 395002 country: India name: Piyush Desai role: PRINCIPAL_INVESTIGATOR lat: 21.19594 lon: 72.83023 facility: Victoria Hospital, Bangalore Medical College And Research Institute city: Bangalore state: Karnataka zip: 560002 country: India name: Sivaranjani Holigi role: PRINCIPAL_INVESTIGATOR lat: 12.97194 lon: 77.59369 facility: Government Medical College - Kozhikode city: Kozhikode state: Kerala zip: 673008 country: India name: Chandni R role: PRINCIPAL_INVESTIGATOR lat: 11.24802 lon: 75.7804 facility: S C B Medical College and Hospital city: Cuttack state: Odisha zip: 753001 country: India name: Jayanta Panda role: PRINCIPAL_INVESTIGATOR lat: 20.46497 lon: 85.87927 facility: Eternal Heart Care Center and Research Institute city: Jaipur state: Rajasthan zip: 302020 country: India name: Jugal Gupta role: PRINCIPAL_INVESTIGATOR lat: 26.91962 lon: 75.78781 facility: Brij Medical Centre Private Limited city: Kanpur state: Uttar Pradesh zip: 208020 country: India name: brij mohan role: PRINCIPAL_INVESTIGATOR lat: 26.46523 lon: 80.34975 facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran city: Mexico City state: Distrito Federal zip: 14080 country: Mexico name: Emma Chávez Manzanera role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Grupo Ollin Care city: Pachuca state: Hidalgo zip: 42000 country: Mexico name: Eduardo Zambrano Ruiz role: PRINCIPAL_INVESTIGATOR lat: 20.11697 lon: -98.73329 facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad city: Guadalajara state: Jalisco zip: 04460 country: Mexico name: Guillermo Gonzalez Galvez role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Unidad biomedica avanzada monterrey city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: Raymundo Garcia Reza role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Clínica García Flores SC city: Monterrey state: Nuevo León zip: 64610 country: Mexico name: Pedro Garcia role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Centro de investigación y control metabólico city: Monterrey state: Nuevo León zip: 66465 country: Mexico name: Ramiro Banda Elizondo role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Medical Care and Research SA de CV city: Merida state: Yucatán zip: 97070 country: Mexico name: Carlos Medina role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: EME RED Hospitalaria city: Mérida state: Yucatán zip: 97000 country: Mexico name: Hugo Laviada Molina role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: Arké SMO S.A de C.V city: Veracruz zip: 91910 country: Mexico name: Luis Aguilar Espinoza role: PRINCIPAL_INVESTIGATOR lat: 19.18095 lon: -96.1429 facility: Dorado Medical Complex city: Dorado zip: 00646 country: Puerto Rico name: Luis Pagan-Cardona role: PRINCIPAL_INVESTIGATOR lat: 18.45883 lon: -66.26767 facility: Ponce Medical School Foundation Inc. city: Ponce zip: 00716 country: Puerto Rico name: Elizabeth Barranco Santana role: PRINCIPAL_INVESTIGATOR lat: 18.01108 lon: -66.61406 hasResults: False

 nctId: NCT06354647 id: HM20028419 briefTitle: Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-06-01 date: 2024-04-09 date: 2024-04-09 name: Virginia Commonwealth University class: OTHER briefSummary: The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection. conditions: Dental Caries conditions: Tooth Decay studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 75 type: ESTIMATED name: Zirconia-based primary anterior crowns with retention grooves name: Zirconia-based primary anterior crowns without retention grooves measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes measure: Parental satisfaction measure: Child satisfaction measure: Oral health impact during early childhood sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23298 country: United States name: Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD role: CONTACT phone: (804) 828-9095 email: jayaramanj@vcu.edu name: Alpna Khatri role: CONTACT phone: (571) 302-6719 email: khatria4@vcu.edu lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06354634 id: HM20028439 briefTitle: Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-07 date: 2027-07 date: 2024-04-09 date: 2024-04-09 name: Virginia Commonwealth University class: OTHER briefSummary: The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection. conditions: Dental Caries conditions: Tooth Decay studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each participant will receive both interventions. primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Resin polymer (NuSmile Bioflx) crown name: Stainless steel crown measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments measure: Parental satisfaction measure: Child satisfaction sex: ALL minimumAge: 3 Years maximumAge: 7 Years stdAges: CHILD facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23298 country: United States name: Jayakumar Jayaraman role: CONTACT phone: 804-828-2362 email: jayaramanj@vcu.edu lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06354621 id: D/185/FIMS briefTitle: Impact of Vitamin D Supplementation on Fetomaternal Outcomes in LTBI Pregnant Females acronym: RCT overallStatus: COMPLETED date: 2023-09-01 date: 2024-02-28 date: 2024-03-20 date: 2024-04-09 date: 2024-04-09 name: University of the Punjab class: OTHER briefSummary: The goal of this randomized controlled trial is to see the effect of vitamin D supplementation on fetomaternal outcomes in pregnant females with Latent Tuberculosis infection

The main question\[s\] it aims to answer are:

If Vitamin D supplementation has any impact on maternal outcomes. If Vitamin D supplementation has any impact on fetal outcomes. conditions: Maternal and Child Health studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 99 type: ACTUAL name: Vitamin-D supplementation measure: Pre-Eclampsia (Maternal Outcome) measure: Gestational Diabetes Mellitus (Maternal Outcome) measure: C/Section delivery (Maternal Outcomes) measure: Low Birth Weight (Foetal Outcome) measure: Pre-Term delivery (Foetal Outcome) measure: Apgar Score (Foetal Outcome) measure: Improvement in maternal vitamin-D levels sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of the Punjab city: Lahore state: Punjab zip: 54600 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06354608 id: duygudemirr briefTitle: The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children overallStatus: RECRUITING date: 2023-10-25 date: 2024-04-01 date: 2024-04-30 date: 2024-04-09 date: 2024-04-09 name: University of Yalova class: OTHER briefSummary: The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear. conditions: Procedural Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is an experimental, parallel-group (intervention-control), randomized controlled design primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ESTIMATED name: Audio Book Group name: Local Vibration Group measure: Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES measure: Comparison of the fear score values of the groups measure: Comparison of the fear score values of the groups sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: University of Yalova status: RECRUITING city: Yalova country: Turkey name: Duygu Demir, PhD role: CONTACT phone: +905053662358 email: duygu.emir@yalova.edu.tr lat: 40.65501 lon: 29.27693 hasResults: False

 nctId: NCT06354595 id: XiamenU1 briefTitle: Feasibility Study of Multidimensional Rehabilitation in the Metaverse overallStatus: RECRUITING date: 2024-03-01 date: 2024-04-30 date: 2024-05-01 date: 2024-04-09 date: 2024-04-09 name: Qu Shen class: OTHER name: The First Affiliated Hospital of Xiamen University briefSummary: The investigators evaluated and optimized the Metaverse multi-dimensional rehabilitation platform based on the use of the Metaverse multi-dimensional rehabilitation platform by colorectal cancer survivors and their families, and finally launched the Metaverse multi-dimensional rehabilitation platform. conditions: Colorectal Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Multidimensional Rehabilitation in the Metaverse measure: Post-Study System Usability Questionnaire (PSSUQ) Third Edition measure: System Usability Scale (SUS) measure: Semi-structured interview sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yuru Hu status: RECRUITING city: Xiamen state: Fujian zip: 361005 country: China name: Yuru HU role: CONTACT phone: 18189530895 email: 15903017593@163.com lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06354582 id: 2024-085-01 briefTitle: Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia acronym: EIVCIMFAELA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-02 date: 2024-04-09 date: 2024-04-09 name: Kunyue Li class: OTHER name: Third Affiliated Hospital of Zhengzhou University briefSummary: This study aims to explore the effect of intravenous vitamin C infusion on intrapartum fever after epidural labor analgesia, to reduce the impact of intrapartum fever on maternal and infant, improve maternal and infant outcomes, and provide a reference for clinical preventive medication. conditions: Obstetric Labor Complications conditions: Fever studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parturients are randomly assigned to either vitamin C(1,2,3) or control. The vitamin C group received 1 g, 2g, and 3g of vitamin C intravenously respectively and the control group received normal saline, administered after the induction of epidural labor anesthesia. There will be 100 cases in each group. The infusion speed will be set at 5ml/min. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 400 type: ESTIMATED name: Vitamin C Injection name: Normal saline measure: Intrapartum fever or not measure: The temperature of parturients measure: The duration of intrapartum fever measure: Complete blood count indicators measure: Visual analogue scale(VAS) measure: Amount of total analgesics measure: Side effects on mothers measure: the duration of total labor measure: Incidence of rupture of membranes measure: Delivery characteristics 2 measure: Record the weight of the baby. measure: Record the gender of the baby. measure: Apgar score measure: the incidence of fetal distress measure: Record the infant ward administration. sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06354569 id: 2022.232 briefTitle: Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children overallStatus: RECRUITING date: 2024-12-31 date: 2024-12-31 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: Sichuan Provincial People's Hospital class: OTHER briefSummary: to explore the risk factors of perioperative respiratory adverse events in children, and to establish a risk prediction model of perioperative respiratory adverse events in children conditions: Perioperative Respiratory Adverse Events studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: The occurrence of perioperative respiratory adverse events sex: ALL minimumAge: 1 Month maximumAge: 12 Years stdAges: CHILD facility: Sichuan provincial Peopel'Hospital status: RECRUITING city: Chengdu state: Sichuan country: China name: Yanyu Liu role: CONTACT phone: +8613438348895 email: 43197113@qq.com name: Ting Xu role: CONTACT phone: +8317708130267 lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06354556 id: HRS-1893-102 briefTitle: Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-05 date: 2024-05-30 date: 2024-04-09 date: 2024-04-09 name: Shandong Suncadia Medicine Co., Ltd. class: INDUSTRY briefSummary: The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects. conditions: Obstructive Hypertrophic Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single center, open, single arm, fixed sequence primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: HRS-1893 tablet name: Verapamil tablet measure: Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose measure: Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose measure: Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose measure: Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose measure: Elimination half-life (T1/2) for HRS-1893 after single dose measure: Apparent oral clearance (CL/F) for HRS-1893 after single dose measure: Apparent volume of distribution (Vz/F) for HRS-1893 after single dose measure: Accumulated amount of excretion (Ae) for HRS-1893 after single dose measure: Urinary excretion fraction（fe）for HRS-1893 after single dose measure: Renal clearance（CLr）for HRS-1893 after single dose measure: Number of subjects with adverse events and the severity of adverse events sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06354543 id: CA01-TK-ARTHRO briefTitle: Arthroplasty Cements Outcomes - A Post-market Follow-up overallStatus: RECRUITING date: 2020-12-16 date: 2035-12 date: 2045-12 date: 2024-04-09 date: 2024-04-09 name: Teknimed class: INDUSTRY briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.

Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.

The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site. conditions: Arthroplasty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1050 type: ESTIMATED name: Cemented joint arthroplasty measure: Survival rate measure: Superficial and/or deep postoperative infection rate. measure: Pain Level measure: Patients' satisfaction measure: Restoration of function measure: Evaluation of function and radiological outcomes measure: Complications rate measure: Antalgic consumption measure: Restoration of function measure: Restoration of function measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique du Vivarais status: RECRUITING city: Aubenas state: Auvergne-rhône-alpes zip: 07200 country: France name: Michel MILAIRE, MD role: CONTACT email: michel.milaire@yahoo.com name: Michel MILAIRE, MD role: PRINCIPAL_INVESTIGATOR lat: 44.62006 lon: 4.38994 facility: Clinique du Val d'Ouest status: RECRUITING city: Ecully state: Auvergne-rhône-alpes zip: 69130 country: France name: Benoît GIRAUD, MD role: CONTACT email: b.giraud@chirortho-valdouest.fr name: Benoît GIRAUD, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77726 lon: 4.77481 facility: Cabinet de consultation status: RECRUITING city: Evreux state: Eure zip: 27000 country: France name: Edouard DECRETTE, MD role: CONTACT email: decrette.edouard@gmail.com name: Edouard DECRETTE, MD role: PRINCIPAL_INVESTIGATOR lat: 49.02414 lon: 1.15082 facility: Clinique du Dr Henri Guillard status: RECRUITING city: Coutances state: Normandie zip: 50200 country: France name: Olivier COSSART, MD role: CONTACT email: o.cossart@hotmail.fr name: Olivier COSSART, MD role: PRINCIPAL_INVESTIGATOR lat: 49.05 lon: -1.43333 facility: Clinique de l'Atlantique status: RECRUITING city: Puilboreau state: Nouvelle-aquitaine zip: 17138 country: France name: Cédric BOUQUET, MD role: CONTACT email: docteurbouquet@gmail.com name: Cédric BOUQUET, MD role: PRINCIPAL_INVESTIGATOR lat: 46.1862 lon: -1.11797 facility: Hôpital Européen Marseille status: RECRUITING city: Marseille state: Provence-alpes-cote D'azur zip: 13003 country: France name: Maxime MUNIER, MD role: CONTACT email: dr.maxime.munier@gmail.com name: Maxime MUNIER, MD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Ospedale Santissima Annunziata status: RECRUITING city: Cento state: Emilie-Romagne zip: 44042 country: Italy name: Luca CASTAGNINI, MD role: CONTACT email: luca.castagnini@ausl.fe.it name: Luca CASTAGNINI, MD role: PRINCIPAL_INVESTIGATOR lat: 44.73099 lon: 11.28716 facility: Instituto Ortopedico Rizzoli status: RECRUITING city: Bologna state: Émilie-Romagne zip: 40136 country: Italy name: Stefano ZAFFAGNINI, MD role: CONTACT email: stefano.zaffagnini@unibo.it name: Stefano ZAFFAGNINI, MD role: PRINCIPAL_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06354530 id: 2023 (315) briefTitle: A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-03-08 date: 2025-12-31 date: 2026-12-31 date: 2024-04-09 date: 2024-04-09 name: Army Medical Center of PLA class: OTHER_GOV briefSummary: The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma. conditions: Neoadjuvant Therapy conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 266 type: ESTIMATED name: anlotinib name: Thoracic radiotherapy measure: Pathological complete response (pCR), Major pathological response (MPR) measure: Major pathological response (MPR) measure: Objective response rate (ORR) measure: 3-year disease free survival measure: R0 excision rate measure: 3-year overall survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Army Medical Center of PLA status: RECRUITING city: Chongqing state: None Selected country: China name: Mengxia Li role: CONTACT phone: +86-18580408265 email: mengxia.li@outlook.com name: Xiao Yang role: CONTACT phone: +86-19923257675 email: yangxiao625@outlook.com lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06354517 id: YIU-M-CI-003 briefTitle: The Impact of the SENSE Program on NICU overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-30 date: 2025-05-30 date: 2024-04-09 date: 2024-04-09 name: Yuksek Ihtisas University class: OTHER briefSummary: The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined. conditions: Pre-Term conditions: Individualized Developmental Care conditions: Sensory Experiences studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: SENSE group measure: Hammersmıth Neonatal Neurologıcal Examınatıon measure: Parental Stress Scale: Neonatal Intensive Care Unit measure: State-trait Anxiety Inventory measure: Edinburgh Postnatal Depression Scale sex: ALL minimumAge: 24 Weeks maximumAge: 42 Weeks stdAges: CHILD facility: Yuksek Ihtisas University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06354504 id: 20.02.2019/177 briefTitle: Bactericidal Permeability Protein Inhibitor and Interleukin-1beta Levels After Non-surgical Periodontal Treatment overallStatus: COMPLETED date: 2019-11-19 date: 2020-09-20 date: 2020-09-20 date: 2024-04-09 date: 2024-04-09 name: Akdeniz University class: OTHER briefSummary: The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß). conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Non-surgical periodontal treatment measure: Gingival crevicular fluid Bactericidal/permeability-increasing proteins levels measure: Gingival crevicular fluid interleukin-1Beta levels sex: ALL minimumAge: 22 Years maximumAge: 64 Years stdAges: ADULT facility: Akdeniz Üniversity city: Antalya zip: 07070 country: Turkey lat: 36.90812 lon: 30.69556 facility: Akdeniz Üniversitesi Diş Hekimliği Fakültesi city: Antalya country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06354491 id: 2023-1494 briefTitle: An Imaging-based Quantitative Biomarker Assay for NAFLD in Children overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-09 date: 2024-04-09 name: University of Wisconsin, Madison class: OTHER briefSummary: This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI). conditions: NAFLD conditions: NASH studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 24 type: ESTIMATED name: Magnetic Resonance Imaging (MRI) name: Ultrasound (US) measure: MRI measure: Quantitative US sex: ALL minimumAge: 10 Years maximumAge: 14 Years stdAges: CHILD facility: University of Wisconsin, Madison status: RECRUITING city: Madison state: Wisconsin zip: 53705 country: United States name: Gemma Gliori, MS role: CONTACT phone: 608-262-7269 email: ggliori@uwhealth.org name: Suzanne Hanson, BS role: CONTACT phone: 608-262-7269 email: shanson@uwhealth.org lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06354478 id: ms-103-2021 briefTitle: IV Dexmedetomidine vs Oral Gabapentin and Their Combination for Postoperative Analgesia in Cancer Patients Undergoing Modified Radical Mastectomy overallStatus: COMPLETED date: 2021-01-01 date: 2022-02-01 date: 2022-07-01 date: 2024-04-09 date: 2024-04-09 name: National Cancer Institute, Egypt class: OTHER briefSummary: Breast cancer is the most common malignant tumour among females with an incidence of about 2.1 million women every year.Nearly about 40-60% of breast surgery patients develop severe acute postoperative pain.⁴ Opioids are the current best standard drugs for postoperative pain relief, however, exposure to large doses of opioids leads to multiple side effects like prolonged sedation, respiratory depression, nausea, and vomiting.We are comparing two different drugs and their combination for perioperative analgesia for MRM.

This work is a comparative study that aims to compare the analgesic effects of perioperative IV infusion of dexmedetomidine, preoperative oral gabapentin, and their combination in patients undergoing modified radical mastectomy surgery regarding the time of first rescue analgesia, postoperative morphine consumption, and possible complications. conditions: Breast Cancer conditions: Pain, Postoperative conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Both patients and Investigator for postoperative pain will be blinded:

* Group 1(D): (n=30) Patients will receive oral placebo starch capsules 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia.
* Group 2(G): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous saline infusion with general anaesthesia.
* Group 3(DG): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ACTUAL name: Dexmedetomidine Hydrochloride 0.5 MG/ML name: Gabapentin measure: The time to first rescue analgesia during the first 24 hour Postoperatively. measure: Total postoperative morphine consumption till the first 24 hours measure: The degree of postoperative sedation according to Ramsay scores measure: VAS scores both at rest and during shoulder movement measure: Postoperative nausea and vomiting (PONV) as side effects of morphine. sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Institute city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06354465 id: IRB1967355 id: K23DA055695 type: NIH link: https://reporter.nih.gov/quickSearch/K23DA055695 briefTitle: Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews overallStatus: RECRUITING date: 2023-07-01 date: 2024-07-01 date: 2024-07-01 date: 2024-04-09 date: 2024-04-09 name: Lifespan class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders. conditions: Opioid Use Disorder conditions: Criminal Justice conditions: Treatment Adherence and Compliance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 25 type: ESTIMATED measure: Qualitative Transcripts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rhode Island Department of Corrections status: RECRUITING city: Cranston state: Rhode Island zip: 02920 country: United States name: Jessica Migliaccio role: CONTACT phone: 401-462-3921 email: doc.planning@doc.ri.gov lat: 41.77982 lon: -71.43728 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-09 uploadDate: 2024-03-31T17:37 filename: Prot_000.pdf size: 125769 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-01-07 uploadDate: 2024-04-04T09:46 filename: ICF_001.pdf size: 488632 hasResults: False

 nctId: NCT06354452 id: HGG2024_01 briefTitle: Effect of Statin Therapy on Sepsis-related Mortality in Intensive Care Unit Patients acronym: HGG_UCI1 overallStatus: COMPLETED date: 2018-01-01 date: 2019-12-31 date: 2020-01-31 date: 2024-04-09 date: 2024-04-09 name: Hospital de Granollers class: OTHER name: Department of Health, Generalitat de Catalunya briefSummary: The average age of patients with sepsis has increased in recent years in parallel with the incidence of sepsis. Many of these patients are frail and require various medications for the treatment of their chronic diseases. Common treatments, including e.g. sarcopenic drugs (statins, sulphonylureas, methyglinides), antioxidants that prevent sarcopenia (allopurinol) or immunoregulators (corticosteroids) may influence the survival and functional prognosis of these patients. Knowing which drugs influence sepsis survival and to what degree patients who survive sepsis have functional deterioration and increased comorbidity and which modifiable factors limit this may be essential. conditions: Sepsis conditions: Septic Shock studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 59578 type: ACTUAL name: Person-level linkage of the database looking for relationship with sepsis survival and previous intake of certain drug families and previous dependence on health services. measure: Death due to sepsis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital General de Granollers city: Granollers state: Barcelona zip: 08402 country: Spain lat: 41.60797 lon: 2.28773 hasResults: False

 nctId: NCT06354439 id: 77015224.6.1001.5327 briefTitle: Use of Letrozole for Ectopic Pregnancy acronym: EcZOL overallStatus: RECRUITING date: 2024-03-27 date: 2026-12-31 date: 2026-12-31 date: 2024-04-09 date: 2024-04-09 name: Hospital de Clinicas de Porto Alegre class: OTHER briefSummary: A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate conditions: Ectopic Pregnancy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: TREATMENT masking: NONE maskingDescription: Due to the nature of the outcome and the interventions, blinding was not considered an issue. count: 130 type: ESTIMATED name: Letrozole tablets name: Methotrexate Sodium measure: levels of beta fraction of human chorionic gonadotropin (beta-hCG) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de Clínicas de Porto Alegre status: RECRUITING city: Porto Alegre state: RS zip: 90035-903 country: Brazil name: RICARDO F SAVARIS, MD,PHD role: CONTACT phone: 55 51 33598117 email: rsavaris@hcpa.edu.br name: Michele S Savaris, BBA role: CONTACT phone: 555133598624 email: msavaris@hcpa.edu.br lat: -30.03306 lon: -51.23 hasResults: False

 nctId: NCT06354426 id: BVT2022/01 briefTitle: Short-term Mortality Prediction by the SOFA Score in Acute Decompensated Heart Failure overallStatus: COMPLETED date: 2022-07-01 date: 2023-08-31 date: 2023-08-31 date: 2024-04-09 date: 2024-04-09 name: Hanoi Heart Hospital class: OTHER briefSummary: Data on the use of sequential organ failure assessment (SOFA) in patients with cardiovascular disease are increasing. Several studies demonstrated that the SOFA score can identify short-term mortality in patients with acute decompensated heart failure (ADHF). This study was conducted to determine the prognostic value of the admission SOFA score in patients hospitalised for ADHF and to assess its ability in predicting the 30-day readmission rate. conditions: Acute Decompensated Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 216 type: ACTUAL measure: Mortality measure: Re-admission rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hanoi Heart Hospital city: Hanoi state: Hoan Kiem zip: 110000 country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False

 nctId: NCT06354413 id: 2023-2261 briefTitle: Outcomes of Concomitant Bypass Surgery in Septal Myectomy overallStatus: COMPLETED date: 2009-01 date: 2020-12 date: 2023-12 date: 2024-04-09 date: 2024-04-09 name: Chinese Academy of Medical Sciences, Fuwai Hospital class: OTHER briefSummary: To investigate clinical characteristics and survival outcomes of patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting during septal myectomy. conditions: Hypertrophic Cardiomyopathy conditions: Coronary Artery Disease conditions: Myocardial Bridging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 320 type: ACTUAL name: CABG during myectomy measure: all-cause mortality measure: cardiac-related deaths and readmission sex: ALL minimumAge: 8 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354400 id: 2022/001-002 briefTitle: Core Stabilization Training on Chest Expansion, Functional Capacity, Trunk Muscle Endurance in Hearing-Impaired Children overallStatus: RECRUITING date: 2024-03-30 date: 2024-05-30 date: 2024-06-30 date: 2024-04-09 date: 2024-04-09 name: Bezmialem Vakif University class: OTHER name: Nuh Naci Yazgan University briefSummary: Children's motor skills and physical performance increase with age due to the development of neuromuscular and cardiorespiratory systems. Sensory impairment seen in children with hearing loss can cause balance and coordination disorders, as well as decreased muscle strength and respiratory functions.

Anatomically, core stabilization is provided by the diaphragm, abdominal, hip, pelvic floor, and gluteal muscles. Training for these muscles is intended to improve strength, endurance, and neuromuscular control. This training can help to improve the control of intra-abdominal pressure, intersegmental control of the spine, and muscular control of trunk movement. It also helps in strengthening the respiratory muscles, especially the main inspiratory muscle, the diaphragm. In this study, the effects of core stabilization training on children with hearing impairments' thoracic mobility, functional ability, and trunk muscle endurance will be examined. conditions: Core Stabilization conditions: Respiration conditions: Functional Capacity conditions: Endurance conditions: Hearing Impaired Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Core stabilization training measure: Chest expansion measure: Functional capacity measure: Trunk muscle endurance sex: ALL minimumAge: 10 Years maximumAge: 15 Years stdAges: CHILD facility: Nuh Naci Yazgan University status: RECRUITING city: Kayseri country: Turkey name: Busra Kepenek-Varol, PhD, PT role: CONTACT phone: +905449106628 email: bkvarol@nny.edu.tr name: Busra Kepenek Varol, PhD, PT role: PRINCIPAL_INVESTIGATOR lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06354387 id: CMUH110-REC3-246 briefTitle: Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expression of PD-L1 overallStatus: RECRUITING date: 2022-02-16 date: 2024-12-31 date: 2025-06-01 date: 2024-04-09 date: 2024-04-09 name: China Medical University Hospital class: OTHER briefSummary: Hepatocellular carcinoma (HCC) is the fourth most common cause of cancer-related death and the second most deadly malignancy in Taiwan. Despite decades' intensive studies, surgery and local-regional chemo-embolization, radio-frequency ablation or radiation therapy remain the mainstay of HCC treatments. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Alectinib (Alecensa), Nivolumab (Opdivo) measure: Objective response rate(ORR) measure: PFS measure: TTP measure: DOR measure: DCR measure: OS sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CMUH status: RECRUITING city: Taichung country: Taiwan name: Chang-Fang Chiu, PhD role: CONTACT phone: 8864-22052121 email: 005686@tool.caaumed.org.tw lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06354374 id: 24-026 briefTitle: Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment. overallStatus: RECRUITING date: 2024-02-22 date: 2024-07 date: 2024-12 date: 2024-04-09 date: 2024-04-09 name: Ain Shams University class: OTHER name: British University In Egypt briefSummary: Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Therefore, the present study will be to evaluate the relationship between soft tissue volume and the dimensions \& tomographic alveolar ridge classes as well as to incorporate the soft tissue volumetric evaluation in the classification system. conditions: Soft Tissue Volume studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 350 type: ESTIMATED name: volume survey measure: the relationship between soft tissue volume & tomographic alveolar ridge classes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahmed Hamdy status: RECRUITING city: Al Shorouk City state: Cairo zip: 11837 country: Egypt name: Ahmed Hamdy role: CONTACT phone: +201061112512 email: ahmed.esmaail@bue.edu.eg hasResults: False

 nctId: NCT06354361 id: 17440 briefTitle: Trauma-Informed Goal Management Training for Public Safety Personnel (PSP) With Post-traumatic Stress Disorder (PTSD) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-09 date: 2024-04-09 date: 2024-04-18 name: McMaster University class: OTHER name: Workplace Safety and Insurance Board briefSummary: Goal Management Training (GMT) is a program designed to help improve cognitive functioning. For this study, researchers have worked closely with the developers of this program to create a modified version called Trauma-Informed Goal Management Training (TI-GMT), that is more sensitive to the needs of public safety personnel (PSP) diagnosed with Post-Traumatic Stress Disorder (PTSD).

The goal of this clinical trial is to find out how effective this modified, Trauma-Informed Goal Management Training program is for public safety personnel diagnosed with Post-Traumatic Stress Disorder, in comparison to the standard Goal Management Training program.

The main questions it aims to answer are:

1. Does Trauma-Informed Goal Management Training result in better neuropsychological functioning and greater reductions in the severity of PTSD symptoms when compared to standard Goal Management Training?
2. Does Trauma-Informed Goal Management Training result in self-reported improvements in cognitive functioning and the overall ability to function (including intent to return to work, and/or intent to stay at work, reductions in disability status, etc.) when compared to standard Goal Management Training?
3. Does Trauma-Informed Goal Management Training continue to benefit individuals three months after treatment?

Participants will:

* complete three separate assessments before starting the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
* participate in a nine-week group treatment program (one day a week for two hours)
* complete three separate assessments after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
* complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires conditions: Post-Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomised into two groups.

One group will receive nine sessions of Trauma-Informed Goal Management Training, and the other group will receive nine sessions of standard Goal Management Training.

Each group session will be 2 hours long, and offered virtually (using Zoom for Healthcare). primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Trauma-Informed Goal Management Training (TI-GMT) name: Goal Management Training (GMT) measure: Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('CAPS-5') at post-intervention and follow-up measure: Change from baseline in scores on the Sustained Attention Response Task ('SART') subtest of the Creyos Battery at post-intervention and follow-up measure: Demographic Information measure: Scores on the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('LEC-5') at baseline measure: Scores on the Childhood Trauma Questionnaire ('CTQ') at baseline measure: Scores on the Advanced Clinical Solutions ('ACS') Test of Premorbid Functioning ('TOPF') at baseline measure: Change from baseline in scores on selected neuropsychological assessment measures of Executive functioning, Processing speed and Attention at post-intervention and follow-up measure: Change from baseline in scores on selected neuropsychological assessment measures of Declarative memory at post-intervention and follow-up measure: Change from baseline in scores on selected neuropsychological assessment measures of Intellectual functioning at post-intervention and follow-up measure: Change from baseline in scores on selected neuropsychological assessment measures of Visuospatial and Visuoconstructive Ability and Sensorimotor integration at post-intervention and follow-up measure: Change from baseline in scores on the Mini International Neuropsychiatric Interview 7.0.2 ('M.I.N.I.') at post-intervention and follow-up measure: Change from baseline in scores on selected neuropsychological assessment measures of Visual and Visuospatial Working Memory at post-intervention and follow-up measure: Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention and follow-up measure: Change from baseline in score on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('PCL-5') at post-intervention and follow-up measure: Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention and follow-up measure: Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention and follow-up measure: Change from baseline in score on the twenty-item Toronto Alexithymia Scale ('TAS-20') at post-intervention and follow-up measure: Change from baseline in score on the Moral Injury Assessment for Public Safety Personnel ('MIA-PSP') at post-intervention and follow-up measure: Change from baseline in scores on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) at post-intervention and follow-up measure: Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention and follow-up measure: Change from baseline in scores on the Return to work Obstacles and Coping Efficacy - Common Mental Disorders ('ROSES-CMD') at post-intervention and follow-up measure: Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention and follow-up measure: Change from baseline in scores on the Lam Employment Absence and Productivity Scale ('LEAPS') at post-intervention and follow-up measure: Change from baseline in scores on the Survey of Perceived Organizational Support ('SPOS') at post-intervention and follow-up sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354348 id: GastrectomyUSG briefTitle: Practical Ultrasonographic Detection of Sarcopenia in Patients With Long-term Gastrectomy overallStatus: COMPLETED date: 2023-12-06 date: 2024-03-30 date: 2024-03-30 date: 2024-04-09 date: 2024-04-09 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: The investigators aimed to evaluate long-term sarcopenia in patients with total and distal gastrectomy by measuring the anterior thigh muscle with USG, which is a more specific and easy method. conditions: Sarcopenia conditions: Gastrectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ACTUAL name: USG, Grip strength, Chair stand test (CST) measure: Sarcopenia (Sonographic thigh adjustment ratio (STAR) was calculated by dividing the anterior thigh muscle thickness (mm) by BMI ) sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06354335 id: 1-16-02-62-20 briefTitle: Impact of a Major Organizational Change on Employee Productivity and Mental Health acronym: PRO-MENTA overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-01 date: 2024-12-31 date: 2026-12-31 date: 2024-04-09 date: 2024-04-11 name: Aarhus University Hospital class: OTHER name: University of Aarhus name: Herning Hospital name: Bispebjerg Hospital briefSummary: The study investigates the short- and long-term impact of a major organizational change on employee health and productivity. Changes in organizations is a common aspect of modern work life in all sectors and public healthcare is no exception. However, emerging evidence suggests that organizational changes may be a potential stressor which can impact on employee well-being and contribute to stress-related health problems. Using a large-scale natural experiment, the overall aim of the study is to investigate the impact of a major organizational change that took place during 2016-19 on employee health and productivity. In addition, we aim to identify groups that may be at increased risk of experiencing negative consequences of the reorganization. These at-risk groups can in turn be candidates for extended preventive measures when planning future major organizational changes. conditions: Work Related Stress conditions: Mental Health Issue conditions: Work-related Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 31555 type: ACTUAL name: Employees exposed to a major hospital reorganisation measure: Employee health measured by rate of absenteeism, use of health care services and redeemed drug prescriptions measure: Workplace productivity measured by number of patient contacts and medical procedures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital city: Aarhus state: Central Denmark Region zip: 8200 country: Denmark lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06354322 id: APHP230630 briefTitle: Unclassified GENotypes of Autoinflammatory Diseases and AA Amyloidosis acronym: IPHYGENI MAI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-06 date: 2034-05 date: 2024-04-09 date: 2024-04-09 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Patients with autoinflammatory diseases (AID) have recurrent episodes of systemic inflammation accompanied by nonspecific elevation of blood inflammation markers typically absent between attacks. A complication of autoinflammatory diseases is AA amyloidosis, which can lead to renal failure and dialysis. Advances in genetic analysis have led to the identification of new autoinflammatory diseases and thus new pathophysiological pathways.

However, genetic analyses are sometimes confronted with results that are difficult to interpret. These are the Variants of Unknown Significance, for which genetic analysis alone does not allow to determine if the genetic mutation is responsible for the symptoms.

genetic analysis sometimes has limitations in the diagnosis of AID which can only be overcome by pathophysiological studies of the variants found. conditions: AA Amyloidosis conditions: Autoinflammatory Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Exploration of VUS in AutoInflammatory Diseases measure: Pathophysiology of Autoinflammatory Diseases measure: Role of other innate immune cells in AutoInflammatory Diseases measure: Improve knowledge of AA amyloidosis sex: ALL minimumAge: 3 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354309 id: vr_study briefTitle: The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study overallStatus: COMPLETED date: 2023-08-01 date: 2023-10-20 date: 2023-10-20 date: 2024-04-09 date: 2024-04-09 name: He Eye Hospital class: OTHER briefSummary: The research project titled "The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study" aimed to evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants. 38 adults (76 eyes) with normal corrected vision and stereo vision were recruited. All subjects used HMVR device for two consecutive training sessions (30 minutes each, 10 minutes intervals). Before training, after the first training and the second training, recorded the results including best corrected visual acuity (BCVA), ocular position, stereo vision, postural stability, non-invasive tear breakup time (NITBUT), tear meniscus height (TMH), red eye analysis, lipid layer classification (TFLL), eye blink frequency, eye surface temperature, simulator sickness questionnaire (SSQ) score, ocular surface disease index (OSDI) dry eye questionnaire score, visual quality questionnaire score and visual fatigue questionnaire score. conditions: Amblyopia conditions: Motion Sickness conditions: Dry Eye studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 38 type: ACTUAL name: Virtual reality game measure: Simulator Sickness Questionnaire Score measure: Postural stability measure: Non-invasive tear breakup time measure: Tear meniscus height measure: Lipid layer classification measure: Eye blink frequency measure: Eye surface temperature measure: Ocular surface disease index dry eye questionnaire score measure: Visual quality questionnaire score measure: Visual fatigue questionnaire score sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: He Eye Hospital city: Shenyang state: Liaoning zip: 110034 country: China lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06354296 id: CAF2024 briefTitle: Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-15 date: 2024-08-31 date: 2024-04-09 date: 2024-04-09 name: He Eye Hospital class: OTHER briefSummary: The Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. In cases where only IOL-Master data are available, Holladay 1 (Double-K) \[Holladay 1 (D-K)\] can be used for IOL power calculation in cataract patients with a history of RK. The traditional Haigis formula has also been shown to be effective for cataract patients after RK. To compare the accuracy of four intraocular lens (IOL) power calculation formulas in cataract patients after RK. They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula. conditions: Cataract studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED measure: Accuracy of the IOL formula sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354283 id: Progresif briefTitle: Progressive Muscle Relaxation Exercises Women With Low Sexual Satisfaction Sexual Satisfaction and Functioning of Women and Their Partners overallStatus: COMPLETED date: 2023-04-10 date: 2024-01-30 date: 2024-02-08 date: 2024-04-09 date: 2024-04-09 name: Halic University class: OTHER briefSummary: This study was conducted to investigate the effect of progressive muscle relaxation exercises on sexual satisfaction and functioning of women and their partners in women with low sexual satisfaction.

Method: The single-blind, randomized controlled study was conducted between April 2023 and January 2024. The sample of the study was women with low sexual satisfaction and their partners were randomized into two groups as intervention and control. Each group consisted of 120 couples, n=60. The women in the intervention group were given progressive muscle relaxation techniques three times a week for four weeks. The results of the study focused on the effect on sexual satisfaction and functioning of men and women. conditions: Women With Low Sexual Satisfaction conditions: Partners of Women With Low Sexual Satisfaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention Group and Control Group primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The progressive relaxation intervention and follow-up was conducted by the researcher who was not blinded to the interventions (PSI). Randomization was performed by another academic who was not an investigator in the study. In order to avoid bias, the researcher who conducted the intervention did not participate in any step of the pre-test, post-test and statistical evaluation process. Group information was not shared with the statistician who performed the analysis. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ACTUAL name: Progressive Muscle Relaxation Exercises measure: Sexual Satisfaction measure: Sexual Function sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Fatma Şule Bilgiç city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06354270 id: 300104 briefTitle: A Clinical Study to Evaluate the Anti-Sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-11 date: 2024-06-24 date: 2024-06-24 date: 2024-04-09 date: 2024-04-25 name: HALEON class: INDUSTRY briefSummary: The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste. conditions: Dentin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 115 type: ACTUAL name: Stannous fluoride toothpaste name: Regular fluoride toothpaste (Crest Cavity Protection) measure: Change from Baseline in Schiff Sensitivity Score at Day 56 measure: Change from Baseline in Tactile Threshold at Day 56 measure: Change from Baseline in Schiff Sensitivity Score at Day 28 measure: Change from Baseline in Tactile Threshold at Day 28 measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 measure: Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56 measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Family and Cosmetic Dentistry, All Sums Research Center Ltd. city: Melbourne state: Florida zip: 32940 country: United States lat: 28.08363 lon: -80.60811 hasResults: False

 nctId: NCT06354257 id: 220104 briefTitle: A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-10-30 date: 2024-10-30 date: 2024-04-09 date: 2024-04-09 name: GlaxoSmithKline class: INDUSTRY briefSummary: The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used. conditions: Tuberculosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Fixed sequence primaryPurpose: PREVENTION masking: NONE maskingDescription: Open-label count: 25 type: ESTIMATED name: EE/LNG name: GSK3036656 Dose Level 1 name: GSK3036656 Dose Level 2 measure: Area under the plasma drug concentration (AUC)-time curve from time zero to extrapolated to infinity (AUC[0-inf]) of EE after being administered with 14 days of GSK3036656 at DL 2 measure: Maximum observed concentration (Cmax) of EE after being administered with 14 days of GSK3036656 at DL 2 measure: AUC(0-inf) of LNG after being administered with 14 days of GSK3036656 at DL 2 measure: Cmax of LNG after being administered with 14 days of GSK3036656 at DL 2 measure: AUC over the dosing interval (0-tau) of GSK3036656 after being administered with a single dose of EE/LNG measure: Cmax of GSK3036656 after being administered with a single dose of EE/LNG measure: Steady state assessment using trough plasma concentration (Ctau) of GSK3036656 after being administered with a single dose of EE/LNG measure: Tmax of GSK3036656 after being administered with a single dose of EE/LNG measure: AUC versus time curve (AUC[0-t]) of EE/LNG after being administered with a single dose of EE/LNG measure: AUC(0-t) of EE/LNG after being administered with 14 days of treatment with GSK3036656 at DL 2 measure: Tmax of EE/LNG after being administered with a single dose of EE/LNG measure: Tmax of EE/LNG after being administered with 14 days of GSK3036656 DL 2 measure: Apparent terminal half-life (t1/2) of EE and LNG after a single dose of EE/LNG measure: t1/2 of EE and LNG after a single dose of EE/LNG in combination with 14 days of treatment with GSK3036656 at DL 2 measure: Number of participants with serious adverse events (SAEs) measure: Number of participants with Grade 3 or higher severity adverse events (AEs) measure: Number of participants with drug-related AEs measure: Number of participants with drug-related AEs following the administration of GSK3036656 measure: Number of participants withdrawn from the treatment/study due to AEs measure: Percentage of participants with ECG values of Potential Clinical Importance (PCI) measure: Percentage of participants with clinical chemistry laboratory values of PCI measure: Percentage of participants with haematology laboratory values of PCI measure: Percentage of participants with vital signs parameters of PCI sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Madrid zip: 28046 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Alberto Borobia Perez role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06354244 id: 2023-183-KY-02 briefTitle: Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions overallStatus: RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-09 date: 2024-04-09 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions conditions: Urinary Retention conditions: Lower Motor Neurone Lesion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Electroacupuncture of 2 sessions per week name: Electroacupuncture of 3 sessions per week name: Electroacupuncture of 4 sessions per week measure: The response rate. measure: The response rate. measure: The change in post void residuals (PVR) from baseline. measure: The change in the proportion of patients reporting severe urinating difficulty from baseline. measure: The change in the proportion of patients having stool retention from baseline. measure: The change in the proportion of patients requiring catheterization from baseline. measure: The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I). measure: The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences status: RECRUITING city: Beijing country: China name: Zhishun Liu, PhD role: CONTACT phone: +861088002331 email: zhishunjournal@163.com name: Min Yang role: CONTACT phone: +8618810268077 email: yangmin2019@yeah.net lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06354231 id: RC48-C012 briefTitle: DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC overallStatus: RECRUITING date: 2023-07-20 date: 2026-12-30 date: 2026-12-30 date: 2024-04-09 date: 2024-04-11 name: Fudan University class: OTHER briefSummary: Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment. conditions: Renal Insufficiency conditions: Upper Urinary Tract Urothelial Carcinoma conditions: Solitary Kidney studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: DV name: Toripalimab name: Laser surgery measure: Kidney-intact disease-free survival, KI-DFS measure: Time to progression, TTP measure: Time to RNU measure: Disease-specific survival time, DSS measure: Overall survival measure: 3m complete remission sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai country: China name: dingwei ye role: CONTACT phone: 64175590-82800 lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06354218 id: GXL-005 briefTitle: Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age overallStatus: RECRUITING date: 2023-12-01 date: 2025-12-01 date: 2027-12-01 date: 2024-04-09 date: 2024-04-09 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: This study is a Single Arm, Prospective, Exploratory, Single Center Phase II Clinical Study to evaluate the effectiveness of the combination of Serplulimab and Concurrent Chemoradiotherapy in the treatment of elderly patients with locally advanced esophageal cancer who cannot be treated surgically.Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. conditions: Esophageal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Serplulimab measure: mPFS measure: ORR measure: OS measure: DOR measure: Toxic side reactions sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Xiaolin MM Ge, PHD role: CONTACT phone: 13951818797 email: doctorsxl@163.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06354205 id: 24-3.1T/98 briefTitle: Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels overallStatus: RECRUITING date: 2024-06-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-09 date: 2024-04-09 name: Ege University class: OTHER name: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE briefSummary: Recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. Saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. In the current literature, elevated levels of saliva CRP, TNF-α, IL-6, and IFN-γ have been reported in inflammatory conditions. However, while there are animal studies suggesting the use of saliva PCT levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections.

The aim of this study is to evaluate the correlation between serum PCT levels and saliva PCT levels in children suspected of SBE and to determine the diagnostic value of saliva PCT. conditions: Bacterial Infections conditions: Children, Only conditions: Procalcitonin conditions: Saliva studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 160 type: ESTIMATED name: Sliva Procalcitonin measure: Correlation measure: Diagnose sex: ALL minimumAge: 0 Years maximumAge: 1 Year stdAges: CHILD facility: Ege University School of Medicine status: RECRUITING city: İzmir zip: 35100 country: Turkey name: Caner Turan role: CONTACT lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06354192 id: 0450 briefTitle: Precision Nudging for Hypertension Management: Observational Study overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2025-10-11 date: 2026-10-11 date: 2024-04-09 date: 2024-04-09 name: Lirio class: INDUSTRY name: Cone Health briefSummary: The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management. In the current intervention, behavioral reinforcement learning is applied to personalize intervention content to maximize the behavioral outcomes of three target behaviors critical for effective hypertension management: clinical encounters, medication adherence, and self-monitoring of blood pressure (SMBP). conditions: Hypertension studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 12000 type: ESTIMATED name: Precision Nudging for Hypertension Management measure: Clinical encounter behavioral outcome measure: Blood pressure reading clinical outcome measure: Engagement measure: Medication adherence behavioral outcome measure: Self-monitoring of blood pressure behavioral outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354179 id: 87RI23_0031 (EASY) briefTitle: Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY) acronym: EASY overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-01 date: 2027-07-01 date: 2024-04-09 date: 2024-04-11 name: University Hospital, Limoges class: OTHER briefSummary: World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and graft loss making it a critical determinant of patient outcome. The prevalence of non-adherence in transplant patients, including liver transplant patients, can be as high as 40%. Among others, life-long intake and complexity of immunosuppressive regimen make patients prone to non-adherence. For instance, non-adherence is more prevalent among patients with higher numbers of immunosuppressive drugs. One of the most commonly cited causes of non-adherence is forgetfulness and disruptions in routine, with the evening dose of twice daily regimens being the most likely to be affected6. Besides non-adherence, the constraints generated in everyday life by immunosuppression (including timely and regular drug intake) and the complexity of the immunosuppressive regimens represent a burden for the patients and are probably associated with a health-related quality of life deterioration. Therefore, long-term adherence and quality of life after liver transplantation might be improved by using a well-tolerated and easy-to-handle immunosuppressive regimen.

The immunosuppressive regimen after liver transplantation is in most cases based on different combinations of tacrolimus, mycophenolate mofetil and corticosteroids. While corticosteroids are administered once daily, tacrolimus can be administered either twice-daily (BID) as an immediate-release, or once-daily (QD) as an extended-release formulation. Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients. It has demonstrated similar outcomes compared to immediate-release tacrolimus BID, in both kidney and liver transplantation. Mycophenolate has only been approved for BID administration, preventing from taking all immunosuppressive drugs once daily. Yet, single daily dosing would probably contribute to better adherence and quality of life in patients receiving a life-long treatment.

Although the half-life of mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF) is compatible with once-daily administration, no published randomized clinical study has ever evaluated the efficacy and safety of MMF administered QD.

The narrow therapeutic index and wide pharmacokinetic variability of tacrolimus and mycophenolate justify individual dose adjustment by means of therapeutic drug monitoring (TDM), in order to minimize the risk of acute rejection and the occurrence of adverse events. For tacrolimus, TDM is generally based on the trough concentration (C0) and sometimes on the area under the concentration-time curve (AUC), while for mycophenolate it should be based on the AUC of MPA. However, the dose adjustment of MMF in liver transplant patients is most of the time performed a posteriori, based on clinical signs of inefficacy of toxicity.

Limited sampling strategies with maximum a posteriori Bayesian estimation have been developed by our team for both molecules in adult liver transplant patients to estimate their AUC, which is considered the best marker of exposure for both. Therefore, tacrolimus AUC0-24h can be estimated by Bayesian estimation using samples collected before administration (C0), 8 (C8h) and 12 (C12h) hours after the administration of ENVARSUS XR®, or 1 and 3 hours after the administration of PROGRAF® and ADVAGRAF®. For mycophenolate, the MPA AUC can be estimated using samples collected 20 min, 1 and 3 hours after MMF administration, by Bayesian estimation.

Even if limited to 2 or 3 blood samples, tacrolimus TDM for ENVARSUS® requires late sampling (12h post-dose). To overcome the necessity of a longer hospital stay, microsampling devices (MSD) such as the Volumetric absorptive microsampling (VAMS®) device (Mitra®) can be used by the patients to take samples themselves, at home. Moreover, they are less invasive than venipuncture and collect low but accurate volumes of blood for analysis.

In this context, we propose a randomized controlled non-inferiority study to demonstrate that in liver transplant recipients, an immunosuppressive strategy based on single daily doses of LCP-tacrolimus (ENVARSUS XR®) and mycophenolate mofetil (CELLCEPT®) started at M6 post-transplantation is not inferior to XR-tacrolimus (ADVAGRAF®) and MMF administered BID, in terms of incidence of treatment failure (see below) at the end of the first year after transplantation, and to obtain adherence, quality of life and safety data. In order to compare solely MMF QD to MMF BID, patients on ENVARSUS XR® and MMF QD will be compared to a third group of patients receiving ENVARSUS XR® and MMF BID. A direct comparison of efficacy and safety, quality of life, adherence and exposure indices will be performed between ENVARSUS XR® and ADVAGRAF®. conditions: Liver Transplantation conditions: Immunosuppression studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 162 type: ESTIMATED name: XR-tacrolimus QD + MMF BID name: LCP-tacrolimus QD + MMF BID name: LCP-tacrolimus QD + MMF QD measure: Treatment failure measure: Adherence to treatment measure: measuring of quality of life measure: Adherence to treatment measure: measuring of quality of life measure: Appearance Adverse events measure: Appearance Adverse events measure: Comparison tacrolimus daily exposure measure: Comparison of MPA daily exposure measure: Comparison of Tacrolimus dose measure: Comparison of Tacrolimus AUC 0-24h measure: Comparison of MPA AUC 0-24h sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beaujon hospital - APHP city: Clichy zip: 92110 country: France lat: 48.90018 lon: 2.30952 facility: Lille university hospital city: Lille zip: 59000 country: France name: Sébastien DHARANCY, MD role: CONTACT email: sebastien.dharancy@chru-lille.fr name: Sébastien DHARANCY, MD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Limoges university hospital city: Limoges zip: 87042 country: France name: Marilyne DEBETTE-GRATIEN, MD role: CONTACT email: MARILYNE.GRATIEN@chu-limoges.fr name: Marilyne DEBETTE-GRATIEN, MD role: PRINCIPAL_INVESTIGATOR lat: 45.83153 lon: 1.25781 facility: Lyon university hospital city: Lyon zip: 69000 country: France name: Teresa ANTONINI, MD role: CONTACT email: teresa.antonini@chu-lyon.fr name: Teresa ANTONINI, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Montpellier university hospital city: Montpellier zip: 34000 country: France name: Georges-Philippe PAGEAUX, MD role: CONTACT email: gp-pageaux@chu-montpellier.fr name: Georges-Philippe PAGEAUX, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: Nice university hospital city: Nice zip: 06202 country: France name: Rodolphe ANTY, MD role: CONTACT email: anty.r@chu-nice.fr name: Rodolphe ANTY, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Pitie Salpetriere hospital - APHP city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 facility: Bordeaux university hospital city: Pessac zip: 33604 country: France name: Jean-Baptiste HIRIART, MD role: CONTACT email: jean-baptiste.hiriart@chu-bordeaux.fr name: Jean-Baptiste HIRIART, MD role: PRINCIPAL_INVESTIGATOR lat: 44.81011 lon: -0.64129 facility: Poitiers university hospital city: Poitiers zip: 86000 country: France name: Christine SILVAIN, MD role: CONTACT email: c.silvain@chu-poitiers.fr name: Christine SILVAIN, MD role: PRINCIPAL_INVESTIGATOR lat: 46.58333 lon: 0.33333 facility: Rennes university hospital city: Rennes zip: 35033 country: France name: Pauline HOUSSEL-DEBRY, MD role: CONTACT email: pauline.houssel-debry@chu-rennes.fr name: Pauline HOUSSEL-DEBRY, MD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 facility: Strasbourg university hospital city: Strasbourg zip: 67000 country: France name: Camille BESCH, MD role: CONTACT email: camille.besch@chru-strasbourg.fr name: Camille BESCH, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Tours university Hospital city: Tours zip: 37000 country: France lat: 47.38333 lon: 0.68333 facility: Paul Brousse Hospital - APHP city: Villejuif zip: 94800 country: France lat: 48.7939 lon: 2.35992 hasResults: False

 nctId: NCT06354166 id: 2023-A02745-40 briefTitle: Study Human Digital Support Transitional Care acronym: SUNH-ST overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-09 date: 2024-04-09 name: Divoluci class: OTHER briefSummary: The purpose of the study is to compare the effectiveness of Divomed in organising complex hospital discharges with a conventional organisation. Effectiveness will be assessed by reducing the length of stay of patients in geriatric short-stay care. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Interventional, randomised (1:1 ratio), single-centre study primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: open-label study count: 150 type: ESTIMATED name: Unscheduled hospital admissions measure: length of stay sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT facility: CHRU de Tours - Hôpital Bretonneau city: Tours zip: 37044 country: France name: Wassim GANA, MD role: CONTACT email: w.gana@chu-tours.fr lat: 47.38333 lon: 0.68333 hasResults: False

 nctId: NCT06354153 id: 0305898 briefTitle: Polarity Management Training Program for First Line Nurse Manager overallStatus: COMPLETED date: 2022-12-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-09 date: 2024-04-09 name: Matrouh University class: OTHER briefSummary: Polarities are vital issues in healthcare systems. Nursing is a profession riddled with polarities. If first-line nurse managers are well trained to manage polarities in the workplace, this could lead to positive outcomes for nurses, nurse managers and organization performance. conditions: Intervention conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: A quasi-experimental design utilized one group for pre-, post, and follow-up intervention. whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Polarity Management Training Program measure: Questionnaire to measure nurse managers' knowledge measure: Nursing polarity case study situations to assess first-line nurse manager's ability to differentiate between problems to solve and polarities to manage measure: Questionnaire to measure creativity behavior of first-line nurse managers measure: questionnaire to measure intrinsic work motivation among first-line nurse managers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Marsa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False

 nctId: NCT06354140 id: WeGuo briefTitle: PPIO-008S-1 Combined With Tislelizumab in Patients With Primary Residual Node-negative Esophageal Squamous Cell Carcinoma (ESCC) After Radical Resection With Neoadjuvant Immunotherapy Combined With Chemotherapy, PHASE II STUDY overallStatus: RECRUITING date: 2024-04-07 date: 2027-04-30 date: 2028-04-30 date: 2024-04-09 date: 2024-04-09 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy conditions: Postoperative Assistance for Esophageal Squamous Cell Carcinoma With Negative Lymph Nodes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: The study was a one-arm open study count: 45 type: ESTIMATED name: Tegafur measure: 1-year DFS rate measure: Overall survival measure: Progression-free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Army Medical Center of the People's Liberation Army status: RECRUITING city: Chongqing state: Chongqing zip: 400042 country: China name: Guo role: CONTACT phone: +8613527323568 email: gyguowei@hotmail.com lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06354127 id: DW_DWP450009 briefTitle: DWP450 for Treating Moderate to Severe Glabellar Lines overallStatus: COMPLETED date: 2020-08-12 date: 2020-11-24 date: 2021-01-25 date: 2024-04-09 date: 2024-04-09 name: Daewoong Pharmaceutical Co. LTD. class: INDUSTRY briefSummary: A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of moderate to severe glabellar lines conditions: Moderate to Severe Glabellar Lines studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 473 type: ACTUAL name: DWP450 name: Botox® measure: Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06354114 id: SYHX2011-003 briefTitle: A Study to Evaluate the Efficacy and Safety in Subjects With Advanced Breast Cancer Treated With SYHX2011 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10-31 date: 2026-12 date: 2024-04-09 date: 2024-04-09 name: CSPC Ouyi Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the efficacy and safety in subjects with advanced breast cancer treated with SYHX2011 conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: SYHX2011 measure: Objective Response Rate (ORR) by Investigator measure: Progression-Free-Survival (PFS) measure: Time to progression (TTP) measure: Incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Harbin Medical University Cancer Hospital city: Harbin state: Heilongjiang country: China name: Qingyuan Zhang role: CONTACT phone: 86-13313612989 email: 13313612989@163.com lat: 45.75 lon: 126.65 hasResults: False

 nctId: NCT06354101 id: CorEvitas-VITALITY briefTitle: The Purpose of This Registry Study is to Learn More About Metabolic Health: Approximately 15,000 Participants Who Are Overweight or Have Obesity With or Without Metabolic Diseases Are Expected to Participate in This Registry Study. overallStatus: WITHDRAWN date: 2023-07-01 date: 2023-07-01 date: 2023-07-01 date: 2024-04-09 date: 2024-04-09 name: CorEvitas class: NETWORK name: Eli Lilly and Company briefSummary: The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study. conditions: Metabolic Health studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 0 type: ACTUAL name: Tirzepatide name: Semaglutide measure: Main Objective of Registry sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06354088 id: AAAU9636 briefTitle: Human Models of Selective Insulin Resistance: Alpelisib, Part I overallStatus: RECRUITING date: 2024-04-24 date: 2026-05 date: 2026-12 date: 2024-04-09 date: 2024-04-29 name: Columbia University class: OTHER name: University of California, Berkeley briefSummary: The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.

The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels. conditions: Insulin Resistance conditions: Prediabetic State conditions: Overweight and Obesity conditions: Non-Alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: Alpelisib 300 mg name: Placebo name: [1-13C] sodium acetate name: [6,6-2H2] D-glucose name: Nestlé BOOST Plus measure: Hepatic de novo lipogenesis (DNL) (absolute value) measure: Hepatic de novo lipogenesis (DNL) (relative value) measure: Endogenous glucose production (EGP) (absolute value) measure: Endogenous glucose production (EGP) (relative value) measure: Serum insulin level measure: Plasma glucose level measure: Triglycerides level measure: Free fatty acids level measure: Glucose kinetics: rate of appearance (absolute value) measure: Glucose kinetics: rate of appearance (relative value) measure: Glucose kinetics: rate of disappearance (absolute value) measure: Glucose kinetics: rate of disappearance (relative value) measure: Apolipoprotein B level sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Columbia University Irving Medical Center status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Joshua R Cook, MD, PhD role: CONTACT phone: 212-305-6289 email: jrc2175@cumc.columbia.edu name: Zachary D Sone role: CONTACT phone: 2123059336 email: zds2120@cumc.columbia.edu name: Joshua R Cook, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Blandine Laferrère, MD, PhD role: SUB_INVESTIGATOR name: Henry N Ginsberg, MD role: SUB_INVESTIGATOR name: Julia J Wattacheril, MD role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06354075 id: IRBN302024/CHUSTE briefTitle: Evaluation of Patient Information in Interventional Radiology overallStatus: RECRUITING date: 2024-04-01 date: 2026-03 date: 2026-03 date: 2024-04-09 date: 2024-04-10 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Interventional radiology is developing. Patient information modalities are also evolving, in particular information videos. conditions: Patient Satisfaction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Questionary measure: to evaluate satisfaction of patient of explanatory videos in interventional radiology measure: To evaluate satisfaction of patient of comic book in interventional radiology sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Saint-Etienne status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: Sylvain GRANGE, MD role: PRINCIPAL_INVESTIGATOR name: Rémi GRANGE, MD role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06354062 id: 0305896 briefTitle: Talent Management Intervention Program for First-Line Nurse Managers overallStatus: COMPLETED date: 2022-12-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-09 date: 2024-04-09 name: Matrouh University class: OTHER briefSummary: Nurse leaders will be required to manage the rapid change in the healthcare system. Talent management training plays a crucial role in preparing nursing leaders and improving their performance in health care systems. conditions: Intervention conditions: Behavior conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A quasi-experimental design primaryPurpose: OTHER masking: SINGLE maskingDescription: First Line Nurse Managers received talent Management intervention program whoMasked: PARTICIPANT count: 125 type: ACTUAL name: Talent management intervention program measure: Questionnaire to measure nurse managers' knowledge measure: Questionnaire to measure talent management practice among first line nurse managers. measure: Questionnaire to measure first-line nurse manager job performance sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Mersa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False

 nctId: NCT06354049 id: CASE3Z24 briefTitle: Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI) overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-12-31 date: 2025-03-31 date: 2024-04-09 date: 2024-04-09 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population. conditions: Cancer Pain conditions: Oncology Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Reiki measure: Recruitment rate as measured by the percentage of participants enrolled measure: Retention rate as measured by the number of participants retained until the final survey point measure: Attendance rate as measured by number of sessions attended per 6 sessions measure: Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention measure: Acceptability as measured by the patient mean of participant satisfaction survey measure: Data completeness rate measure: Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score measure: Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44106 country: United States lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06354036 id: NCC4465 briefTitle: Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy overallStatus: RECRUITING date: 2023-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-04-09 date: 2024-04-10 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method.

Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. The production time of the muscle flap is based on the electric knife incision of the muscle flap as the starting point, and successfully penetrating the muscle flap as the endpoint. The tunnel passes through time, pulling the residual end of the esophagus, and starting to pass through the gastric muscle flap tunnel as the time starting point. The complete placement of the gastric tube into the lower mediastinum is used as the time endpoint. The anastomosis time is calculated from the first needle of suturing the residual stomach and the posterior wall of the esophagus until the end of the plasma flap suturing. Record perioperative indicators such as surgical time, bleeding volume, and postoperative hospital stay. The definition of anastomotic stenosis is that in gastroscopy, those who cannot pass through the anastomotic site with ultra-fine endoscopy are judged as anastomotic stenosis.

Postoperative pathology was performed using the 8th edition AJCC staging. Follow up every three months after surgery, including blood tests, liver and kidney function, and tumor markers. According to the situation, choose gastroscopy, upper gastrointestinal imaging, and chest abdominal pelvic enhanced CT. Evaluate postoperative reflux symptoms such as heartburn and sternal pain using the Visick grading system. Gastroscopy Los Angeles grading was used to evaluate postoperative reflux esophagitis. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: the Transhiatal Tunnel Valvuloplasty technique measure: The incidence of postoperative reflux esophagitis measure: the incidence of postoperative anastomotic fistula measure: the incidence of anastomotic stenosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing zip: 100021 country: China name: Dongbing R Zhao, M.D. role: CONTACT phone: +86-13901331816 email: dbzhao2003@sina.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06354023 id: IAGH for Osteoarthritis briefTitle: Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2025-05-08 date: 2025-05-08 date: 2024-04-09 date: 2024-04-17 name: John Sledge class: OTHER briefSummary: The goal of this clinical trial is to learn if growth hormone injections can be used to treat osteoarthritis (OA) in the knee. Human studies have shown that repeated injections of human growth hormone leads to the production of articular chondrocytes, which are the cells that make up the cartilage in the knee joint. Restoring cartilage in the knee can alleviate pain, improve function, and postpone the need for a joint replacement procedure. The main questions the study aims to answer are:

* Do growth hormone injections in the knee joint stimulate cartilage growth?
* Do the injections lower pain and stiffness in the participant's treated knee?
* Does the participant have more mobility after the injections?

The physician will monitor the participant's progress through X-ray images, questionnaires, and physical evaluation of the treated knee.

For the trial, participants will:

* Receive a growth hormone injection in their knee once per week for six weeks, for a total of 6 injections.
* Complete at-home exercises during the treatment period.
* Use crutches as needed during the trial.
* Have X-rays taken at 8 weeks, 6 months, and 12 months after the first injection.
* Go to follow-up visits at 8 weeks, 6 months, and 12 months after the first injection.
* Complete treatment surveys before treatment starts and after it is finished. conditions: Osteoarthritis, Knee studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The proposed clinical trial is a single-arm intervention model. Once per week for six weeks, each participant will receive an intra-articular injection of recombinant human growth hormone (rGH) 15 IU in their affected knee. During the treatment course, the participants will use the same knee brace and crutches (as needed) and be given the same exercises to complete at home. They will all be evaluated 8 weeks, 6 months, and 12 months after their initial injection. primaryPurpose: TREATMENT masking: NONE maskingDescription: None, each participant will receive the same treatment count: 23 type: ESTIMATED name: Recombinant human growth hormone measure: Knee Society Score measure: Kellgren-Lawrence Grading Scale measure: Serum IGF-1 Levels sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BioShift Life Sciences city: Santa Monica state: California zip: 90404 country: United States name: Maggie Phillips role: CONTACT phone: 301-655-4651 email: maggie@bioshift.com lat: 34.01945 lon: -118.49119 hasResults: False

 nctId: NCT06354010 id: SENS-NH02 briefTitle: Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis acronym: SONG overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-07 date: 2027-07 date: 2024-04-09 date: 2024-04-09 name: Sensorion class: INDUSTRY briefSummary: The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene. conditions: Sensorineural Hearing Loss, Bilateral studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 100 type: ESTIMATED name: Genotyping name: Audiological assessments measure: Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene. measure: Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene measure: Genetic characteristics of adult patients with early-onset presbycusis measure: Audiological characteristics of adult patients with early-onset presbycusis measure: Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene sex: ALL minimumAge: 30 Years maximumAge: 55 Years stdAges: ADULT facility: CHU Gui de Chauliac city: Montpellier zip: 34295 country: France name: Frederic Venail, Pr role: CONTACT lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06353997 id: 2024000099 briefTitle: Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2029-06 date: 2024-04-09 date: 2024-04-09 name: Providence Health & Services class: OTHER name: Inhibrx, Inc. briefSummary: This is a Phase II trial to assess feasibility of pembrolizumab + INBRX-106 as a chemotherapy-sparing neoadjuvant therapy. One therapeutic arm is being evaluated to provide an informal comparison of pharmacodynamic and clinical effects of concurrent dosing schedule. conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Pembrolizumab name: INBRX-106 measure: Pathological response (post-IO) measure: Pathological response (post-chemotherapy) measure: IO-path response assessed prior to Cycle 2 measure: Volumetric response measure: Event free survival measure: Overall survival measure: Toxicity profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ellison Institute of Technology (EITM) city: Los Angeles state: California zip: 90064 country: United States name: Reva Basho, MD role: CONTACT phone: 310-272-7640 lat: 34.05223 lon: -118.24368 facility: Providence Portland Cancer Institute - Franz Clinic city: Portland state: Oregon zip: 97213 country: United States name: Nicole Moxon, RN role: CONTACT email: canrsrchstudies@providence.org name: Alison Conlin, MD role: SUB_INVESTIGATOR name: Evelyn Brosnan, MD role: SUB_INVESTIGATOR name: Evie Hobbs, MD role: SUB_INVESTIGATOR name: Rui Li, MD, PhD role: SUB_INVESTIGATOR name: Sasha Stanton, MD, PhD role: SUB_INVESTIGATOR name: Zheng Topp, MD role: SUB_INVESTIGATOR name: Amy Hartman, NP role: SUB_INVESTIGATOR name: Kathleen Dronkowski, NP role: SUB_INVESTIGATOR name: Kimberlie Dame, NP role: SUB_INVESTIGATOR name: Molly Davis, NP role: SUB_INVESTIGATOR name: RaYoung Chung, NP role: SUB_INVESTIGATOR name: Roxanne Griswold, NP role: SUB_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Providence St. Vincent Medical Center city: Portland state: Oregon zip: 97225 country: United States name: Nicole Moxon, RN role: CONTACT email: canrsrchstudies@providence.org name: David Page, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Swedish Cancer Institute city: Seattle state: Washington zip: 98104 country: United States name: Danielle File, MD role: CONTACT phone: 206-386-3900 lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06353984 id: Minimeal 1.0 briefTitle: Effects of In-between Meal Products on Cognitive Function in Older Adults acronym: Minimeal overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-12 date: 2025-12 date: 2024-04-09 date: 2024-04-09 name: Örebro University, Sweden class: OTHER briefSummary: The overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older. Secondary, the study also investigates the impact of the intervention on low grade inflammation, immune function, gut health, body composition, physical function, and well-being as secondary or exploratory outcomes. The present study has as the potential to prevent or slow down the onset of cognitive decline as it targets healthy older adults and gives additional insight regarding secondary and exploratory outcomes. conditions: Cognitive Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded control arm without any intervention primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Investigators and participants are partly blinded as the control group receives no placebo product whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Minimeal product name: Reference product measure: Functional brain activity measure: Fasting blood glucose/insulin measure: Blood fats/lipid status measure: Interleukin-6 measure: High-sensitivity C-reactive protein measure: Tumor necrosis factor measure: Interferon-gamma measure: Zonulin measure: Intestinal fatty-acid binding protein measure: Cognitive function measure: Magnetic resonance imaging (MRI) measure: The Perceived Stress Scale measure: Hospital Anxiety and Depression Scale measure: SF 36 measure: Western Ontario and McMaster Osteoarthritis Index measure: Clinical Outcomes in Routine Evaluation measure: Gastrointestinal Symptoms Rating Scale measure: Pittsburgh Sleep Quality Index measure: International Physical Activity Questionnaire for the Elderly short form measure: Historical Physical Activity Questionnaire measure: Food frequency questionnaire measure: Physical activity measure: Muscle mass measure: Fat mass measure: Body mass index measure: Waist circumference measure: Aerobic capacity measure: Balance measure: 30-sec repeated chair raise measure: Maximal leg strength measure: Maximal handgrip strength sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353971 id: JSP-CP-010 id: 2023-507534-24 type: EUDRACT_NUMBER briefTitle: A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines acronym: SPOTLIGHT overallStatus: RECRUITING date: 2024-03-18 date: 2025-04-21 date: 2025-08-04 date: 2024-04-09 date: 2024-04-10 name: Jasper Therapeutics, Inc. class: INDUSTRY briefSummary: This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore two ascending dose levels which will be tested in two sequential cohorts. conditions: Chronic Inducible Urticaria studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This is an open-label, single ascending dose, Phase 1b/2a trial.

Cohort 1 follows a 3+3 design and will be treated with a single 40mg dose. Cohort 2 will be treated with a single 120mg dose. primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Briquilimab measure: Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines. measure: Preliminary efficacy of briquilimab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - University Clinic Berlin status: RECRUITING city: Berlin zip: 12203 country: Germany lat: 52.52437 lon: 13.41053 facility: University Hospital Dresden status: RECRUITING city: Dresden zip: 01307 country: Germany lat: 51.05089 lon: 13.73832 facility: Medical University Hannover status: NOT_YET_RECRUITING city: Hannover zip: 30625 country: Germany lat: 52.37052 lon: 9.73322 facility: University Clinic Schleswig-Holstein status: RECRUITING city: Lübeck zip: 23538 country: Germany lat: 53.86893 lon: 10.68729 hasResults: False

 nctId: NCT06353958 id: MiSaver PIIa briefTitle: MiSaver® Stem Cell Treatment for Acute Myocardial Infarction acronym: MiSaver® overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-09 date: 2024-04-09 name: Honya Medical Inc class: INDUSTRY name: Chung Shan Medical University briefSummary: Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.

Primary Endpoint:

The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.

Secondary Outcomes:

Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups. conditions: Acute Myocardial Infarction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 30 type: ACTUAL name: MiSaver measure: Safety and adverse events events measure: Efficacy on ventricular ejection fraction (LVEF) improvement sex: ALL minimumAge: 41 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung Shan Medical University Hospital city: Taichung country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06353945 id: HB062-24 briefTitle: Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use. overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-05-07 date: 2024-05-15 date: 2024-04-09 date: 2024-04-09 name: Herbarium Laboratorio Botanico Ltda class: INDUSTRY briefSummary: The present research project aims to evaluate the perceived effectiveness of the product under investigation under normal conditions of use for 28 days, to defend the claims "High hydration power, relief of discomfort and improvement of vaginal tone." conditions: Vaginal Atrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: vaginal moisturizer measure: evaluate the perceived effectiveness of the investigational product sex: FEMALE minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353932 id: KA-23026 briefTitle: The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range overallStatus: COMPLETED date: 2024-01-25 date: 2024-02-25 date: 2024-02-25 date: 2024-04-09 date: 2024-04-09 name: Hacettepe University class: OTHER briefSummary: The main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation duration, smoking, presence of chest disease, presence of blood on the intubation tube after extubation, presence of NG\\OG, and type of surgery on the incidence of sore throat, hoarseness, and cough.The patients were randomly divided into two: a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoring.The endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation, before extubation, and in long cases, at the 3rd hour after intubation.Patients were evaluated for sore throat, cough, and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups. conditions: Endotracheal Tube conditions: Cuff Pressure conditions: Sore Throat studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 263 type: ACTUAL name: keeping the endotracheal tube cuff pressure within a certain range measure: Sore throat measure: cough measure: hoarseness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University Hospital city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06353919 id: NUNM briefTitle: Remote Yoga Nidra for Deprescribing BZRAs overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-04-09 date: 2024-04-09 name: National University of Natural Medicine class: OTHER name: US Department of Veterans Affairs briefSummary: The overall goal of this application is to assess feasibility and impact of a remotely delivered guided meditation practice called Yoga Nidra, for reducing or stopping use of Benzodiazepine Receptor Agonists (BZRAs) for insomnia and anxiety in a population of older adults recruited from within the Birmingham VA medical system. conditions: Anxiety conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Yoga Nidra name: Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education measure: Demand measure: Recruitment Success measure: Implementation practicality measure: Acceptability measure: Retention measure: Adherence to Protocol measure: Use of Benzodiazepine Receptor Agonist medications measure: Cessation of Benzodiazepine Receptor Agonist medication measure: Baseline Urine Benzodiazepine Receptor Agonist Concentration measure: Close-out Urine Benzodiazepine Receptor Agonist Concentration measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Insomnia Severity Index measure: Patient reported outcomes measurement information system 29 measure: Patient reported outcomes measurement information system 29 measure: Generalized Anxiety Disorder 7 Questionnaire measure: Generalized Anxiety Disorder 7 Questionnaire sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353906 id: N22APC briefTitle: Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer acronym: PRIAM overallStatus: NOT_YET_RECRUITING date: 2024-06-14 date: 2026-10-14 date: 2028-01-14 date: 2024-04-09 date: 2024-04-09 name: The Netherlands Cancer Institute class: OTHER name: Merck Sharp & Dohme LLC briefSummary: This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis conditions: Urologic Neoplasms conditions: Urogenital Neoplasms conditions: Male Urogenital Diseases conditions: Penile Cancer conditions: Penile Squamous Cell Carcinoma conditions: Locally Advanced Penile Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Carboplatin/Paclitaxel name: Pembrolizumab name: Partial or total penectomy with inguinal and/or pelvic lymph node dissection measure: Pathological complete response (pCR) measure: Drug toxicity measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Assessment of correlation between clinical endpoints and tumor characteristics measure: Tumor tissue HPV status in relation to treatment response measure: Tumor tissue PD-L1 expression in relation to treatment response measure: Evaluation of changes in patient reported outcome regarding Quality of Life (QoL) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353893 id: Integrity-001 briefTitle: MRI Evaluation of Integrity Bio-Inductive Implant for Rotator Cuff Tears overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2026-05-01 date: 2024-04-09 date: 2024-04-09 name: Foundation for Orthopaedic Research and Education class: OTHER name: Anika Therapeutics, Inc. briefSummary: The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are:

* How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS?
* What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant?

Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair. conditions: Rotator Cuff Tears studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: Anika Integrity Implant System measure: MRI Assessment of Adverse Events and Structural Integrity measure: Effectiveness Evaluation with PROMIS outcome tool measure: Effectiveness Evaluation with PROMIS tool measure: Effectiveness Evaluation with SANE score measure: Effectiveness Evaluation with SANE score measure: Effectiveness Evaluation with ASES rating scale measure: Effectiveness Evaluation with ASES rating scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation for Orthopaedic Research and Education city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06353880 id: 24K08-001 briefTitle: Obesity With Sperm Quality in Men With Fertility Need overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-12 date: 2024-04-09 date: 2024-04-09 name: Yu xiaowei class: OTHER briefSummary: This study aims to investigate the impact of different types of obesity on sperm quality. Participants will be divided into three groups: a normal BMI group, an obese group without pudendal fat wrapping the testicles, and an obese group with pudendal fat wrapping the testicles. Sperm quality parameters will be compared among these groups to assess potential differences associated with different types of obesity. conditions: Sperm Quality conditions: Obesity conditions: Sex Hormones conditions: Visceral Fat studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED name: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition. measure: Investigation of Testicular Fat-Wrapped Testes Incidence and Associated Risk Factors measure: Comparison of Sperm Quality Across BMI Categories and Testicular Fat-Wrapped Subgroups measure: Comparison of Sex Hormone Levels Across BMI Categories and Testicular Fat-Wrapped Subgroups sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353867 id: 56365223-050.01.04-2023.13754 briefTitle: The Effect of Group Exercise in Children With Special Needs overallStatus: COMPLETED date: 2022-12-27 date: 2023-04-15 date: 2023-04-25 date: 2024-04-09 date: 2024-04-09 name: Istanbul Gedik University class: OTHER briefSummary: Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention. conditions: Developmental Disability conditions: Child Autism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ACTUAL name: Group Exercise measure: Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF) measure: Paediatric Balance Scale measure: Functional Reach Test measure: Timed Up and Go Test measure: Stroop Test sex: ALL minimumAge: 6 Years maximumAge: 15 Years stdAges: CHILD facility: Marmara University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06353854 id: FFCD 2112-CORESIM briefTitle: Prospective Cohort Study of Immunotherapy Resistance in Metastatic Colorectal Cancer Patients With MSI acronym: CORESIM overallStatus: RECRUITING date: 2024-02-12 date: 2029-02-12 date: 2030-02-12 date: 2024-04-09 date: 2024-04-09 name: Federation Francophone de Cancerologie Digestive class: OTHER briefSummary: Over the last ten years, the discovery of the mechanisms by which tumours escape the control of the immune system, and in particular the T lymphocyte response, has led to the emergence of new therapeutic strategies against cancer, such as the use of "immune checkpoint inhibitors" (ICI). The immune system plays a crucial role in controlling tumour proliferation, and involves several players.

Schematically, after recognition of the MHC-peptide complex by the TCR, the T lymphocyte response is modulated by several activating or inhibiting co-stimulatory signals (or "checkpoints"). The balance of these different signals determines whether the T lymphocyte (LT) is activated, resulting in the destruction of the target cell, or whether the T lymphocyte is inhibited (anergy), inducing immune tolerance. By hijacking this system through the expression of inhibitory checkpoints on its surface, the tumour cell is able to evade the effector immune response (1). Monoclonal antibodies (mAbs) directed against inhibitory co-stimulatory molecules such as Programmed-cell death 1 (PD-1) and cytotoxic T lymphocyte antigen 4 (CTLA-4) or their ligand Programmed-cell death ligand 1 (PD-L1) have been developed to restore effective anti-tumour immunity. These ICIs have led to a major improvement in the prognosis of certain cancers, notably melanoma and non-small cell lung cancer.

However, the efficacy of ICIs varies from one cancer to another. In addition to the expression of PDL1 by the tumour and/or immune cells, and the mutational load, one of the primary factors predicting response to immunotherapy mentioned in several studies is microsatellite instability (MSI). conditions: Colorectal Cancer Metastatic conditions: Microsatellite Instability-High Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 600 type: ESTIMATED measure: Identification of predictive factors of resistance to pembrolizumab immunotherapy in first-line treatment of unresectable mRCC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ch - Centre Hospitalier de La Côte Basque status: NOT_YET_RECRUITING city: Bayonne CEDEX zip: 64100 country: France name: Franck AUDEMAR, Dr role: CONTACT phone: +33 5 59 44 37 22 email: faudemar@ch-cotebasque.fr name: Anne GUILNGAR, Dr role: CONTACT phone: +33 5 59 44 37 22 email: aguilngar@ch-cotebasque.fr name: Franck AUDEMAR, Dr role: PRINCIPAL_INVESTIGATOR lat: 43.48333 lon: -1.48333 facility: Ch - Ch Beauvais status: NOT_YET_RECRUITING city: Beauvais country: France name: Fayçal HOCINE role: CONTACT phone: 03 44 11 23 09 email: f.hocine@ch-beauvais.fr ; fayoncologie@yahoo.fr lat: 49.43333 lon: 2.08333 facility: CH Jean Minjoz status: NOT_YET_RECRUITING city: Besançon zip: 25030 country: France name: Stéfano KIM, Dr role: CONTACT email: alrollin@chu-besancon.fr lat: 47.24878 lon: 6.01815 facility: Polyclinique Saint Privat status: RECRUITING city: Boujan-sur-Libron zip: 34760 country: France name: Michaël HUMMELSBERGER, Dr role: CONTACT email: michael.hummelsberger@orange.fr lat: 43.36996 lon: 3.24759 facility: Ch - Duchenne status: NOT_YET_RECRUITING city: Boulogne-sur-Mer country: France name: Vincent BOURGEOIS role: CONTACT phone: 06 84 88 43 37 email: vincebourgeois@hotmail.com name: Vincent BOURGEOIS role: PRINCIPAL_INVESTIGATOR lat: 50.71667 lon: 1.61667 facility: Ch - Centre Hospitalier Metropole Savoie status: NOT_YET_RECRUITING city: Chambéry CEDEX zip: 73011 country: France name: Olivier BERTHELET, Dr role: CONTACT phone: 0479965087 email: olivier.berthelet@ch-metropole-savoie.fr name: Tarik HABET, Arc Étude role: CONTACT phone: 0479965910 email: tarik.habet@ch-metropole-savoie.fr name: Olivier BERTHELET, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.56667 lon: 5.93333 facility: Ch - Centre Hospitalier de Cholet status: NOT_YET_RECRUITING city: Cholet zip: 49300 country: France name: You-Heng LAM, Dr role: CONTACT phone: 02 41 49 66 79 email: you-heng.lam@ch-cholet.fr name: Laura VALLEE, Arc Étude role: CONTACT phone: 02 41 49 69 91 email: laura.vallee@ch-cholet.fr name: You-Heng LAM, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: -0.88333 facility: CH - Compiegne status: NOT_YET_RECRUITING city: Compiègne country: France name: Virginie SEBBAGH role: CONTACT phone: 0344236278 email: v.sebbagh@compiegnenoyon.fr name: Virginie SEBBAGH role: PRINCIPAL_INVESTIGATOR lat: 49.41794 lon: 2.82606 facility: Ch - Chd Vendée status: NOT_YET_RECRUITING city: La Roche-sur-Yon zip: 85925 country: France name: Margot LALY, Dr role: CONTACT phone: +33 2 51 44 61 68 email: margot.laly@chd-vendee.fr name: Paul GIROT, Dr role: CONTACT phone: +33 2 51 44 61 68 email: paul.girot@chd-vendee.fr name: Margot LALY, Dr role: PRINCIPAL_INVESTIGATOR lat: 46.66667 lon: -1.43333 facility: CH - Louis Pasteur status: NOT_YET_RECRUITING city: Le Coudray country: France name: Sylvie APRELON role: CONTACT phone: 0237303030 email: saprelon@ch-chartres.fr lat: 48.42115 lon: 1.50057 facility: Centre Hospitalier Regional et Universitaire de Lille status: RECRUITING city: Lille zip: 59037 country: France name: ANTONY TURPIN, MD role: CONTACT phone: 0320445461 lat: 50.63297 lon: 3.05858 facility: CH Saint Joseph - Saint Luc status: NOT_YET_RECRUITING city: Lyon zip: 69365 country: France name: Denis PERE VERGE, Dr role: CONTACT email: dpereverge@ch-stjoseph-stluc-lyon.fr; fannydenis@sfr.fr lat: 45.74848 lon: 4.84669 facility: Caluire et Cuire - Infirmerie Protestante de Lyon status: NOT_YET_RECRUITING city: Lyon country: France name: Johannes HARTWIG role: CONTACT email: johannes.hartwig@infirmerie-protestante.com name: Johannes HARTWIG role: PRINCIPAL_INVESTIGATOR name: David TAVAN role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Ch - Hôpital Saint Joseph status: NOT_YET_RECRUITING city: Marseille zip: 13285 country: France name: Hervé PERRIER, Dr role: CONTACT phone: 0491808211 email: hperrier@hopital-saint-joseph.fr name: Christelle BASTHISTE-PELE, Dr role: CONTACT phone: 0491808203 email: cbasthiste@hopital-saint-joseph.fr name: Hervé PERRIER, Dr role: PRINCIPAL_INVESTIGATOR name: Christelle BASTHISTE-PELE, Dr role: SUB_INVESTIGATOR name: Patrick BEAURAIN, Dr role: SUB_INVESTIGATOR name: Hélène BRUNETEAU, Dr role: SUB_INVESTIGATOR name: Aurélie CAMOIN, Dr role: SUB_INVESTIGATOR name: Annick CHICOUENE-BRUNELLE, Dr role: SUB_INVESTIGATOR name: Christophe LAPLACE, Dr role: SUB_INVESTIGATOR name: Nadjet SAADALLAH-BOUCHEMOT, Dr role: SUB_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: CH Saint Joseph status: NOT_YET_RECRUITING city: Marseille country: France name: Hervé PERRIER role: CONTACT email: recherche-clinique@infirmerie-protestante.com; herve.perrier@infirmerie-protestante.com name: Hervé PERRIER role: PRINCIPAL_INVESTIGATOR name: Xavier ADHOUTE role: SUB_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Centre Hospitalier status: NOT_YET_RECRUITING city: Mulhouse zip: 68070 country: France name: D. B. Vedrenne, MD role: CONTACT phone: 33-3-8964-7049 lat: 47.75 lon: 7.33333 facility: CHR D'Orleans - Hopital de la Source status: NOT_YET_RECRUITING city: Orleans zip: 45100 country: France name: Jean-Paul Lagasse role: CONTACT phone: 33-02-3651-4704 lat: 47.90289 lon: 1.90389 facility: Prive - Institut Montsouris status: RECRUITING city: Paris country: France name: Raphael COLLE role: CONTACT phone: 0156616035 email: raphael.colle@imm.fr name: Emilie SOULARUE role: CONTACT phone: 0633312811 email: emilie.solarue@aphp.fr name: Christophe LOUVET role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Ch - Centre Hospitalier de Soisson status: NOT_YET_RECRUITING city: Soissons CEDEX zip: 02209 country: France name: Sarah MONTEMBAULT, Dr role: CONTACT phone: 0326966859 email: sarah.montembault@ch-soissons.fr name: Valérie PANIS, Arc Étude role: CONTACT phone: 0322824002 email: paris.valerie@chu-amiens.fr name: Sarah MONTEMBAULT, Dr role: PRINCIPAL_INVESTIGATOR lat: 49.38167 lon: 3.32361 facility: CH - Gustave Dron status: NOT_YET_RECRUITING city: Tourcoing country: France name: Loïc LEBELLEC role: CONTACT phone: 0320694488 email: llebellec@ch-tourcoing.fr name: Floriane RICHA role: CONTACT phone: 0320694949 email: fverhaeghe@ch-tourcoing.fr name: Loïc LEBELLEC role: PRINCIPAL_INVESTIGATOR lat: 50.72391 lon: 3.16117 hasResults: False

 nctId: NCT06353841 id: 2023/435 briefTitle: Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children overallStatus: RECRUITING date: 2023-05-03 date: 2024-05-01 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children. conditions: Functional Constipation conditions: Therapeutic Touch conditions: Infants conditions: Children conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The data analyst will be blinded to the procedure and results of randomization, group allocation, and intervention. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Therapeutic Touch measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Bristol Stool Scale sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Burdur Bucak State Hospital status: RECRUITING city: Burdur state: Bucak zip: 15030 country: Turkey name: Selda Ateş Beşirik, PhD. role: CONTACT phone: +905076228189 email: seldaates07@gmail.com name: Selda Ateş Beşirik, PhD. role: PRINCIPAL_INVESTIGATOR name: Emine Geçkil, Prof. role: SUB_INVESTIGATOR lat: 37.72028 lon: 30.29083 hasResults: False

 nctId: NCT06353828 id: ICBD-UC-01 briefTitle: Phase 2a Study to Evaluate IcBD-01 Enema in Active Ulcerative Colitis Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2024-04-01 date: 2025-04-01 date: 2024-04-09 date: 2024-04-09 name: CannaMore Biotechs class: INDUSTRY briefSummary: Ulcerative proctitis can lead to considerable morbidity, and the available treatment options are limited. Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa, possesses potent immunomodulatory and anti-inflammatory properties as described in both acute and chronic animal models of inflammation, including IBD models.

Based on positive safety and initial efficacy profiles of CBD found in IBD animal and clinical studies, the main aim of this study is to evaluate the safety, tolerability and efficacy of a novel enema formulation of CBD for the treatment of active ulcerative proctitis. conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: CBD, synthetic form name: Placebo measure: Change from baseline in Full Mayo Score measure: Change in Partial Mayo Score measure: Change in patient reported outcome (PRO-UC) measure: Change in endoscopic Mayo subscore in distal 15 cm of anus measure: Change in the length of the inflamed colon sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Meir Medical Center city: Kfar Saba country: Israel lat: 32.175 lon: 34.90694 hasResults: False

 nctId: NCT06353815 id: anaesthetic efficacy briefTitle: Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-02 date: 2025-06 date: 2024-04-09 date: 2024-04-09 name: Cairo University class: OTHER briefSummary: Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars conditions: Restorative Dental Treatment by Buccal Infiltration Anaesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 44 type: ESTIMATED name: 4% articaine infiltration measure: Success of local anesthesia measure: Child behavior during treatment sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD hasResults: False

 nctId: NCT06353802 id: P.T.REC/012/004963 briefTitle: Relationship Between Chronic Non-Specific Neck Pain And Lumbar Reposition Sense overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-04 date: 2024-05 date: 2024-04-09 date: 2024-04-09 name: Cairo University class: OTHER briefSummary: to investigate the correlation between chronic non-specific neck pain and lumbar reposition sense. conditions: Chronic Non-specific Neck Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 67 type: ACTUAL name: Chronic non-specific neck pain and lumbar reposition sense measure: Correlation Between Chronic Non-Specific Neck Pain And Lumbar Reposition Sense Using iPhone inclinometer app sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Physical Therapy College Cairo University city: Giza zip: 12613 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06353789 id: RoADPain Clinical Study briefTitle: Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study acronym: RoADPain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-09 date: 2024-04-09 name: University of Oxford class: OTHER name: University of Exeter name: University of York name: Endometriosis UK briefSummary: This study aims to understand whether changes in a variety of body systems which are seen in adult women with period pain are also seen in adolescents in the first few years of having periods. This information will help us to understand 1) how quickly any changes occur, informing clinical practice, and 2) how period pain might lead to other types of chronic pain, potentially allowing development of preventative strategies. conditions: Dysmenorrhea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 132 type: ESTIMATED measure: Quantitative Sensory Testing (QST) measure: Heart rate (HR) measure: Change in heart rate measure: Bladder sensitivity to filling measure: Volume voided at maximum tolerance measure: Pain Catastrophising: Pain Catastrophising Scale (PCS) (Sullivan) measure: Area under the curve (AUC) of single day salivary cortisol profile measure: Change of pressure pain threshold (PPT) measure: fMRI scan sex: FEMALE minimumAge: 11 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06353776 id: 02052023 briefTitle: MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface overallStatus: COMPLETED date: 2023-05-03 date: 2023-10-31 date: 2023-10-31 date: 2024-04-09 date: 2024-04-09 name: University Tunis El Manar class: OTHER briefSummary: MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface. conditions: Conjunctiva conditions: Cornea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ACTUAL name: conjunctival biopsy after micropulse transscleral laser therapy measure: conjunctival inflammation or fibrosis measure: intraocular pression measure: ocular surface disease index score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohamed Taher Maamouri Hospital city: Nabeul zip: 8000 country: Tunisia lat: 36.45606 lon: 10.73763 hasResults: False

 nctId: NCT06353763 id: CV briefTitle: Design, Implementation, and Evaluation of Virtual Reality in the Nursing Curriculum overallStatus: COMPLETED date: 2022-02-24 date: 2022-05-30 date: 2022-06-30 date: 2024-04-09 date: 2024-04-09 name: Clinica Universidad de Navarra, Universidad de Navarra class: OTHER briefSummary: The aim of the study is to determine the effectiveness of an immersive virtual reality learning programme for nursing students, based on virtual glasses, in acquiring the competence (knowledge, skills and attitudes) to care for patients with pressure ulcers, and to compare it with the traditional teaching method.

The design was an exploratory randomised controlled trial. The variables used to measure effectiveness were competence and its attributes: knowledge assessment by a multiple-choice test (Pressure Ulcer Knowledge Assessment Tool, Pukat 2.0 instrument), skill performance by direct observation of procedural skills (simulated cases with standardised patients) and satisfaction and usability assessment (Usefulness, Satisfaction and Ease of Use Questionnaire). conditions: Pressure Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants were blinded in their group assignment. whoMasked: PARTICIPANT count: 127 type: ACTUAL name: Immersive virtual reality learning program measure: Knowledge measure: Skill performance measure: Usefulness, Satisfaction, and Ease of Use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Navarra city: Pamplona state: Navarra country: Spain lat: 42.81687 lon: -1.64323 hasResults: False

 nctId: NCT06353750 id: 331039 briefTitle: Intracellular Magnesium and Heart Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-02-28 date: 2026-04-25 date: 2024-04-09 date: 2024-04-09 name: University of Oxford class: OTHER name: British Heart Foundation name: Oxford University Hospitals NHS Trust briefSummary: Low magnesium levels are surprisingly common in those with a heart condition known as HFpEF, where the heart pumps well but is too rigid to fill properly with blood. While routine blood tests can check magnesium levels, they don't tell us how much magnesium is actually inside the heart and muscle cells, where it's vital for energy and overall function. Our research aims to get a clearer picture by looking directly at the magnesium inside these cells and understanding its role in the body's energy production and usage. We're also interested in how magnesium levels affect symptoms and the body's handling of sugar. We're using advanced medical imaging techniques, like heart magnetic resonance imaging (MRI) and other heart and muscle function tests, at rest and when the heart is working hard to help answer these questions. We'll compare the magnesium levels inside the cells before and after giving a supplement of magnesium to see if this can make a difference in how the heart and muscles work. conditions: Heart Failure With Preserved Ejection Fraction conditions: Hypomagnesemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 85 type: ESTIMATED name: Magnesium supplement measure: Myocardial/ skeletal muscle metabolism and energetics at rest and stress. measure: Serum versus intracellular magnesium concentration measure: Cardiac function measure: Skeletal muscle performance measure: Symptoms measure: Insulin sensitivity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oxford Centre for Magnetic Resonance (OCMR) city: Oxford zip: OX3 9DU country: United Kingdom name: Jennifer L Holland, BMBS role: CONTACT email: jennifer.holland@wolfson.ox.ac.uk name: Oliver Rider, BM BCh role: CONTACT email: oliver.rider@cardiov.ox.ac.uk lat: 51.75222 lon: -1.25596 hasResults: False

 nctId: NCT06353737 id: CTO 4489 briefTitle: Looking for Asymptomatic Mpox in a Population at High Risk acronym: LAMP overallStatus: RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-09 date: 2024-04-18 name: Unity Health Toronto class: OTHER briefSummary: Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature. conditions: Mpox (Monkeypox) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 450 type: ESTIMATED measure: Asymptomatic prevalence measure: Symptomatic prevalence measure: Mpox seropositivity measure: Characteristics measure: Characteristics of seropositivity sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unity Health Toronto status: RECRUITING city: Toronto state: Ontario zip: M5B 1T8 country: Canada name: Reva Persaud role: CONTACT phone: 416-360-4000 phoneExt: 77105 email: reva.persaud@unityhealth.to name: Darrell HS Tan role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06353724 id: RP2218 briefTitle: Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent acronym: stent overallStatus: COMPLETED date: 2019-10-14 date: 2020-10-01 date: 2021-01-01 date: 2024-04-09 date: 2024-04-09 name: Tanta University class: OTHER briefSummary: The goal of this clinical trial is to compare between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy tissues, salivary PH. The main question it aims to answer are: Does the difference in manufacturing method affect on Healthy tissues, salivary PH.

Participants will use radiation positioning stent during radiotherapy sessions Two groups will be compared

* Group A: OPRS was constructed according to the conventional technique.
* Group B: OPRS was constructed digitally using CAD /CAM technology. to evaluate Dosimetric analysis to quantify the radiation dose in OARs, PH of saliva measurement and Mucositis assessment. conditions: Radiotherapy Side Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 16 type: ACTUAL name: conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning name: Digital positioning stent measure: Dosimetric analysis measure: PH of saliva measurement: measure: Mucositis assessment: sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry city: Tanta state: Gharbia zip: 31527 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06353711 id: IRB-23-0746 id: R34MH129782 type: NIH link: https://reporter.nih.gov/quickSearch/R34MH129782 briefTitle: CA-LINC Black Youth Suicide Detection and Intervention Study acronym: CA-LINC overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-03 date: 2025-05 date: 2024-04-09 date: 2024-04-10 name: University of North Carolina, Charlotte class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The Culturally Adapted Linking Individuals Needing Care (CA-LINC) study will recruit a sample of Black youth to participate in a two-arm parallel-comparison single-blinded pilot randomized control trial (RCT). For the pilot RCT, 68 Black youth participants ages 14-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: CA-LINC (n=34) or TAU (n=34).

CA-LINC is a 90-day culturally adapted LINC intervention developed with and for Black youth. The CA-LINC intervention integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/reﬁne safety plans, and create villages of care. The CA-LINC intervention incorporates African-centered principles and empowerment and motivational strategies aimed to support, enhance strengths, promote hope, improve family relationships, and reinforce caring messages. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement and delivery standards.

CA-LINC is implemented by Peer Support Specialists and Community Health Workers assigned to mental health "hubs" in Black Faith-Based Organizations (FBOs) that facilitate standardization and access to care for Black youth/families regardless of religious affiliation. Black FBOs effectively mobilize Black communities to promote positive health behaviors. The RCT will explore the "fit" of the culturally adapted intervention (CA-LINC) in Black communities in Charlotte, North Carolina, and inform a scalable RCT for a future study. conditions: Suicide conditions: Suicide Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 68 type: ESTIMATED name: CA-LINC Intervention name: Treatment as Usual measure: Change in Suicide Ideation measure: Change in Suicide Behaviors measure: Treatment Acceptability measure: Change in Therapeutic Alliance measure: Change in Cultural Humility measure: Change in Family Relationships measure: Change in Engagement Behaviors sex: ALL minimumAge: 14 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: The University of North Carolina at Charlotte city: Charlotte state: North Carolina zip: 28223 country: United States name: Sonyia Richardson, PhD role: CONTACT phone: 704-687-7935 email: smcopela@charlotte.edu name: Sonyia C Richardson, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 hasResults: False

 nctId: NCT06353698 id: Nnftri briefTitle: Fasting Mimicking Diet With Chemotherapy in Patients With Leukemia overallStatus: RECRUITING date: 2023-07-02 date: 2024-04-01 date: 2024-05-01 date: 2024-04-09 date: 2024-04-09 name: National Nutrition and Food Technology Institute class: OTHER briefSummary: The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia. conditions: Fasting Mimicking Diet conditions: Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: fasting mimicking diet measure: Blast cell count measure: Quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azita Hekmatdoost status: RECRUITING city: Tehran state: Middle East zip: 19835 country: Iran, Islamic Republic of name: Azita Hekmatdoost, MD, PhD role: CONTACT phone: +989123065084 email: a_hekmat2000@yahoo.com lat: 35.69439 lon: 51.42151 facility: Ehsan Hejazi status: RECRUITING city: Tehran zip: 19839-63113 country: Iran, Islamic Republic of name: Ehsan Hejazi, PhD role: CONTACT phone: 00989121530775 email: ehsanhejazi@sbmu.ac.ir lat: 35.69439 lon: 51.42151 hasResults: False

 nctId: NCT06353685 id: neo-CHART-HNC briefTitle: De-Escalation Postoperative Radiotherapy for Oral Squamous Cell Carcinoma With pCR/MPR. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2028-12-31 date: 2024-04-09 date: 2024-04-19 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The prognosis of locally advanced oral squamous cell carcinoma(OSCC ) is poor, and there are still many problems to be solved in the current treatment paradigm. Neoadjuvant chemotherapy combined with immunotherapy can significantly improve the pCR and MPR rates in patients with locally advanced OSCC. For patients who achieve pCR and MPR after neoadjuvant therapy and surgery, it is still hotly debated regarding whether to implement postoperative de-escalation radiotherapy. Neoadjuvant therapy is an ideal predictor of radiosensitivity. In theory, neoadjuvant therapy can eliminate microscopic lesions, thereby reducing the dose and volume of irradiation.

Continuous hyperfractionated accelerated radiotherapy (CHART, based on hyperfractionated radiotherapy, increasing daily or weekly treatments and shortening the total treatment duration, but reducing the total dose), is to give a higher dose of radiation to tumor tissue in a shorter period of time, so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells. It is beneficial to improve the local control rate of tumor, control the acute injury of normal tissue and the yield acceptable late treatment-related complications. The specific protocol was as follows: high-risk CTV area (CTV1), 45Gy in total, fraction dose of 1.5Gy, twice a day, bioequivalent dose (BED) of 51.75Gy; Low-risk CTV area(CTV2), 39Gy in total , fraction dose of 1.3Gy, twice a day, BED of 44.07Gy; A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks. conditions: De-escalated Radiotherapy; Head and Neck Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 103 type: ESTIMATED name: Continuous, hyperfractionated, accelerated radiotherapy(CHART) measure: 2-year PFS measure: 2-year OS sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353672 id: RLR-01 briefTitle: A Study to Evaluate Safety and Feasibility of Robotic Liver Resection overallStatus: RECRUITING date: 2020-12-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-09 date: 2024-04-09 name: Zhejiang University class: OTHER briefSummary: The robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. Several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. Previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (RLR) over laparoscopic liver resection (LLR) or open liver resection (OLR), considering the various degrees of difficulty in liver surgeries.

This study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with LLR or OLR, and gain veritable and relevant data on the benefits of RLR. conditions: Liver Diseases conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1000 type: ESTIMATED name: Robotic liver resection measure: Postoperative complications measure: Postoperative hospital stay measure: Postoperative unplanned reoperation measure: Unplanned readmission sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Medical College of Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310003 country: China name: Tingbo Liang, MD,PHD role: CONTACT phone: 086-571-87236688 email: liangtingbo@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06353659 id: M2024077 briefTitle: The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-06-30 date: 2026-06-30 date: 2024-04-09 date: 2024-04-09 name: Peking University Third Hospital class: OTHER briefSummary: The goal of this observational study is to quantitatively assess the renal microcirculation changes by contrast-enhanced ultrasound (CEUS) and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore the diagnostic value of CEUS in critically ill acute kidney injury. conditions: Intensive Care Unit conditions: Acute Kidney Injury conditions: Ultrasound studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Contrast-enhanced Ultrasound measure: Acute kidney injury (according to KDIGO 2012 criteria) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353646 id: XKY-C-004 briefTitle: XH001 Combination With Ipilimumab and Chemotherapy for Patients With Resected Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-06 date: 2026-12 date: 2024-04-09 date: 2024-04-09 name: Wu Wenming class: OTHER name: NeoCura briefSummary: This is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of XH001 (neoantigen cancer vaccine) sequential combination with ipilimumab and chemotherapy in pancreatic cancer patients following surgical resection. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: XH001 name: Ipilimumab Injection name: Chemotherapy measure: DFS measure: 1-year DFS rate measure: MFS measure: OS measure: Elispot measure: Adverse Event measure: ctDNA measure: CA19-9 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06353633 id: AHekmatdoost briefTitle: The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-10-20 date: 2024-12-25 date: 2024-04-09 date: 2024-04-09 name: National Nutrition and Food Technology Institute class: OTHER briefSummary: In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: formula name: exclusion diet measure: PCDAI measure: CRP measure: ESR measure: FC measure: Alb measure: Arm Circumferance measure: BMI measure: Height measure: weight sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06353620 id: 1018 briefTitle: Structural-functional Connectome in Drug-resistant Epilepsies and Neurodevelopmental Syndromes With Epilepsy overallStatus: RECRUITING date: 2024-02-13 date: 2024-03-18 date: 2027-02-28 date: 2024-04-09 date: 2024-04-09 name: IRCCS Eugenio Medea class: OTHER briefSummary: Recent studies have shown that the aperiodic part of the signal (neuronal avalanches) of electroencephalography (EEG) contains important information about the dynamics of neuronal networks. Indeed, this has helped to identify functionally altered areas in patients with temporal epilepsy by simply using the resting EEG signal. Furthermore, it has been seen that the propagation of neuronal avalanches (VNs) correlates with the morphological organization of the cerebral cortex. Therefore, NAs represent a measure with direct utility for studying functional reorganization pre and post drug/surgical treatment. In addition, the aperiodic portion of the signal may represent a noninvasive measure of the excitation/inhibition relationship, which is known of being altered both in epilepsy and in some rare neurodevelopmental syndromes (example: Angelman and Dup15q) conditions: Epilepsy conditions: Angelman Syndrome conditions: Dup15q Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 120 type: ESTIMATED name: High Density EEG recording name: Rey Complex Figure Test measure: Differences in the network coherence values in theta and alpha band after treatment measure: Stability of the alpha frequency band in the EEG activity measure: Correlation of neural excitation and memory performance sex: ALL minimumAge: 6 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS E.Medea status: RECRUITING city: Conegliano state: Treviso zip: 31015 country: Italy name: Duma Gian Marco, PhD role: CONTACT phone: +39 0438414248 email: gianmarco.duma@lanostrafamiglia.it lat: 45.88805 lon: 12.30201 hasResults: False

 nctId: NCT06353607 id: 2023-02267; kt23Berdajs briefTitle: Genetic Architecture of Acute Aortic Syndromes and Aortic Aneurysm. overallStatus: RECRUITING date: 2024-04-08 date: 2028-12-31 date: 2028-12-31 date: 2024-04-09 date: 2024-04-22 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: The aim of this study is to explore the genetic information associated with the development of TAA and aAD in individuals without history or syndromic features (Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome etc.) for aortic disease. For this purpose, whole genome sequencing will be performed in patients with documented aortic aneurysm or/and aortic dissection. conditions: Acute Aortic Dissection conditions: Thoracic Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 730 type: ESTIMATED measure: Assessment of the association between the prevalence of TAA and/or aAD in variants with genes associated with thoracic aortic disease. measure: Investigate the genetic landscape of aortic specimens retrieved from surgical intervention tissues, and relate the genetic profile to cell molecular pathology. measure: To assess the association between the aortic segment dimension (in CT scan and TEE images), tissue pathology and gene variants to determine the images predictive factors for TAA and/or aAD. measure: To establish a risk prediction model for aAD and TAA based on genetic, clinical, and imaging endpoints. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel zip: 4031 country: Switzerland name: Denis Berdajs, Prof. Dr. role: CONTACT phone: 0041 61 328 71 80 email: denis.berdajs@usb.ch name: Islam Salikhanov, Dr. role: CONTACT phone: 0041 61 26 53225 email: islam.salikhanov@usb.ch lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06353594 id: COPERNICAN TRIAL briefTitle: Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI acronym: COPERNICAN overallStatus: RECRUITING date: 2024-03-11 date: 2026-09 date: 2035-09 date: 2024-04-09 date: 2024-04-09 name: Jorge Sanz Sanchez class: OTHER briefSummary: The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).

Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:

* Study group: reduced stent PCI strategy (DCB-based)
* Control group: conventional PCI strategy (DES-based). conditions: ST Elevation Myocardial Infarction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1272 type: ESTIMATED name: Primary PCI measure: Target lesion failure (TLF) measure: Incidence of all-cause death measure: Incidence of myocardial infarction measure: Incidence of cardiovascular death measure: Incidence of target lesion revascularization measure: Incidence of stent thrombosis measure: Incidence of acute vessel closure measure: Incidence of stroke measure: Incidence of acute kidney injury measure: Incidence of bleeding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Y Politecnico La Fe status: RECRUITING city: Valencia state: Comunidad Valenciana country: Spain name: Jorge Sanz Sánchez, PI role: CONTACT lat: 39.46975 lon: -0.37739 facility: Consorcio Hospitalario Provincial de Castellon status: NOT_YET_RECRUITING city: Castelló country: Spain name: David Tejada Ponce, PI role: CONTACT lat: 41.01149 lon: 0.84856 facility: Hospital General Universitario de Elche status: NOT_YET_RECRUITING city: Elche country: Spain name: Paula Tejedor Viñuela, PI role: CONTACT lat: 38.26218 lon: -0.70107 facility: Hospital Universitari de Bellvitge status: NOT_YET_RECRUITING city: Hospitalet de Llobregat country: Spain name: Neus Salvatella Giralt, PI role: CONTACT lat: 41.35967 lon: 2.10028 facility: Hospital Universitario 12 de Octubre status: NOT_YET_RECRUITING city: Madrid country: Spain name: Fernando Sarnago Cebada, PI role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario de La Princesa status: NOT_YET_RECRUITING city: Madrid country: Spain name: Fernando Rivero Crespo, PI role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Puerta de Hierro Majadahonda status: NOT_YET_RECRUITING city: Madrid country: Spain name: Juan F Oteo Domínguez, PI role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Regional de Malaga status: NOT_YET_RECRUITING city: Málaga country: Spain name: Cristobal Urbano Carrillo, PI role: CONTACT lat: 36.72016 lon: -4.42034 facility: Hospital Universitario de Navarra status: NOT_YET_RECRUITING city: Pamplona country: Spain name: Guillermo Sánchez Elvira, PI role: CONTACT lat: 42.81687 lon: -1.64323 facility: Hospital Universitario Virgen Del Rocio status: NOT_YET_RECRUITING city: Sevilla country: Spain name: José Díaz Fernández, PI role: CONTACT lat: 37.38283 lon: -5.97317 facility: Hospital Universitari Joan Xxiii de Tarragona status: NOT_YET_RECRUITING city: Tarragona country: Spain name: Mauricio Torres Sánchez, PI role: CONTACT lat: 41.11667 lon: 1.25 facility: Consorcio Hospital General Universitario de Valencia status: RECRUITING city: Valencia country: Spain name: Eva Rumiz González, PI role: CONTACT lat: 39.46975 lon: -0.37739 facility: Hospital Clinico Universitario de Valladolid status: NOT_YET_RECRUITING city: Valladolid country: Spain name: Ignacio J Amat Santos, PI role: CONTACT lat: 41.65518 lon: -4.72372 facility: Hospital Clinico Universitario Lozano Blesa status: NOT_YET_RECRUITING city: Zaragoza country: Spain name: Antonela Lukic Otanovic, PI role: CONTACT lat: 41.65606 lon: -0.87734 facility: Hospital Universitario Miguel Servet status: NOT_YET_RECRUITING city: Zaragoza country: Spain name: Georgina A Fuertes Ferre role: CONTACT lat: 41.65606 lon: -0.87734 hasResults: False

 nctId: NCT06353581 id: 4-2021-0924 briefTitle: Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX overallStatus: ACTIVE_NOT_RECRUITING date: 2022-02-16 date: 2024-05-08 date: 2024-05-08 date: 2024-04-09 date: 2024-04-09 name: Yonsei University class: OTHER briefSummary: Neutropenia, a decrease in the number of neutrophils, a type of white blood cell, due to the myelosuppressive effects of chemotherapeutic drugs, is a frequent occurrence in patients receiving anticancer drug therapy, which increases the risk of infection, which can have serious consequences such as antibiotic treatment, hospitalization, intensive care unit treatment, and death, and also reduces the effectiveness of anticancer treatment due to dose reduction and cycle delay. Therefore,G-CSF,which acts as a neutrophil growth factor, can be administered immediately after chemotherapy to increase the production rate of neutrophils and promote the efflux of mature neutrophils from the bone marrow, thereby increasing the absolute neutrophil count. Guidelines for the use of G-CSF published by the NCCN indicate that primary prophylaxis with G-CSF has clinical benefit for patients receiving anticancer drug therapy with a risk of febrile neutropenia greater than 20%. For those at 10-20% risk, consider primary prophylaxis based on risk factors. The frequency of neutropenic fever with FOLFIRINOX chemotherapy, which is commonly used in patients with locally advanced or metastatic pancreatic cancer, was 5.4% in a prospective study of patients receiving high-dose regimens, but 42.5% of patients received prophylactic G-CSF, and 63.0% of patients received prophylactic G-CSF compared to 3.0% when given as postoperative adjuvant therapy demonstrating the need for G-CSF administration.In a retrospective study in Japan, a modified FOLFIRINOX chemotherapy regimen without pegylated G-CSF was associated with a 23% incidence of neutropenic fever and 61.5% grade 3-4 neutropenia, while prophylactic administration of pegylated G-CSF was associated with zero neutropenic fever and grade 3-4 neutropenia and longer survival .A retrospective study from Korea also reported that prophylactic G-CSF administration reduced neutropenic fever from 18.5% to 1.8% and Grade 3-4 neutropenia from 55.6% to 31.6 in pancreatic cancer patients receiving FOLFIRINOX .Pegteograstim (Neulapeg®) is a pegylated human recombinant granulocyte colony-stimulating factor with a long half-life (15-80 hours) compared to filgrastim (3-4 hours). Although several studies have demonstrated that G-CSF primary prophylaxis reduces the frequency of hematologic toxicities, particularly febrile neutropenia, during chemotherapy, it has not been prospectively studied whether primary prophylaxis reduces the frequency of grade 3-4 neutropenia and neutropenic fever in the modified FOLFIRINOX chemotherapy regimen in patients with pancreatic cancer. Therefore, this study is designed to determine if prophylactic administration of NEURAPEC reduces the frequency of Grade 3-4 neutropenia and neutropenic fever in patients with locally advanced or metastatic pancreatic cancer receiving modified FOLFIRINOX chemotherapy. conditions: Locally Advanced Pancreatic Cancer conditions: Metastatic Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 78 type: ACTUAL name: Neulapeg name: Control measure: Development of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL) measure: development of neutropenic fever (febrile neutropenia) measure: relative dose intensity measure: quality of life assessed according to EORTC QLQ-C30 measure: Number of patients experiencing Adverse events (AEs) measure: objective response rate measure: Progression-free survival measure: Overall survival measure: Change in blood cytokine concentrations measure: G-CSF induced bone pain as assessed by questionnaires sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Severance Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06353568 id: 5.888.210 briefTitle: Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2027-10-30 date: 2027-12-30 date: 2024-04-09 date: 2024-04-09 name: University of Nove de Julho class: OTHER briefSummary: This study seeks to evaluate the effect of photobiomodulation (PBM) in the prevention of Diabetic foot (DF), in patients at moderate and high risk for its development, through a controlled, randomized, double-blind clinical trial. Individuals between 18 and 75 years old of both sexes, with type 2 diabetes mellitus (DM), and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each. The PBM Group will use a boot with 1344 LEDs, 504 of which are 660 nm located on the sides of the boot (28.5 milliwatt, 10 J per LED); 504 850 nm also located on the sides of the boot (23 milliwatt, 8 J per LED); 168 of 660 nm located at the base of the boot (28.5 milliwatt, 10 J per LED); 168 of 850 nm also located at the base of the boot (23 milliwatt, 8 J per LED) once a day for 6 minutes, for 60 days and will receive therapeutic education. Participants will be evaluated at baseline, after 30 days (clinical examination) and after 60 days (clinical examination, Peripheral Neuropathy (PN) assessment, Peripheral Artery Disease (PAD) assessment, blood and urine tests, and quality of life). conditions: Diabetic Foot studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The PBM Group will use a boot with 1344 LEDs once daily for 6 minutes, over 60 days, and will receive therapeutic education.

The Control Group will use a non-therapeutic LED boot (placebo) for 6 minutes once daily for 60 days and will also receive therapeutic education.

Participants will be assessed at the beginning of the study (baseline) and after 30 days (clinical examination) and 60 days (clinical examination, assessment of Peripheral neuropathy, assessment of peripheral artery disease, blood and urine tests, and quality of life evaluation). primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: * 1 physician-researcher who will conduct all initial evaluations and follow-up examinations (excluding Doppler ultrasound, Ankle-Brachial Index - ABI, and Toe-Brachial Index - TBI), without knowledge of the subjects' allocation, and will administer the Informed Consent Form (ICF).
* 1 Vascular surgeon researcher who will perform Doppler ultrasound, Ankle-Brachial Index (ABI), and Toe-Brachial Index (TBI) measurements during the initial assessment and follow-up examinations, without knowledge of the subjects' allocation.
* 1 Nurse researcher who will retrieve the allocation envelope and provide the appropriate PBM equipment (active or placebo), as well as provide recommendations for its use at home.
* 1 Researcher, who will not participate in any assessments, will prepare randomization and envelopes to ensure allocation confidentiality.
* 2 physician residents who will provide daily contact for device usage control, guidance, addressing inquiries, etc. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Photobiomodulation name: Simulation of Photobiomodulation name: Therapeutic education measure: Ulcer Incidence measure: Ulcer Incidence measure: Ulcer Incidence measure: Tactile sensitivity with Semmes-Weinstein monofilament measure: Tactile sensitivity with Semmes-Weinstein monofilament measure: Vibratory sensitivity measure: Vibratory sensitivity measure: Assessment of Achilles reflex measure: Assessment of Achilles reflex measure: Neuropathy Symptom Score (NSS) measure: Neuropathy Symptom Score (NSS) measure: Neuropathic Impairment Score (NIS) measure: Neuropathic Impairment Score (NIS) measure: Evaluation of the degree of ischemia measure: Evaluation of the degree of ischemia measure: Systolic peak velocity measure: Systolic peak velocity measure: Resistance Index measure: Resistance Index measure: Waveform pattern measure: Waveform pattern measure: Evaluation of claudication measure: Evaluation of claudication measure: Thermography measure: Thermography measure: Quality of Life Assessment measure: Quality of Life Assessment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353555 id: PUMCH-20240311 briefTitle: Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage overallStatus: RECRUITING date: 2023-10-11 date: 2025-06-01 date: 2025-12-31 date: 2024-04-09 date: 2024-04-09 name: Peking Union Medical College Hospital class: OTHER briefSummary: Low levels of serum triiodothyronine (T3) thyroid hormones (T4) are a strong predictor of mortality and poor prognosis in critical care patients. Few reports, however, have focused on neurocritical patients.

Patients with severe neurological diseases often experience more complications and exhibit higher mortality rates, and many studies have provided evidence for a low T3/T4 state being an important prognostic indicator in such cases; Lieberman et al. found that 87% of individuals with severe traumatic brain injury have thyroid function below the mid-normal range. Other researchers showed that low T3 syndrome is a predictor of poor prognosis in cerebral infarction patients; their findings indicated the central hypothyroidism and disturbance of thyroid hormone metabolism were involved. Low T3 syndrome is common in patients with brain tumors and has been shown to be associated with shorter survival in glioma patients. Despite these observations, however, whether the thyroid hormone abnormalities in the critically ill are a physiological adaptation or a pathological change, and whether hormone replacement therapy (HRT) can benefit such patients, remain to be established.

As acute progression ceases, thyroid hormone levels may return to normal. This may imply that thyroid hormone supplements could improve the prognosis of patients with secondary hypothyroidism. Previous clinical studies have examined the effect of thyroid HRT on patients undergoing cardiac surgery; patients with malnutrition, heart failure, or acute renal failure; and premature infants with acute respiratory distress syndrome. Most of these past studies found no significant positive effects on prognosis, and no harmful effects either. Some smaller studies have demonstrated potential promise for the use of HRT; for example, one study showed that T3 supplementation in patients undergoing cardiac surgery could lead to less need for inotropic support and better hemodynamic parameters. There are no reports of thyroid HRT improving the prognosis of neurocritical patients with secondary hypothyroidism.

The application of hormone replacement therapy in the treatment of neurocritical patients with secondary hypothyroidism remains controversial.

This study aims to explore the safety and effectiveness of thyroid hormone replacement therapy in patients with spontaneous intracerebral hemorrhage and concomitant secondary hypothyroidism. conditions: Intracerebral Hemorrhage conditions: Low T3 Syndrome conditions: Neurocritical Care conditions: Hormone Replacement Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Euthyrox name: Euthyrox measure: blood pressure measure: cerebral blood flow dynamics measure: Whether to use vasoactive vasopressors measure: neurological function measure: Days of the patients received intensive care measure: Mechanical ventilation time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking union medical college hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Junji Wei role: CONTACT phone: +8615801056698 email: weijunji@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06353542 id: HCB/2023/1206 id: PI23/01856 type: OTHER domain: Institut d'Investigacions Biomèdiques August Pi i Sunyer briefTitle: Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS) acronym: BEGAS overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-03 date: 2026-09 date: 2024-04-09 date: 2024-04-09 name: Hospital Clinic of Barcelona class: OTHER briefSummary: Two primary care-based screening systems will be tested to identify subjects with referrable glaucoma to hospital care.

Subjects between 45 to 64 years old living in the metropolitan area of Barcelona will be invited to participate in a one-time visit, with an optic disc examination and intraocular pressure (IOP).

The criteria for referring a patient will be the detection of glaucoma but with two different approaches depending on which Integrated Practice Unit (IPU) the patients will be allocated to: one arm using an Artificial Intelligence (AI) reading software of the optic disc picture; and the other one will base their referral after an ophthalmic examination performed by an ophthalmologist.

In both circuits, an optic nerve head photography will be obtained, and a masked reading center will be established to determine the ground truth for diagnosis.

This screening trial will explore the level of agreement between both systems and the cost-effectiveness of each of them.

Secondary analyses will include potential diagnostic composite scores (including other ancillary tests, such as optical coherence tomography images, that could maximize the screening process); the identification of population and disease characteristics (type of glaucoma, intraocular pressure) that could increase the effectivity and adherence to the screening process. conditions: Glaucoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 500 type: ESTIMATED name: Software analysis name: Ophthalmologist examination measure: Diagnostic agreement between the AI software and the ophthalmic examination measure: Health-Related Quality of Life (HRQoL) measure: Demographics measure: Intraocular pressure measure: Optical coherence tomography (OCT) measure: Visual field measure: Cost-effective analysis of both screening methods measure: Risk score with parameters associated with positive screening of glaucoma sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínic - ICOF city: Barcelona zip: 08028 country: Spain name: Nestor Ventura Abreu, MD, PhD role: CONTACT phone: +34932275400 phoneExt: 9336 email: neventura@clinic.cat name: Marta Pazos, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06353529 id: 17065 briefTitle: Sphenopalatine Ganglion Block for Postop Pain Management acronym: SPGB overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-09 date: 2024-04-09 name: Hamilton Health Sciences Corporation class: OTHER briefSummary: To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. The aim is to improve patient outcomes and reduce the need for pain medication after surgery. conditions: Pituitary conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution name: Placebo measure: Post-operative pain score measure: Post-operative bleeding measure: Post-operative complications measure: Analgesic requirement measure: Length of stay sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hamilton General Hospital city: Hamilton state: Ontario zip: L8L 2X2 country: Canada name: Dr. Kesava Reddy, MD role: CONTACT phone: 905-521-2100 email: reddy@hhsc.ca name: Ms. Jessy Moore, MSc role: CONTACT phone: 289-686-8827 email: moorej@hhsc.ca lat: 43.25011 lon: -79.84963 hasResults: False

 nctId: NCT06353516 id: 2310-117-126 briefTitle: The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients overallStatus: RECRUITING date: 2024-02-14 date: 2024-09 date: 2024-12 date: 2024-04-09 date: 2024-04-09 name: Chung-Ang University Gwangmyeong Hospital class: OTHER name: National Research Foundation of Korea briefSummary: The goal of this clinical trial is to compare the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients undergoing surgery. The main questions it aims to answer are:

* \[Is the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients different?\]
* \[Is the incidence of postoperative cognitive dysfunction between the intravenous anesthesia group and the inhalation gas anesthesia group different?\] Participants will be anesthetized with different categories of anesthetics.

  * Intravenous anesthetics
  * Inhalation gas anesthetics conditions: Postoperative Cognitive Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: This study is a double-blinded randomized controlled trial. The group assignment is conducted by the pre-generated random number table. The participant, investigator and the outcome assessor are blinded to the group assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: Propofol name: Sevoflurane measure: Concentration of serum S100B levels measure: Incidence of Delirium measure: Incidence of Postoperative Cognitive Dysfunction measure: Concentration of serum albumin measure: Concentration of serum CRP measure: Concentration of serum IL6 levels measure: Concentration of serum TNFα levels measure: Concentration of cerebrospinal fluid (CSF) albumin sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung-Ang University Gwangmyeong Hospital status: RECRUITING city: Gwangmyeong state: Gyeonggi-do zip: 14353 country: Korea, Republic of name: Wongook Wi, M.D. role: CONTACT phone: 02-2222-1553 email: hestia.w@gmail.com hasResults: False

 nctId: NCT06353503 id: KAZ briefTitle: Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment. overallStatus: RECRUITING date: 2024-04-02 date: 2024-09-27 date: 2024-09-27 date: 2024-04-09 date: 2024-04-09 name: abdulmajeed hammadi class: INDUSTRY briefSummary: A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia. conditions: Anterior Cruciate Ligament Tear studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single armed study open label primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: autologous bone marrow aspirate concentrate measure: Functional recovery by clinical assessments of the ACL and overall knee joint stability. measure: magnetic resonance imaging of the knee joint sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Ministry of Health status: RECRUITING city: Baghdad zip: 964 country: Iraq name: thamer A alrubaie, MD role: CONTACT phone: +9647700009294 email: alzaitounhospital@gmail.com lat: 33.34058 lon: 44.40088 hasResults: False

 nctId: NCT06353490 id: Geon-111001 briefTitle: The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers overallStatus: ACTIVE_NOT_RECRUITING date: 2022-08-12 date: 2023-11-08 date: 2024-08-11 date: 2024-04-09 date: 2024-04-09 name: Geon Corporation class: INDUSTRY briefSummary: Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices.

The main objectives of this study are:

1. To verify that the investigational devices and the reference medical devices have a reasonable deviation value.
2. To verify the consistency of repeated measurements of investigational devices. conditions: Febrile conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 150 type: ACTUAL name: Infrared Forehead Thermometer (GE-TF03) name: Infrared Ear Thermometer (GE-TE06) name: Electronic Thermometer (MT-B321FB) name: Electronic Thermometer (MT-B231) measure: Clinical Bias measure: Limits of Agreement measure: Clinical Repeatability sex: ALL maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hsinchu MacKay Memorial Hospital city: Hsinchu country: Taiwan lat: 24.80361 lon: 120.96861 facility: HsinChu Municipal MacKay Memorial Hospital city: Hsinchu country: Taiwan lat: 24.80361 lon: 120.96861 hasResults: False

 nctId: NCT06353477 id: EOU 2019-10 briefTitle: Hand, Foot, and Mouth Disease: Could EPs®7630 be a Treatment Option overallStatus: COMPLETED date: 2019-06-01 date: 2022-06-01 date: 2023-01-01 date: 2024-04-09 date: 2024-04-09 name: Eskisehir Osmangazi University class: OTHER name: Abdi Ibrahim Ilac San. ve Tic A.S. briefSummary: This randomized controlled study aims to evaluate the effectiveness and safety of the pharmaceutical extract EPs® 7630 from P.sidoides in treating hand, foot, and mouth disease in children. The study will investigate the impact of EPs® 7630 on the severity of the disease over a specific period and its effects on hospitalization rates and potential complications. This research aims to contribute to the treatment of hand, foot, and mouth disease in children. conditions: Hand, Foot, and Mouth Disease studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: EPs® 7630 is an extract from the roots of Pelargonium sidoides, drug-extract ratio 1 : 8-10, extraction solvent ethanol 11% (w/w). The patients were divided into two groups: (i) group 1 received herbal drug EPs® 7630 by oral route \[Umca® solution; (3x10 drops; between 1-5 years of age, 3x20 drops; 6-12 years of age, 3x30 drops for children \>12 years of age)\] for 7 days and (ii) group 2 (control group) did not receive any herbal medication. The medication was administered orally, at least 30 minutes before or after meals. Patients in both groups were prescribed paracetamol (10 mg/kg/dose, 4 times a day, maximum 4,000 mg/day.) as an antipyretic agent. Temperature measurement was made at home and in the hospital via the axillary route. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 240 type: ACTUAL name: EPs® 7630 measure: the patient's fever status, restlessness, inappetence, and sleeplessness scores sex: ALL minimumAge: 1 Year maximumAge: 10 Years stdAges: CHILD facility: Istinye University Medicine Faculty Hospital city: Esenyurt state: İstanbul zip: 34517 country: Turkey lat: 41.02697 lon: 28.67732 hasResults: False

 nctId: NCT06353464 id: 2306009984 briefTitle: A Translational Understanding of Obesity-Related Phenotypes Using Brain Imaging and Manipulation acronym: OPBIM overallStatus: RECRUITING date: 2023-10-04 date: 2025-09 date: 2025-09 date: 2024-04-09 date: 2024-04-09 name: Drexel University class: OTHER briefSummary: This study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: individuals consume two distinct preloads at separate sessions primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Participants consume two preloads one at each visit, but are not informed which preload is being consumed on which test visit. count: 80 type: ESTIMATED name: Ensure and Water measure: Grams of pizza consumed measure: Baseline medial prefrontal cortex oxygenated hemoglobin measure: Baseline lateral prefrontal cortex oxygenated hemoglobin measure: medial prefrontal cortex Oxygenated hemoglobin concentration measure: lateral prefrontal cortex Oxygenated hemoglobin concentration measure: medial prefrontal cortex Time to Peak Light Intensity measure: lateral prefrontal cortex Time to Peak Light Intensity measure: Preload Oxygenated Hemoglobin Difference sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Drexel University status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Principal Investigator, PhD RD role: CONTACT phone: 267-359-6287 email: foodbrainstudies@drexel.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06353451 id: EK GZ 67/2021-2024 briefTitle: Digital Detox Study: A Randomized Controlled Trial overallStatus: COMPLETED date: 2023-10-23 date: 2024-01-21 date: 2024-01-21 date: 2024-04-09 date: 2024-04-09 name: Danube University Krems class: OTHER briefSummary: The aim of the present RCT is to investigate the effect of smartphone screen time reduction on mental health indicators in healthy, 18-29 yo Austrian students.

After inclusion and randomization to intervention- and control group, normal screen time behavior will be assessed for 10-days. After that, the mental health parameters will be carried out in both groups as a baseline survey (T0). After that, intervention group should limit smartphone screen time to less than 2 hours per day for three consecutive weeks. Control group should use smartphones as usual. After that, mental health parameters will be assessed again in both groups (post-intervention, T1). After T1, there are no further requirements regarding screen time. Mental health parameters will be assessed again in both groups at follow-up (T2).

Main outcome parameters are 1) Well-Being (WHO-5), depressive symptoms (PHQ-9), stress (PSQ-20), and sleep quality (ISI).

The primary hypothesis (stated at Open Science Framework before Enrollment: https://osf.io/a9k76) is that mental health indicators, particularly stress, depressive symptoms, and sleep quality will improve throughout the intervention compared to the control group as well as to baseline. conditions: Health Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups, non blinded, randomized controlled trial primaryPurpose: PREVENTION masking: NONE count: 111 type: ACTUAL name: Digital Detox measure: Depressive Symptoms measure: Stress measure: Sleep Quality measure: Well-being measure: Problematic smartphone use measure: Body Appreciation measure: Anxiety Symptoms measure: Eating Disorder measure: Physical Activity measure: Heart rate variability (HRV) measure: Resting Heart Rate (RHR) measure: Screen time sex: ALL minimumAge: 18 Years maximumAge: 29 Years stdAges: ADULT facility: Danube University Krems city: Krems state: Lower Austria zip: 3500 country: Austria lat: 48.40921 lon: 15.61415 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-08 uploadDate: 2024-03-26T06:01 filename: Prot_SAP_000.pdf size: 251127 hasResults: False

 nctId: NCT06353438 id: 2024XXXX briefTitle: Hydraulic Resistance and Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: College of Staten Island, the City University of New York class: OTHER name: Bay Ridge Center briefSummary: The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are:

* Does the use of hydraulic exercise equipment decrease fall risk in older adults?
* Does the use of hydraulic exercise equipment improve function in older adults?

Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric). conditions: Aging conditions: Fall conditions: Old Age; Debility conditions: Muscle Weakness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Exercise Program measure: Berg Balance Scale measure: Timed Up and Go measure: Tinetti Balance and Gait Assessment Tool measure: Lower Extremity Functional Scale measure: Strength sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bay Ridge Center city: Brooklyn state: New York zip: 11209 country: United States name: Mary Ann Coughlin role: CONTACT phone: 718-306-2924 email: mcoughlin@bayridgecenter.org lat: 40.6501 lon: -73.94958 hasResults: False

 nctId: NCT06353425 id: 0562/66 briefTitle: Multi-country Survey on Violence Against Women Among Women overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-09 date: 2024-04-09 name: Chulalongkorn University class: OTHER name: Asia and Oceania Federation of Obstetrics and Gynaecology briefSummary: The goal of this observational study is to explore and learn about violence against women (VAW) among reproductive-aged women in Asia and Oceania countries. The main questions it aims to answer are:

* pattern and prevalence of VAW among reproductive-aged women
* knowledge, attitude, and practice (KAP) towards VAW among reproductive-aged women
* the need of support services for VAW among reproductive-aged women

Participants will be ever-partnered women aged 15-49 years. The definition of "ever-partnered women" included women who have current and former husbands; current and former cohabiting; or non-cohabiting male intimate partners. conditions: Violence Against Women studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED measure: prevalence of violence against women measure: KAP towards violence against women measure: need of support services for violence against women sex: FEMALE minimumAge: 15 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06353412 id: treatment methods of IIH briefTitle: Current Treatment Methods of Idiopathic Intracranial Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-09-01 date: 2026-03-09 date: 2024-04-09 date: 2024-04-09 name: Assiut University class: OTHER briefSummary: Aim of the study :

1. to determine the response to each treatment plan.
2. to determine when to choose specific treatment method.
3. to determine complication of each type of treatment method conditions: IIH - Idiopathic Intracranial Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: Lumbar puncture measure: Patient improvement regarding headache, visual symptoms measure: Patients improvement regarding fundus examination during regular visual assessment measure: Complication measure: Other sex: ALL minimumAge: 16 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353399 id: 23.0366 briefTitle: Guided Bone Regeneration With and Without the Use of Intra-marrow Penetrations overallStatus: RECRUITING date: 2023-06-15 date: 2024-06-30 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: University of Louisville class: OTHER briefSummary: The primary aims of this study are to compare, after 6 months, the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures. conditions: Ridge Augmentation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The study involves an investigator (surgeon) and an examiner. The examiner measures the clinical parameters before and after surgery and is blinded to the surgical procedure and if intra-marrow penetrations are utilized. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Intra-marrow penetrations name: No Intra-marrow penetrations measure: Alveolar Ridge Width measure: Alveolar Ridge Height measure: Buccal Soft Tissue Thickness measure: Histomorphometric Measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Louisville status: RECRUITING city: Louisville state: Kentucky zip: 40202 country: United States name: Bindu Dukka, BDS, MSD, MPH role: CONTACT phone: 502- 852- 1817 email: himabindu.dukka@louisville.edu name: Niti Patel, DMD role: CONTACT phone: 859-685-5423 email: niti.patel@louisville.edu name: Bindu Dukka, BDS, MSD, MPH role: PRINCIPAL_INVESTIGATOR lat: 38.25424 lon: -85.75941 facility: University of Louisville status: RECRUITING city: Louisville state: Kentucky zip: 40202 country: United States name: Himabindu Dukka, BDS, MSD role: CONTACT lat: 38.25424 lon: -85.75941 hasResults: False

 nctId: NCT06353386 id: 5684-01A id: MK-5684-01A type: OTHER domain: Merck id: 2023-506288-33 type: REGISTRY domain: EU CT id: U1111-1292-6912 type: OTHER domain: UTN briefTitle: Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2028-03-31 date: 2028-03-31 date: 2024-04-09 date: 2024-04-29 name: Merck Sharp & Dohme LLC class: INDUSTRY name: Orion Corporation, Orion Pharma briefSummary: Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).

The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study. conditions: Prostatic Neoplasms, Castration-Resistant studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: Opevesostat name: Olaparib name: Docetaxel name: Cabazitaxel measure: Number of participants who experience one or more dose-limiting toxicities (DLTs) measure: Number of participants who experience one or more adverse events (AEs) measure: Number of participants who discontinue study intervention due to an AE measure: Prostate-specific antigen (PSA) response rate measure: Objective response rate (ORR) measure: Radiographic progression-free survival (rPFS) measure: Overall survival (OS) measure: Duration of response (DOR) measure: Time to first subsequent anticancer therapy (TFST) measure: Time to pain progression (TTPP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353373 id: HZKY-PJ-2024-7 briefTitle: Smart Technology Facilitated Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies acronym: SmaVTE-BEST overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-02-28 date: 2025-02-28 date: 2024-04-09 date: 2024-04-09 name: Navy General Hospital, Beijing class: OTHER briefSummary: Venous thromboembolism (VTE) is the third leading cause of cardiovascular disease deaths globally, and its incidence is increasing over the years. Hospital-acquired VTE accounts for approximately 75% of all deaths attributed to VTE. However, only half of patients with indications for VTE prophylaxis take preventive measures, and high rates of inappropriate VTE prophylaxis prescribing contribute to the gap between VTE prophylaxis and guidelines. To further minimize the gap between clinical practice and guidelines, a range of strategies have been employed across various fields of VTE prophylaxis. One of the most effective measures is the utilization of a Clinical Decision Support System (CDSS). Smart technology-based CDSS facilitates automated evaluation of VTE risk and detection, addressing issues at both the beginning and end of the in-hospital VTE prevention process. but there is still a lack of research on how to effectively implement evidence-based VTE prophylaxis in the middle of the process.

In our hospital, routine use of DeVTEcare system (a CDSS for VTE risk assessment and integrated care) for in-hospital management of VTE has been launched since 2021. This study aims to investigate the effect of integrating bundled guideline-based VTE prevention strategies into the DeVTEcare system on in-hospital VTE prophylaxis. conditions: Venous Thromboembolism conditions: Clinical Decision Support Systems conditions: Digital Health studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 15626 type: ESTIMATED name: Application of the modified DeVTEcare system measure: In-hospital VTE measure: Guideline-compliant prescription of VTE prophylaxis measure: Preventable VTE measure: Hospital-related VTE death measure: Major bleeding measure: Non-major bleeding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353360 id: HL-06 briefTitle: TTField in Combination With TMZ and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma. overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2025-07-15 date: 2026-03-09 date: 2024-04-09 date: 2024-04-09 name: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd class: INDUSTRY briefSummary: The goal of this clinical trial is To investigate the safety and efficacy of Tumor-Treating Fields (TTFields) in combined with temozolomide (TMZ) and tislelizumab in the treatment of newly diagnosed glioblastoma (GBM). conditions: Glioblastoma Multiforme studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Tumor Treating Fields name: Tislelizumab name: Temozolomide (TMZ) measure: Progression-Free Survival (PFS) measure: Number of participants with adverse events (AEs) measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Overall Survival (OS) measure: PFS rate at 6 months measure: PFS rate at 1 year measure: OS rate at 1-year sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353347 id: HTD1801.PCT106 briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin overallStatus: RECRUITING date: 2023-11-13 date: 2025-03 date: 2025-12 date: 2024-04-09 date: 2024-04-18 name: HighTide Biopharma Pty Ltd class: INDUSTRY briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 555 type: ESTIMATED name: HTD1801 name: Placebo measure: Primary Endpoint: mean change in HbA1c measure: Double-blind (DB) Phase: mean change in fasting plasma glucose measure: DB Phase: mean change in 2-hour postprandial glucose measure: DB Phase: proportion of patients achieving HbA1c <7.0% measure: DB Phase: proportion of patients achieving HbA1c <6.5% measure: DB Phase: mean change in insulin sensitivity (HOMA-IR) measure: DB Phase: mean change in low-density lipoprotein cholesterol (LDL-C) measure: Open-Label Extension (OLE) Phase: mean change in HbA1c measure: OLE Phase: mean change in 2-Hour postprandial glucose measure: OLE Phase: proportion of patients achieving HbA1c <7.0% measure: OLE Phase: proportion of patients achieving HbA1c <6.5% measure: OLE Phase: mean change in insulin sensitivity (HOMA-IR) measure: OLE Phase: mean change in LDL-C sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baogang Hospital of Inner Mongolia status: RECRUITING city: Baotou country: China lat: 40.65222 lon: 109.82222 facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Beijing Luhe Hospital Capital Medical University status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Beijing Pinggu Hospital status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: The Second Norman Bethune Hospital of Jilin University status: RECRUITING city: Changchun country: China lat: 43.88 lon: 125.32278 facility: The First People's Hospital of Changde City status: RECRUITING city: Changde country: China lat: 29.04638 lon: 111.6783 facility: Hunan Provincial People's Hospital status: RECRUITING city: Changsha country: China lat: 28.19874 lon: 112.97087 facility: The Third Xiangya Hospital of Central South University status: RECRUITING city: Changsha country: China lat: 28.19874 lon: 112.97087 facility: Chongqing University Three Gorges Hospital status: RECRUITING city: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: The Third People's Hospital of Datong status: RECRUITING city: Datong country: China lat: 40.09361 lon: 113.29139 facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou country: China lat: 23.11667 lon: 113.25 facility: Handan First Hospital status: RECRUITING city: Handan country: China lat: 36.60056 lon: 114.46778 facility: The Fourth Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin country: China lat: 45.75 lon: 126.65 facility: Anhui Provincial Hospital status: RECRUITING city: Hefei country: China lat: 31.86389 lon: 117.28083 facility: The Second Hospital of Anhui Medical University status: RECRUITING city: Hefei country: China lat: 31.86389 lon: 117.28083 facility: Hengshui People's Hospital (Harrison International Peace Hospital) status: RECRUITING city: Hengshui country: China lat: 37.73222 lon: 115.70111 facility: Heze Municipal Hospital status: RECRUITING city: Heze country: China lat: 35.23929 lon: 115.47358 facility: Huai'an First People's Hospital status: RECRUITING city: Huai'an country: China lat: 33.50389 lon: 119.14417 facility: Huangshi Central Hospital status: RECRUITING city: Huangshi country: China lat: 30.24706 lon: 115.04814 facility: Huizhou Municipal Central Hospital status: RECRUITING city: Huizhou country: China lat: 23.11147 lon: 114.41523 facility: Huzhou Central Hospital status: RECRUITING city: Huzhou country: China lat: 30.8703 lon: 120.0933 facility: Jinan Central Hospital status: RECRUITING city: Jinan country: China lat: 36.66833 lon: 116.99722 facility: Jingzhou Central Hospital status: RECRUITING city: Jingzhou country: China lat: 30.35028 lon: 112.19028 facility: Jinzhou Central Hospital status: RECRUITING city: Jinzhou country: China lat: 41.10778 lon: 121.14167 facility: The First People's Hospital of Kashgar status: RECRUITING city: Kashgar country: China lat: 39.47066 lon: 75.98951 facility: Hebei Petro China Center Hospital status: RECRUITING city: Langfang country: China lat: 39.50972 lon: 116.69472 facility: Liaocheng People's Hospital status: RECRUITING city: Liaocheng country: China lat: 36.45596 lon: 115.97766 facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua) status: RECRUITING city: Luoyang country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan) status: RECRUITING city: Luoyang country: China lat: 34.68361 lon: 112.45361 facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: Nanjing First Hospital status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: Nanjing Jiangning Hospital status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: Sir Run Run Hospital Nanjing Medical University status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: The First People's Hospital of Nanning status: RECRUITING city: Nanning country: China lat: 22.81667 lon: 108.31667 facility: The First Affiliated Hospital of Nanyang Medical College status: RECRUITING city: Nanyang country: China lat: 32.99472 lon: 112.53278 facility: Panjin Liaohe Oilfield Gem Flower Hospital status: RECRUITING city: Panjin country: China lat: 41.121 lon: 122.0739 facility: The First Hospital of Qiqihar status: RECRUITING city: Qiqihar country: China lat: 47.34088 lon: 123.96045 facility: Shanghai East Hospital of Tongji University status: RECRUITING city: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Shanghai Pudong New Area People's Hospital status: RECRUITING city: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Shengjing Hospital of China Medical University status: RECRUITING city: Shenyang country: China lat: 41.79222 lon: 123.43278 facility: The Sixth People's Hospital of Shenyang status: RECRUITING city: Shenyang country: China lat: 41.79222 lon: 123.43278 facility: Shenzhen People's Hospital status: RECRUITING city: Shenzhen country: China lat: 22.54554 lon: 114.0683 facility: The University of Hong Kong - Shenzhen Hospital status: RECRUITING city: Shenzhen country: China lat: 22.54554 lon: 114.0683 facility: Taihe Hospital status: RECRUITING city: Shiyan country: China lat: 32.6475 lon: 110.77806 facility: Siping City Central People's Hospital status: RECRUITING city: Siping country: China lat: 43.16143 lon: 124.37785 facility: The First Affiliated Hospital of Suzhou University status: RECRUITING city: Suzhou country: China lat: 31.30408 lon: 120.59538 facility: People's Hospital of Tianjin status: RECRUITING city: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: Tonghua Central Hospital status: RECRUITING city: Tonghua country: China lat: 41.71972 lon: 125.92639 facility: The Central Hospital of Wuhan status: RECRUITING city: Wuhan country: China lat: 30.58333 lon: 114.26667 facility: Yijishan Hospital of Wannan Medical College status: RECRUITING city: Wuhu country: China lat: 31.33728 lon: 118.37351 facility: The First People's Hospital of Xiangtan City status: RECRUITING city: Xiangtan country: China lat: 27.85 lon: 112.9 facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou country: China lat: 34.18045 lon: 117.15707 facility: Yanan University Affiliated Hospital status: RECRUITING city: Yanan country: China facility: Yueyang People's Hospital status: RECRUITING city: Yueyang country: China lat: 29.37455 lon: 113.09481 facility: Yuncheng Central Hospital status: RECRUITING city: Yuncheng country: China lat: 35.02306 lon: 110.99278 facility: The Second Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou country: China lat: 34.75778 lon: 113.64861 facility: Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang country: China lat: 32.21086 lon: 119.45508 facility: Zhumadian Central Hospital status: RECRUITING city: Zhumadian country: China lat: 32.97944 lon: 114.02944 facility: Zhuzhou Central Hospital status: RECRUITING city: Zhuzhou country: China lat: 27.83333 lon: 113.15 facility: Zibo Central Hospital status: RECRUITING city: Zibo country: China lat: 36.79056 lon: 118.06333 facility: The First People's Hospital of Zunyi status: RECRUITING city: Zunyi country: China lat: 27.68667 lon: 106.90722 hasResults: False

 nctId: NCT06353334 id: 2024-3-22-8 briefTitle: Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial) overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-12-31 date: 2025-12-31 date: 2024-04-09 date: 2024-04-09 name: Tang Ziren class: OTHER briefSummary: Butylphthalide (NBP) is a neuroprotective medication capable of ameliorating neurological dysfunction induced by ischemia, hypoxia, and reperfusion injury in the brain. However, evidence regarding the improvement of neurological function prognosis in patients with return of spontaneous circulation (ROSC) after cardiac arrest (CA) by NBP is limited. This study aims to evaluate the safety and efficacy of NBP treatment in improving the neurological function prognosis of patients with ROSC after CA.The study will be a single-center, randomized, double-blind, placebo-controlled trial. The sample size is estimated to be 100 patients. Eligible patients will be randomly allocated in a 1:1 ratio to receive either NBP or placebo treatment daily for a duration of 14 days. The initial administration of NBP or placebo treatment will commence within 6 hours after ROSC following CA. The primary outcome is the proportion of patients with Cerebral Performance Category (CPC) scores of 1-2 at 90 days after randomization in each group. The primary safety outcome is the percentage of severe adverse events occurring during the 14-day treatment period. This trial will determine the efficacy of NBP in providing neuroprotective effects for patients with ROSC after CA. conditions: Butylphthalide conditions: Cardiac Arrest conditions: Neuroprotective Drugs studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Butylphthalide and Sodium Chloride Injection name: Saline Solution measure: The proportion of patients with a CPC score of 1-2 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Chao-Yang Hospital city: Beijing state: Beijing zip: 100020 country: China name: Xingsheng Wang, M.D role: CONTACT phone: +86 15265386100 email: wangxingsheng1995@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06353321 id: STU-2024-0024 briefTitle: Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2025-10-01 date: 2024-04-09 date: 2024-04-09 name: University of Texas Southwestern Medical Center class: OTHER name: RefleXion Medical briefSummary: To qualitatively determine the imaging performance of PET-CT imaging subsystem of the RefleXion X1 System Device in patients undergoing standard-of-care (SOC) \[68Ga\]-PSMA-11 PET-CT using Illuccix on the same day. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: PET-CT imaging subsystem of the RefleXion X1 System Device measure: Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353308 id: EA230308 briefTitle: Effectiveness of an Online Intervention Using a Feminist Approach on Gender Equality Promotion and Sexual Violence Prevention in China overallStatus: COMPLETED date: 2023-05-12 date: 2024-02-10 date: 2024-03-02 date: 2024-04-09 date: 2024-04-09 name: The University of Hong Kong class: OTHER briefSummary: This paper presents the findings of a clustered randomized controlled trial (cRCT) that evaluated the effectiveness of an online feminist sexual health intervention among Chinese young adults, providing insights into the impacts of this innovative approach and contribute to the growing body of literature on feminist interventions for sexual health and equality promotion. conditions: Sexual Violence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 422 type: ACTUAL name: Sexual Violence Prevention name: Sexual health intervention measure: Rape myth acceptance measure: Sociocultural Attitudes toward Appearance measure: Sexual Attitudes Scale measure: Sexual Desire Inventory sex: ALL minimumAge: 18 Years maximumAge: 29 Years stdAges: ADULT facility: The university of Hong Kong city: Hong Kong zip: 000000 country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06353295 id: 22-38098 id: CO-US-412-6436 type: OTHER_GRANT domain: Gilead Sciences briefTitle: Community-based, Peer-delivered PrEP for Female Sex Workers in Rural Uganda: The Peers for PrEP (P4P) Study acronym: P4P overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06 date: 2025-06 date: 2024-04-09 date: 2024-04-09 name: University of California, San Francisco class: OTHER name: Gilead Sciences briefSummary: The overall goal of the P4P: Peers for PrEP (pre-exposure prophylaxis) study is to pilot test a peer-led and delivered intervention for biomedical HIV prevention that is tailored to women who engage in sex work in southwestern Uganda. This study will evaluate whether this intervention is feasible, acceptable, and increases uptake of biomedical prevention. conditions: HIV/AIDS studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A single-arm pilot trial to evaluate a community-based, peer-led and delivered intervention to provide biomedical prevention products (e.g. pre-exposure prophylaxis \[PrEP\] and post-exposure prophylaxis \[PEP\]) for women who engage in sex work in southwestern Uganda. This study will test whether the intervention is feasible, acceptable, and increases biomedical prevention uptake. primaryPurpose: PREVENTION masking: NONE count: 140 type: ESTIMATED name: P4P intervention measure: Uptake of biomedical prevention measure: Feasibility of delivery of the P4P intervention by peers measure: Acceptability of the P4P intervention sex: FEMALE minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Infectious Diseases Research Collaboration city: Kampala country: Uganda name: Jane Kabami, MPH, PhDc role: CONTACT phone: +256 312 281-479 email: jkabami@idrc-uganda.org lat: 0.31628 lon: 32.58219 hasResults: False

 nctId: NCT06353282 id: 24-000795 briefTitle: MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents overallStatus: NOT_YET_RECRUITING date: 2025-07-01 date: 2026-01-31 date: 2026-12-31 date: 2024-04-09 date: 2024-04-09 name: University of California, Los Angeles class: OTHER briefSummary: The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms. conditions: PTSD, Post Traumatic Stress Disorder conditions: Adolescents conditions: Psychotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: MDMA name: Psychotherapy measure: Changes in heart rhythm via Carnation Ambulatory Heart Monitor measure: Changes in blood pressure measure: Change in pulse measure: Change in body temperature measure: Mean change in score of visual analog scale to assess potential for misuse of MDMA measure: Mean change in PTSD symptom severity via the Child PTSD Symptom Scale measure: Mean change in PTSD symptom severity via the Clinician-Administered PTSD Scale (CAPS-CA-5) measure: Mean change in depression symptom severity via the Patient Health Questionnaire-9 (PHQ-9). measure: Mean change in anxiety symptom severity via the Generalized Anxiety Disorder 7-item (GAD-7) sex: ALL minimumAge: 16 Years maximumAge: 17 Years stdAges: CHILD facility: UCLA Semel Institute for Neuroscience and Human Behavior city: Los Angeles state: California zip: 90095 country: United States name: Jessica K Jeffrey, MD, MPH, MBA role: CONTACT phone: 310-825-5263 email: jjeffrey@mednet.ucla.edu name: Marc J Weintraub, Ph.D. role: CONTACT phone: 310-825-1300 email: mjweintraub@mednet.ucla.edu name: Jessica K Jeffrey, MD, MPH, MBA role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06353269 id: 4255 briefTitle: Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections overallStatus: RECRUITING date: 2024-04 date: 2027-01 date: 2027-10 date: 2024-04-09 date: 2024-04-09 name: University of California, Irvine class: OTHER briefSummary: * The goal of this clinical trial is to learn about medication adherence to difference types of vaginal estrogen in women with low levels of estrogen (for example, post-menopausal women) who have recurrent urinary tract infections. Medication adherence means whether patients take their medicine as prescribed.
* Another goal of the study is to learn about changes to the skin of the vagina before and after estrogen treatment, using a specialized imaging modality called optical coherence tomography, which is similar to receiving an ultrasound.
* A third goal of the study is to learn about changes to the microbiome (all the bacteria that naturally live in our bodies) before and after treatment with vaginal estrogen. The researchers will be looking specifically at the microbiome in the urine and the vagina.

Participants will be assigned by chance (like the flip of a coin) to receive one of three possible vaginal estrogen treatments - cream, tablets, or drug-eluting ring.

* The main study tests and procedures include an initial visit in which the researchers will collect baseline information about participants and have participants complete a series of questionnaires.
* There will then be 3 and 6 month follow-ups in which the researchers will have participants complete additional questionnaires and the researchers also assess whether participants are using the vaginal estrogen treatment that you were prescribed.

If a participant is part of the microbiome cohort, they will also be asked to do the following:

* a baseline visit in which urinary and vaginal specimens are collected to assess their baseline microbiome. The vaginal specimen collection will involve a q-tip swab inside the vagina; it is similar to a pap smear.
* Finally, participants will have an imaging modality performed on their vagina called optical coherence tomography, which allows the researchers to assess the thickness of the vaginal walls and the blood vessel density. This imaging modality involves the insertion of a thin probe into the vagina to obtain the images of the vaginal wall.
* These tests will then be repeated at 6 months to assess if vaginal estrogen treatment causes changes to the vagina. conditions: Recurrent Urinary Tract Infection conditions: Hypoestrogenism studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 111 type: ESTIMATED name: Estring Vaginal Product name: Vagifem name: Estrace 0.01% Vaginal Cream measure: Adherence to vaginal estrogen treatment measure: UTI rates measure: validated patient questionnaire - Urinary Distress Inventory Short Form (UDI-6) measure: validated patient questionnaires - UTI Symptoms Assessment Questionnaire (UTISA) measure: validated patient questionnaires - Treatment Satisfaction with Medications Questionnaire (SATMED-Q) measure: validated patient questionnaires - Patient Global Impression of Improvement Questionnaire (PGI-I) measure: validated patient questionnaires - Medication Adherence Report Scale (MARS-5) measure: optical coherence tomography measurements for nested OCT cohort - vaginal epithelial thickness measure: optical coherence tomography measurements for nested OCT cohort - blood vessel density measure: Vaginal health index for nested microbiome cohort measure: Vaginal maturation index for nested microbiome cohort measure: Urologic microbiome results for nested microbiome cohort measure: Vaginal microbiome results for nested microbiome cohort sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California Irvine Medical Center status: RECRUITING city: Orange state: California zip: 92868 country: United States name: CHARLOTTE TER HAAR role: CONTACT email: terhaarc@hs.uci.edu lat: 33.78779 lon: -117.85311 hasResults: False

 nctId: NCT06353256 id: 300012607 id: UL1TR003096 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR003096 id: 24POST1198805 type: OTHER_GRANT domain: American Heart Association briefTitle: A Community Health Worker Intervention to Address Preeclampsia acronym: AW2H overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-04-30 date: 2024-04-09 date: 2024-04-09 name: University of Alabama at Birmingham class: OTHER name: American Heart Association name: National Center for Advancing Translational Sciences (NCATS) briefSummary: United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with PE to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants. conditions: Preeclampsia Postpartum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: usual postpartum care measure: Acceptability sex: FEMALE minimumAge: 16 Years maximumAge: 56 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06353243 id: STUDY00022901 briefTitle: Bilateral Infant Stimulation Study acronym: BLISS overallStatus: RECRUITING date: 2024-02-26 date: 2024-08 date: 2024-08 date: 2024-04-09 date: 2024-04-09 name: Oregon Health and Science University class: OTHER briefSummary: This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention. conditions: Parent-Child Relations conditions: Preterm Birth conditions: Stress Reaction conditions: Hospitalism in Children studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Bilateral alternating stimulation measure: Parental anxiety measure: Physiologic stress response measure: Parental distress sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Health and Science University Neonatal Intensive Care Unit status: RECRUITING city: Portland state: Oregon zip: 97219 country: United States name: Emily Garavatti, MD role: CONTACT phone: 503-494-2634 email: garavatt@ohsu.edu lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06353230 id: 0001 briefTitle: Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children acronym: Prolapse overallStatus: COMPLETED date: 2019-10-15 date: 2020-10-14 date: 2021-04-13 date: 2024-04-09 date: 2024-04-15 name: King Edward Medical University class: OTHER briefSummary: Introduction Patients with rectal prolapse are treated with injection sclerotherapy, which is the most often used first-line surgical technique. Injection sclerotherapy has a success rate of 90-100% in youngsters, according to certain studies. Objective To compare the outcome of injection sclerotherapy using 5% Phenol in almond oil, 15% hypertonic saline and 50% dextrose water in the treatment of rectal prolapse in children. conditions: Rectal Prolapse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Comparison of 5% phenol in almond oil, 15% hypertonic saline and 50% dextrose water for sclerotherapy treatment of rectal prolapse in children. primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomly allocated groupA,B or C by computer generated lottery method.and participants ,care provider and outcome assessor were kept blind by removing the drug name from injection vial count: 93 type: ACTUAL name: injection 5% phenol in almond oil name: injection 15% hypertonic saline name: injection 50% dextrose water measure: Recurrence measure: fecal incontinence sex: ALL minimumAge: 3 Years maximumAge: 13 Years stdAges: CHILD facility: department of pediatric surgery King Edward Medical University city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06353217 id: IRB00419034 id: K23DK128572 type: NIH link: https://reporter.nih.gov/quickSearch/K23DK128572 briefTitle: Study of a Primary Care Hypoglycemia Prevention Program overallStatus: RECRUITING date: 2024-04-14 date: 2026-04-14 date: 2026-04-14 date: 2024-04-09 date: 2024-04-10 name: Johns Hopkins University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial. conditions: Diabetes Mellitus conditions: Hypoglycemia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre/post pilot study primaryPurpose: PREVENTION masking: NONE count: 35 type: ESTIMATED name: Patient Group (Hypoglycemia Prevention Program) name: Primary Care Physician Group name: Clinic Staff Group measure: Overall acceptability to patients measure: Overall acceptability to primary care providers measure: Overall acceptability to clinic staff measure: Intervention coherence (patients) measure: Opportunity costs (patients) measure: Ethicality (patients) measure: Affective attitude (patients) measure: Burden (patients) measure: Self-efficacy (patients) measure: Perceived effectiveness (primary care providers) measure: Intervention coherence (primary care providers) measure: Opportunity costs (primary care providers) measure: Affective attitude (primary care providers) measure: Burden (primary care providers) measure: Self-efficacy (primary care providers) measure: Burden (clinic staff) measure: Opportunity costs (clinic staff) measure: Recruitment rate measure: Retention rate for second clinic visit measure: Continuous glucose monitoring (CGM) completion measure: Continuous glucose monitoring (CGM) wear time measure: Time needed to complete patient hypoglycemia profile measure: Duration of clinical visit measure: Patient completion of hypoglycemia assessment measure: Primary care provider use of provider hypoglycemia toolkit measure: Patient hypoglycemia burden on continuous glucose monitoring (CGM) measure: Patient time below range on continuous glucose monitoring (CGM) measure: Patient time above range on continuous glucose monitoring (CGM) measure: Patient mean glucose on continuous glucose monitoring (CGM) measure: Patient satisfaction with care measure: Patient activation measure: Patient self-reported hypoglycemic events measure: Changes to hypoglycemia-causing medications measure: Glucagon prescription measure: Continuous glucose monitoring (CGM) prescription measure: Change in Frequency of Referrals to Diabetes Self Management Training (DSMT) measure: Frequency of hypoglycemia history discussions measure: Frequency of Hypoglycemia anticipatory guidance discussions measure: Frequency of Medication adherence discussions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins University School of Medicine status: RECRUITING city: Baltimore state: Maryland zip: 21287 country: United States name: Scott J Pilla, MD, MHS role: CONTACT phone: 908-768-0002 email: spilla1@jhmi.edu lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06353204 id: 3325 briefTitle: Effectiveness of the Justice Diversion Halt-intervention overallStatus: RECRUITING date: 2024-02-01 date: 2027-07 date: 2027-07 date: 2024-04-09 date: 2024-04-09 name: Wetenschappelijk Onderzoek en Datacentrum class: OTHER_GOV name: Utrecht University name: Leiden University briefSummary: In the current study the effectiveness of the Dutch diversion measure Halt is investigated using a randomized controlled trial. Because of the thorough scientific substantiation of the intervention theory, it is hypothesized that receiving the Halt-intervention will lead to less recidivism in comparison to receiving no intervention. conditions: Criminal Recidivism conditions: Delinquency conditions: Antisocial Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A comparison between two groups will be made. One half of the participants will be randomly assigned to a group that receives the Halt-intervention, while the other group receives no Halt-intervention. primaryPurpose: TREATMENT masking: NONE count: 1300 type: ESTIMATED name: Halt-intervention measure: Criminal Recidivism based on self-report measure: Criminal Recidivism based on official police records measure: Criminal Recidivism based on official judiciary records measure: Truancy based on self-report measure: Conventional beliefs measure: Minimizing/mislabeling measure: Social skills measure: Taking responsibility for the consequences of behavior measure: Correct wrongdoing measure: Support from social network measure: Experienced legitimacy measure: Experienced treatment measure: Receiving adequate information measure: The right to be informed measure: Experienced voluntariness measure: Access to legal assistance measure: Knowledge of not obtaining a criminal record measure: Experienced stigmatisation measure: Experienced re-integration measure: Mental health problems during the last six months measure: Experienced problems measure: Delinquent friends measure: Parental involvement measure: Demographical characteristics measure: Halt-intervention program integrity measure: Characteristics Halt-employee measure: Perceived relationship with Halt-employee measure: Educational attainment measure: Type of criminal offense measure: Characteristics of referral to Halt-intervention measure: Types of modules used during the Halt-intervention measure: Parts of the Halt-intervention carries out as group or solo intervention sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: WODC status: RECRUITING city: The Hague state: Zuid-Holland zip: 2500EH country: Netherlands name: Benthe J van Delft, MSc role: CONTACT email: b.j.van.delft@wodc.nl lat: 52.07667 lon: 4.29861 hasResults: False

 nctId: NCT06353191 id: 19-002566 id: NCI-2024-00943 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19-002566 type: OTHER domain: Mayo Clinic in Florida id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 id: R01HL169268 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL169268 id: R56HL160643 type: NIH link: https://reporter.nih.gov/quickSearch/R56HL160643 briefTitle: Biomarkers to Predict Cancer Therapy-related Cardiotoxicity overallStatus: RECRUITING date: 2019-05-03 date: 2026-06-01 date: 2026-06-01 date: 2024-04-08 date: 2024-04-08 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy. conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Malignant Solid Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Non-Interventional Study measure: Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Myrah Manuel role: CONTACT phone: 480-574-3157 email: Manuel.Myrah@mayo.edu name: Lida A. Mina, MD role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Pamela Williamson role: CONTACT phone: 904-953-4694 email: Williamson.Pamela@mayo.edu name: Nadine Norton, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Mayo Clinic in Rochester status: SUSPENDED city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06353178 id: 20240314 briefTitle: Building Empowerment and Coping Outcomes for caNcer Patients, Survivors and Their Caregivers acronym: BEACON overallStatus: RECRUITING date: 2024-04-08 date: 2025-02-01 date: 2025-04-01 date: 2024-04-08 date: 2024-04-08 name: Color Health, Inc. class: INDUSTRY briefSummary: Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program. conditions: Cancer conditions: Caregiving Stress conditions: Caregiver Burnout conditions: Survivorship studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to waitlist or intervention group. Those in intervention group will receive the peer program; those on the waitlist will receive it after being on the waitlist for 3 months. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Participants will be notified of a waitlist assignment upon enrolling. Those on the waitlist will receive the intervention after 3 months. count: 120 type: ESTIMATED name: Cancer Connect Program measure: Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Color Health status: RECRUITING city: Burlingame state: California zip: 94010 country: United States lat: 37.5841 lon: -122.36608 hasResults: False

 nctId: NCT06353165 id: CRO-2022-12-BAC-SNF-THA-YPZ briefTitle: Anti-bacterial Clinical Study on Teeth, Tongue, Cheek, Gum, and Saliva overallStatus: COMPLETED date: 2023-03-08 date: 2023-04-12 date: 2023-04-12 date: 2024-04-08 date: 2024-04-15 name: Colgate Palmolive class: INDUSTRY briefSummary: This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use. conditions: Plaque, Dental studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: blinded primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ACTUAL name: Stannous fluoride toothpaste name: Colgate Dental Cream measure: Whole mouth scores of dental plaque measure: Measurement of total bacterial counts on tongue measure: Measurement of total bacterial counts on cheek measure: Measurement of gingivitis measure: Measurement of total bacterial counts in saliva sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: M U International Oral Science Research, Ltd. city: Bangkok state: Krung Thep Maha Nakhon zip: 10250 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06353152 id: GC506-507 briefTitle: Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells for Gastric/Gastroesophageal Junction Adenocarcinoma overallStatus: RECRUITING date: 2023-11-17 date: 2025-11-16 date: 2025-11-16 date: 2024-04-08 date: 2024-04-08 name: Peking University class: OTHER name: Gracell Biopharmaceuticals, Inc. briefSummary: A single-arm, open-label early-stage exploratory clinical study to evaluate the safety, tolerability and efficacy of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in subjects with gastric/gastroesophageal junction adenocarcinoma. conditions: Gastric Adenocarcinoma conditions: Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Claudin18.2-Targeted Chimeric Antigen Receptor T Cell Injection measure: Occurrence of Dose limiting toxicity. measure: Incidence of treatment-emergent AEs, AESIs, and SAEs. measure: Disease control rate (DCR) measure: Objective response rate (ORR) measure: Duration of disease control (DDC) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Proliferation and persistence of Claudin18.2-Targeted Chimeric Antigen Receptor T Cell measure: Incidence of anti-CAR-T cell antibody in peripheral blood after infusion. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing state: Beijing zip: 100142 country: China name: Shen Lin, Professor role: CONTACT phone: 010-88196561 email: doctorshenlin@sina.cn name: Shen Lin, professor role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06353139 id: 90591 briefTitle: The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction overallStatus: RECRUITING date: 2023-07-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-08 date: 2024-04-08 name: Peking University Third Hospital class: OTHER briefSummary: The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are:

Is it possible that the device can treat olfactory disorders in adults? Compared to the conventional device, how efficient is the modified olfactory training device for treating patients with olfactory disfunction? conditions: Olfactory Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: Modified olfactory training device measure: Clinically significant olfactory improvement sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dawei Wu status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Dawei Wu, MD, PhD role: CONTACT phone: 13522503401 email: davidwuorl@163.com role: CONTACT phoneExt: Wu email: davidwuorl@163.com name: Dawei Wu, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06353126 id: DTACESALT briefTitle: DEB-TACE Prior to Liver Transplantation in the Treatment of HCC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-01 date: 2027-07-01 date: 2024-04-08 date: 2024-04-08 name: RenJi Hospital class: OTHER name: Boston Scientific Corporation briefSummary: The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to SALT (Sequential Adult Left Lateral Liver Transplantation) can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for SALT receive DEB-TACE 2 weeks prior to the surgery.

The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing SALT; 4) Adverse events related to DEB-TACE. conditions: Liver Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: DEB-TACE measure: Recurrence-free survival (RFS) measure: Overall survival (OS) measure: Pathological response rate (Pathological Response) measure: Proportion of patients completing SALT measure: Adverse events related to DEB-TACE sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353113 id: HS-2023-0254 briefTitle: Feasibility of a Prenatal Yoga Mobile App in African American Pregnant Women overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-09 date: 2024-04-08 date: 2024-04-08 name: San Diego State University class: OTHER briefSummary: The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are:

1. Is the Down Dog prenatal yoga app feasible for AA pregnant women?
2. How does mental and physical health change after using the Down Dog app for 12-weeks?
3. What cultural adaptations to the Down Dog app are needed?

The study lasts for 12 weeks and participants are asked to:

* do prenatal yoga with the app for at least 20 min/day, three days/week, from home
* wear a Garmin Vivosmart 5 watch daily
* complete four online surveys
* complete an optional virtual interview

This project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes. conditions: Pregnancy Related conditions: Mental Health Issue conditions: Discrimination, Racial conditions: Stress conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Down Dog Prenatal Yoga App measure: Acceptability of the intervention measure: Demand of the intervention measure: Retention measure: Ease of recruitment measure: Discrimination measure: Perceived stress measure: Perinatal Depression measure: Self-awareness measure: Mindfulness measure: Subjective physical activity measure: Objective physical activity (steps) measure: Objective physical activity (intensity) measure: Cardiac health (heart rate) measure: Cardiac health (heart rate variability) measure: Cultural adaptations measure: Birth outcomes (gestational age) measure: Birth outcomes (type of delivery) measure: Birth outcomes (intervention used for delivery) measure: Birth outcomes (birth weight) measure: Birth outcomes (maternal weight) measure: Birth outcomes (pregnancy-related disorders) sex: FEMALE minimumAge: 18 Years maximumAge: 46 Years stdAges: ADULT facility: San Diego State University status: RECRUITING city: San Diego state: California zip: 92182 country: United States name: Jeni Green, PhD role: CONTACT lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06353100 id: 230602006 briefTitle: Chronic Pain in the General Population of Chile acronym: RDC overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-12-30 date: 2024-12-30 date: 2024-04-08 date: 2024-04-08 name: Pontificia Universidad Catolica de Chile class: OTHER name: Chilean Safety Association (ACHS) briefSummary: The present study seeks to follow up the cohort of adults representative of Chile's urban population whose levels of chronic pain were evaluated in March 2023 (baseline) as part of the Mental Health Thermometer (MHT) study. The study consists of a 12 month follow-up telephone interview to assess parameters of chronic pain (CP) and subtypes, mental and physical health, lifestyle and adversity and work characteristics.

The study objectives are as follows:

1. Estimate the prevalence of CP and subtypes in the general population
2. Explore the association between mental health indicators, perceived work stress and presence of CP in the population.
3. Investigate the impact of CP (functional, occupational and social) among the subset of participants reporting CP
4. Describe the use of management strategies in those who suffer from CP. conditions: Chronic Pain conditions: Migraine Disability conditions: Neuropathic Pain conditions: Fibromyalgia conditions: Depression, Anxiety conditions: Self Harm conditions: Insomnia conditions: Loneliness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2365 type: ACTUAL measure: Chronic pain (past 3 months) measure: Depression (2 weeks) measure: Anxiety (2 weeks) measure: Migraine Disability measure: Neuropathic Pain measure: Fibromyalgia measure: Self harm (2 weeks) measure: Insomnia (2 weeks) measure: Loneliness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pontificia Universidad Catolica de Chile city: Santiago state: RM zip: 7550139 country: Chile lat: -33.45694 lon: -70.64827 hasResults: False

 nctId: NCT06353087 id: B7451114 briefTitle: Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry) acronym: ATTRACT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-11-15 date: 2025-11-15 date: 2024-04-08 date: 2024-04-08 name: Pfizer class: INDUSTRY briefSummary: This study is to describe the real-world treatment patterns and clinical outcomes in moderate-to-severe AD patients receiving abrocitinib over a 12-month observation period, and to describe patient demographic and baseline characteristics. conditions: Dermatitis, Atopic conditions: Dermatitis conditions: Eczema conditions: Skin Diseases conditions: Immune System Diseases conditions: Janus Kinase Inhibitors studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Percentage of Participants Achieving >= 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) Response at Week 2, 12, 52 measure: Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 2, 12, 52 measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 2, 12, 52 measure: Duration of Abrocitinib Treatment: All Participants measure: Demographic and baseline characteristics measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 12, 16, 24, and 52 measure: Change From Baseline in Investigator's Global Assessment (IGA) at Weeks 2, 4, 12, 16, 24, and 52 measure: Change From Baseline in Percentage Body Surface Area at Week 2, 4, 12, 16, 24, and 52 measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 12, and 52 measure: Change from baseline of Atopic Dermatitis Control Tool (ADCT) score at Week 2, 4, 12, and 52 measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 2, 4, 12, and 52 measure: Change From Baseline in Patient Global Assessment (PtGA) measure: Percentage Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 2, 4, 12, 16, 24, and 52 measure: Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52 measure: Percentage of Participants Achieving 0 or 1 in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52 sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353074 id: 1335cemre. briefTitle: Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Hemorrhage overallStatus: COMPLETED date: 2021-01-01 date: 2023-11-30 date: 2023-11-30 date: 2024-04-08 date: 2024-04-08 name: Necmettin Erbakan University class: OTHER briefSummary: This study is aimed to show effectiveness of a new suture technique to stop postpartum uterine bleeding due to uterine atony. conditions: Uterine Atony With Hemorrhage conditions: Postpartum Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 16 type: ACTUAL measure: Postpartum hysterectomy and/or intensive care unit need ratio sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Cemre Alan city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06353061 id: LACC-MET briefTitle: Chemoradiotherapy With or Without Metformin in Locally Advanced Cervical Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-08-01 date: 2026-02-01 date: 2024-04-08 date: 2024-04-08 name: Peking Union Medical College Hospital class: OTHER briefSummary: This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. The study aims to compare the improvement of tumor hypoxia with synchronous chemoradiotherapy with or without metformin, using CA-IX PET/CT and radiation positioning spectral CT to evaluate tumor hypoxia, screening hypoxic patients for inclusion in the study, and comparing the effects of synchronous chemoradiotherapy with or without metformin on the degree of hypoxia and progression-free survival in the two groups of patients. conditions: Cervical Cancer conditions: Radiotherapy conditions: Metformin conditions: Hypoxia conditions: PET/CT studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 51 type: ESTIMATED name: Metformin name: Radiotherapy name: Chemotherapy name: PET/CT measure: The degree to which metformin improves the hypoxic index measured by CAIX PET measure: Progression-free survival（PFS） measure: Changes in tumor volume during treatment measure: Hematologic and gastrointestinal toxicities assessed by CTCAE v5.0 measure: Quality of life assessed by QLQ-C30 sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06353048 id: Soh-Med-24-02-04MS briefTitle: Short Term Radiological and Clinical Outcomes of Fixation of Schatzker II Tibial Plateau Fractures by Screws Only Versus Plate and Screws , Comparative Study overallStatus: RECRUITING date: 2024-02-10 date: 2025-02-15 date: 2025-02-15 date: 2024-04-08 date: 2024-04-08 name: Sohag University class: OTHER name: sohag university hospital briefSummary: Tibial plateau fractures are complex injuries produced by high- or low-energy trauma. They principally affect young adults or the 'third age' population ,the tibial plateau is a major weight-bearing surface within the largest and most kinematically complex joint in the human body. Fractures occur as a result of a combination of an axial loading force and a coronal plane (varus/valgus) moment leading to articular shear and depression and mechanical axis malalignment,So Limb alignment and articular surface restoration, allowing early knee motion, are the main goals of surgical treatment.

Soft-tissue damage in fractures around the knee is of critical importance. The oedema and inflammation associated with the trauma can easily lead to local venous compromise, dermal hypoxia, and additional soft-tissue injury. This commonly leads to blistering of the skin and in some cases dermal and even muscle necrosis. Blood-filled blisters should be expected to be associated with a worse outcome than clear fluid-filled ones. Management in the early stages of treatment should focus on preventing further soft-tissue injury while waiting to repair the fracture.

Traditionally, initial radiograph diagnosis should include anteroposterior (AP), lateral and oblique views. But single radiographs do not allow an exact fragment identification and the initial fracture classification can change in 5% to 24% (mean 12%) of cases and treatment can change in up to 26% of cases after CT scan imaging . These findings and the wider availability of CT scanning have made the oblique views less important in the diagnosis. Intra- and peri-articular soft-tissue structures can be affected even in less complex fracture patterns and some X-ray or CT scan data can also suggest the existence of a lateral or medial meniscal tear. Articular depression \> 6 mm and/or articular widening \> 5 mm are associated with the existence of lateral meniscus, lateral collateral ligament (LCL) or posterior cruciate ligament injuries .

Schatzer classification (published in 1974) will be used to complete understanding of the personality of these fracture which is the key element in decision making process when choosing the best possible treatment .

In general ,tibial plateau fracture are to be operated on , but the decision whether to be operated or not on a specific fracture should be based on the fracture morphology ,soft tissues , the patient general condition and the expected limb axis and articular surface restoration.

Usual indications for surgical treatment are :

1. Intra-articular displacement of ⩾ 2 mm
2. Metaphyseal -diaphyseal translation \> 1 cm
3. Angular deformity more than 10 degree in the coronal or sagittal view
4. Open fracture , compartment syndrome and associated ligament injury require repair.
5. Associated fractures of the ipsilateral tibia or fibula

Frequently the depressed articular fragments have to elevated back toward the knee , followed by fixation and sometimes supplemented with bone graft to fill any cancellous bone voids left beneath the joint surface after fracture reduction .

We will evaluate treatment outcomes of closed reduction and percutaneous cannulated screw fixation for tibial plateau fractures versus open reduction and fixation by plate conditions: Tibial Plateau Fractures Schatzker Type II studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: fixation of tibial plateau fractures measure: range of motion of knee joint using Rasmussen score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06353035 id: NaturalResourcesIFinland id: 346136 type: OTHER_GRANT domain: Strategic Research Council Finland id: 346138 type: OTHER_GRANT domain: Strategic Research Council Finland briefTitle: Biodiversity Interventions for Well-Being acronym: BIWE overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-30 date: 2027-06-30 date: 2027-09-30 date: 2024-04-08 date: 2024-04-08 name: Natural Resources Institute Finland class: OTHER_GOV name: Tampere University briefSummary: Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.

In Biodiversity interventions for well-being (BIWE), microbial biodiversity interventions are performed to increase biodiversity in urban built areas. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.

The investigators set up an intervention study in which urban private yards are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways. conditions: Microbial Colonization conditions: Immune System Diseases conditions: Well-Being, Psychological conditions: Nature, Human studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention-control study in which intervention study subjects private yards are rewilded and control receives no treatment. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: The research subjects were not randomized or masked to the intervention and control group, because the control group needs volunteers who have no intention of following the yard management instructions advised to the intervention group. count: 30 type: ACTUAL name: Rewilding measure: Skin Gammaproteobacteria measure: Salivary cytokines measure: Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota measure: Difference in observed species richness of skin, saliva and stool microbiota measure: Difference in taxonomies of skin, saliva and stool microbiota measure: Difference in microbial gene pathways of saliva and stool microbiota measure: Cortisol levels measure: Perceived Stress Scale measure: Warwick-Edinburgh Mental Wellbeing Scale measure: Depression Scale measure: Nature Relatedness Scale measure: Metabolites in urine measure: Associations between environmental factors and microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Natural Resources Institute Finland city: Helsinki state: Uusimaa zip: 00970 country: Finland lat: 60.16952 lon: 24.93545 hasResults: False

 nctId: NCT06353022 id: RC23_0267 id: 2023-508310-41 type: EUDRACT_NUMBER briefTitle: Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma acronym: IFm2022-01 overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2030-06-20 date: 2024-04-08 date: 2024-04-08 name: Nantes University Hospital class: OTHER name: Janssen Pharmaceutica briefSummary: This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively).

The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 103 type: ESTIMATED name: Teclistamab name: Talquetamab name: Lenalidomide name: Bortezomib name: Daratumumab name: Dexamethasone measure: Rate of sustained MRD negativity (NGS, 10^-5) measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5) measure: Number of adverse events measure: Rate of sustained MRD negativity (NGS, 10^-6) measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-6). measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5). measure: Number of the death measure: Number of responses measure: Number of progression-free survival measure: Percentage of duration of response measure: Percenatge of time to response measure: Percentage of value of biological prognostic factors influencing outcome and response. measure: Percentage of score of quality of life sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH de la Côte Basque city: Bayonne zip: 64109 country: France lat: 43.48333 lon: -1.48333 facility: CHU Caen city: Caen zip: 14033 country: France lat: 49.18585 lon: -0.35912 facility: CHRU DIjon city: Dijon zip: 21000 country: France lat: 47.31667 lon: 5.01667 facility: Chd Vendee city: La Roche-sur-Yon zip: 85925 country: France lat: 46.66667 lon: -1.43333 facility: CHRU LILLE - Hôpital Claude Huriez city: Lille zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: CHU Limoges city: Limoges zip: 87000 country: France lat: 45.83153 lon: 1.25781 facility: CH Lyon Sud city: Lyon zip: 69495 country: France lat: 45.74848 lon: 4.84669 facility: IPC Marseille Institut Paoli Calmettes city: Marseille zip: 13009 country: France lat: 43.29551 lon: 5.38958 facility: CHU Montpellier city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 facility: CHU de Nantes city: Nantes zip: 44093 country: France lat: 47.21725 lon: -1.55336 facility: APHP Hôpital Saint Louis city: Paris zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: APHP Hôpital Saint-Antoine city: Paris zip: 75012 country: France lat: 48.85341 lon: 2.3488 facility: APHP Hôpital La Pitié Salpétrière city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 facility: CHU BORDEAUX - Hôpital du Haut Lévêque city: Pessac zip: 33604 country: France lat: 44.81011 lon: -0.64129 facility: CHU Poitiers city: Poitiers zip: 86000 country: France lat: 46.58333 lon: 0.33333 facility: CHRU Rennes - Hôpital de Pontchaillou city: Rennes zip: 35033 country: France lat: 48.11198 lon: -1.67429 facility: ICANS Institut de Cancérologie Strasbourg Europe city: Strasbourg zip: 67200 country: France lat: 48.58392 lon: 7.74553 facility: CHU Toulouse city: Toulouse zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: CHU Tours Hôpital Bretonneau city: Tours zip: 37044 country: France lat: 47.38333 lon: 0.68333 facility: CHRU Nancy - Hôpitaux de Brabois city: Vandœuvre-lès-Nancy zip: 54511 country: France lat: 48.65 lon: 6.18333 hasResults: False

 nctId: NCT06353009 id: ICM 2021-2720 briefTitle: Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography acronym: SUPPER overallStatus: COMPLETED date: 2020-08-20 date: 2023-04-28 date: 2023-04-28 date: 2024-04-08 date: 2024-04-08 name: Matthieu Pelletier-Galarneau, MD MSc class: OTHER briefSummary: The objective of this study is to evaluate the effect of an ultra-processed meal on myocardial endothelial function using positron emission tomography (PET).

The proposed study is an open-label, randomized crossover clinical trial. Participants will be divided into 2 groups: half of the participants will consume a Mediterranean meal during the first experimental visit and an ultra-processed meal during the second, and vice versa for the other half. The order in which the meals will be consumed will be determined randomly.

This project will contribute to clarify the role of diet in the development and progression of coronary artery disease. The results obtained from this study may potentially demonstrate the harmful effect of ultra-processed foods, even in the short term, on coronary arteries. conditions: Myocardial Endothelial Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 15 type: ACTUAL name: NOVA4 meal name: NOVA1-3 meal measure: Myocardial blood flow values (ml/min/g) at maximum dose of adenosine. measure: Myocardial blood flow values (ml/min/g) at rest and myocardial reserve. measure: Myocardial blood flow values (ml/min/g) at intermediate dose of adenosine. sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Matthieu Pelletier-Galarneau city: Montreal state: Quebec zip: H1T 1C8 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06352996 id: Dentist Anas Kassas briefTitle: Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-09 date: 2024-03-09 date: 2024-07-30 date: 2024-04-08 date: 2024-04-08 name: Mansoura University class: OTHER briefSummary: Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.

Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.

Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction. conditions: Power Arm Canine Retraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm name: Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm measure: Canine tipping measure: Canine mobility measure: Implant stability measure: Pain assessment measure: canine rotation measure: canine retraction rate sex: ALL minimumAge: 14 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Faculty of dentistry Mansoura University city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06352983 id: 2014/11 briefTitle: Zirconium Dioxide Fixed Dental Prosthesis. overallStatus: COMPLETED date: 2017-12-20 date: 2019-09-27 date: 2023-01-20 date: 2024-04-08 date: 2024-04-08 name: Malmö University class: OTHER briefSummary: The purpose of this clinical trial is to evaluate and compare bridges to replace one or two missing teeth in the mouth. The bridges will be made of two variants of ceramic material. We will evaluate the bridges for up to five years regarding technical and biological complications. conditions: Missing Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Both participant, care providers, dental technicians and the investigator are blinded in the process. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 31 type: ACTUAL name: Fixed dental prosthesis measure: Fractures measure: De-bonding measure: Caries measure: Endodontic measure: Function measure: Esthetics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Malmo university city: Malmo state: Skane zip: 214 21 country: Sweden lat: 55.60587 lon: 13.00073 facility: Malmo university city: Malmo state: Skane zip: 21421 country: Sweden lat: 55.60587 lon: 13.00073 hasResults: False

 nctId: NCT06352970 id: LundU-2024 briefTitle: Effects of Tuberculosis Infection on Development and Function of the Placenta overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: Lund University class: OTHER name: Addis Ababa University name: Armauer Hansen Research Institute, Ethiopia briefSummary: The goal of this observational study is to understand how tuberculosis (TB) infection impacts the function and development of the placenta, and whether TB infection can contribute to pregnancy-related disorders through effects on the placenta.

The main questions it aims to answer are:

* Does TB infection affect the structure of the placenta?
* Does TB infection affect the function of the placenta?

Pregnant women attending delivery clinics in Addis Abeba, Ethiopia, will be enrolled and classified for TB infection using a blood-based test. We will compare the following outcomes between women with TB infection and women without TB infection:

* Pathological lesions of the placenta
* Gene and protein expression patterns linked to pregnancy-related disorders
* Infant outcome at birth and at 6 weeks after birth conditions: Pregnancy Related conditions: Tuberculosis Infection conditions: Placenta Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: TB infection measure: Proportion of women with pathological placental findings according to the Amsterdam consensus criteria measure: Proportions of women with placental RNA and protein expression patterns linked to pregnancy- related disorders measure: Proportions of infants (born to participating women) with adverse outcome sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352957 id: 23022022CERC briefTitle: Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study acronym: ETERNITY-ITA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: Istituto di Fisiologia Clinica CNR class: OTHER briefSummary: The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from baseline, with resulting correct bone mineralization and inhibition vascular calcification in hemodialysis patients.

The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months. conditions: Hemodialysis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED measure: Levels of VKDP measure: Calcium measure: Phosphate measure: Magnesium measure: ALP measure: PTH measure: 25(OH)D measure: P1NP measure: CTX measure: TRAP 5b measure: BSAP measure: cFGF23 measure: Klotho measure: Sclerostin measure: DKK1 measure: Fetuin A measure: Zinc measure: Irisin measure: Serum Calcification Propensity T50 test measure: Hemoglobin (Hb) measure: Hematocrit (Ht) measure: Plates (PLTS) measure: Reticulocytes measure: Iron measure: Ferritin measure: Transferrin measure: Transferrin Saturation measure: Albumin measure: KT/V measure: Aluminium measure: C-reactive Protein (CRP) measure: Cholesterol measure: Triglycerides measure: Cholesterol HDL measure: Cholesterol LDL measure: Vascular Calcification measure: Vertebral Fractures measure: BMD: Bone Mineral Density measure: Association between Verterbal Fractures and Vascular Calcificatiom measure: Novel quantitative computer-assisted scoring method for vascular calcifications. measure: Effect of Etelcalcetide on cardiovascular events and all-cause mortality. measure: Etelcalcetide Safety: Number of participants with treatment-related adverse events. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352944 id: AssiutMD briefTitle: Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-07 date: 2026-07 date: 2024-04-08 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity ) conditions: Non-cystic Fibrosis Bronchiectasis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: procalcitonin measure: procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06352931 id: TCD & TCUS in infants briefTitle: Transcranial Ultrasound and Transcranial Doppler in Diagnosis and Detection of Outcome in Infants With Neurological Diseases overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-30 date: 2025-07-30 date: 2024-04-08 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging. conditions: Trancranial Doppler studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: transcranial and transcranial dopp;er measure: To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial doppler sex: ALL minimumAge: 1 Day maximumAge: 1 Year stdAges: CHILD hasResults: False

 nctId: NCT06352918 id: B.30.2.ATA.0.01.00/395 briefTitle: Peripheral Central Catheter (PICC) Care acronym: PICC overallStatus: COMPLETED date: 2023-05-01 date: 2023-11-30 date: 2023-12-31 date: 2024-04-08 date: 2024-04-08 name: Ataturk University class: OTHER briefSummary: Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes.

Today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. Palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. This research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in PICC care in preterm babies. conditions: NEWBORN conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: Palmar grasp reflex stimulation measure: Pain level measure: Comfort sex: ALL minimumAge: 28 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: Ataturk University city: Erzurum zip: 25240 country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06352905 id: 2157711 briefTitle: Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease overallStatus: RECRUITING date: 2022-09-01 date: 2025-04 date: 2025-04 date: 2024-04-08 date: 2024-04-08 name: Baylor University class: OTHER name: University of St. Augustine for Health Sciences briefSummary: This is an exploratory study to assess the impact of whole body vibration on backward walking speed in people with Parkinson disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Whole body vibration (WBV) name: Control measure: 3-meter backward walk test (3MBWT) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor University status: RECRUITING city: Waco state: Texas zip: 76798 country: United States name: Anne Boddy role: CONTACT phone: 904-806-2126 email: anne_boddy@baylor.edu lat: 31.54933 lon: -97.14667 hasResults: False

 nctId: NCT06352892 id: 20210201 briefTitle: A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-09-03 date: 2024-09-03 date: 2024-04-08 date: 2024-04-08 name: Amgen class: INDUSTRY briefSummary: The main objective of the study is to assess the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) administration in overweight or obese Chinese participants. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: AMG 133 measure: Maximum Observed Plasma Concentration (Cmax) of AMG 133 measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133 measure: AUC from Time Zero Extrapolated to Infinity (AUCinf) of AMG 133 measure: Number of Participants with Treatment-emergent Adverse Events measure: Number of Participants with Serious Adverse Events measure: Number of Participants with Anti-AMG 133 Antibodies sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352879 id: 18-Al-KindyCM briefTitle: Prevalence, Types and Risk Factors of Urinary Incontinence Among Women in Baghdad, Iraq. overallStatus: RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-06-15 date: 2024-04-08 date: 2024-04-08 name: Al-Kindy College of Medicine class: OTHER briefSummary: The goal of this observational study is to observe and describe the prevalence, types, and risk factors of urinary incontinence (UI) in adult women attending primary healthcare centers in Baghdad, Iraq. The main questions it aims to answer are:

* What is the prevalence of incontinence among the targeted group?
* What are the types of incontinence and what is the frequency of each type among the targeted group?
* What is the effect of several risk factors on the occurrence and severity of urinary incontinence (including age, job, sexual activity, chronic constipation, chronic cough, parity, largest birth weight, and body mass index)? Participants will be asked to fill out a questionnaire consisting of the Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) in addition to questions about the aforementioned risk factors. conditions: Urinary Incontinence conditions: Urge Incontinence conditions: Stress Incontinence studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 384 type: ESTIMATED measure: Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) measure: Risk factors for urinary incontinence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baghdad Al- Karkh Health Directorate status: RECRUITING city: Baghdad country: Iraq name: Harth Mohamed Kamber, FICMS (Uro.) role: CONTACT phone: 009647706029071 email: harthkamber@kmc.uobaghdad.edu.iq name: Shahad Hameed Kadhom, MBChB role: PRINCIPAL_INVESTIGATOR lat: 33.34058 lon: 44.40088 facility: Baghdad Al-Russafa Health Directorate status: RECRUITING city: Baghdad country: Iraq name: Harth Mohamed Kamber, FICMS (Uro.) role: CONTACT phone: 009647706029071 email: harthkamber@kmc.uobaghdad.edu.iq name: Shahad Hameed Kadhom, MBChB role: PRINCIPAL_INVESTIGATOR lat: 33.34058 lon: 44.40088 hasResults: False

 nctId: NCT06352866 id: CASE3A23 briefTitle: Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-04-01 date: 2025-12-01 date: 2024-04-08 date: 2024-04-16 name: Jack Khouri class: OTHER briefSummary: The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) in participants prior to teclistamab administration. CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body. Siltuximab is experimental because it is not approved by the Food and Drug Administration (FDA) for prophylactic use prior to administration of teclistamab infusion. conditions: Multiple Myeloma conditions: Cytokine Release Syndrome conditions: Refractory Multiple Myeloma conditions: Immune Effector Cell Associated Neurotoxicity Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is an open label single cohort feasibility and efficacy study of siltuximab prophylaxis prior to infusion of teclistamab for treatment of RRMM. There is no planned dose escalation and no separate cohorts.

Participants will receive a single dose of prophylactic siltuximab, 11 mg/kg, 2 hours prior to the administration of the first dose of teclistamab on day 1. There is no planned dose escalation of siltuximab, and teclistamab dosing will be done following the standard planned ramp-up. Participants will be hospitalized for 9 days according to teclistamab package insert and Cleveland Clinic institutional practice. Participants will be followed for the incidence of CRS and ICANS for the first two 22-day cycles of treatment. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Siltuximab name: Teclistamab(FDA-approved) measure: Change in CRS Rate measure: Safety assessment of a single dose of siltuximab as CRS prophylaxis measure: Incidence of grade ≥ 2 cytokine release syndrome after siltuximab prophylaxis measure: Incidence of all grade ICANS after siltuximab prophylaxis measure: Incidence of adverse events after siltuximab prophylaxis measure: Overall response rate measure: Progression free survival measure: Overall survival measure: Hospitalization rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio city: Cleveland state: Ohio zip: 44195 country: United States name: Jack Khouri, MD role: CONTACT phone: 866-223-8100 email: TaussigResearch@ccf.org name: Jack Khouri, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06352853 id: Diathermy and skin incision cs briefTitle: Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section overallStatus: COMPLETED date: 2022-04-01 date: 2022-09-01 date: 2022-10-01 date: 2024-04-08 date: 2024-04-09 name: Cairo University class: OTHER briefSummary: This study aims to compare between using of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in incisional time, incisional blood loss, postoperative pain, wound healing and wound complications. conditions: Skin Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 120 type: ACTUAL name: Skin incision in Cesarean Section by Diathermy name: Skin incision in Cesarean Section by Scalpel measure: Skin incision time in scalpel versus diathermy group measure: Estimation of incision blood loss in both groups measure: Postoperative pain in both groups measure: Postoperative wound healing in both groups sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Shaimaa El Shemy city: Giza state: Cairo zip: 11562 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06352840 id: HUM00231526 id: 5K23HD099283-03 type: NIH link: https://reporter.nih.gov/quickSearch/5K23HD099283-03 briefTitle: Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-08 date: 2024-04-08 name: University of Michigan class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).

The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach. conditions: Chronic Pelvic Pain conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Both participants and outcome assessors will be blinded to study group assignment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 125 type: ESTIMATED name: My Pelvic Plan Website name: Control Group website measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups measure: PROMIS pain intensity 1a between groups measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups measure: PROMIS pain intensity 1a between groups measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Sara Till, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06352827 id: HUM00228948 id: 1K23DK134752-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DK134752-01 briefTitle: Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-08 date: 2024-04-08 name: University of Michigan class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation. conditions: Constipation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 109 type: ESTIMATED name: Surveys measure: Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment measure: Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment measure: Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM) measure: Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM) measure: Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL) measure: Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Brenda Ayala role: CONTACT phone: 734-936-4780 email: beayala@umich.edu name: Eric Shah, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06352814 id: 1977152 briefTitle: Activities-based Locomotor Training Program Versus Traditional Physical Therapy in Children With Cerebral Palsy overallStatus: RECRUITING date: 2024-03-08 date: 2027-05-30 date: 2027-05-30 date: 2024-04-08 date: 2024-04-08 name: Baylor University class: OTHER briefSummary: The purpose of this study is to investigate the impact of an intensive activities-based locomotor training program as compared to traditional physical therapy on activity, participation, and central and peripheral neurophysiological adaptation in children with cerebral palsy. conditions: Cerebral Palsy studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Activities-based locomotor training (physical therapy) measure: Gross Motor Function Measure-66 (GMFM) measure: Pediatric Neuromuscular Recovery Scale (PedsNRS) measure: Pediatric Evaluation of Disability Inventory (PEDI-CAT) measure: Pediatric Quality of Life Inventory CP Module (PedsQL-CP) measure: Functional near-infrared spectroscopy measure: Electromyography measure: ActiGraph sensors sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: Baylor University status: RECRUITING city: Waco state: Texas zip: 76798 country: United States name: Megan Flores role: CONTACT phone: 512-529-4421 email: megan_flores@baylor.edu lat: 31.54933 lon: -97.14667 hasResults: False

 nctId: NCT06352801 id: EA230530 briefTitle: Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder overallStatus: RECRUITING date: 2023-12-28 date: 2026-05-31 date: 2026-05-31 date: 2024-04-08 date: 2024-04-09 name: The University of Hong Kong class: OTHER briefSummary: The study aims to investigate the underlying mechanism between Attention Deficit/Hyperactivity Disorder traits (AD/HD traits) and psychological well-being through studying the role of perceived criticism, rejection sensitivity, self-compassion and growth mindset. It also aims to explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong. The study will contribute to the current understanding of the supportive measures for children with AD/HD, and hopefully help to mobilize more resources to preserve children with AD/HD's mental health.

The intervention program includes the following components:

Participants will be randomly assigned to the self-compassion intervention group or the waitlist control group. The intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes.

To investigate the intervention effectiveness, children will be asked to complete a questionnaire assessing their levels of self-compassion, emotional regulation, as well as psychological well-being in terms of life satisfaction, positive and negative affect. Parents and teachers of participants will also be asked to complete a questionnaire covering children's emotional regulation, positive and negative affect. Questionnaire data collection will be conducted prior to the intervention (i.e., Time 1), immediately after the 6-session student and 3-session parent sessions (i.e., Time 2), and 2 months after the intervention (i.e., Time 3, a 2-month follow up). It takes approximately 20-30 minutes for children and parents to complete their questionnaires.

Study Objectives:

1. To investigate the underlying mechanism of the relationship between AD/HD traits and psychological well-being
2. To explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong

Hypotheses:

1. AD/HD traits negatively predicts psychological well-being
2. AD/HD traits positively predicts perceived criticism or rejection sensitivity
3. Perceived criticism or rejective sensitivity negatively predicts psychological well-being
4. Perceived criticism or rejective sensitivity mediates the relationship between AD/HD traits and psychological well-being
5. Self-compassion moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
6. Growth mindset moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
7. Children with AD/HD from self-compassion intervention group yield greater improvement in self-compassion, emotional regulation and psychological well-being, than waitlist-control group. conditions: ADHD conditions: Self-Compassion conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention Group: In Phase 1, children participants receive a 6-session self-compassion intervention training, plus parents of the participants receive a 3-session parent group. once to twice a week, 90 minutes per session.

Wait-list Control: receives the same intervention in Phase 2 primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Self-Compassion Intervention measure: Self-Compassion Scale for Children (SCS-C) measure: Self-Compassion Scale for Children (SCS-C) measure: Self-Compassion Scale for Children (SCS-C) measure: Behavioural ratings on children's executive functions measure: Behavioural ratings on children's executive functions measure: Behavioural ratings on children's executive functions measure: Student's Life Satisfaction Scale (SLSS) measure: Student's Life Satisfaction Scale (SLSS) measure: Student's Life Satisfaction Scale (SLSS) measure: Positive and Negative Affect Schedule for Children (PANAS-C/P) measure: Positive and Negative Affect Schedule for Children (PANAS-C/P) measure: Positive and Negative Affect Schedule for Children (PANAS-C/P) measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) measure: The Perceived Criticism Scale (PCS) measure: The Perceived Criticism Scale (PCS) measure: The Perceived Criticism Scale (PCS) measure: Children's Rejection Sensitivity Questionnaire (CRSQ) measure: Children's Rejection Sensitivity Questionnaire (CRSQ) measure: Children's Rejection Sensitivity Questionnaire (CRSQ) measure: Growth Mindset Scale measure: Growth Mindset Scale measure: Growth Mindset Scale sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: The University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Kwan Lok TANG role: CONTACT phone: +852-66532947 email: tangkl1020@gmail.com lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06352788 id: 202007224 briefTitle: From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices acronym: AFOSVA overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-08-31 date: 2028-09-01 date: 2024-04-08 date: 2024-04-08 name: Jason Wilken class: OTHER name: Mayo Clinic name: Vanderbilt University Medical Center name: Navy Medical Center San Diego name: Minneapolis Veterans Affairs Medical Center name: Johns Hopkins University briefSummary: This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury. conditions: Foot Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be cast and fit with either a carbon fiber custom dynamic orthosis (CDO) with a modular or mono design. After being fit with the CDO they will complete testing with the CDO in three different configurations (A, B, C) in a randomized order and without the CDO. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Study participants, investigators, and outcome assessors will be blinded to the condition being tested and will only be introduced to each condition as A, B, or C. Only study coordinators, who will verify adherence with the study protocol (CDO configuration), will not be blinded. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: Modular Carbon Fiber Custom Dynamic Orthosis (CDO) name: Mono Carbon Fiber Custom Dynamic Orthosis (CDO) measure: PROMIS Physical Function measure: PROMIS Pain Interference measure: OPUS Satisfaction with Device and Services measure: Modified Socket Comfort Score - Comfort measure: Modified Socket Comfort Score - Smoothness measure: Numerical Pain Rating Scale measure: Preference - Ranked measure: Preference - CDO Configuration measure: Four Square Step Test (seconds) measure: Sit to Stand 5 Times (seconds) measure: Center of Pressure Velocity Magnitude (m/s) measure: Center of Pressure Velocity Timing (%stance) measure: Ankle Zero Moment Crossing (%stance) measure: Peak Ankle Dorsiflexion (degree) measure: Peak Ankle Plantarflexion Moment (Nm/kg) measure: Peak Ankle Push-Off Power (W/kg) measure: PROMIS Satisfaction with Participation in Social Activities measure: PROMIS Satisfaction with Participation in Discretionary Social Activities measure: PROMIS Depression measure: 10 Meter Shuttle Run (seconds) measure: Self Selected Walking Velocity (m/s) measure: Ankle Range of Motion (degrees) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352775 id: IRB00107112 briefTitle: Calcium Carbonate on Labor Induction overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-30 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: Aurora Health Care class: OTHER briefSummary: The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes. conditions: Pregnancy conditions: Uterine Contraction studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The quasi-experimental design will include a prospective treatment group and retrospective historical control group. The prospective treatment group will identify 50 patients who will be voluntarily consented and receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin. This group will be compared against a retrospective historical control group of 200 randomly selected patients (1:4 ratio) who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone. primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Calcium Carbonate measure: Duration of induction time measure: Rate of labor dystocia measure: Rate of cesarean deliveries measure: Total amount of oxytocin after cervical ripening measure: Gastrointestinal side effects measure: Blood loss measure: Rate of postpartum hemorrhage (>/= 500mL) measure: Neonatal composite adverse outcomes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aurora Sinai Medical Center city: Milwaukee state: Wisconsin zip: 53233 country: United States name: Marie Forgie, DO role: CONTACT phone: 414-219-5800 email: marie.forgie@aah.org name: Emily Malloy, PhD, CNM role: CONTACT phone: 414-219-6649 email: emily.malloy@aah.org lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06352762 id: Izmir Dokuz Eylul University briefTitle: The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy overallStatus: COMPLETED date: 2017-02-15 date: 2017-08-15 date: 2017-12-15 date: 2024-04-08 date: 2024-04-08 name: Izmir Bakircay University class: OTHER briefSummary: Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP).

Methods: 34 hCP patients attended the study. 17 children in the training group recived conventional physiotherapy and Robotic Rehabilitation. 17 children in the control group recived only conventional physiotherapy. Convantional physiotherapy program lasted 45 minutes, Robotic Rehabilitation program lasted 30 minutes. All participants were enrolled in sessions 3 times a week for 5 weeks. Measurements were made before and after the therapy. Outcome measures were Modified Ashworth Scale (MAS) for muscle tone, Abilhand-Kids Test for manual skills, The Quality of Upper Extremity Skills Test (QUEST) for upper extremity motor function and The WeeFIM for functional independence level. conditions: Spastic Hemiplegic Cerebral Palsy conditions: Upper Extremity Paresis conditions: Robotic Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted as a randomized controlled study.The first of the cases that met the study criteria was included in the study group, and the second in the control group. Randomization continued in this way. primaryPurpose: TREATMENT masking: NONE count: 36 type: ACTUAL name: Conventional physiotherapy name: Robotic Rehabilitation measure: Muscle Tone measure: Upper Extremity Motor Function measure: Manual Ability measure: Functional Independence sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nuriye Büyüktaş city: Bursa state: Nilüfer zip: 16130 country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False

 nctId: NCT06352749 id: BasqueCU2024 briefTitle: Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH) acronym: ExerMOT-NH overallStatus: RECRUITING date: 2024-03-18 date: 2025-11-30 date: 2025-11-30 date: 2024-04-08 date: 2024-04-08 name: University of the Basque Country (UPV/EHU) class: OTHER name: Fundación Miranda name: Residencia Albiz Santiago Llanos name: Aspaldiko name: Residencia Nuestra Señora de Begoña, Santurtzi briefSummary: The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10_2022_405_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active. conditions: Physical Function conditions: Cognitive Decline conditions: Psychological Well-Being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Each group will be assigned to control, online intervention or face-to-face intervention primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The investigators in charge of doing the statistical analysis and assessing the outcome measures will be blinded to group allocation. Due to the characteristics of the study, blinding the participants and the care provider (i.e., the professional conducting the exercise sessions) to the group allocation is not possible. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Advice to increase physical activity and reduce sedentary behavior name: Online Physical Exercise name: Face-to-Face Exercise measure: Trail Making Test (TMT) measure: Spanish Version of the Yesavage Depression Scale measure: 30-seconds Chair Sit to Stand test measure: MoCA (Montreal Cognitive Assessment) measure: Wechsler Adult Intelligence Scale III (WAIS-III) measure: EuroQol-5 dimensions (EQ-5D-5L) measure: The Spanish adaptation of the Basic Psychological Needs in Exercise Scale (BPNES) (Moreno et al., 2008) measure: Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008) measure: Satisfaction with Life Scale measure: Short Physical Performance Battery (SPPB) measure: The Biceps Curl Test measure: The 2-minute Walk Test (2-MWT) measure: The 8 Feet Up-and-Go test measure: Handgrip strength test measure: Serum Brain Derived Neurotrophic Factor (BDNF) measure: Serum Klotho measure: Serum Glucose measure: Serum Urea measure: Serum Creatinine measure: Serum Uric Acid measure: Serum Cholesterol measure: Serum Triglycerides measure: Serum HDL-Cholesterol measure: Serum LDL-Cholesterol measure: Serum Glutamate Pyruvate Transaminase measure: Serum Glutamate Oxaloacetate Transaminase measure: Serum gamma glutamyl transferase measure: Serum Alkaline Phosphatase measure: Serum Creatin Kinase measure: Serum Lactate Dehydrogenase measure: Serum Bilirubin measure: Serum Sodium measure: Serum Potassium measure: Serum Chloride measure: Serum C Reactive Protein measure: Serum Albumin measure: Serum Total Protein measure: Serum Calcium measure: Serum Phosphorus measure: Serum D Vitamin measure: Erythrocyte count measure: Hemoglobin measure: Hematocrit measure: Mean Corpuscular Volume (MCV) measure: Mean Corpuscular Hemoglobin (MCH) measure: Mean Corpuscular Hemoglobin Concentration (MCHC) measure: Red Cell Distribution Width (RDW) measure: Leucocyte Count measure: Neutrophil Count and Percentage measure: Lymphocyte Count and Percentage measure: Monocyte Count and Percentage measure: Eosinophil Count and Percentage measure: Basophil Count and Percentage measure: Platelet Count measure: Platelet Mean Volumen measure: Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry measure: Fried's frailty phenotype score measure: Frail-NH frailty scale measure: The Pittsburgh Sleep Quality Index measure: Attendance rate measure: Dose modification measure: Adverse Events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Residencia Aspaldiko status: RECRUITING city: Portugalete state: Bizkaia zip: 48920 country: Spain name: Alvaro Mosquera role: CONTACT phone: 34-946250000 email: amosquera@aspaldiko.org lat: 43.32099 lon: -3.02064 facility: Residencia Nuestra Señora de Begoña status: NOT_YET_RECRUITING city: Santurtzi state: Bizkaia zip: 48980 country: Spain name: Janire R Ochoa role: CONTACT phone: 944836875 email: psicologa@residencia-santurtzi.com lat: 43.32842 lon: -3.03248 facility: Residencia Albiz Santiago LLanos status: NOT_YET_RECRUITING city: Sestao state: Bizkaia zip: 48910 country: Spain name: Olatz Larrinaga role: CONTACT phone: 946572220 email: direccion@residenciaalbiz.eus lat: 43.30975 lon: -3.00716 facility: Fundación Miranda status: NOT_YET_RECRUITING city: Barakaldo state: Vizcaya zip: 48902 country: Spain name: Celia Gómez role: CONTACT phone: 944382675 email: innovación@fundaciónmiranda.org lat: 43.29639 lon: -2.98813 hasResults: False

 nctId: NCT06352736 id: LUTS2023 briefTitle: Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community overallStatus: RECRUITING date: 2023-06-01 date: 2025-10-01 date: 2025-12-31 date: 2024-04-08 date: 2024-04-15 name: Chinese PLA General Hospital class: OTHER briefSummary: This study, set up as a cross-sectional survey, seeks to delve into the disease burden and the demographic specifics of lower urinary tract symptoms (LUTS) among the male community in China. The investigators's main aim is to map out the overall and age-specific prevalence rates of LUTS within the Chinese male population. These insights are critical for understanding the public health dimensions of this condition. Moreover, the investigators plan to investigate several secondary aspects: the correlation of LUTS prevalence with factors like urbanization levels (rural vs. urban), geographical distribution, and lifestyle choices. Another significant focus will involve examining the treatment landscape for LUTS, looking at the portion of sufferers receiving treatment, the diversity in treatment durations, and the types of treatments employed (medication vs. surgery). This comprehensive analysis is intended to shed light on the prevailing management strategies for LUTS in China. The study is scheduled to unfold over 36 months and will comprise three pivotal phases: initial preparations, recruitment of subjects and collection of data, followed by the analysis of data and compilation of reports. The investigators will employ a range of methods such as questionnaires, physical exams, laboratory tests, imaging, and other medical evaluations to amass extensive data. This will allow the investigators to evaluate the prevalence of LUTS across various age groups among men and address the current gaps in epidemiological understanding. conditions: Lower Urinary Tract Symptoms studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 12567 type: ESTIMATED measure: International Prostate Symptom Score(IPSS) measure: Overactive Bladder Syndrome Score(OABSS) measure: International Consultation on Incontinence Questionnaire - Short Form(ICIQ-SF) measure: Quality of Life Score（QOL） measure: Prostatic volume measure: Maximum urinary flow rate measure: Residual urine measure: free prostatic specific antigen(fPSA) measure: total prostatic specific antigen(tPSA) measure: fPSA/ tPSA sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General Hospital status: RECRUITING city: Beijing zip: 100853 country: China name: Qing Yuan, Doctor's degree role: CONTACT phone: 18910980422 email: qyuanmd@outlook.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06352723 id: 2024P000856 briefTitle: Cenobamate in the Intensive Care Unit acronym: CENOBITE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-04-08 date: 2024-04-08 name: Brigham and Women's Hospital class: OTHER briefSummary: The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.

Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome. conditions: Epilepsy conditions: Neurologic Disorder studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm pilot study primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Cenobamate measure: Target level measure: Maintenance level measure: Seizure cessation measure: Seizure burden change sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06352710 id: 2022-01510 briefTitle: Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project overallStatus: RECRUITING date: 2023-06-12 date: 2025-06-12 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: Cantonal Hospital of St. Gallen class: OTHER briefSummary: Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality.

The increasing use of smartphones offers unprecedented opportunities for data collection. We developed a free smartphone application to assess fluctuations of patients' well-being as a result of surgical treatment and possible AEs. The application is installed on each patient's smartphone and collects standardized data at defined timepoints before and after surgery (well-being, AE description and severity).

By acquiring longitudinal patient-reported outcome before and after neurosurgical interventions, we aim to determine the regular postoperative course for specific surgical procedures, as well as any deviation thereof, depending on the occurrence and severity of AEs. We will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. We hope that this will result in an increase in standardized reporting of patient outcome, and ultimately allow for evidence-based patient information and decision-making. conditions: Disc Disease conditions: Instabilities Lumbar conditions: Brain Tumor conditions: Aneurysm studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: OP-Tracker App measure: Subjective Well-Being (SWI) measure: EQ-5D-5L measure: Rate of adverse events measure: Severity of adverse events measure: Correlation between TDN/CDG and SWI/QoL measure: Correlation between baseline factors and TDN grade measure: Difference between rate of adverse events and TDN distribution between different surgery groups sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kantonsspital St.Gallen status: RECRUITING city: St.Gallen zip: 9007 country: Switzerland name: Linda Bättig, MD role: CONTACT phone: +41 71 494 11 99 email: linda.baettig@kssg.ch lat: 47.42391 lon: 9.37477 hasResults: False

 nctId: NCT06352697 id: DELI_MASLD briefTitle: Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study) overallStatus: COMPLETED date: 2023-02-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-08 date: 2024-04-09 name: Bogomolets National Medical University class: OTHER name: Taras Shevchenko National University of Kyiv name: Danylo Halytsky Lviv National Medical University name: Kyiv City Clinical Endocrinology Center name: Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine name: MirImmunoFarm name: Stellar Biotics briefSummary: The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by biochemichal hepatic steatosis indeces, serum lipid profile, transaminases activity and chronic systemic inflammatory markers in MASLD patients.

The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month. conditions: Metabolic Dysfunction Associated Steatotic Liver Disease conditions: Steatotic Liver Disease conditions: Hepatic Steatosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Randomization was done by the study statistician based on a computer-generated list. The groups were homogeneous according to age, sex and diagnostic criteria. The assignment of groups was blind to participants, research staff and outcome assessors moreover, to maintain blind parallel study the statistician was not aware of the allocation of participants to intervention whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: Probiotic lysate (postbiotic and metabiotc) name: Placebo measure: changes in fatty liver index (FLI) measure: hepatic steatosis index (HSI) measure: TyG index measure: Concentration of AST measure: Concentration of ALT measure: Concentration of Gamma-glutamyl Transferase (GGT) measure: Concentration of Total Cholesterol (TC) measure: Concentration of Tryglicerides (TG) measure: Concentration of LDL-Cholesterol (LDL-C) measure: Concentration of VLDL-Cholesterol (VLDL-C) measure: Concentration of HDL-Cholesterol (HDL-C) measure: Concentration of high sensitivity CRP (hs-CRP) measure: Concentration of IL-6 measure: waist circumferences (WC) measure: body mass index (BMI) measure: visceral fat content sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bogomolets National Medical University city: Kyiv zip: 01601 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Kyiv City Clinical Endocrinology Center city: Kyiv zip: 01601 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Taras Shevchenko National University of Kyiv city: Kyiv zip: 01601 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine city: Kyiv zip: 02000 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Danylo Halytsky Lviv National Medical University city: Lviv zip: 79010 country: Ukraine lat: 49.83826 lon: 24.02324 hasResults: False

 nctId: NCT06352684 id: DP0001-SEV-CAB-II id: RS-2023-00227526 type: OTHER_GRANT domain: Korea Ministry of Science and ICT briefTitle: Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-24 date: 2025-01-14 date: 2025-01-14 date: 2024-04-08 date: 2024-04-08 name: BeamWorks Inc. class: INDUSTRY name: Severance Hospital briefSummary: The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ACTUAL name: CadAI-B for Breast measure: Area Under the LROC Curve measure: Lesion detection sensitivity and specificity sex: FEMALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University Severance Hospital city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06352671 id: 023-286 briefTitle: Prospective Long-Term Outcomes of a Standardized Ross Procedure acronym: ROSS overallStatus: RECRUITING date: 2023-10-12 date: 2025-12-01 date: 2026-01-01 date: 2024-04-08 date: 2024-04-08 name: Baylor Research Institute class: OTHER briefSummary: This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction. conditions: Ross Procedure (Pulmonary Autograft Replacement) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED measure: Survival of the patient at 1-, 5- and 10-year intervals measure: Rate of re-hospitalization measure: Rate of peri operative morbidity measure: Rate of re-operation measure: Rate of re-intervention measure: NYHA status measure: Anticoagulant usage measure: Bleeding events measure: Post operative infection sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor Scott and White Heart Hospital status: RECRUITING city: Plano state: Texas zip: 75093 country: United States name: Rincy Rajan role: CONTACT phone: 469-814-4981 email: Rincy.Rajan@BSWHealth.org name: Sarah Hale role: CONTACT phone: 4698144845 email: sarah.hale@bswhealth.org name: William Brinkman, MD role: PRINCIPAL_INVESTIGATOR lat: 33.01984 lon: -96.69889 hasResults: False

 nctId: NCT06352658 id: #1/2024 briefTitle: Efficacy of Mandibular Advancement Device for Mild-Moderate Apnea overallStatus: COMPLETED date: 2023-02-01 date: 2024-01-01 date: 2024-01-10 date: 2024-04-08 date: 2024-04-08 name: Nourhan M.Aly class: OTHER briefSummary: This was a prospective randomized controlled clinical trial that aimed to compare the efficacy of conventional and CAD CAM mandibular advancement device. conditions: Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 26 type: ACTUAL name: Conventional mandibular advancement device name: CAD CAM mandibular advancement device measure: Apnea hypopnea index measure: Epwoth sleeplness scale (ESS) measure: Oxygen saturation measure: Snoring index sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry, Alexandria University, Egypt city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06352645 id: STUDY00004879 briefTitle: Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-04-08 date: 2024-04-09 name: Tufts University class: OTHER name: Guangdong Bixdo Health Technology Co., Ltd. briefSummary: The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal. conditions: Plaque Induced Gingivitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled clinical trial primaryPurpose: TREATMENT masking: NONE count: 165 type: ESTIMATED name: Bixdo Ultra Compact Water Flosser name: Manual toothbrush measure: Inflammation Reduction measure: Bacterial plaque removal sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts University School of Dental Medicine city: Boston state: Massachusetts zip: 02111 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06352632 id: ACT-GLOBAL_Master briefTitle: A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke acronym: ACT-GLOBAL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2034-04 date: 2024-04-08 date: 2024-04-23 name: The George Institute class: OTHER name: University of Calgary name: Berry Consultants briefSummary: Stroke is causing 6.6 million deaths and is a major cause of disability worldwide in 2019. There remains an urgent need for interventions that improve outcomes which can be implemented with wide applicability for stroke. ACT-GLOBAL is a multi-factorial, multi-arm, multi-stage, randomised, global adaptive platform trial for stroke, aiming to identify the treatment/s associated with the highest chance of improving outcome in stroke patients. In ACT-GLOBAL multiple questions will be evaluated simultaneously and sequentially as data accrues and can evaluate interactions between different treatment options. conditions: Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Adaptive Platform Trial evaluating multiple interventions in multiple domains primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20000 type: ESTIMATED name: Standard-dose intravenous tenecteplase name: Low-dose intravenous tenecteplase name: No intravenous tenecteplase name: Conservative Blood Pressure Control name: Moderate Blood Pressure Control name: Intensive Blood Pressure Control name: Placebo name: NoNO-42 measure: modified Rankin scale (mRS) scores measure: Excellent functional neurological outcome measure: Independent functional neurological outcome measure: Health Related Quality of Life measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352619 id: ACT-GLOBAL_AIS_03 briefTitle: Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial acronym: ENCHANTED3/MT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-08 date: 2024-04-23 name: The George Institute class: OTHER name: University of Calgary name: Changhai Hospital briefSummary: Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure (BP) lowering in post-EVT acute ischaemic stroke (AIS) patients. Although two trials indicate harm from very intensive target-based treatment (SBP \<130 mmHg), the others neutral effects in the SBP range 140-160 mmHg. The ENCHANTED3/MT domain of the ACT-GLOBAL platform trial aims to test different approaches to the treatment of elevated SBP in post-EVT AIS patients to find an optimal BP management strategy. ENCHANTED3/MT will randomize (1:1:1) up to 2,000 patients with SBP ≥150 mmHg post-EVT to conservative (no or minimal SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP \[≥180mmHg\]), moderate (SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP \[150-160mmHg\]), or intensive (SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher) BP management. conditions: Ischemic Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 2000 type: ESTIMATED name: Conservative SBP Control name: Moderate SBP Control name: Intensive SBP Control measure: modified Rankin scale measure: Excellent functional neurological outcome measure: Independent functional neurological outcome measure: Health Related Quality of Life measure: Mortality measure: Ordinal shift of 7 levels of modified Rankin scale measure: National Institute of Health Stroke Scale (NIHSS) score measure: Any intracranial haemorrhage (ICH) measure: Symptomatic intracerebral haemorrhage (sICH) measure: Serious Adverse Event (SAE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352606 id: 36264PR558/2/24 briefTitle: Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy overallStatus: RECRUITING date: 2024-04-06 date: 2024-09-01 date: 2024-09-01 date: 2024-04-08 date: 2024-04-09 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy. conditions: Spinal Anesthesia conditions: General Anesthesia conditions: Neonates conditions: Inguinal Herniorrhaphy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 74 type: ESTIMATED name: Spinal anesthesia name: General anesthesia measure: Heart rate measure: Heart rate measure: Mean arterial blood pressure measure: Incidence of bradycardia measure: Incidence of hypotension measure: Incidence of postoperative apnea measure: The duration of surgery measure: Need for postoperative O2 supplementation measure: Hospital stays sex: ALL minimumAge: 1 Day maximumAge: 1 Month stdAges: CHILD facility: Tanta University Hospitals status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Ahmed E Abo ElKheir, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06352593 id: 36264PR557/2/24 briefTitle: Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage overallStatus: RECRUITING date: 2024-04-06 date: 2024-09-01 date: 2024-09-01 date: 2024-04-08 date: 2024-04-09 name: Tanta University class: OTHER briefSummary: The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage. conditions: Dexmedetomidine conditions: Infusion conditions: Endovascular conditions: Aneurysmal Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Intraoperative Dexmedetomidine name: Placebo measure: Incidence of vasospasm measure: Incidence of morbidity and mortality (M/M) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University Hospitals status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Ahmed E Abo ElKheir, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06352580 id: COVID-19 Pediatric briefTitle: Covid-19 Pandemic and Pediatric Dentistry overallStatus: COMPLETED date: 2022-03-01 date: 2022-06-30 date: 2022-06-30 date: 2024-04-08 date: 2024-04-08 name: Abant Izzet Baysal University class: OTHER briefSummary: Coronavirus (SARS-CoV-2), which emerged in Wuhan, China in 2019 and causes severe respiratory infection, poses a potential risk for dentists and patients during dental treatments. It is a common situation during the pandemic period for parents of children needing dental treatment to want to postpone their children's treatment due to Covid-19. This study aimed to evaluate parents' concerns about their children's dentist appointments and ongoing dental treatments in the presence of the quarantine imposed due to Covid-19 and the Covid-19 vaccines that have started to be administered worldwide. In the study, an informative survey consisting of 26 questions was applied to determine how parents feel about the COVID-19 pandemic, how concerned they are about their children's oral health and dental treatment plan, and the changes caused by COVID-19 vaccination practices. The questions were created by 3 different experienced dentists and analysed by 2 different experienced dentists. Questions 7 and 26 were repeated at the beginning and end of the survey to give the same question and answer meaning. Thus, the reliability of the survey was tested. conditions: COVID-19 Pandemic studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: CROSS_SECTIONAL count: 438 type: ACTUAL name: Survey measure: Approach to dental treatments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Deniz Sıla Özdemir Çelik city: Merkez state: Bolu zip: 14030 country: Turkey hasResults: False

 nctId: NCT06352567 id: BakircayU1394/1414 briefTitle: Symptoms Associated With Chemotherapy-Induced Peripheral Neuropathy overallStatus: RECRUITING date: 2024-01-18 date: 2024-06-22 date: 2024-08 date: 2024-04-08 date: 2024-04-09 name: Izmir Bakircay University class: OTHER briefSummary: Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.). conditions: Chemotherapy-induced Peripheral Neuropathy conditions: Breast Cancer conditions: Breast Cancer Female studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 112 type: ESTIMATED name: European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire measure: Assessment of perceived Chemotherapy Induced Peripheral Neuropathy symptoms sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology status: RECRUITING city: İzmir state: Çiğli zip: 35620 country: Turkey name: Murat Akyol, MD role: CONTACT phone: +902324930000 email: dr-muratakyol@hotmail.com name: Alper Tuğral, PT, MSc role: CONTACT phone: +905074421420 email: alper.tugral@bakircay.edu.tr lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06352554 id: 2023/ETH02474:STING id: 224842/Z/21/Z type: OTHER_GRANT domain: Wellcome Trust id: 75A50122C00028 type: OTHER_GRANT domain: HHS/BARDA OTA briefTitle: Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections acronym: STING overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-12-30 date: 2025-01-30 date: 2024-04-08 date: 2024-04-09 name: SpeeDx Pty Ltd class: INDUSTRY name: Biomedical Advanced Research and Development Authority name: Wellcome Trust name: German Federal Ministry of Education and Research name: Australian Research Council Research Hub to Combat Antimicrobial Resistance briefSummary: This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples.

The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation in antibiotic for susceptible strains and not resistant strains.

Furthermore, this study will also add to our understanding on the performance of this test in various clinical specimens. conditions: Diagnosis conditions: Gonorrhea conditions: Resistance Bacterial studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: To determine the feasibility of performing antibiotic susceptibility testing (AST) for Neisseria gonorrhoeae directly from patient samples using InSignia workflow and assay against commonly used & clinically relevant antibiotics. measure: To study the performance of the InSignia assay in determining antibiotic susceptibility of NG against commonly used & clinically relevant agents in clinical samples with comparison to gold standard methods. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352541 id: SOPH232-1122/I briefTitle: Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo. acronym: PRO-232 overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-06-30 date: 2025-06-30 date: 2024-04-08 date: 2024-04-11 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, parallel groups, double blind, one center. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double blind. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: PRO-232 name: Placebo measure: Incidence Unexpected Related Adverse Reactions measure: Changes in intraocular pressure (IOP) measure: Incidence of Stinging measure: Incidence of Expected Related Adverse Events measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in the integrity of the ocular surface (fluorescein staining) measure: Incidence of ocular symptoms (foreign body sensation and tearing) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06352528 id: CA127-1070 briefTitle: A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2025-07-24 date: 2025-07-24 date: 2024-04-08 date: 2024-04-08 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function. conditions: Hepatic Impairment conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Repotrectinib measure: Maximum observed plasma concentration (Cmax) measure: Time of maximum observed plasma concentration (Tmax) measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) measure: Number of participants with Adverse Events (AEs) measure: Number of participants with Severe Adverse Events (SAEs) measure: Number of participants with physical examination abnormalities measure: Number of participants with vital sign abnormalities measure: Number of participants with electrocardiogram (ECG) abnormalities measure: Number of participants with clinical safety laboratory test abnormalities sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Local Institution - 0003 city: Miami Lakes state: Florida zip: 33014 country: United States name: Site 0003 role: CONTACT lat: 25.90871 lon: -80.30866 facility: Local Institution - 0001 city: Orlando state: Florida zip: 32809 country: United States name: Site 0001 role: CONTACT lat: 28.53834 lon: -81.37924 facility: Local Institution - 0002 city: San Antonio state: Texas zip: 78215 country: United States name: Site 0002 role: CONTACT lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06352515 id: T cells in Ulcerative colitis briefTitle: T Lymphocyte Subsets in Ulcerative Colitis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-06-01 date: 2024-04-08 date: 2024-04-29 name: Assiut University class: OTHER briefSummary: 1. Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients.
2. Correlation of T-cell subsets to therapeutic response/ disease activity.
3. Assess the value of circulating IgG anti-Integrin αvβ6 in UC. conditions: Ulcerative Colitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED name: Flow cytometry measure: Study the distribution of T-cell subsets among ulcerative colitis patients. measure: Correlation of T-cell subtypes to therapeutic response sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352502 id: 202112-28 briefTitle: An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis overallStatus: RECRUITING date: 2022-01-28 date: 2024-09-30 date: 2024-09-30 date: 2024-04-08 date: 2024-04-08 name: Tang-Du Hospital class: OTHER briefSummary: EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis. conditions: EGF-R Positive Non-Small Cell Lung Cancer conditions: CNS Metastases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Furmonertinib measure: Intracranial Objective response rate measure: Intracranial Disease Control Rate measure: Intracranial progression-free survival measure: Progression-free survival measure: Overall Survival measure: Safety/Adverse event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tangdu Hopspital status: RECRUITING city: Xi'an state: Shanxi zip: 710038 country: China name: Haichuan Su, PhD role: CONTACT phone: 18629190366 email: such@fmmu.edu.cn name: Jie Min, PhD role: CONTACT phone: 13709202616 email: minjie1504@163.com name: Haichuan Su, PhD role: PRINCIPAL_INVESTIGATOR name: Jie Min, PhD role: SUB_INVESTIGATOR lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06352489 id: Posterior component separation briefTitle: Evaluation of Posterior Component Separation Technique in the Management of Complex Ventral Hernia. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05 date: 2026-06 date: 2024-04-08 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: * Assess short term outcome of posterior component separation technique(PCS) including the regain of the physiological function of the abdominal wall.
* Detect most common post operative complications related to AWR techniques in a 6 months duration after operation. conditions: Ventral Hernia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Posterior component separation technique. measure: Hernia recurrence measure: post operative short term complications sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352476 id: 10881-669 briefTitle: The Effect of Sleep Hygiene Given to Epilepsy Patients on Seizure Frequency and Sleep Quality overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-01 date: 2024-12-01 date: 2024-12-01 date: 2024-04-08 date: 2024-04-08 name: Marmara University class: OTHER briefSummary: Epilepsy is a disease that can be seen in everyone, including neurological, chronic, elderly and children. An estimated 50 million people in the world have epilepsy, patients have a history of two or more seizures, the exact cause is unknown, it negatively affects home, work and school life, and it directs individuals from their independent roles to semi-dependent and fully dependent roles (Smith \& Wagner \& Jonathan, 2015). "Neuronal networks hypersynchronization" develops epileptic seizures, can cause insomnia, and sleep quality may decrease with drug treatment (Sünter and Ağan, 2019). NREM sleep causes seizures through the "ictal and interactive effect" of sleep (Alp and Altındağ, 2014). Insomnia increases seizure discharges, neurological and systemic complications may develop, and serious morbidity and mortality may occur (Özer, 2005). Epilepsy patients frequently experience daytime sleepiness and nighttime insomnia (Gümüşyayla and Vural, 2017). Complementary medical approaches are also recommended along with drug treatment. Sleep hygiene training is recommended for sleep health in epilepsy as in chronic diseases. With good sleep health, symptoms can be eliminated and sequelae can be prevented by reducing epileptic discharges (Gammino at all., 2016). Quality sleep is essential for physiological and psychological health, and sleep disorders can be corrected with sleep hygiene training (Günaş, 2018). Randomized studies including sleep hygiene training are needed to prevent seizure recurrences, prevent or treat comorbid psychological diseases, and improve life activities of epilepsy patients (Lee at all., 2015). One-third of people's lives are spent in sleep, regular and adequate sleep protects physiological and psychological health, sleep hygiene training contributes to the recovery of sleep disorders and accompanying psychological comorbid diseases, sleep hygiene training is cost-free and easy to implement, where daily activities and behaviors are regulated, appropriate environmental conditions are provided. By regulating the circadian rhythm, melatonin is released during sleep at night and sleep disorders are prevented by preventing excessive cortisol release (http://www.psikiyatri.net/uyku-hijyeni / Access date: 28 May 2022; Alp and Altındağ, 2014; Güneş, 2018). . No research has been found on sleep hygiene training to relieve sleep deprivation, which is common in epilepsy patients. With good sleep hygiene, sleep and quality of life can be improved and epileptic seizures can be prevented or reduced.

Purpose of the research; To determine the effect of sleep hygiene training given to epilepsy patients on seizure frequency and sleep quality. Non-drug clinical research is an experimentally planned research with a pre-test post-test control group trial model. conditions: Epilepsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research is an experimental study with a pre-test and post-test control group trial model. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The participant will not know whether he or she is in the experimental or control group. whoMasked: PARTICIPANT count: 160 type: ESTIMATED name: Sleep Hygiene Training measure: Pittsburgh Sleep Quality Index measure: Pittsburgh Sleep Quality Index measure: epileptic seizure diary sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06352463 id: 406.XS.03.068 briefTitle: Intervention Social Anxiety: Combining Parent-child Treatment acronym: ISA overallStatus: RECRUITING date: 2024-04-15 date: 2025-07-01 date: 2025-07-01 date: 2024-04-08 date: 2024-04-08 name: Leiden University class: OTHER name: Leids Universitair Behandel en Expertise Centrum (LUBEC) name: GGZ Delfland name: Netherlands Organisation for Scientific Research briefSummary: The aim of this pilot project is to investigate a treatment program for children with social anxiety, in which children and their parents, parallel to each other, follow separate evidence-based interventions. The added value of this pilot project is that the investigators are examining how both programs interact when offered simultaneously. conditions: Social Anxiety Disorder of Childhood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 9 type: ESTIMATED name: Denken + Doen = Durven name: Supportive Parenting for Anxious Childhood Emotions measure: Change in severity of social anxiety in children measure: Change in anxiety-related symptoms and family accommodation sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD facility: GGZ Delfland status: NOT_YET_RECRUITING city: Delft state: South-Holland zip: 2600GA country: Netherlands name: Anika Bexkens role: CONTACT email: a.bexkens@fsw.leidenuniv.nl lat: 52.00667 lon: 4.35556 facility: Leiden University status: RECRUITING city: Leiden state: South-Holland zip: 2333AK country: Netherlands lat: 52.15833 lon: 4.49306 facility: LUBEC status: RECRUITING city: Leiden state: South-Holland zip: 2333ZB country: Netherlands name: Anika Bexkens role: CONTACT email: a.bexkens@fsw.leidenuniv.nl lat: 52.15833 lon: 4.49306 hasResults: False

 nctId: NCT06352450 id: DPT/Batch-Fall19/558 briefTitle: Comparison of Active Isolated Stretching Versus Myofascial Release of Knee Joint in Office Workers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-05-20 date: 2024-06-28 date: 2024-04-08 date: 2024-04-08 name: Superior University class: OTHER briefSummary: "Office workers often spend long hours sitting, which can lead to stiffness and reduced mobility. By studying these two techniques AIS and MFR, we can determine which one is more effective in helping office workers to improve their flexibility and range of motion in the knee joint because their sedentary work environment often leads to musculoskeletal issues, including limited knee joint mobility.

AIS involves stretching specific muscles while actively engaging opposing muscles to enhance the effectiveness of the stretch. It aims to increase the extensibility of muscles and improve joint mobility. On the other hand, MFR focuses on releasing tension and adhesions in the fascia, the connective tissue surrounding muscles and joints, to restore mobility and reduce pain.

Understanding the benefits and effectiveness of these techniques will contribute to evidence-based practices in occupational health and help office workers maintain optimal joint health" conditions: Stiffness; Spine conditions: Mobility Limitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Active isolated stretching (AIS) name: Myofascial release (MFR) measure: Numaric Pain Scale sex: ALL minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Al-Zahra Medical complex Johar town, Laser spine center Model town, Laser spine center Johar town. city: Lahore country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06352437 id: 1507-0001 id: 2023-508767-79-00 type: REGISTRY domain: CTIS id: U1111-1302-5933 type: REGISTRY domain: WHO International Clinical Trials Registry Platform (ICTRP) briefTitle: A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-07-14 date: 2025-07-14 date: 2024-04-08 date: 2024-04-08 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy.

The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men (Part A) and people with overweight or obesity (Part B). Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood.

Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo. In this study, BI 3034701 is given to humans for the first time.

Participants in Part A are in the study up to 10 weeks. During this time, they visit the study site 8 times. Participants in Part B are in the study for about 6 months. They visit the study regularly. At some of the visits, participants in both parts stay at the study site for up to 5 nights. During the study, the doctors collect information on any health problems of the participants. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 124 type: ESTIMATED name: BI 3034701 name: Placebo matching BI 3034701 measure: Part A and Part B: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator measure: Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) following a single dose of BI 3034701 measure: Part A: Maximum measured concentration of the analyte in plasma (Cmax) following a single dose of BI 3034701 measure: Part B: Area under the concentration-time curve in plasma over the time interval from 0 to 168 hours (AUC0-168) following multiple doses of BI 3034701 measure: Part B: Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352424 id: 1458-0006 id: 2023-506233-30-01 type: REGISTRY domain: CTIS (EU) id: U1111-1293-4672 type: REGISTRY domain: WHO Registry briefTitle: A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-09 date: 2024-12-09 date: 2024-04-08 date: 2024-04-08 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: BI 456906 name: BI 1820237 name: Placebo for BI 1820237 name: Placebo for BI 456906 measure: Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06352411 id: 1404-0009 id: 2023-508557-13-00 type: REGISTRY domain: CTIS id: U1111-1298-3135 type: REGISTRY domain: WHO registry briefTitle: A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2024-11-26 date: 2024-11-26 date: 2024-04-08 date: 2024-04-08 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study.

The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems. BI 456906 is being developed to treat people with obesity and liver problems. People living with these conditions often also have kidney problems. Therefore, it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood.

Study participants receive a single dose of BI 456906 as an injection under the skin. Participants are divided into 4 groups based on how well their kidneys work: 1 group without kidney problems, and 3 groups with mild, moderate, and severe kidney problems. Each participant without kidney problems is matched with participants from the other groups based on factors such as age, gender, race, and body mass index (BMI) to ensure accurate comparisons.

Participants are in the study for about 2 months. They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The participants also answer questions about their well-being. The doctors regularly check participants' health and take note of any unwanted effects. conditions: Healthy conditions: Renal Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: BI 456906 measure: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) measure: Maximum measured concentration of BI 456906 in plasma (Cmax) measure: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352398 id: BBTuysuz briefTitle: Comparison of Analgesic Efficacy in Video-Assisted Thoracoscopic Surgery Patients overallStatus: COMPLETED date: 2023-12-20 date: 2024-02-01 date: 2024-04-01 date: 2024-04-08 date: 2024-04-08 name: Burcu Bozdogan Tuysuz class: OTHER briefSummary: The 52 patients included in the study were divided into two groups as ESPB (n=26) and SPSIPB (n=26). Before the operation, 0.25% bupivacaine 30 ml was administered to both groups. After admission to the operating room, all patients underwent standard anaesthesia procedures. Morphine 0.05 mg/kg i.v. and parol 1 g i.v. were administered 30 min before the end of the operation. Post operatively the patient was followed up with controlled analgesia. Demographic data, ASA scores, body mass indexes, peri-operative haemodynamic values, remifentanil consumption and duration of surgery were recorded. Post-operative first 24 hours NRS scores, morphine consumption, number of nausea and vomiting episodes were recorded. conditions: Video-Assisted Thoracoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 52 type: ACTUAL name: erector spina plan block name: Serratus posterior superior intercostal plan block (SPSIPB) name: 0.25% bupivacaine measure: morphine consumption first 24 hours measure: NRS pain score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medenıyet Unıversıty city: Istanbul state: Kadıkoy zip: 34734 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06352385 id: SH9H-2024-TK16-1.0 briefTitle: Epidemiological Investigation of Malocclusion in China overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-08 date: 2024-04-08 name: Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: Malocclusion is a kind of craniomaxillofacial complex deformity caused by heredity, environment, bad habits, trauma, inflammation, tumor and aging. Notably, the last comprehensive national prevalence data on malocclusion in China, which encompassed a significant sample size, dates back over two decades. Given the evolving nature of these epidemiological metrics, such as prevalence rates, it is imperative to update our understanding. Consequently, there is an urgent need for China to undertake a unified, standardized epidemiological survey of malocclusion with a substantial sample size to ensure accurate and timely data collection. conditions: Epidemiological Investigation conditions: Malocclusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 19847 type: ESTIMATED measure: The Prevalence rate of malocclusion measure: Dental Aesthetic Index of each age group measure: Index of Orthodontic Treatment Need of each age group measure: dietary habit measure: oral hygiene habits measure: Bad oral habit sex: ALL minimumAge: 4 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06352372 id: tPBM Study briefTitle: Safety and Efficacy of tPBM for Epileptiform Activity in Autism acronym: tPBM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-06 date: 2024-04-08 date: 2024-04-08 name: Richard Frye class: OTHER briefSummary: For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions. conditions: Autism Spectrum Disorder conditions: EEG With Periodic Abnormalities conditions: Epilepsy conditions: Neurodevelopmental Disorders conditions: Neurological Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective, open label study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after treatment with, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) measure: Childhood Autism Rating Scores (CARS) measure: EEG Delta Power measure: Seizure frequency and severity measure: Social Responsiveness Scale (SRS) measure: Clinical Global Impression Scale (CGI) measure: NIH Toolbox sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD facility: Rossignol Medical Center city: Phoenix state: Arizona zip: 85050 country: United States name: Richard E Frye, M.D., PhD role: CONTACT phone: 321-259-7111 email: drfrye@rossignolmedicalcenter.com name: Richard E Frye, M.D., PhD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 hasResults: False

 nctId: NCT06352359 id: ONC-841-002 briefTitle: Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2025-06-30 date: 2027-06-30 date: 2024-04-08 date: 2024-04-10 name: OncoC4, Inc. class: INDUSTRY briefSummary: This is a Phase I open label, dose-escalation study of intravenous (IV) infusion of ONC-841 as a single agent in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: ONC-841 measure: Dose Limiting Toxicity (DLT) measure: Maximum Toxicity Dose (MTD) measure: Cmax of ONC-841 measure: The serum half-life of ONC-841 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California at Davis Cancer Center city: Sacramento state: California zip: 95817 country: United States name: Tianhong Li, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: Norton Cancer Center city: Louisville state: Kentucky zip: 40202 country: United States name: John Hamm, MD role: PRINCIPAL_INVESTIGATOR lat: 38.25424 lon: -85.75941 facility: Tranquil Clinical Research city: Houston state: Texas zip: 77598 country: United States name: John Knecht, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06352346 id: Plan Game_ABI&Psychiatry briefTitle: A Single-case Design to Investigate a Compensatory Brain Game Supporting Goal Management Training Intervention in a Psychiatric Brain Injury Population overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2025-12 date: 2024-04-08 date: 2024-04-08 name: ProPersona class: OTHER briefSummary: The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by Executive Function (EF) deficits. EF deficits are often seen in patients with psychiatric disorders i.e. depression or anxiety. In order to minimize everyday disorganization, effective EF interventions are required. Interventions using compensatory strategies have the potential to enable patients to minimize disabilities, minimize participation problems and to function more independently in daily life. A well-known evidence-based intervention that uses compensatory strategies is Goal Management Training (GMT), a training that has been found to alleviate depressive symptoms in a depressed population. GMT entails learning and applying an algorithm, in which a daily task is subdivided into multiple steps to handle executive difficulties of planning, and problem solving. To adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks. Therefore, GMT is comprehensive, time-consuming and thus labour-intensive. Along with this, brain games become increasingly attractive as an (add-on) intervention, most notably in an effort to develop home-based personalized care. Until now, however, the rationale behind brain games is based on what can be considered the restorative approach (i.e. strengthening of executive problems) rather than practicing compensatory strategies, with little or no transfer to improvements in daily life functioning. This study therefore aims to assess the potential of a newly developed Brain Game, based on compensatory strategies, as an add-on to GMT to develop a shortened and partly self-paced GMT intervention. The primary objective of this study is to assess whether the use of a compensatory brain game supported GMT treatment could be of interest in people with EF deficits after ABI that also suffer from depression or anxiety, to improve goal achievement, their executive function performance during goal-related tasks, and their executive performance during an ecological valid shopping task. Also we assess whether psychological symptoms alleviate following the GMT intervention and at 6-weeks follow-up. The study will be a multiple-baseline across individuals single-case experimental design (SCED). The study population consists of brain-injured patients, between 18 and 75 years old that receive in-patient mental neuropsychiatric healthcare. Participants eligible for the study must have EF deficits due to (nonprogressive) Acquired Brain Injury (ABI), minumum time post-onset of 3 months and depressive or anxiety symptoms. EF deficits will be assessed by extensive neuropsychological examination. Participants will be recruited from an inpatient clinic. In the course of one and a half year four participants will be recruited. conditions: Acquired Brain Injury conditions: Depressive Symptoms conditions: Anxiety conditions: Executive Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A randomized Single-case Experimental Design (SCED) with a follow-up period of 6 weeks. Participants will be first assigned to a baseline phase (phase A). The start of the treatment phase (phase B) is determined randomly for each participant, given the restriction that the baseline phase (phase A) should last for at least three weeks (21 days) and at most five weeks (30 days). This means that the treatment phase can start on any day between the 21th and the 30th days. So, in the first three weeks, all participants are in the baseline condition. The duration of baseline will thus be different for each subject. Nonspecific effects, such as linear trends, retesting or non-specific recovery, can be controlled by this approach, since expected changes in level of performance due to treatment should parallel this stepwise onset of therapy procedure.

Phase A acts as a control and is therefore compared with phase B. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The target behavior (i.e. performance on an untrained shopping task) will be measured repeatedly, on a minimum of six occasions in each phase where possible, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria. Repeated measures of target behavior will be assessed via the OxMET-NL task and is scored automatically: no assessor input is required to either save or score the main outcome data. The secondary outcome measure(s) are scored by an outcome assessor who is blind to the order in which the secondary outcome measure(s) were taken. whoMasked: OUTCOMES_ASSESSOR count: 4 type: ESTIMATED name: Compensatory brain game supporting Goal Management Training intervention measure: Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B measure: Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up measure: Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS) measure: Change in performance on two trained IADL task (treatment goals) measure: Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL) measure: Change in strategy use during the performance of trained and untrained IADL tasks measure: Change in subjective experience of strategy use in daily life measure: Change in subjectively experienced psychological symptoms such as depressive, anxiety and stress symptoms. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ProPersona city: Wolfheze state: Gelderland zip: 6874 BE Wolfheze country: Netherlands name: Bea Tiemens, PhD role: CONTACT email: b.tiemens@propersona.nl name: Floor Poerschke, MSc role: SUB_INVESTIGATOR name: Emily Vink, MSc role: SUB_INVESTIGATOR lat: 52.00333 lon: 5.79028 hasResults: False

 nctId: NCT06352333 id: Parasagittal Vs Cornerpocket briefTitle: Parasagittal Vs Cornerpocket Approaches overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-11-01 date: 2025-01-01 date: 2024-04-08 date: 2024-04-08 name: Sohag University class: OTHER briefSummary: Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery.

Although many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent.

Each approach of ultrasound guided supraclavicular brachial plexus block (US -SCBPB ) has a different success rate and complications. .

A supraclavicular block can provide effective surgical anesthesia of the forearm and hand.

The most commonly performed US- SCBPB is the corner pocket approach which was described by Chan et al with probe resting posterior to the clavicle, with postero latero-anteromedial orientation provides a very stable location, but has the disadvantage of "looking" across the first rib, with the apex of the lung visualized close to thePlexus .

A new Parasagittal approach for brachial plexus block at the supraclavicular level was studied by Adrian Searle where the arc of the first rib was used to provide a deep limit to needle transit in order to minimize the risk of pneumothorax ;the aim of our study is to further evaluate the parasagittal approach for brachial plexus block and compare it with the popular corner pocket approach conditions: Supraclavicular Brachial Plexus Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Inclusion criteria:

* 18to60 yearsold
* ASA grade I to II
* Elective upper limb surgery primaryPurpose: SCREENING masking: NONE count: 80 type: ESTIMATED name: supraclavicular ultrasound guided brachial plexus block measure: Needle visibility in both approaches measure: Duration of sensory and motor block measure: Success rate measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Sohag university Hospital city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06352320 id: XJTU1AF2023LSK-533 briefTitle: Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH） overallStatus: NOT_YET_RECRUITING date: 2024-12-31 date: 2030-08-31 date: 2032-08-31 date: 2024-04-08 date: 2024-04-08 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER briefSummary: This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment. conditions: Cardiomyopathies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED name: Diagnosis of HCM name: Diagnosis of DCM name: Diagnosis of ARVC name: Diagnosis of NDLVC name: Diagnosis of RCM name: Diagnosis of LVNC measure: Change in the incidence of mortality rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Xi'an Jiantong University city: Xi'an state: Shaanxi zip: 710061 country: China lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06352307 id: XJTU1AF2023LSK-532 briefTitle: Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy acronym: STARTER overallStatus: NOT_YET_RECRUITING date: 2024-12-31 date: 2030-08-31 date: 2032-08-31 date: 2024-04-08 date: 2024-04-08 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER briefSummary: This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM. conditions: Arrhythmogenic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1500 type: ESTIMATED name: Diagnosis of ACM measure: Change in the incidence of mortality rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Xi'an Jiantong University city: Xi'an state: Shaanxi zip: 710061 country: China name: Guoliang Li role: CONTACT phone: 008613759982523 email: liguoliang_med@163.com name: Yang Yan role: CONTACT phone: +86.29.85323869 email: yangyan3@xjtu.edu.cn lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06352294 id: MSDALAKCI briefTitle: The Effects of Myofascial Relaxation Technique Applied Together With Core Stabilization Trainings on Balance, Pain, Joint Range of Motion and Functionality in Individuals With Chronic Neck Pain overallStatus: RECRUITING date: 2024-03-29 date: 2024-07 date: 2024-07 date: 2024-04-08 date: 2024-04-08 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Chronic neck pain is a musculoskeletal disorder that affects people frequently in life. Nov.

Postural control is based on the process of correctly identifying and selectively focusing the incoming afferent input of the Central Nervous System (CNS).

The main treatment options for people with neck pain include soft tissue and joint mobilizations, stabilization exercises for the neck, trunk and shoulder muscles, cervical Deckings, relaxation training, strengthening exercises and body awareness and posture training Nov.

In this study, it was aimed to investigate the effects of myofascial relaxation on balance, pain, joint range of motion and functionality in individuals with chronic neck pain by dividing them into two groups in the form of core stabilization and core stabilization and myofascial relaxation.

The study included 45 people between the ages of 18 and 65 Dec. In two groups, the core stabilization group will be 22 people, and the core stabilization and myofascial relaxation group will be 23 people. The study period is planned as 6 weeks and 3 sessions per week. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: Core stability training name: Core stability training and myofascial relase measure: Pain severity measure: Pressure pain threshold (PPT) measure: Balance measure: Range of motion measure: Neck Disability İndex measure: DASH sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kırşehir Ahi Evran Üniversitesi status: RECRUITING city: Merkez state: Kırşehir country: Turkey name: Muhammed Samed Dalakçı role: CONTACT phone: 905445325572 email: samed.dalakci@gmail.com hasResults: False

 nctId: NCT06352281 id: KM-007 briefTitle: Efficacy and Safety of CAR-T Cells Therepy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP) overallStatus: RECRUITING date: 2024-02-01 date: 2026-01-01 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China class: OTHER briefSummary: It is a single-center, single-arm, open-labeled clinical trial to evaluate the efficacy and safety of CAR-T cells therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP). conditions: ITP - Immune Thrombocytopenia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: CAR-T cells measure: Portion of patients with response (R) measure: Portion of patients with complete response (CR) measure: Portion of patients with relapse measure: Time (in days) from treatment start to response (R) measure: Time (in days) from treatment to complete response (CR) measure: Duration (in days) of response (R) measure: Incidence of adverse events(AE) after infusion sex: ALL minimumAge: 8 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China status: RECRUITING city: Kunming state: Yunnan zip: 650000 country: China name: Wang Sanbin, Doctor role: CONTACT phone: 13187424131 phoneExt: +86 email: sanbin1011@163.com lat: 25.03889 lon: 102.71833 hasResults: False

 nctId: NCT06352268 id: IEC-368/17.07.2023 briefTitle: Lesioning Procedures for Movement Disorders overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-12-31 date: 2028-12-31 date: 2024-04-08 date: 2024-04-08 name: All India Institute of Medical Sciences, New Delhi class: OTHER briefSummary: Dystonia is a rare syndrome with varying etiologies. Similarly, tremor conditions refractory to medical management and disabling that they need surgical interventions are rare in our setting. So far there are no randomized controlled trials of pallidotomy for management of dystonia. There is scant literature on the long term efficacy and safety of Pallidotomy, thalamotomy and other such lesioning procedures in the management of movement disorders. The current literature is significantly plagued by publication bias as case reports with successful outcomes are likely to be selectively published in journals or conference abstracts. Lesioning procedures though seem to be effective are often considered to be risky, especially bilateral pallidotomy is not preferred by several centres. However, our center routinely performs simultaneous bilateral pallidotomy. To generate long term data on the efficacy and safety of lesioning procedures in rare diseases like dystonias especially the effect of functional neurosurgery on varying etiologies of the disease, robust registries are required which collect data on all consecutive patients who undergo the procedure. conditions: Dystonia conditions: Parkinson Disease conditions: Essential Tremor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Pallidal, subthalamic or thalamic lesioning measure: Long term functional outcomes measure: Long term functional outcomes measure: Predictors of outcomes measure: Demography measure: Clinical features measure: Laboratory findings measure: Imaging features measure: Treatment trends measure: Clinical features measure: Treatment trends sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: All India Institute of Medical Sciences, New Delhi city: New Delhi state: Delhi zip: 110029 country: India name: Arunmozhimaran Elavarasi, MD DM role: CONTACT phone: +919013844274 email: arun_ela@yahoo.com lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06352255 id: AR1937 briefTitle: Pain and Anxiety During Local Block overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2025-07 date: 2024-04-08 date: 2024-04-08 name: University of Seville class: OTHER briefSummary: INTRODUCTION: Currently, there is no scientific evidence about pain in the anesthetic blockage of the first finger according to the application method. However, clinical evidence has valued the use of carpule, due to the low pain it generates in the patient to the application of anesthetic. Most studies on anesthesia and pain, especially with the use of carpule and distracting methods, belong to the field of dentistry.

OBJECTIVES: It is intended to determine the pain after an anesthetic block in H of Frost in the first finger with different application methods, such as syringe and carpule. As secondary objectives, it is intended to establish the difference in pain according to the sex and age of the patients.

METHODOLOGY: Experimental, transverse and random clinical trial type analytical study, in which a sample of 200 individuals will be selected, 100 per group, which would require digital anesthesia of the first finger and that would fulfill the inclusion criteria.

Result: after the completion of the study CONCLUSIONS: After the completion of the study conditions: Anesthesia, Local conditions: Pain conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Digital block measure: Grade of Pain postinyection measure: Anxiety before the intervention sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352242 id: RECHMPL24-0076 UF 9572 briefTitle: Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma? acronym: CARTROG overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2026-04-08 date: 2026-04-08 date: 2024-04-08 date: 2024-04-08 name: University Hospital, Montpellier class: OTHER briefSummary: CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R/R). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Recent studies have shown that the level of trogocytosis by immune cells correlates with the persistence of tumor cells in patients with hematological malignancies. Our main objective is to identify a phenotypic "signature" of trogocytosis predictive of therapeutic response 6 months after injection of CAR-T cells for DLBCL. conditions: Diffuse Large B Cell Lymphoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 85 type: ESTIMATED name: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients name: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers measure: Identification of a phenotypic "signature" of trogocytosis predictive of failure to achieve a complete metabolic response for patients with diffuse large B-cell lymphoma. measure: Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of grade II or more immunological adverse events measure: Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of serious hematological side effects. measure: Determination of the trogocytosis level of normal lymphocytes and NK cells in healthy subjects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352229 id: 514-0335/23-2000 briefTitle: The Playful Learning in Infancy Program acronym: PLIP overallStatus: RECRUITING date: 2023-06-01 date: 2026-11-30 date: 2026-11-30 date: 2024-04-08 date: 2024-04-08 name: University of Copenhagen class: OTHER name: LEGO Foundation briefSummary: In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors.

The aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study.

Evaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program. conditions: Parent-Child Relations conditions: Infant Development studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Evaluation is based on a parallel group study, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 2327 type: ESTIMATED name: Playful Learning in Infancy Program name: Postnatal care as usual measure: Parental Playful interactions measure: Parental Stress measure: Infant Socio-emotional Development measure: Infant Level of Play measure: Parental Mind-Mindedness measure: Parental Attachment Style measure: Parental Mental Well-Being measure: Infant Screen Time measure: Questions developed for the study regarding Parental Involvement measure: Questions developed for the study regarding Parental Knowledge of Play measure: Parental Experience of the PLIP measure: Health Visitors' Experience of the PLIP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen status: RECRUITING city: Copenhagen zip: 1353 country: Denmark name: Mette S. Væver, PhD role: CONTACT phone: +45 35324906 email: mette.vaever@psy.ku.dk name: Maja Nyström-Hansen, PhD role: CONTACT phone: +4535336499 email: mnh@psy.ku.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06352216 id: Elo-Ger-2023-1642 briefTitle: Prevalence of Synovitis in Patients With Haemophilia A acronym: SynoPrev overallStatus: RECRUITING date: 2024-04-15 date: 2027-02 date: 2027-03 date: 2024-04-08 date: 2024-04-16 name: University Hospital, Bonn class: OTHER name: Swedish Orphan Biovitrum briefSummary: The aim of this study is to evaluate the prevalence of synovitis in adult patients with haemophilia A. conditions: Haemophilia A conditions: Synovitis conditions: Hemophilia Arthropathy conditions: Sonography studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US); Haemophilia joint health score (HJHS) measure: Haemophilia early arthropathy detection with ultrasound (HEAD-US) measure: The Hemophilia Joint Health Score version 2.1 (HJHS) measure: PROMIS-29 Questionaire measure: Haemophilia Activities List (HAL) measure: Baseline Characteristics sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bonn status: RECRUITING city: Bonn state: NRW zip: 53113 country: Germany name: Andreas C. Strauss, PD Dr. med. role: CONTACT phone: 004922828714176 email: andreas.strauss@ukbonn.de name: Andreas C. Strauss, PD Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 50.73438 lon: 7.09549 hasResults: False

 nctId: NCT06352203 id: AUT/23.02 briefTitle: Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-11 date: 2024-04-08 date: 2024-04-08 name: ProbiSearch SL class: INDUSTRY briefSummary: Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.

An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.

The duration of the study will be of 6 months approximately, including 6 months of product intake.

Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group. conditions: Neurodevelopmental Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Probiotic name: Placebo measure: Number of children with intestinal dysbiosis after 6 months of treatment. sex: ALL minimumAge: 3 Years maximumAge: 7 Years stdAges: CHILD hasResults: False

 nctId: NCT06352190 id: SY-5007-I-04 briefTitle: A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-08 date: 2024-04-08 name: Shouyao Holdings (Beijing) Co. LTD class: OTHER briefSummary: This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: [14C] SY-5007 measure: Total radioactivity in plasma PK: Cmax measure: Total radioactivity in plasma PK: Tmax measure: Total radioactivity in plasma PK: AUC0-t measure: Total radioactivity in plasma PK: t½ measure: Total radioactivity in plasma PK: CL/F measure: Whole blood to plasma total radioactivity ratio measure: Cumulative total radioactivity in urine and faeces measure: Metabolic profiling in plasma, urinary and fecal excretion measure: Cmax of SY-5007 and its metabolites measure: Tmax of SY-5007 and its metabolites measure: AUC0-t of SY-5007 and its metabolites measure: t½ of SY-5007 and its metabolites measure: CL/F of SY-5007 and its metabolites measure: Incidence of adverse events sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing zip: 100050 country: China name: Ruihua Dong, MD role: CONTACT phone: 86-010-63139033 email: ruihua_dong_rw@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06352177 id: protocol-1 briefTitle: Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD acronym: ENLIGHTEN overallStatus: NOT_YET_RECRUITING date: 2025-04-01 date: 2029-12-31 date: 2030-08-01 date: 2024-04-08 date: 2024-04-08 name: Milton S. Hershey Medical Center class: OTHER briefSummary: The ENLIGHTEN study that will evaluate the efficacy of a novel DTx lifestyle intervention in participants with non-cirrhotic MASH. People who have MASH, the progressive subtype of MASLD, have the highest risk for liver disease progression and poor outcomes, including cirrhosis and hepatocellular carcinoma, and greater overall mortality. Thus, these participants are expected to experience the greatest benefit from treatment.

This is a randomized, controlled trial comparing DTx lifestyle intervention in participants with non-cirrhotic MASH to standard clinical care. The study includes a screening period (up to 2 wks.) followed by randomization, 48-wk treatment period and 12-wk follow-up period (total duration up to 62 wks.). conditions: NASH conditions: NASH - Nonalcoholic Steatohepatitis conditions: Liver Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 50/50 randomization primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Noom Weight Application measure: Clinically significant liver fat loss measure: Sustained clinically significant body weight loss measure: Sustained clinically significant body weight loss measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Liver fat and liver stiffness using imaging analysis measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Clinically meaningful improvement in liver fat and stiffness measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of hepatic injury measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis measure: Circulating biomarkers of liver fibrosis and fibrogenesis sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352164 id: ZYS2024-03 briefTitle: Efficacy Classification Prediction of the Effects of Acupuncture on Abdominal Pain in Patients With Crohn's Disease overallStatus: COMPLETED date: 2015-03-01 date: 2023-12-31 date: 2024-03-31 date: 2024-04-08 date: 2024-04-09 name: Shanghai Institute of Acupuncture, Moxibustion and Meridian class: OTHER briefSummary: Machine learning algorithms are applied to discover gut flora markers that predict the clinical efficacy of acupuncture, so as to screen the appropriate population for acupuncture and optimise the allocation of healthcare resources. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 55 type: ACTUAL name: Acupuncture treatment measure: Characterisation of gut microflora strains predictive of acupuncture efficacy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian city: Shanghai zip: 200000 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06352151 id: 2022-041 briefTitle: Effects of Orofacial Therapy and Therapeutic Yoga in Children With Down Syndrome overallStatus: RECRUITING date: 2023-10-01 date: 2024-09-28 date: 2024-12-30 date: 2024-04-08 date: 2024-04-09 name: Hasan Kalyoncu University class: OTHER briefSummary: The study aims to compare the effects of orofacial therapy and therapeutic yoga on swallowing, sleep habits, and quality of life in children with Down syndrome. conditions: Down Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Routine Physiotherapy Group name: Orofacial Treatment Group name: Therapeutic Yoga Group measure: The Pediatric Functional Independence Measure measure: Pediatric Eating Assessment Tool-10 measure: Children's Sleep Habits Questionnaire measure: The Health-Related Quality of Life Scale-KIDSCREEN-27 sex: ALL minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Hasan Kalyoncu University status: RECRUITING city: Gaziantep zip: 27410 country: Turkey name: Aysenur Tuncer, PhD role: CONTACT phone: +903422118080 name: Yasemin Kotevoglu, MSc role: CONTACT lat: 37.05944 lon: 37.3825 hasResults: False

 nctId: NCT06352138 id: ENCASE briefTitle: Comparative Study of Two Recombinant Human Erythropoietin Products on Chronic Kidney Disease Patients acronym: ENCASE overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-03 date: 2027-03 date: 2024-04-08 date: 2024-04-08 name: Megalabs class: INDUSTRY name: Azidus Laboratories briefSummary: Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for subcutaneous use, compared to Eprex® (Janssen-Cilag Farmacêutica Ltda.), in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis conditions: Anemia of Chronic Kidney Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicentre, double-blind, randomised, parallel, equivalence trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 280 type: ESTIMATED name: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. name: Active comparator: European Union licenced epoetin alfa measure: Mean Absolute Change in Hemoglobin Levels measure: Change in Mean Hb Level measure: immunogenicity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Megalabs city: Colonia Nicolich state: Canelones zip: 15000 country: Uruguay name: Victoria Rodriguez, MD role: CONTACT phone: 26836300 phoneExt: 3110 email: vrodriguez@megalabs.global lat: -34.81516 lon: -56.02435 hasResults: False

 nctId: NCT06352125 id: TP-CLN-100503 briefTitle: An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge overallStatus: COMPLETED date: 2021-12-09 date: 2023-01-31 date: 2023-01-31 date: 2024-04-08 date: 2024-04-08 name: Haemonetics Corporation class: INDUSTRY name: ClinStatDevice name: Boston Healthcare Technologies Consultants, LLC briefSummary: This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators. conditions: Surgery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 338 type: ACTUAL name: TEG 6s Citrated K, KH, RTH, FFH Cartridge name: Clauss Fibrinogen measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison measure: Primary Method Comparison sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California - San Francisco city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 facility: University of Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Ochsner Clinic city: New Orleans state: Louisiana zip: 70121 country: United States lat: 29.95465 lon: -90.07507 facility: Lifebridge Health (Sinai Hospital) city: Baltimore state: Maryland zip: 21215 country: United States lat: 39.29038 lon: -76.61219 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: University of Texas Health Science Center - San Antonio city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06352112 id: 02.04.2024 - POP briefTitle: Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse overallStatus: COMPLETED date: 2023-03-15 date: 2024-01-15 date: 2024-02-15 date: 2024-04-08 date: 2024-04-10 name: Hacettepe University class: OTHER name: Istanbul Training and Research Hospital briefSummary: The aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks. For this purpose, the participants were randomly divided into two groups: \[PFMT alone (n:15) and PFMT combined with HE(n:17)\]. DuoBravo EMG device for evaluation of PFM activation and "Pelvic Floor Distress Inventory-20" was used to evaluate the severity of PFD. All evaluations were performed twice in total, at baseline and at week 8. conditions: Pelvic Floor Disorders conditions: Prolapse; Female studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ACTUAL name: Pelvic Floor Muscle Training name: Hypopressive Exercises measure: Pelvic Floor Muscle Activation measure: Severity of pelvic floor dysfunction sex: FEMALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Istanbul Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06352099 id: 6315 briefTitle: Dietary Supplementation and Cognitive Functions in the Elderly acronym: ESPINS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2025-04 date: 2024-04-08 date: 2024-04-08 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: In recent years, globally, there has been a growth in both the size and the proportion of older adults in the world population. The World Health Organization (WHO) has estimated that by 2030, 1 in 6 people will be 60 years of age or older, and that by 2050, the population of older adults will reach 2.1 billion. The population of older adults (over 80 years) will triple to 426 million by 2050. In particular, Italy represents the second country with the oldest population in the world.

Age-related evolution is a gradual and continuous process involving a series of physical and cognitive changes, which, however, has no real 'onset' age. In fact, rather than chronological age, the concept of 'elderly' is based on the individual's degree of self-sufficiency and independence. From a biological point of view, ageing is the set of changes at the molecular and cellular level that occur over time and lead to multi-system functional impairment. It is a process directly related to frailty, falls, and disability.

An important factor in counteracting frailty is nutritional intake. Humans ingest approximately 500 g of chemical compounds daily through their diet, most of which are components of plants or vegetables in general. In addition to the well-known macronutrients (proteins, fats, and carbohydrates) and micronutrients (minerals and vitamins), the plant world provides other elements, such as phenols, terpenes, terpenoids, alkaloids, purines, pyrimidines, nucleic acids, and steroids, that exert powerful biological activities. These components are generically called phytochemicals. Epidemiological studies have established that diets rich in plant-based foods help prevent many diseases, such as cardiovascular, metabolic, neurovegetative, and inflammatory diseases.

Phytochemical compounds are an extremely diverse set of elements that, when taken at significant levels, have a protective effect on human health. These substances exert various biological functions, such as antioxidant activity, modulation of detoxifying enzymes, stimulation of the immune system, reduction of platelet aggregation, modulation of hormone metabolism, reduction of blood pressure, and antibacterial and antiviral activity.

Among the phytochemical compounds, flavonoids represent a category of polyfunctional substances with high bioactivity, comprising more than 5000 compounds. They possess biochemical properties of functional interest in the nutritional and therapeutic fields; for example, rutin, diosmin, and hesperidin are present in some pharmaceutical specialties; flavonoids from ginkgo biloba, hawthorn, and red vine are the main components of many phytotherapeutic extracts. Flavonoids have been shown to play an important role in cardioprotection. Furthermore, in neuroprotection, anthocyanin-rich fruits play a protective role against age-related decline in cognitive functions.

However, few studies have evaluated the effect of hesperidin and proanthocyanidins on motor, cognitive, and functional aspects in the elderly.

Altemor® is a food supplement based on micronized diosmin, hesperidin, and herbal extracts that has an important integrative supporting action in optimising blood microcirculation.

The aim of the study is to evaluate the contribution of dietary supplementation with Altemor® on cognitive function, balance, fatigue, and some domains of quality of life in elderly subjects. conditions: Cognitive Impairment conditions: Old Age; Debility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Dietary supplement with micronised diosmin, hesperidin and herbal extracts measure: Trial Making Test (TMT) measure: Short Physical Performance Battery (SPPB) measure: HandGrip Strenght Test (HGST) measure: Silver Index (SI) measure: Mental Deterioration battery (MDB) measure: Hospital Anxiety and Depression Scale (HADS) measure: EuroQol- 5 Dimension (EQ-5D) measure: Modified Fatigue Impact Scale (MFIS) sex: ALL minimumAge: 50 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma state: RM zip: 00168 country: Italy name: Silvia Giovannini, MD, PhD role: CONTACT phone: +390630154382 email: silvia.giovannini@policlinicogemelli.it name: Letizia Castelli, PhD role: CONTACT phone: +390630154382 email: letizia.castelli@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06352086 id: STUDY00009227 briefTitle: Understanding Visual Processing After Occipital Stroke overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-09 date: 2029-09 date: 2024-04-08 date: 2024-04-08 name: University of Rochester class: OTHER briefSummary: The purpose of this study is to investigate how visual orientation discrimination and metacognition (i.e., perceptual confidence) are affected by occipital stroke that causes hemianopia and quadrantanopia in adults. This research will provide insight as to how the residual visual system, which not directly damaged by the occipital stroke, processes orientation (assayed in terms of orientation discrimination) and metacognition (by measuring perceptual confidence for orientation discrimination). These measures will be used to refine computational models that attempt to explain how the brain copes with loss of primary visual cortex (V1) as a result of stroke. This knowledge is essential to devise more effective visual rehabilitation therapies for patients suffering from occipital strokes. conditions: Vision Loss Partial conditions: Vision; Loss, Both Eyes conditions: Hemianopia, Homonymous conditions: Hemianopia conditions: Quadrantanopia conditions: Stroke, Ischemic conditions: Stroke - Occipital Infarction conditions: Cortical Blindness conditions: Occipital Lobe Infarct conditions: Peripheral Visual Field Defect of Both Eyes studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED measure: Orientation discrimination threshold measure: Perceptual Confidence in Orientation Discrimination sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06352073 id: 23-2625 id: R668-EE-2380 type: OTHER domain: Regeneron briefTitle: Dupilumab for Eosinophilic Esophagitis With Severe Strictures acronym: DESTRICT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-11 date: 2026-04 date: 2024-04-08 date: 2024-04-08 name: University of North Carolina, Chapel Hill class: OTHER name: Regeneron Pharmaceuticals name: Sanofi briefSummary: The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab.

Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses.

Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed.

At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned male at birth (AMAB) will be contacted about their / their partner's pregnancy status and participants assigned female at birth (AFAB) may be asked to come for an in-person visit to complete a urine pregnancy test. conditions: Eosinophilic Esophagitis conditions: EoE studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Dupilumab measure: Histologic Response to Dupilumab measure: Change in Minimum Esophageal Caliber measure: Decrease in Number of Dilations measure: Change in Endoscopic Severity measure: Change in Histologic Severity sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Julia Phillips role: CONTACT phone: 919-843-4453 email: julia_phillips@med.unc.edu name: Hiwot Ekuban role: CONTACT email: hiwot_ekuban@med.unc.edu lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06352060 id: KCHRRF_MONITOR AF_030 briefTitle: Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study overallStatus: RECRUITING date: 2024-04 date: 2024-06 date: 2024-09 date: 2024-04-08 date: 2024-04-08 name: Kansas City Heart Rhythm Research Foundation class: OTHER briefSummary: Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2500 type: ESTIMATED name: No intervention or administration will be performed due to the observational nature of the study measure: No.of patients with arrhythmia recurrence measure: No.of patients with redo ablation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Menorah Medical Center status: RECRUITING city: Overland Park state: Kansas zip: 66209 country: United States name: Donita Atkins role: CONTACT lat: 38.98223 lon: -94.67079 facility: Kansas City Heart Rhythm Institute - Roe Clinic status: RECRUITING city: Overland Park state: Kansas zip: 66211 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 facility: Overland Park Regional Medical Center status: RECRUITING city: Overland Park state: Kansas zip: 66215 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: datkins@kchrf.com name: Naga Venkata K. Pothineni role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 facility: Centerpoint Medical Center Clinic status: RECRUITING city: Independence state: Missouri zip: 64057 country: United States name: Donita Atkins role: CONTACT lat: 39.09112 lon: -94.41551 facility: Centerpoint Medical Center status: RECRUITING city: Independence state: Missouri zip: 64057 country: United States name: Donita Atkins role: CONTACT lat: 39.09112 lon: -94.41551 facility: Research Medical Center Clinic status: RECRUITING city: Kansas City state: Missouri zip: 64032 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 facility: Research Medical Center status: RECRUITING city: Kansas City state: Missouri zip: 64032 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 hasResults: False

 nctId: NCT06352047 id: Karadeniz Tech. University briefTitle: The Effects of Positioning After Extubation of Preterm Infants on the Respiratory Functions overallStatus: COMPLETED date: 2018-11-01 date: 2019-06-01 date: 2019-06-01 date: 2024-04-08 date: 2024-04-08 name: Karadeniz Technical University class: OTHER briefSummary: The aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation.

Hypothesis 0a (H0a): There is no difference between the oxygen saturation (SpO2) levels of preterm infants in supine and prone positions after extubation.

Hypothesis 0b (H0b): There is no difference between the respiratory rate of preterm infants in supine and prone positions after extubation.

Hypothesis 0c (H0c): There is no difference between the respiratory rhythms of preterm infants in supine and prone positions after extubation.

Hypothesis 0d (H0d): There is no difference between respiratory distress in preterm infants in supine and prone positions after extubation. conditions: Premature Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Simple randomization method was used in the sample of the study. In previous studies, there were no published data on the effect of supine and prone positioning after extubation on the pulmonary functions of premature infants. Therefore, the sample size was calculated using the G-power 3.1.3 program according to the SpO2 level and standard deviation values of 4 infants who were mechanically ventilated in the neonatal intensive care unit. The study was conducted with a total of 42 premature babies, two groups of 21 premature babies, each of whom had the characteristics of the research groups. Premature infants were divided into two groups, the supine position and the prone group, by randomization using a computer-based random number generator (www.randomizer.org). primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ACTUAL name: The effect of positioning on respiratory functions of preterm infants after extubation. measure: Newborn Evaluation Form sex: ALL minimumAge: 37 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: İlknur Kahriman city: Trabzon zip: 61080 country: Turkey lat: 41.005 lon: 39.72694 facility: Karadeniz Technical University Health Application and Research Center Farabi Hospital city: Trabzon zip: 61080 country: Turkey lat: 41.005 lon: 39.72694 hasResults: False

 nctId: NCT06352034 id: Empathy Training for Students briefTitle: Empathy Training for Future Mental Health Practitioners in University Students overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-04-30 date: 2024-10-01 date: 2024-04-08 date: 2024-04-08 name: Peking University class: OTHER briefSummary: This study aims to investigate the efficacy of empathy training for future psychological counselors in university students. The training contains 5 sessions of psychoeducation, three-role group exercises, and Q\&A. Self-reported, listener-reported, and observer-reported measurements will be applied for empathy assessment. conditions: Empathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Empathy Training measure: Change from counseling duration measure: Change from Baseline of 12-Item Version of the Barrett-Lennard Relationship Inventory measure: Change from consultation willingness question inquiry measure: Change from morphed emotion perception task measure: Change from Baseline of the Measure of Empathy Scale measure: Change from Baseline of the Emotion Perception Scale measure: Change from Baseline of the Peking Alexithymia Scale measure: Change from Baseline of the Patient Health Questionnaire measure: Change from Baseline of the Generalized Anxiety Disorder Scale measure: Change from Baseline of the Peking Irritability Scale measure: Change from Baseline of the the Fatigue Assessment Scale measure: Change from Baseline of the the Patient Health Questionnaire measure: Change from Baseline of the Cognitive-Emotion Regulation Questionnaire measure: Change from Baseline of the Difficulties in Emotion Regulation Scale measure: Change from Baseline of the the Satisfaction with Life Scale measure: Change from Baseline of the the Subjective Happiness Scale measure: Change from Baseline of the Connor-Davidson Resilience Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University city: Peking state: Beijing zip: 100871 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06352021 id: KAHRİMAN İlknur briefTitle: The Effect of Distraction With a Kaleidoscope on the Level of Perceived Pain During Blood Sampling in Children overallStatus: COMPLETED date: 2019-05-30 date: 2019-06-30 date: 2019-06-30 date: 2024-04-08 date: 2024-04-08 name: İlknur KAHRİMAN class: OTHER briefSummary: This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.

Hypothesis 0 (H0): There is no difference between the pain scores of the kaleidoscope group and the control group during blood sampling.

Hypothesis 1 (H1): There is a difference between the pain scores of the kaleidoscope group and the control group during blood sampling. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: kaleidoscope measure: The Wong-Baker Pain Scale sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Karadeniz Technical University Health Application and Research Center Farabi Hospital city: Trabzon zip: 61080 country: Turkey lat: 41.005 lon: 39.72694 hasResults: False

 nctId: NCT06352008 id: Zhansheng Jiang briefTitle: To Evaluate the Efficacy and Safety of Anrotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2026-06-01 date: 2024-04-08 date: 2024-04-08 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: To explore the effectiveness of anrotinib hydrochloride capsule in postoperative non-pCR non-small cell lung cancer patients with adjuvant intensive therapy conditions: Event-free Lifetime studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Anlotinib measure: EFS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianiin Medical University Cancer Institute & Hospital city: Tianjin country: China role: CONTACT phone: +008618526812877 lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06351995 id: KOR-19-22 briefTitle: Neostigmine and Glycopyrrolate by Iontophoresis overallStatus: ACTIVE_NOT_RECRUITING date: 2020-11-06 date: 2022-10-25 date: 2025-01-01 date: 2024-04-08 date: 2024-04-08 name: James J. Peters Veterans Affairs Medical Center class: FED briefSummary: To determine a lower effective dose of neostigmine to induce bowel evacuation by transcutaneous administration by iontophoresis. conditions: Spinal Cord Injuries conditions: Constipation conditions: Fecal Incontinence conditions: Neurogenic Bowel studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ACTUAL name: Combination of Neostigmine and Glycopyrrolate name: I-Box by Dynatronics measure: Presence or absence of bowel evacuation measure: Time to bowel evacuation measure: Stool Consistency measure: Stool Quantity measure: Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps. sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: James J. Peters Veterans Affairs Medical Center city: Bronx state: New York zip: 10468 country: United States lat: 40.84985 lon: -73.86641 hasResults: False

 nctId: NCT06351982 id: 211123PER3-3-2 briefTitle: Treatment Of Shallow Periodontal Pockets 4-6mm Using AIRFLOW Prophylaxis Master Device With Erythritol vs Manual Scalers overallStatus: RECRUITING date: 2024-03-01 date: 2025-06-01 date: 2026-01-01 date: 2024-04-08 date: 2024-04-08 name: Cairo University class: OTHER briefSummary: Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments.

Both hand and ultrasonic instruments are characterized by being time-consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages.

The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder. conditions: Periodontal Pocket conditions: Periodontitis conditions: Gingival Diseases conditions: Gingival Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Electro Medical Systems AIRFLOW® Prophylaxis Master Device name: Hand and ultrasonic scalers and curettes measure: Change in probing pocket depth measure: Bleeding On Probing measure: Clinical Attachment Level measure: Plaque index measure: Calculus index measure: Patient pain/discomfort measure: Patient satisfaction measure: Cost effectiveness measure: Treatment time measure: Number of healed pockets sex: ALL minimumAge: 16 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry, Cairo University status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06351969 id: Ms 9-12-2023 briefTitle: Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss overallStatus: RECRUITING date: 2023-12-21 date: 2024-12 date: 2024-12 date: 2024-04-08 date: 2024-04-08 name: Benha University class: OTHER briefSummary: Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placenta attachment in the prediction of postpartum hemorrhage and to evaluate both of them as as parameters for identifying high-risk patients. conditions: Post Partum Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Evaluating Placental Thickness in cm and Thickness of Uterine Muscle in cm at Placenta Attachment in Prediction of Postpartum Blood Loss sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Benha Univeristy status: RECRUITING city: Banhā country: Egypt name: Ashraf Ismail mohamed, professor role: CONTACT phone: +201119709696 lat: 30.45906 lon: 31.17858 hasResults: False

 nctId: NCT06351956 id: Arrhythmias in Septic Patients briefTitle: New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes. overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2026-12-30 date: 2024-04-08 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes conditions: Cardiac Arrhythmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 72 type: ESTIMATED measure: Risk Factors of cardiac arrhythmias in septic patients in CU. measure: Fates of cardiac arrhythmia. measure: The frequent type of arrhythmias. measure: Mortality rate due to new onset arrhythmia. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351943 id: ImageDB pilot briefTitle: Proximal Femur Image Database Validation overallStatus: ACTIVE_NOT_RECRUITING date: 2021-05-01 date: 2024-10-01 date: 2025-06-30 date: 2024-04-08 date: 2024-04-08 name: AO Innovation Translation Center class: OTHER name: University of Turin, Italy briefSummary: The AO@AI Turin project is a collaborative project with a Turin group and the AO (Arbeitsgemeinschaft für Osteosynthesefragen, or in English, Association for the Study of Internal Fixation) foundation. An Image database (DB) has been built to host AP pelvic radiographs ready for artificial intelligence (AI) development.

The goal of this project is to determine the agreement between the Turin annotation of fracture status and the annotation from an external group of AO expert surgeons for a random subset of the Turin images. conditions: Proximal Femoral Fracture studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2932 type: ESTIMATED name: Fracture classification annotations provided by the Turin group name: Fracture classification annotations provided by the AO expert surgeon group measure: Annotations of fracture status of the image measure: In case of fracture, Arbeitsgemeinschaft für Osteosynthesefragen (AO, in English, Association for the Study of Internal Fixation)/Orthopedic Trauma Association (OTA) classification: Type measure: In case of fracture, AO/OTA classification: Group measure: In case of fracture, AO/OTA classification: Subgroup measure: In case of fracture, AO/OTA classification: Qualifier for 31A1.1 measure: In case of fracture, AO/OTA classification: Qualifier for 31B2 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: AO Foundation city: Dübendorf zip: 8600 country: Switzerland lat: 47.39721 lon: 8.61871 hasResults: False

 nctId: NCT06351930 id: EA210473 briefTitle: CBT for Insomnia in Adolescents With ADHD overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: The University of Hong Kong class: OTHER name: Kwai Chung Hospital, Hong Kong briefSummary: Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms as well as overall functional improvement. conditions: Insomnia conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomised, assessor-blind, parallel group controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: CBT-I + UC group measure: Change in Insomnia Symptoms measure: Change in ADHD Symptoms (Self-report) measure: Change in Internalising and Externalising Symptoms (Parent-rated) measure: Change in depressive symptoms (Self-report) measure: Change in anxiety symptoms (Self-report) measure: Change in Sleep Diary Measure - Time in Bed (TIB) measure: Change in Sleep Diary Measure - Total Sleep Time (TST) measure: Change in Sleep Diary Measure - Sleep Onset Latency (SOL) measure: Change in Sleep Diary Measure - Wake After Sleep Onset (WASO) measure: Change in Sleep Diary Measure - Sleep Efficiency (SE) measure: Change in Objective Sleep Measures - Time in Bed (TIB) measure: Change in Objective Sleep Measures - Total Sleep Time (TST) measure: Change in Objective Sleep Measures - Sleep Onset Latency (SOL) measure: Change in Objective Sleep Measures - Wake After Sleep Onset (WASO) measure: Change in Objective Sleep Measures - Sleep Efficiency (SE) measure: Change in Individual Beliefs and Attitude about Sleep measure: Change in Adolescent Sleep Hygiene measure: Change in Quality of Life sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Waiyan Vivian CHIU, Clinical Psychologist role: CONTACT lat: 22.27832 lon: 114.17469 facility: Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Shirley X Li, PhD, DClinPsy role: CONTACT phone: 852-39177035 email: shirley.li@hku.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06351917 id: LEVEXE briefTitle: Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-08 date: 2024-04-10 name: RDC Clinical Pty Ltd class: INDUSTRY briefSummary: This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration. conditions: Knee Joint Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: PlexoZome® Levagen® topical spray solution name: Placebo topical spray solution measure: Joint pain measure: Time to pain relief measure: Number of Adverse Events measure: Severity of Adverse Events measure: Rescue medication use sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RDC Clinical Pty Ltd city: Brisbane state: Queensland zip: 4006 country: Australia name: Amanda Rao, PhD role: CONTACT phone: +61 414 488 559 email: amanda@rdcglobal.com.au name: David Briskey, PhD role: CONTACT phone: +61 421 784 077 email: david@rdcglobal.com.au name: Amanda Rao, PhD role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False

 nctId: NCT06351904 id: RAG-01-01 briefTitle: A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy overallStatus: RECRUITING date: 2024-04-03 date: 2025-06-30 date: 2025-08-31 date: 2024-04-08 date: 2024-04-16 name: Ractigen Therapeutics. class: OTHER briefSummary: This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy. conditions: Non-Muscle-Invasive Bladder Cancer (NMIBC) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: RAG-01 measure: Safety and tolerability of RAG-01 in patients with non-muscle-invasive bladder cancer (NMIBC) measure: Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of RAG-01 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GenesisCare North Shore status: RECRUITING city: St Leonards state: New South Wales zip: 2065 country: Australia name: Laurence Krieger, MBCHB role: CONTACT phone: +61 2 8037 4100 email: laurence_krieger@hotmail.com lat: -33.82344 lon: 151.19836 hasResults: False

 nctId: NCT06351891 id: SHARE2402 briefTitle: Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-08 date: 2024-04-08 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated. conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 248 type: ESTIMATED name: 14-day bismuth quadruple regimen containing cefuroxime and tetracycline name: 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin measure: Eradication rate measure: Rate of adverse reactions measure: Patient compliance sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University city: Jinan state: Shandong zip: 250012 country: China name: Yueyue Li, MD,PhD role: CONTACT phone: 86-18560089751 email: lyynqj@162.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06351878 id: Pro00113559 briefTitle: TipTraQ Home Sleep Test Validation Study overallStatus: RECRUITING date: 2024-02-28 date: 2024-08-23 date: 2024-08-23 date: 2024-04-08 date: 2024-04-08 name: PranaQ Pte. Ltd. class: INDUSTRY briefSummary: A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test. conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 125 type: ESTIMATED measure: Apnea Hypopnea Index(AHI) measure: Oxygen Desaturation Index(ODI) measure: Total Sleep Time(TST) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University status: RECRUITING city: Durham state: North Carolina zip: 27705 country: United States name: Alexis Schuettke role: CONTACT phone: 919-668-2842 email: alexis.schuettke@duke.edu lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06351865 id: PHU/2023/21 briefTitle: Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent acronym: PRC overallStatus: RECRUITING date: 2024-03-07 date: 2024-09-19 date: 2024-10-31 date: 2024-04-08 date: 2024-04-09 name: Portsmouth Hospitals NHS Trust class: OTHER_GOV name: University of East Anglia briefSummary: Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems. conditions: Breast Cancer conditions: Complication of Surgical Procedure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Proportion of patients who respond to the feedback questionnaire measure: Final attrition rate measure: Quoted risks in the consent to the incidence of complications measure: Frequency of PRC and CRCs (Consent Form Reported Complications) measure: Understanding of consent measure: Language used in patient reported complications measure: Accuracy of potential complications measure: Participant preparation for surgery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Alexandra Hospital status: RECRUITING city: Portsmouth state: Hampshire zip: PO6 3LY country: United Kingdom name: Edward St John role: CONTACT phone: 02392286000 email: edward.stjohn@porthosp.nhs.uk lat: 50.79899 lon: -1.09125 hasResults: False

 nctId: NCT06351852 id: 1678243 briefTitle: Transdermal Administration by a Novel Wireless Iontophoresis Device overallStatus: RECRUITING date: 2022-03-22 date: 2025-02-15 date: 2025-02-15 date: 2024-04-08 date: 2024-04-08 name: James J. Peters Veterans Affairs Medical Center class: FED briefSummary: Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE).

The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis).

The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation. conditions: Spinal Cord Injuries conditions: Constipation conditions: Fecal Incontinence conditions: Neurogenic Bowel studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Combination of Neostigmine and Glycopyrrolate name: I-Box by Dynatronics measure: Presence or absence of bowel evacuation measure: Time to bowel evacuation measure: Stool Consistency measure: Stool Quantity measure: Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: James J. Peters Veterans Affairs Medical Center status: RECRUITING city: Bronx state: New York zip: 10468 country: United States name: Christopher P Cardozo, MD role: CONTACT phone: 718-584-9000 phoneExt: 1828 email: christopher.cardozo@va.gov lat: 40.84985 lon: -73.86641 hasResults: False

 nctId: NCT06351839 id: 2024/500457(REK) briefTitle: Sleep Well Despite Persistent Pain Symptoms acronym: Sleep-Well overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2026-12 date: 2027-12 date: 2024-04-08 date: 2024-04-08 name: University of Tromso class: OTHER name: University Hospital of North Norway name: Diakonhjemmet Hospital briefSummary: Background: The prevalence of comorbid insomnia is 8-10 times higher in patients with chronic pain than in the general population. Insomnia adds a considerable burden as it worsens the quality of life, restoration and repair, mental health and pain symptoms. Since pain and sleep problems are mutually reinforcing, improvements in sleep may have beneficial effects on pain. Unfortunately, the customary use of sleep medication (TAU: treatment-as-usual) often yields short-lived plus side effects. The "Sleep-Well" intervention examines if a group-based intervention program focusing on sleep literacy, sleep restriction, stimulus control and metacognitive therapy modules may perform better than TAU in improving patients' insomnia and sleep quality.

Eligible patients: Investigators target adult patients referred to the University Hospital of North Norway (Tromsø) for a diagnostic evaluation of their pain condition. Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder. Patients are not eligible if they use drugs or large doses of morphine (\>100 equivalents), are engaged in an insurance case due to their diagnosis, or participate in other ongoing group programs at the hospital.

Aims: This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients (TAU). The primary outcome measures are reductions in diagnostic criteria for insomnia, self-reported insomnia symptoms, quality of life, and actigraphy-measured insomnia indicators (long sleep onset latency, frequent nightly awakenings and early morning awakening). The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve. In addition, it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints, dysfunctional sleep and pain cognitions, anxiety and depression.

The intervention: The Sleep-Well program schedules group sessions that cover four topics (sleep literacy, behavioural and mental strategies, maintenance and relapse prevention). All sessions are led by two therapists. Those randomized to the active control group (TAU) cross over to the Sleep-Well intervention three months later. conditions: Insomnia Chronic conditions: Insomnia Due to Medical Condition conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We randomize patients to receive either the Sleep-Well intervention or to the TAU condition (active waiting-list group). After 3 months, the TAU patients cross over and receive the Sleep-Well intervention; hence, the design is semi-crossover. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 106 type: ESTIMATED name: Sleep-Well despite persistent pain name: TAU (treatment-as-usual) measure: Insomnia symptoms measure: Insomnia diagnosis measure: Actigraphy insomnia indicators (SOL, WASO and EMA in minutes) measure: Actigraphy insomnia indicators (SE %) measure: Sleep diary insomnia indicators (SOL, WASO and EMA in minutes) measure: Sleep brain activity as measured by a simplified polysomnography device, i.e., a Home Sleep Test (HST) measure: Anxiety and depression (HADS) measure: Quality of Life (EQ-5Q-5L) measure: Fatigue (Chalder Fatigue Scale) measure: Pain intensity, interference and locations (BPI) measure: Tolerance and Acceptance of chronic pain (CPAQ-R) measure: Mediator: Sleep hygiene (SHI) measure: Hyperactivity (HAS) measure: Mediator: Dysfunctional beliefs and attitudes about sleep (DBAS) measure: Mediator: Metacognitions about insomnia (MCQ-i) measure: Mediator: Insomnia catastrophizing Scale (ISC) measure: Mediator: Pain Catastrophizing Scale (PCS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UiT The Arctic University of Norway city: Tromsø state: Troms County zip: 9037 country: Norway name: Oddgeir Friborg, ph.d. role: CONTACT phone: 4777646772 email: oddgeir.friborg@uit.no name: Svein Bergvik, ph.d. role: CONTACT phone: 4777646323 email: svein.bergvik@uit.no name: Oddgeir Friborg, ph.d. role: PRINCIPAL_INVESTIGATOR name: Jan H Rosenvinge, ph.d. role: SUB_INVESTIGATOR name: Svein Bergvik, PhD role: SUB_INVESTIGATOR lat: 69.6489 lon: 18.95508 hasResults: False

 nctId: NCT06351826 id: 22070876 briefTitle: Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department overallStatus: RECRUITING date: 2024-01-03 date: 2024-04 date: 2024-05 date: 2024-04-08 date: 2024-04-08 name: Indonesia University class: OTHER briefSummary: This clinical trial aims to test the effectiveness of ELLASI intervention in response time, deterioration score, and metabolic status of polytrauma patients in the emergency department. The main questions it aims to answer are:

1. Is the response time of polytrauma patients who receive ELLASI in the intervention group faster than the control group?
2. Is the deterioration score of polytrauma patients who receive ELLASI in the intervention group better than the control group?
3. Is the metabolic status of polytrauma patients who receive ELLASI in the intervention group better than the control group?

Polytrauma patients in the intervention group will receive ELLASI, a structured intervention consisting of the six following:

1. Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway,
2. Patient positioning and giving oxygen, head-up,
3. Stabilisation, including IV insertion, applying pressure and bandage, place monitor, and haemodynamic monitoring
4. Assessment: re-assessment of pain and other main complaints
5. Make sure informed consents are documented
6. Inform patient and family for further intervention

Polytrauma patients in the control group will receive the usual/standard intervention.

Response time, early warning score, and arterial blood gas of polytrauma patients from both groups will be obtained and documented before and after the intervention. conditions: Polytrauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: ELLASI name: Standard measure: Response time measure: Deterioration score measure: Acidic Level (pH) measure: Base Excess (BE) measure: Bicarbonate level (HCO3) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RSCM status: RECRUITING city: Jakarta Pusat state: Jawa Barat zip: 10430 country: Indonesia name: RSCM role: CONTACT phone: 062211500135 email: info@rscm.co.id lat: -6.1818 lon: 106.8223 hasResults: False

 nctId: NCT06351813 id: B2024-029R briefTitle: Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-08 date: 2024-04-08 name: Shanghai Zhongshan Hospital class: OTHER name: Zhongshan Hospital (Xiamen), Fudan University name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University briefSummary: The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes. conditions: Acute Kidney Injury conditions: Critical Illness conditions: Kidney Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 358 type: ESTIMATED measure: AKI nonresolving subphenotype measure: Major adverse kidney events at 30 days measure: Major adverse kidney events at 90 days measure: Major adverse kidney events at 365 days measure: Mortality measure: Receipt of renal replacement treatment measure: Moderate and severe AKI measure: AKI progression measure: Composite Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Zhongshan Hospital city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06351800 id: PE-0280-2018 briefTitle: The PredictPlusPrevent Study overallStatus: NOT_YET_RECRUITING date: 2024-09-15 date: 2025-12-31 date: 2026-04-30 date: 2024-04-08 date: 2024-04-08 name: The Mediterranean Institute for the Advance of Biotechnology and Health Research class: OTHER briefSummary: Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS).

Methods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and/or anxiety at baseline will be randomly assigned to the intervention or active control group "PredictPlusPrevent". The "PredictPlusPrevent" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The "PredictPlusPrevent" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control "PredictPlusPrevent" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and/or anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12). conditions: Depression conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 9000 type: ESTIMATED name: Predictplusprevent intervention name: Psychoeducational intervention measure: Incidence of depression and/or anxiety disorders. measure: Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). measure: Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7). measure: Probability of depression measured by the Spanish predictD risk algorithm. measure: Probability of anxiety measured by the Spanish predictA risk algorithm. measure: Quality of life measured by the 12-item Short Form (SF-12). sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06351787 id: 22-X-97 briefTitle: Project Soma: Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Yogis overallStatus: COMPLETED date: 2022-10-31 date: 2023-06-28 date: 2023-06-28 date: 2024-04-08 date: 2024-04-08 name: Ohio University class: OTHER briefSummary: In this 2-armed randomized cross-sectional experimental study of healthy participants with yoga experience, we will examine the relationship between 4 self-reported enhancing psychological factors, cortical activity captured with functional near-infrared spectroscopy (fNIRS), and pain sensitivity (mechanical pressure pain tolerance) captured with algometry.

Specifically, we will examine the correlates of interoceptive awareness and mindful awareness with cortical activity (Aim 1a) and pain tolerance (Aim 1b); determine cortical activity responsiveness of two brief awareness-focused meditations - a resting-based body scan practice and yoga practice (Aim 2a); characterize cortical activity profiles with sequentially delivered body scan and yoga practices (Aim 2b); and elucidate the relationship between interoceptive awareness with healthy emotionality and psychological wellbeing (Aim 3).

Our central hypotheses are that (Aim 1a) higher interoceptive awareness and mindful awareness will moderately correlate with higher cortical activity for both awareness-focused meditation practices; (Aim 1b) individuals sub-grouped into the 'acceptance in action cluster' based on 2 self-report measures will exhibit higher pain tolerance; (Aim 2a) cortical activity will be higher in the yoga practice compared to the body scan practice; and (Aim 2b) higher cortical activity will be observed in the body scan-\>yoga intervention sequence compared to the yoga-\>body scan intervention sequence. Furthermore, (Aim 3) we predict that interoceptive awareness will moderately correlate with healthy emotionality and psychological well-being. conditions: Well-Being, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A 2-armed randomized cross-sectional experimental study with 20 healthy participants who hold yoga experience. primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: Resting and movement-based focused awareness meditations measure: Cortical activity measure: Interoceptive awareness measure: Mindful awareness measure: Pressure pain threshold and tolerance measure: Healthy emotionality measure: Well-being sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio University city: Athens state: Ohio zip: 45701 country: United States lat: 39.32924 lon: -82.10126 hasResults: False

 nctId: NCT06351774 id: 21-F-45 briefTitle: Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain acronym: AdaPT overallStatus: COMPLETED date: 2022-05-24 date: 2024-02-08 date: 2024-03-25 date: 2024-04-08 date: 2024-04-08 name: Ohio University class: OTHER name: University of Wisconsin, Madison briefSummary: In the proposed research, we will elucidate the comparative effectiveness of standalone physiotherapy (PT) vs. PT augmented with a self-guided, app-based Healthy Minds Innovation wellbeing program (PT+HMI) aimed at cultivating awareness, connection, insight, and purpose for people with chronic low back pain (CLBP). conditions: Back Pain Lower Back Chronic conditions: Disability Physical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A 2 armed sequential, multiple-assignment randomized trial design primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The investigator was masked to the initial treatment assignment. The outcome assessor was not masked to treatment assignment and monitored treatment response at the mid-intervention in order to recommend continuation of current treatment or to augment treatment with the Healthy Mind Innovations training program for individuals who did not favorably respond to standalone PT. whoMasked: INVESTIGATOR count: 13 type: ACTUAL name: Physical therapy measure: Oswestry Disability Index measure: PROMIS Pain Interference measure: Actigraphy measure: 3D Motion Capture measure: Pain acceptance measure: Committed action measure: Healthy emotionality measure: Exercise behavior measure: Back pain screening tool 1 measure: Back pain screening tool 1 measure: Kinesiophobia measure: Attitudes towards complementary and alternative medicine measure: Treatment expectancy measure: Lumbar pressure pain threshold measure: Thermal method of limits sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio University city: Athens state: Ohio zip: 45701 country: United States lat: 39.32924 lon: -82.10126 hasResults: False

 nctId: NCT06351761 id: SCT02-ECG briefTitle: WIBOFA - Validation of SCT02 With ECG-App for Detection of AF acronym: WIBOFA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-03 date: 2024-04-08 date: 2024-04-08 name: Withings class: INDUSTRY briefSummary: The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 270 type: ESTIMATED name: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording name: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording measure: Co-primary outcome 1 - Sensitivity of Investigational Device measure: Co-primary outcome 2 - Specificity of Investigational Device measure: Rhythm classification by ranges of heart rate measure: Quality of plots measured by the IMD - ECG Waveform Visibility measure: Quality of plots measured by the IMD - ECG Waveforms Polarity measure: Quality of plots measured by the IMD - ECG Waveforms Intervals measure: Quality of plots measured by the IMD - Heart Rate calculation sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FWD Clinical Research city: Boca Raton state: Florida zip: 33486 country: United States lat: 26.3669 lon: -80.13033 facility: Diverse Clinical Research city: Miami state: Florida zip: 33175 country: United States lat: 25.77427 lon: -80.19366 facility: Henri Mondor University Hospital city: Créteil state: Val De Marne zip: 94000 country: France lat: 48.78333 lon: 2.46667 hasResults: False

 nctId: NCT06351748 id: NN9535-7877 id: U1111-1296-3151 type: OTHER domain: World Health Organization (WHO) briefTitle: Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR) acronym: SCHOLAR overallStatus: ENROLLING_BY_INVITATION date: 2024-04-05 date: 2024-06-30 date: 2024-06-30 date: 2024-04-08 date: 2024-04-08 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study is to describe the real-world use and impact of semaglutide once-weekly (OW) among participants with type 2 diabetes mellitus (T2DM) in China. Participants diagnosed with T2DM who initiated semaglutide OW for the first time between 1 Jan 2022 (the date when semaglutide OW was listed in the National Reimbursement Drug List \[NRDL\] in China\] and 28 Feb 2023 (9 months prior to the data extraction cut-off date of 30 Nov 2023) will be included in this study. The study period will be 36 months prior to the first date of participants identification period. conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 27000 type: ESTIMATED name: Semaglutide measure: Change in Haemoglobin A1c (HbA1c) level measure: Change in HbA1c level measure: Proportion of participants achieving HbA1c less than (<) 7.0% measure: Change in HbA1c level measure: Change in HbA1c level measure: Proportion of participants achieving HbA1c <7.0% measure: Change in body weight measure: Change in body weight measure: Description of participants with different demographic characteristics measure: Description of participants with different clinical characteristics measure: Proportion of participants with different antidiabetic medications measure: Proportion of participants with different non-antidiabetic medications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Chu Hsien-I Memorial Hospital city: Tianjin country: China lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06351735 id: 2024-0336 briefTitle: Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in ALS Amyotrophic Lateral Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-08 date: 2024-04-08 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: Amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease, affects motor neurons, causing progressive muscle atrophy and weakness. Current treatments are ineffective, with most patients dying within 3-5 years of diagnosis. The disease's exact cause is unclear, but factors such as oxidative stress and protein abnormalities are implicated. Abnormal protein deposits and neurotoxic factors in the brain and spinal cord contribute to ALS pathology. Recent research on the brain's glymphatic-lymphatic system suggests impaired waste clearance may exacerbate ALS. Restoring drainage connections between cervical lymphatic vessels and veins could potentially alleviate neurodegenerative disease progression. conditions: Evaluation of the Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in Patients With Amyotrophic Lateral Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 3 type: ESTIMATED name: Deep cervical lymph node-vein bypass surgery measure: ALSFRS-R scale measure: Cognitive and Behavioral Scale (CAS) measure: Baseline of slow vital capacity (SVC) measure: Evaluation of glymphatic and meningeal lymphatic drainage measure: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5) sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351722 id: smokingnlrp3inflasome briefTitle: Non-surgical Periodontal Treatment in Smokers on SIRT-1, NLRP3 Inflammasome and LncRNAs overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2025-03-15 date: 2024-04-08 date: 2024-04-08 name: Necmettin Erbakan University class: OTHER briefSummary: The goal of this observational is to analyze the relationship between levels of interleukin-18 (IL-18), interleukin (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), interleukin-10 (IL-10), transforming growth factor beta (TGF-β), Nucleotide-binding oligomerization domain -like receptor protein 3 (NLRP3), apoptosis-associated speck-like protein (ASC), caspase-1, Sirtuin 1 (SIRT-1), Long noncoding RNA (lncRNA) small nucleolar RNA host gene 5 (SNHG5), and maternally expressed gene 3 (MEG3) in saliva, serum, and peripheral mononuclear blood cell (PMBC)in patients with periodontitis and smokers, to examine the changes in these biomarkers after non surgical periodontal treatment (NSPT), and to evaluate potential confounders that may mediate this relationship.

The main questions it aims to answer are:

question 1: Is there a relationship between the biomarkers mentioned above and periodontitis and smoking? question 2:How do the above-mentioned biomarkers change after NSPT in smokers and non-smokers? conditions: Periodontitis, Adult studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Before non-surgical periodontal treatment name: non-surgical periodontal treatment name: 3rd month after non-surgical periodontal treatment measure: Pre-treatment clinical and laboratory evaluation measure: Comparison of clinical measurements and laboratory measurements at 3 months post-treatment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351709 id: UmutPaksoy briefTitle: Acute Effects of Heat, Cold and Stretching on Knee Proprioception and Vertical Jump overallStatus: COMPLETED date: 2020-11-02 date: 2021-02-20 date: 2021-02-20 date: 2024-04-08 date: 2024-04-08 name: Istanbul Bilgi University class: OTHER briefSummary: The aim of our study is to investigate the effects of heat, cold and stretching on knee proprioception and vertical jump. 60 healthy individuals were randomized into hot, cold, stretching and control groups of 15 each. Pre-test and post-test measurements were made immediately after the application. Knee proprioception was measured with a digital goniometer using the EPD (joint position sense) test. Vertical jump heights were measured with contact mat by countermovement (CMJ) and squat splash (SQS) tests. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Stretching name: Hot pack application name: Cold pack application measure: Vertical Jump Distance Measurement measure: Joint Position Sense Measurement sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: İstanbul Medipan Tıp Merkezi city: Istanbul zip: 34218 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06351696 id: 43008563 briefTitle: The Effects of Bromelain Supplement in Patients With Ulcerative Colitis overallStatus: RECRUITING date: 2024-04-20 date: 2024-07-20 date: 2024-08-10 date: 2024-04-08 date: 2024-04-09 name: National Nutrition and Food Technology Institute class: OTHER briefSummary: In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks.

IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention. conditions: Ulcerative Colitis conditions: Primary Sclerosing Cholangitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Bromlein name: Placebo measure: SCCAIQ measure: IBDQ measure: Serum TAC measure: Serum hsCRP measure: Serum TNF-a sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azita Hekmatdoost status: RECRUITING city: Tehran state: Middle East zip: 19835 country: Iran, Islamic Republic of name: Azita Hekmatdoost, MD, PhD role: CONTACT phone: +989123065084 email: a_hekmat2000@yahoo.com lat: 35.69439 lon: 51.42151 hasResults: False

 nctId: NCT06351683 id: 24-066-2 id: P30AG067988 type: NIH link: https://reporter.nih.gov/quickSearch/P30AG067988 briefTitle: Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome acronym: Mito-LUTS overallStatus: RECRUITING date: 2024-04-03 date: 2025-12 date: 2025-12 date: 2024-04-08 date: 2024-04-25 name: Iman Al-Naggar, PhD class: OTHER name: National Institute on Aging (NIA) name: American Urological Association name: Urology Care Foundation name: Claude D. Pepper Older Americans Independence Center (OAIC) briefSummary: The goal of this clinical trial is to test the effect of a supplement called MitoQ (mitoquinol mesylate) on bladder symptoms such as urgency and frequency in women aged 50-75 years old who have the metabolic syndrome. The main questions it aims to answer are:

* Is the study design feasible and acceptable to participants?
* Do participants taking the study drug get any improvement to their bladder symptoms compared to participants taking a placebo (a look-alike substance that contains no drug)?

Participants will take 2 capsules of the study drug every morning for 4 months, answer many questions about their health including questions about their bladder health, perform physical and cognitive testing, give blood and urine samples, collect urine over 24 hour periods 3 times over the 4 months of the study, complete 3 day bladder diaries about how much they drink and void, undergo electrocardiograms, have their vitals and measurements (weight, height, waist circumference) taken, participate in 4 visits to the clinical research area and participate in many phone calls of varying length. Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms (urgency, frequency, nocturia, incontinence, etc.) conditions: Lower Urinary Tract Symptoms conditions: Overactive Bladder Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blinded. Pharmacy will randomize and dispense capsules. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: MitoQ (mitoquinol mesylate) name: Placebo measure: Overactive Bladder Symptom Score (OABSS) measure: Three-day bladder voiding diary sex: FEMALE minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UConn Health status: RECRUITING city: Farmington state: Connecticut zip: 06030 country: United States name: Lisa Kenyon-Pesce role: CONTACT phone: 860-679-2305 email: kenyon-pesce@uchc.edu name: Peter C Albertsen, MD role: SUB_INVESTIGATOR name: George A Kuchel, MD role: SUB_INVESTIGATOR name: Jenna M Bartley, PhD role: SUB_INVESTIGATOR name: Oh Sung Kwon, PhD role: SUB_INVESTIGATOR lat: 41.71982 lon: -72.83204 hasResults: False

 nctId: NCT06351670 id: 1109/2024 briefTitle: Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression acronym: SUDETES overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-08 date: 2024-04-09 name: Medical University of Vienna class: OTHER name: University Medical Centre Ljubljana name: Centre Hospitalier Universitaire Dijon name: Queen's University, Belfast name: University of Zurich name: Vista Klinik name: Fundacion Clinic per a la Recerca Biomédica briefSummary: The goal of this prospective, multinational, multicenter observational study is to to predict conversion of early and intermediate AMD with functional vision to advanced AMD with irreversible loss of vision on an individual-based level over 2 years. The main objectives of this study are:

* Identify and quantify focal and global alterations in the retina in regard to disease progression.
* Assess the individual risk of disease progression in intermediate AMD patients converting to advanced AMD based on imaging.
* Specify the course of disease in regard to the sequence of events that lead to the conversion to advanced AMD
* Enhance the ability to classify AMD using artificial intelligence in addition to traditional models.

All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:

* Scanning Laser Fundus Photography
* Color Fundus Photography (CFP)
* Optical Coherence Tomography (OCT)
* Optical Coherence Tomography Angiography (OCTA) Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.

No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label. conditions: Age-Related Macular Degeneration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for conversion to advanced AMD. measure: To identify and quantify disease progression-related biomarkers measure: To evaluate monitoring of AMD progression assisted by AI algorithms sex: ALL minimumAge: 55 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351657 id: 1088/2024 briefTitle: Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression acronym: APENNINES overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-08 date: 2024-04-09 name: Medical University of Vienna class: OTHER name: University Medical Centre Ljubljana name: Centre Hospitalier Universitaire Dijon name: University of Zurich name: Vista Klinik name: Queen's University, Belfast name: Fundacion Clinic per a la Recerca Biomédica briefSummary: The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are:

* Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging.
* Identify and quantify focal and global alterations in the retina in regard to disease progression.
* Evaluate the monitoring of AMD progression using approved AI algorithms.

All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:

* Scanning Laser Fundus Photography
* Color Fundus Photography (CFP)
* Optical Coherence Tomography (OCT)
* Optical Coherence Tomography Angiography (OCTA)

Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.

No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label. conditions: Age-Related Macular Degeneration conditions: Geographic Atrophy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression measure: To identify and quantify disease progression-related biomarkers measure: To evaluate monitoring AMD progression using approved AI algorithms. sex: ALL minimumAge: 55 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351644 id: STUDY-24-00244 briefTitle: ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2028-06-05 date: 2028-06-05 date: 2024-04-08 date: 2024-04-08 name: Adriana Rossi class: OTHER briefSummary: Multiple myeloma (MM) is a malignancy characterized by uncontrolled proliferation of plasma cells for which there is an urgent and unmet need to develop new, effective therapeutics. Onconova Therapeutics has developed a first-in-class oral inhibitor of CDK4 and ARK5 ON 123300 (NARAZACICLIB) which shows potent anti-myeloma activity in vitro and in vivo in preclinical models, and is undergoing evaluation in Phase 1-2 trials worldwide.

In this study, the researchers will test the safety and preliminary efficacy of inhibition of CDK4 and ARK5 by ON 123300 (NARAZACICLIB) in combination with dexamethasone in myeloma patients in a Phase I/II clinical trial. conditions: Relapsed and/or Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single arm optimal biologic dose finding phase I/II clinical trial. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: ON 123300 name: Dexamethasone measure: Phase I: The optimal biological dose (OBD) of the combination of ON 123300 (NARAZACICLIB) and dexamethasone measure: Phase I: Dose-Limiting Toxicity (DLT) rate measure: Phase II: Overall response rates (ORR) measure: Number of Adverse events of Special Interest (AESI) measure: HbA1c measure: Fasting insulin levels measure: Lipid profiles measure: Free fatty acids measure: Best overall response (BOR) measure: Duration of Response (DOR) measure: Time to Progression (TTP) measure: Progression-Free Survival (PFS) measure: Disease Control Rate (DCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Health System city: New York state: New York zip: 10029 country: United States name: Adriana Rossi, MD role: CONTACT name: Katherine Vandris role: CONTACT email: Katherine.Vandris@mssm.edu name: Adriana Rossi role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06351631 id: 3543-017 id: 2023-506996-89 type: OTHER domain: EU CT id: U1111-1294-8621 type: OTHER domain: UTN id: MK-3543-017 type: OTHER domain: Merck ID briefTitle: A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017) overallStatus: NOT_YET_RECRUITING date: 2024-05-21 date: 2034-12-04 date: 2034-12-04 date: 2024-04-08 date: 2024-04-08 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:

* Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.

No hypothesis testing will be conducted in this study. conditions: Thrombocythemia, Essential conditions: Primary Myelofibrosis conditions: Myelofibrosis conditions: Post-polycythemia Vera Myelofibrosis conditions: Post-essential Thrombocythemia Myelofibrosis conditions: Polycythemia Vera studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Bomedemstat measure: Percentage of participants with one or more adverse events (AEs) measure: Percentage of participants who discontinued study treatment due to an AE measure: For participants with ET or PV: Duration of clinicohematologic response measure: For participants with ET or PV: Duration of hematologic remission measure: For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML measure: For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML measure: For participants with MF, ET, or PV: Percentage of participants with thrombotic events measure: For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events measure: For participants with MF, ET, or PV: Event-Free Survival (EFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351618 id: 2023-06114-01 briefTitle: Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-26 date: 2028-01-01 date: 2024-04-08 date: 2024-04-08 name: Lund University class: OTHER briefSummary: This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions. conditions: Sport Injury conditions: Ice-Skates Accident conditions: Sports Accident conditions: Female Athlete Triad conditions: Female studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: No intervention will be conducted. measure: Injuries per 1000 training hours measure: Injuries per 1000 game hours sex: FEMALE minimumAge: 16 Years maximumAge: 110 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Faculty of Medicine at Lund University status: RECRUITING city: Malmö zip: 20213 country: Sweden name: Amanda Lahti role: CONTACT phone: 0704854798 email: amanda.lahti@med.lu.se lat: 55.60587 lon: 13.00073 hasResults: False

 nctId: NCT06351605 id: CSP006 briefTitle: A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT) overallStatus: RECRUITING date: 2023-09-01 date: 2026-09 date: 2026-12 date: 2024-04-08 date: 2024-04-08 name: LumiThera, Inc. class: INDUSTRY briefSummary: The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively. conditions: Dry Age-related Macular Degeneration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 500 type: ESTIMATED name: Valeda Light Delivery System measure: Best-Corrected Visual Acuity (BCVA) measure: OCT Imaging measure: FAF Imaging sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo country: Norway name: Øygunn Utheim, MD role: CONTACT phone: +47 93692578 email: outheim@gmail.com lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06351592 id: ALN-SOD-ALS-2351 id: 2023-510344-20-00 type: REGISTRY domain: EU CT Number briefTitle: First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS) overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2029-04-28 date: 2029-04-28 date: 2024-04-08 date: 2024-04-08 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called ALN-SOD (called "study drug"). This study is focused on people with amyotrophic lateral sclerosis (ALS) who have a mutation in a gene called the superoxide dismutase-1 (SOD1) gene. This type of ALS is known as "SOD1-ALS". This is the first time that ALN-SOD will be given to people. The aim of the study is to see how safe and tolerable the study drug is.

The study is looking at several other research questions, including:

* The effect the study drug has on specific biomarkers, which are molecules in the blood or in the fluid that surrounds the brain and spinal cord, known as cerebrospinal fluid (CSF)
* How much study drug is in the blood and in the CSF, at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
* What effects the study drug has on ALS symptoms conditions: Amyotrophic Lateral Sclerosis (ALS) conditions: Mutation in the Superoxide Dismutase-1 (SOD1) Gene studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: No masking during Open-Label Treatment Period after 4-week Double-Blind Treatment Period. This part of the study consists of a crossover design. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: ALN-SOD name: Diluent name: Placebo (PB) measure: Incidence of treatment-emergent adverse event (TEAEs) in participants treated with ALN-SOD measure: Severity of TEAEs in participants treated with ALN-SOD measure: Concentration of SOD1 protein in cerebrospinal fluid (CSF) over time measure: Change in concentration of SOD1 protein in CSF over time measure: Concentration of neurofilament light chain (NfL) in plasma over time measure: Change in concentration of NfL in plasma over time measure: Concentration of NfL in CSF over time measure: Change in concentration of NfL in CSF over time measure: Concentration of ALN-SOD in plasma over time measure: Concentration of ALN-SOD in CSF over time measure: Incidence of anti-drug antibodies (ADAs) to ALN-SOD in serum over time measure: Titer of ADAs to ALN-SOD in serum over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351579 id: 1010159 briefTitle: Data Collection Post Radical Prostatectomy acronym: ALTO overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2025-12-30 date: 2026-03-15 date: 2024-04-08 date: 2024-04-08 name: Levee Medical, Inc. class: INDUSTRY name: RQMplus briefSummary: The study is to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP. conditions: Stress Urinary Incontinence conditions: Radical Prostatectomy conditions: BPH studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Control measure: The change in average 24-hour pad weight over time measure: Change in pad weight during a 1-hour provocative pad weight test measure: Expanded Prostate Index Composite (EPIC-26) score. sex: MALE minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351566 id: VD3, Prebiotics in Diabetes briefTitle: Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-12-31 date: 2025-12-31 date: 2024-04-08 date: 2024-04-22 name: Huazhong University of Science and Technology class: OTHER briefSummary: The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Vitamin D3 name: Prebiotics name: Vitamin D3 placebo name: Prebiotics placebo measure: Glycated hemoglobin (HbA1c) measure: Concentration of blood lipids measure: Metagenomic analysis of the gut microbiota measure: Concentration of fasting glucose measure: Concentration of fasting insulin measure: Systolic and diastolic blood pressure measure: Estimated glomerular filtration rate (eGFR) measure: Concentration of C-reactive protein (CRP) measure: Concentration of procalcitonin measure: Concentration of interleukin-6 (IL-6) measure: Concentration of serum 25(OH)D measure: Body weight measure: Waist circumference measure: Hip circumference sex: ALL minimumAge: 40 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351553 id: 2023-169 briefTitle: Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation acronym: EASy-PULSE AF overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-08 date: 2024-04-08 name: Hospital General Universitario de Alicante class: OTHER briefSummary: Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.

The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Pulmonary vein isolation exclusively with radiofrequency name: Pulmonary vein isolation exclusively with pulsed field ablation name: Combined pulmonary vein isolation measure: Efficacy primary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Procedure duration. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Laura García Cano city: Alicante zip: 03010 country: Spain lat: 38.34517 lon: -0.48149 hasResults: False

 nctId: NCT06351540 id: IRB00332797 id: R21DA056687 type: NIH link: https://reporter.nih.gov/quickSearch/R21DA056687 briefTitle: Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08-01 date: 2025-12-01 date: 2024-04-08 date: 2024-04-08 name: Johns Hopkins University class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users. conditions: Cannabis Use conditions: Impaired Driving conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: double-blind, placebo-controlled, within-subjects crossover design primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: placebo controlled, double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Cannabis measure: Commission Errors measure: Omission Errors measure: Reaction Time measure: Reaction Time Standard Error measure: Visuomotor Index measure: Saccade Speed measure: Visually Guided Oculomotor Performance measure: Antisaccade measure: Memory-Guided sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Johns Hopkins Behavioral Pharmacology Research Unit city: Baltimore state: Maryland zip: 21224 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06351527 id: ICP-CL-01202 briefTitle: Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2027-06-25 date: 2027-10-25 date: 2024-04-08 date: 2024-04-08 name: InnoCare Pharma Inc. class: INDUSTRY briefSummary: Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies conditions: Mature B-cell Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: ICP-248 measure: Maximum tolerated dose and/or recommended Phase 2 dose measure: To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351514 id: 2023/00745 briefTitle: An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms acronym: NOBLE-TMS overallStatus: RECRUITING date: 2024-04-01 date: 2026-09 date: 2026-09 date: 2024-04-08 date: 2024-04-08 name: Institute of Mental Health, Singapore class: OTHER briefSummary: Schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms. Negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far. Neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent Theta Burst Stimulation (iTBS) to treat negative symptoms in schizophrenia. In this study, we aim to examine the effectiveness of an accelerated iTBS treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms.

We propose a pragmatic, open label and single arm clinical trial. Forty patients with diagnosis of schizophrenia, who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days. Participants will be followed up immediately, 1 month and 3 months after the end of treatment. Clinical assessment includes, BNSS, The Brief Negative Symptom Scale; SANS, Scale for the assessment of negative symptoms; SAPS, Scale for the assessment of positive symptoms; PANSS, Positive and Negative Symptoms Scale; MoCA, Montreal Cognitive Assessment scale; CDSS, Calgary Depression Scale for Schizophrenia: SDS, Sheehans' disability scale and EQ-5D. The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS, negative symptoms subscale immediately after the treatment.

This study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms. The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need. conditions: Schizophrenia; Negative Type studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Accelerated iTBS measure: Change of Negative symptoms measure: Trend of Negative symptoms sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Mental Health status: RECRUITING city: Singapore zip: 539747 country: Singapore name: Jenny Tay role: CONTACT email: jenny_am_tay@imh.com.sg lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06351501 id: P170923J id: 2019-000300-16 type: EUDRACT_NUMBER briefTitle: Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria acronym: TRANSADO overallStatus: NOT_YET_RECRUITING date: 2024-06-06 date: 2029-06-06 date: 2031-06-06 date: 2024-04-08 date: 2024-04-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, regarding the gap felt between gender identity of someone and birth sex. From the start of puberty, most of these adolescents who identify as transgender will persist in this sense and will engage in hormonal-surgical reassignment at some stage. For these adolescents, International recommendations for good practice recommend early treatment at the beginning of pubertal development (Tanner 2) to block pubertal progression, with the possibility of hormonal transition by administration of sex hormones of the desired sex at the age of 16. However, in order to reduce the psychosocial consequences of GD, more and more reference teams are practicing this hormonal transition from the age of 14 without any randomized study showing its benefit compared to a transition at the age of 16 years old. Indeed, in the absence of treatment, comorbidities among adolescents suffering from gender dysphoria is very high, with anxiety and depression, suicidal risk and school dropout.

Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be, it will reduce comorbidities and improve quality of life of these adolescents. This is the first therapeutic randomized study in France on this transgender adolescent population, a field where international recommendations based on "Evidence Based Medicine" principles are scared. We hope that results of this study will guide transgender youth health care allowing them, if the study is positive, to access hormonal treatments earlier and improve their overall functioning, their anxious and depressive symptoms, their quality of life. conditions: Cross Sex Hormonal Treatment in Adolescents With Gender Dysphoria studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicentric, controlled, randomized, open trial with blinded assessment of the primary outcome measure (Prospective Open Blinding Endpoint PROBE study) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The evaluation of the main criterion by the CGAS will be administered by a psychologist trained on this scale who will not have knowledge of the adolescent's attribution group and will not have participated in their care, based on elements keys to the patient's file which will be provided to him without any element that could indicate his group to which he belongs or his original sex, and a telephone interview with the adolescent and with his parents where they will have been previously informed not to not reveal the group to which they belong or the sex of origin. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months name: Cross sex hormones ( œstrogenes or testosterone) started at 16 years old +/- 6 months measure: Global functionning using the Children's Global Assessment Scale (CGAS) measure: DEP-ADO measure: WISC-V (weschler Test) measure: UGDS (Utrecht Gender Dysphoria Scale ) measure: Beck Depression Inventory (BDI) measure: Body Image Scale (BIS) measure: State and Anxiety Inventory for Children (STAI-C) measure: CBCL (Youth Self Report YSR) Child Behaviour Chekcklist measure: World Health Organization Quality Of Life (WHO QOL) measure: Satisfaction With Life Scale (SWLS) measure: Adolescent Depression Rating Scale (ADRS) measure: Mini International Neuropsychiatric Interview (MINI) measure: Inventory of Parents and Peers Attachment (IPPA) sex: ALL minimumAge: 14 Years maximumAge: 14 Years stdAges: CHILD hasResults: False

 nctId: NCT06351488 id: APHP231661 briefTitle: Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection acronym: DART-RREGREF overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2026-02-11 date: 2026-02-11 date: 2024-04-08 date: 2024-04-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: CGenetix name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: In France, 3,500 kidney transplants are carried out per year; and 40,000 people succeed in 2019 with a kidney transplant. Despite regular medical monitoring, nearly 30% of transplant patients will develop rejection. Currently, only solid biopsy of the graft makes it possible to establish the diagnosis of graft rejection, and to characterize its cellular origin based on the Banff classification.

Several studies have shown the possibility of identifying the tissue origin of DNA circulating in the blood, in healthy subjects, on the basis of the epigenetic properties of circulating DNA. In addition, in kidney transplant subjects, an increase in the quantity of circulating DNA originating from the graft in the blood and urine has been shown as well as an increase in urinary chemokine levels during renal dysfunction (notably dismiss). Thus, the company CGenetix in partnership with INSERM units 1155 and 1151 is developing a method to identify and characterize kidney transplant rejection early, through the detection of epigenetic biomarkers on circulating DNA targeting different fractions of the kidney (glomerular, tubular, peritubular capillary and vascular). The main objective is to study the diagnostic performance of the quantity of DNA of renal origin in kidney transplant patients in the blood and in the urine (expressed in copies/ml) for the diagnosis of type Rejection mediated by kidneys. antibody (ABMR) established by kidney graft biopsy (gold standard) and according to the Banff 2022 classification. conditions: Kidney Transplant Patients Eligible for a Solid Biopsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 319 type: ESTIMATED measure: The area under the ROC curve of ABMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of TCMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of mixed rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of glomerulitis-type rejection prediction models (≥g1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of tubulitis-type rejection prediction models (≥t1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of vascularitis-type rejection prediction models (≥v1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: The area under the ROC curve of capillaritis-type rejection prediction models (≥ptc1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest measure: Areas under the ROC curve of rejection prediction models according to renal biopsy and with as covariates of interest the quantities of urinary chemokines (CXCL9 and CXCL10) determined by ELISA and expressed in pg/mL in urine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351475 id: APHP230864 briefTitle: Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy acronym: ALBUCHIP overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-10 date: 2026-10 date: 2024-04-08 date: 2024-04-23 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.

Methods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.

Recruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence.

Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.

Intervention

* 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.
* Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned.

Outcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28

Sample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study.

Discussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery. conditions: Peritoneal Neoplasms conditions: Hyperthermic Intraperitoneal Chemotherapy conditions: Intraoperative Care conditions: Fluid Therapy conditions: Postoperative Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 146 type: ESTIMATED name: Intra-operative albumin administration name: Control measure: Comprehensive Complication Index score measure: Mortality measure: Comprehensive Complication Index score measure: Volume of intra operative and post operative fluid therapy measure: Cumulative incidence of surgical post operative complications measure: Cumulative incidence of medical post operative complications measure: Need for mechanical ventilation measure: Need for renal replacement therapy measure: Sequential organ failure assessment (SOFA) score variation measure: Number of days alive out of intensive care unit measure: Number of days alive out of hospital sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351462 id: APHP200008 briefTitle: Comparative Health Status and Quality of Life of Patients With Sickle Cell Disease (SCD) Who Underwent Matched-sibling Hematopoietic Stem Cell Transplantation Versus Non Transplanted SCD Case-control Patients acronym: TRANSPLANTORN2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-05-01 date: 2024-04-08 date: 2024-04-19 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The long term burden of morbidity and mortality in the natural history of sickle cell disease has not been compared up to date to the risks and mortality of a curative option like bone marrow transplantation in severe sickle-cell disease patients. Given this lack of data, primary-care Sickle Cell Disease (SCD) physicians and transplant physicians are prevented from a factual debate over the benefit/risk ratio for each patient and refining indications of transplant in patients. Therefore, the present study seeks to describe and compare the very long-term outcomes after either Human Leukocyte Antigen (HLA) -matched sibling transplantation (study arm) and "non-transplant care" for severe sickle cell disease SCA patients in order to yield robust comparative data regarding both arms.

The main objective is to assess the benefit of Hematopoietic stem cell transplantation (HSCT) regarding quality of life compared to standard care after 10 years, in patients with severe Sickle Cell Disease (SCD). conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 220 type: ESTIMATED name: Spermogram name: Hospital Anxiety and Depression Scale (HADS) name: SF36 Quality of life questionnaire name: Psychologist interview name: Optional sera banking name: Optional DNA banking measure: Evaluation of quality of life assessed by SF36 measure: Evaluation of gonadal function measure: Evaluation of quality of life measure: Proportion of patients with anxiety and depression sex: ALL minimumAge: 15 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351449 id: 69HCL22_0489 briefTitle: Characterization of Visual Characteristics in Allergic Contact Dermatitis Using the Skincam® Tool acronym: PatchCam overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2027-04-30 date: 2024-04-08 date: 2024-04-08 name: Hospices Civils de Lyon class: OTHER briefSummary: Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries.

The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. It requires experienced medical staff to read the reaction.

Newtones Technologies society has developed a new tool, the SkinCam®, able to capture high resolution cross and parallel images, allowing a quantification of color and relief of skin.

This study aims to illustrate patch test results, describing skin appearance (color, roughness, shine), using photographs taken by the SkinCam®. conditions: Allergic Contact Dermatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: The patch under study is photographed using the SkinCam® measure: To highlight characteristics of allergic contact dermatitis (ACD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351436 id: TBC20240402 briefTitle: Virtual Reality Cave Experience With Mindfulness for Mental Wellbeing overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-08 date: 2024-04-08 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The aim of this study is to investigate the effectiveness of a mindfulness-based intervention using a virtual reality cave system for promoting mental wellbeing in youths. The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counselling. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training.

A single-group pre-post uncontrolled design will be employed. Evaluations will be conducted at baseline (0 weeks) and post-intervention (3 months). conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-group non-randomized uncontrolled trial primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Mindfulness measure: Mental Well-Being in Youths measure: Stress Level in Youths measure: Feasibility of Eligibility and Enrollment measure: Feasibility of Attendance Rate measure: Feasibility of Retention Rate sex: ALL minimumAge: 11 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06351423 id: HE-NHS2023/03 briefTitle: The Effectiveness of MIND Diet and Forest Bathing on Stress Reduction overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-08-31 date: 2024-11-30 date: 2024-04-08 date: 2024-04-23 name: Hong Kong Metropolitan University class: OTHER briefSummary: This clinical trial aims to explore the effectiveness of the Mediterranean DASH Intervention for Neurodegenerative Delay (MIND) diet and Forest Bathing (FB) in reducing psychological stress among older Chinese individuals. The main questions it aims to answer are:

1. what is the effect of FB on stress reduction
2. what is the effect of MIND on stress reduction

Participants of the MIND-FB group will participate will receive

1. FB: a two-hour FB session on four consecutive weekends in a country park,
2. MIND: four nutrition sessions, and adhere to the MIND diet for 12 weeks

Researchers will compare the FB and routine care groups to compare the effectiveness of MIND and FB in reducing psychological stress. conditions: Anxiety conditions: Depression conditions: Stress conditions: Psychological Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a 3-arm randomized controlled study in a parallel design. Eligible participants will be randomly assigned into 3 interventions: (1) FB-MIND, (2) FB and (3) routine care-control. primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Forest Bathing (FB) name: MIND diet measure: Emotional states measure: Systolic Blood Pressure (SBP) measure: Salivary Cortisol sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hong Kong Metropolitan University city: Hong Kong country: Hong Kong name: Fabian Ling Ngai Tung, PhD role: CONTACT phone: 85239708732 email: ftung@hkmu.edu.hk name: Fabian Ling Ngai Tung, PhD role: PRINCIPAL_INVESTIGATOR name: Queenie Pui Sze Law, PhD role: SUB_INVESTIGATOR name: Katherine Ka Yin Yau, DHsC role: SUB_INVESTIGATOR name: Sam Kit San Yuen role: SUB_INVESTIGATOR name: Eric Tsz Fai Chan role: SUB_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06351410 id: JEP 2023-679 briefTitle: Assessment of Tear Production, Corneal Staining, and Comfort Level Wearing Different Types of Contact Lenses overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-07-30 date: 2025-02-28 date: 2024-04-08 date: 2024-04-19 name: National University of Malaysia class: OTHER briefSummary: This research assesses the tear performance of five distinct types of soft contact lenses commonly found in the market. The study involves contact lens participants, all of whom are students enrolled at UKM. Before the study, participants were instructed to discontinue wearing their usual contact lenses for two weeks. The lenses utilized in this clinical trial all possess current refractive power. Participants are required to wear the lenses for an entire day only. Upon completion of the study, participants will be requested to complete a brief questionnaire. conditions: Dry Eye conditions: Dry Eye Syndromes conditions: Contact Lens-induced Corneal Fluorescein Staining studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 18 participants will be fitted with 2 types of lenses on either eye at one time. There will be a 2-week wash-off period before another 2 set of fittings with another 4 types of lenses. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: The 6 types of Contact Lenses used will be labeled as A, B, C, D, E, and F by a co-investigator and will be fitted on the participant's eye randomly. count: 18 type: ESTIMATED name: Eye Wearing Contact Lens measure: To assess the quantity of tears in eyes wearing contact lenses measure: To asess the quality of tears in eyes wearing contact lenses measure: To assess corneal staining in eyes wearing contact lenses measure: To assess comfort level of participants using CL Discomfort Index Questionaire sex: ALL minimumAge: 19 Years maximumAge: 29 Years stdAges: ADULT facility: Optometry Clinic city: Kuala Lumpur zip: 50300 country: Malaysia lat: 3.1412 lon: 101.68653 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-04-02 uploadDate: 2024-04-01T23:49 filename: Prot_000.pdf size: 837117 hasResults: False

 nctId: NCT06351397 id: 75021 briefTitle: Immersive Mixed Reality Simulation to Evoke Empathy acronym: Empathy overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06-30 date: 2025-06-30 date: 2024-04-08 date: 2024-04-12 name: Stanford University class: OTHER briefSummary: This is a quantifiable study evaluating the ability of a mixed reality (MR), immersive simulation experience to evoke empathy in anesthesiology trainees. Quantitative methodologies will be employed using standardized questionnaires including the The Jefferson Scale of Physician Empathy for Health Professions Students, (HP-version). Trainees will assess their preliminary, baseline empathy using the Jefferson Scale and after the simulation and debrief, will reassess empathy scores, once again using the Jefferson Scale. A satisfaction survey to assess simulated patient embodiment as a valuable exercise and contributor to empathy education curriculum. conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 250 type: ESTIMATED name: Mixed Reality (MR) measure: Changes in self-reported empathy from before and after the simulation measure: Satisfaction of Design Features of the Simulation measure: Evaluation of the CHARM system's usability measure: Evaluation of the CHARM system's ergonomics sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lucile Packard Children's Hospital Stanford city: Palo Alto state: California zip: 94303 country: United States name: Astrid Suen, MMedSc role: CONTACT email: msuen@stanfordchildrens.org name: Thomas Caruso, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False

 nctId: NCT06351384 id: 20230744 briefTitle: Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: Sir Run Run Shaw Hospital class: OTHER briefSummary: This is a prospective, observational cohort study to establish the minimal residual disease (MRD) model for predicting relapse risk and identifying disease recurrence in patients with colorectal adenocarcinoma based on the miRNA platform.

Blood miRNA markers will be evaluated. The study will enroll approximately 600 participants, including participants with malignancies or benign diseases, and healthy participants. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: miRNA detection test measure: Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351371 id: NCI-2024-01153 id: NCI-2024-01153 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-K2 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-K2 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2) overallStatus: ACTIVE_NOT_RECRUITING date: 2018-06-19 date: 2024-06-30 date: 2024-06-30 date: 2024-04-08 date: 2024-04-08 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well erdafitinib (JNJ-42756493) works in treating patients with tumors that have FGFR mutations or fusions. Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them. conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Erdafitinib name: Magnetic Resonance Imaging measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06351358 id: GLI.04.US.SL.036 briefTitle: Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies overallStatus: RECRUITING date: 2024-02-19 date: 2024-10-31 date: 2024-10-31 date: 2024-04-08 date: 2024-04-11 name: Galderma R&D class: INDUSTRY briefSummary: Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies. conditions: Photoaging conditions: Weight Loss conditions: Skin Laxity conditions: Photodamaged Skin conditions: Volume Deficiency of the Midface studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Sculptra treatment name: Restylane Treatment measure: Change in skin hydration from baseline measure: Change in skin radiance from baseline measure: Change in skin elasticity from baseline measure: Change in skin thickness from baseline measure: Subject Treatment Satisfaction sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Somenek + Pittman MD: Advanced Plastic Surgery status: ENROLLING_BY_INVITATION city: Washington state: District of Columbia zip: 20037 country: United States lat: 38.89511 lon: -77.03637 facility: Lorenc Aesthetic Plastic Surgery Center status: RECRUITING city: New York state: New York zip: 10028 country: United States name: Paul Lorenc, MD role: CONTACT phone: 212-472-2900 email: lorenc@lorenc.com name: Allison Bonugli role: CONTACT email: allison@lorenc.com name: Paul Z Lorenc, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06351345 id: Pro00115215 briefTitle: 129 Xenon Imaging in Patients Treated With Sotatercept acronym: Sox-PH overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2025-08-01 date: 2024-04-08 date: 2024-04-08 name: Bastiaan Driehuys class: OTHER name: Merck Sharp & Dohme LLC briefSummary: Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH). conditions: Pulmonary Hypertension conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 14 type: ESTIMATED name: 129Xe Hyperpolarized measure: Change in Xenon MRI Red Blood Cell (RBC) percentage measure: Change in cardiogenic oscillation amplitudes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University Medical Center city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06351332 id: 24-005 briefTitle: A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT) overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-03-01 date: 2029-09-01 date: 2024-04-08 date: 2024-04-08 name: Filipa Lynce, MD class: OTHER name: Merck Sharp & Dohme LLC name: Zentalis Pharmaceuticals briefSummary: This research is being done to evaluate the safety and effectiveness of a drug currently known as Azenosertib (ZN-C3) in combination with the drugs carboplatin and pembrolizumab in metastatic triple-negative breast cancer.

The names of the study drugs involved in this study are:

* Azenosertib (a type of WEE1 inhibitor)
* Carboplatin (a type of platinum compound)
* Pembrolizumab (a type of monoclonal antibody) conditions: Breast Cancer conditions: Breast Cancer Female conditions: Triple Negative Breast Cancer conditions: Hormone Receptor Negative Malignant Tumor Breast Triple conditions: HER2-negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 78 type: ESTIMATED name: Azenosertib name: Carboplatin name: Pembrolizumab measure: Number of Participants Experiencing Dose Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Objective Response Rate (ORR) measure: Clinical Beneficial Rate (CBR) measure: Median Progression Free Survival (PFS) measure: Median Overall Survival (OS) measure: Duration of Response (DOR) measure: Grade 3-5 Treatment-Related Toxicity Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Filipa Lynce, MD role: CONTACT phone: 617-632-3800 email: Filipa_Lynce@DFCI.HARVARD.EDU name: Filipa Lynce, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06351319 id: HenanPPH-zhangquncheng briefTitle: Endobronchial Ultrasound-based SVM Model for Differentiating Benign and Malignant Mediastinal and Hilar Lymph Nodes overallStatus: COMPLETED date: 2018-01-01 date: 2023-12-01 date: 2024-04-01 date: 2024-04-08 date: 2024-04-08 name: Quncheng Zhang class: OTHER briefSummary: ABSTRACT Background and objective: To establish a ultrasound radiomics machine learning model based on endobronchial ultrasound (EBUS)to assistdoctors in distinguishing between benign and malignant diagnoses ofmediastinal and hilar lymph nodes.

Methods: The clinical and ultrasonic image data of 197 patients wereretrospectively analyzed. The radiomics features were extracted by EBUS.based radiomics and dimensionality reduction was performed on thesefeatures by the least absolute shrinkage and selection operator (LASSO)EBUS-based radiomics model was established by support vector machine(SVM).205 lesions were randomly divided into a training group (n=143)and a validation group (n=62). The diagnostic efficiency was evaluated byreceiver operating characteristic (ROC).Results: A total of 13 stable features with non-zero coefficients wereselected. The support vector machine (SV) model exhibited promisingperformance in both the training and verification groups. In the traininggroup, the SVM model achieved an area under the curve (AUC) of 0.892(95% CI: 0.885-0.899), with an accuracy of 85.3%, sensitivity of 93.2%and specificity of 79.8%.In the verification group, the SVM modeldemonstrated an AUC of 0.906 (95% C: 0.890-0.923),along with anaccuracy of 74.2%,sensitivity of 70.3%, and specificity of 74.1% Conclusion:EBUS-based radiomics model can be used to differentiatemediastinal and hilar benign and malignant lymph nodes. The SVM modeldemonstrates superiority and holds potential as a diagnostic tool in clinical practice conditions: Benign and Malignant Lymph Nodes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 197 type: ACTUAL name: SVM model measure: AUC measure: accuracy measure: sensitivity measure: specificity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Respiratory and Critical Care Medicine city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06351306 id: AAAU5915 briefTitle: DEC-C and Thioguanine for R/R AML overallStatus: RECRUITING date: 2024-01-30 date: 2027-12 date: 2027-12 date: 2024-04-08 date: 2024-04-08 name: Joseph Jurcic class: OTHER briefSummary: The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory).

This is a "phase II trial with a safety lead-in." The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe. If too many serious side effects are seen with the dose previously studied, some additional patients may be treated with a lower dose to make sure that this dose is safe. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Thioguanine (Tabloid ®) name: DecitabineCedazuridine (Inqovi ®) measure: Composite Complete Remission (CRc) Rate measure: Duration of Remission measure: Time to Complete Remission (CR) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Columbia University status: RECRUITING city: New York state: New York zip: 10032 country: United States name: Research Nurse Navigator role: CONTACT phone: 212-342-5162 email: cancerclinicaltrials@cumc.columbia.edu name: Joseph G. Jurcic, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06351293 id: GLI.04.US.SL.034 briefTitle: A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction overallStatus: ENROLLING_BY_INVITATION date: 2024-02-21 date: 2025-02-28 date: 2025-02-28 date: 2024-04-08 date: 2024-04-11 name: Galderma R&D class: INDUSTRY briefSummary: This is a randomized, split-face, subject-blinded, comparative study. Subjects will receive initial treatment with Defyne on one of the NLFs and with RHA3 on the other based on the pre-determined randomization.

4 weeks after the initial treatment, subjects will receive optional touch-up on one side or both sides at the Investigator's discretion for optimal correction.

Subjects to return to the site at Month 3, 6, and 12 for follow-ups. conditions: Wrinkle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Subjects will be blinded to the treatment assignment, in which randomization and treatment side will be concealed in order to avoid bias in subjective assessment. The clinic staff will mask the product identity by covering the packaging and product name (e.g., using tape, marker, wipe-out, etc.) so that it is not visible to the subjects. The Investigator will not be blinded. whoMasked: PARTICIPANT count: 15 type: ESTIMATED name: Defyne Treatment in Nasolabial Fold name: RHA3 Treatment in Nasolabial Fold measure: Visual Comparison of Nasolabial Fold Ultrasounds measure: Volume Change Imaging Analysis sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Aesthetic Clinique city: Santa Rosa Beach state: Florida zip: 32459 country: United States lat: 30.39603 lon: -86.22883 hasResults: False

 nctId: NCT06351280 id: Sana Nasir Zaidi briefTitle: Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-04-08 date: 2024-04-08 name: Riphah International University class: OTHER briefSummary: A laparotomy is a surgical technique, the increasing rate of this surgical interventions and the subsequent need to evaluate the post-surgical recovery and rehabilitation process comprehensively. This study aims to provide essential insights into the reliability, validity, and responsiveness of such tests, enabling healthcare professionals to make informed decisions about patient recovery progress and the optimization of rehabilitation protocols. conditions: Laparotomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Standardised Physiotherapy Plan measure: 6MWT (Six-Minute Walk Test) measure: 5 Times Sit to Stand measure: 2MWT (Two-Minute Walk Test) measure: Timed Up and GO (TUG) sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Fauji Foundation Hospital city: Rawalpindi state: Punjab zip: 00666 country: Pakistan name: Suman Sheraz, PhD* role: CONTACT phone: 03335646361 email: suman.sheraz@riphah.edu.pk name: Sana Nasir, MS-CPPT* role: SUB_INVESTIGATOR name: Suman Sheraz, PhD* role: PRINCIPAL_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06351267 id: REC/RCR & AHS/23/0568 briefTitle: Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain. overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-10-01 date: 2024-10-15 date: 2024-04-08 date: 2024-04-08 name: Riphah International University class: OTHER briefSummary: The study will be a Randomized controlled trial to check the combined effects of Core Stability Exercises with and without Back strengthening exercises in females with pregnancy-induced back pain, disability, and function so that we can examine the effect of the above techniques on pain, disability and function in pregnant females Non-probability convenience sampling technique will be used, subject following eligibility criteria from Society Hospital Nabipura Lahore will be randomly allocated in two groups. Group A participants will be given core stability exercises with back strengthening exercises, Group B participants will be given core stability exercises for 4 weeks. Assessment will be done via, Numeric Pain Rating Scale, Oswestry disability index questionnaire and Back pain Functional Scale. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: Core Stability Exercises name: Back Strengthening exercises measure: Numeric Pain Rating Scale measure: Oswestry Disability Index Questionnaire measure: Back Pain Functional Scale (BPFS): sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Society Hospital Nabipura city: Lahore state: Punjab zip: 54700 country: Pakistan name: Ghulam Fatima, PhD* role: CONTACT phone: +923034073057 email: ghulam.fatima@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06351254 id: REC/RCR & AHS/23/01101nayab briefTitle: Kinesthetic Exercises and Sine Sound Waves in Cervical Spondylosis overallStatus: RECRUITING date: 2023-11-20 date: 2024-06-01 date: 2024-06-01 date: 2024-04-08 date: 2024-04-08 name: Riphah International University class: OTHER briefSummary: The goal of this Randomized control trial is to determine the Effect of kinesthetic exercises and sound waves on pain, ROM, shoulder alignment and disability in cervical spondylosis. The main question it aims to answer is:

Weather sine sound and kinesthetic exercise are effective in management of pain, rom, alignment, and disability in patients that are suffering from cervical spondylosis conditions: Cervical Spondylosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Sine sound waves name: Kinesthetic exercises name: Sine sound waves plus kinesthetic exercises measure: NPRS measure: Inclinometer measure: Goniometer measure: NDI sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Riphah international university status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Muhammad Sanaullah role: CONTACT phone: 03224819253 email: muhammad.sanaullah@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06351241 id: E.222840/280 briefTitle: Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum overallStatus: COMPLETED date: 2022-11-29 date: 2023-04-14 date: 2023-04-14 date: 2024-04-08 date: 2024-04-08 name: Ege University class: OTHER briefSummary: BACKGROUND: The steep Trendelenburg position and pneumoperitoneum are used to improve surgical visibility in robot-assisted laparoscopic radical prostatectomy (RALRP). However, these procedures can lead to hemodynamic changes. This study aimed to investigate the effects of these interventions on the perfusion index (PI) and the Pleth variability index (PVI) in patients undergoing RALRP under general anesthesia.

METHODS: Fifty-three patients scheduled for RALRP underwent standard monitoring; PI and PVI values were monitored using a finger probe. PI, PVI, hemodynamic and respiratory parameters, and intraabdominal pressure were recorded before and after anesthesia induction, after adopting the Trendelenburg position, after pneumoperitoneum, after pneumoperitoneum and the Trendelenburg position, at 15 min, 30 min, in the supine position, after carbon dioxide (CO2) desufflation, and after extubation. conditions: Perfusion Index conditions: Pleth Variability Index studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 53 type: ACTUAL measure: Hemodynamic effects of steep trendelenburg position and pneumoperitoneum in urologic robotic surgery sex: MALE minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nursen Karaca city: Bornova state: İzmir zip: 35040 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False

 nctId: NCT06351228 id: 5720 briefTitle: Fertility-sparing in Early-stage Cervcial Cancer: The ETERNITY Project acronym: Eternity overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-12-31 date: 2024-12-31 date: 2024-04-08 date: 2024-04-08 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER briefSummary: The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer.

The primary aim is to report outcomes of those patients.

Other aims included:

1. Evaluation about the effectiveness of different treatment modalities;
2. Evaluation of outcomes according to different stages of disease;
3. Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery conditions: Cervical Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Conization plus nodal evaluation measure: oncological outcomes sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano city: Milano state: Lombardia zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06351215 id: APP-24-00554 briefTitle: PO Methadone Ortho Outpatient overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-01 date: 2024-12-15 date: 2024-04-08 date: 2024-04-08 name: Keck School of Medicine of USC class: OTHER briefSummary: The goal of this clinical trial is to learn if oral methadone given before surgery works to minimize post-operative pain and opioid usage. The main questions it aims to answer are:

Does oral methadone improve post-operative pain scores as compared to standard treatment? Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment?

Researchers will compare oral methadone to a placebo (a look-alike substance that contains no drug) to assess the questions above.

Participants will:

Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologist's discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery conditions: Arthroscopic Knee Repair conditions: Arthroscopic Hip Repair studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Methadone group name: Placebo measure: Post-op opioid usage measure: Post-op Pain Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USC Healthcare Consultation 3 city: Los Angeles state: California zip: 90033 country: United States name: Alexander Chen, M.D. role: CONTACT phone: 323-442-7400 email: painmed@usc.edu name: Abigail Song, B.S. role: SUB_INVESTIGATOR name: Benjamin Liu, M.D. role: SUB_INVESTIGATOR name: Paul Lee, M.D., M.S. role: SUB_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06351202 id: RBGP 2023 COLNE id: 2023-A02256-39 type: OTHER domain: ANSM briefTitle: Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms acronym: PREMABDO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-06 date: 2024-04-08 date: 2024-04-10 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea - WA), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, expressed by abdominal distension, regurgitation, irregular transit and abdominal discomfort. It can influence the length of hospitalization and lead to necrotising enterocolitis, a major complication.

At the Clermont-Ferrand University Hospital Center, abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants. The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective.

In this context, the investigators carried out a first study to validate a scale that they created (ECAP scale : Clinical Assessment Scale for Abdominal state of Preterm infant) to assess in a rapid, reliable and reproductible manner the abdominal state of preterm infant - data currently being published). This scale can pose the indications for abdominal massage more objectively.

The hypothesis is that abdominal massage improves feeding tolerance (decrease ECAP score), allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants.

The aim of the study is to assess the effectiveness of abdominal massage, over a period of 14 days, on the feeding tolerance of preterm infants (under 34 weeks of amenorrhea), defined by the achievement and maintenance of an ECAP score less than 4 during 3 days. conditions: Preterm Birth Complication conditions: Digestive System Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Abdominal massage measure: Clinical Abdominal assessment scale for Preterm infants score (ECAP score) measure: Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes measure: Weight gain of preterm infants with feeding intolerance measure: Duration to reach the full ration measure: Duration of hospitalization in level 3 measure: 6-hour fasting windows measure: Incidence of occurrence of necrotizing enterocolitis measure: Evolution of digestive tolerance over time sex: ALL minimumAge: 3 Days maximumAge: 60 Days stdAges: CHILD facility: CHU clermont-ferrand city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 hasResults: False

 nctId: NCT06351189 id: CIVI/2022/AD-01 briefTitle: NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements ? acronym: DYNAMIC SYSTEM overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-06-01 date: 2026-08-01 date: 2024-04-08 date: 2024-04-08 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: This study compares two modes of the NETTI wheelchair (dynamic or sitting) for patients with hyperkinetic syndromes, to discover which mode is the most comfortable and best suited to these patients.

It is a prospective, single-center pilot study comparing two medical devices evaluated using SCED (Single Case Experimental Design) ABAB methodology: NETTI DYNAMIC chair in dynamic mode (intervention group; phase B) versus the same chair in static mode (control group; phase A). The subject will be his/her own control conditions: Hyperextension Spasms conditions: Involuntary Movements studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 5 type: ESTIMATED name: Observation measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in static mode (PHASE A) measure: Forward slippage in dynamic mode (PHASE B) measure: Forward slippage in dynamic mode (PHASE B) measure: Forward slippage in dynamic mode (PHASE B) measure: Forward slippage in dynamic mode (PHASE B) measure: Peak force in static mode (PHASE A) measure: Peak force in static mode (PHASE A) measure: Peak force in static mode (PHASE A) measure: Peak force in static mode (PHASE A) measure: Peak force in dynamic mode (PHASE B) measure: Peak force in dynamic mode (PHASE B) measure: Peak force in dynamic mode (PHASE B) measure: Peak force in dynamic mode (PHASE B) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in static mode (PHASE A) measure: Maximum downward force in dynamic mode (PHASE B) measure: Maximum downward force in dynamic mode (PHASE B) measure: Maximum downward force in dynamic mode (PHASE B) measure: Maximum downward force in dynamic mode (PHASE B) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in static mode (PHASE A) measure: Patient's comfort in dynamic mode (PHASE B) measure: Patient's comfort in dynamic mode (PHASE B) measure: Patient's comfort in dynamic mode (PHASE B) measure: Patient's comfort in dynamic mode (PHASE B) measure: Caregiver's comfort in static mode (PHASE A) measure: Caregiver's comfort in dynamic mode (PHASE B) measure: Caregiver's comfort in dynamic mode (PHASE B) measure: Caregiver's comfort in dynamic mode (PHASE B) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in static mode (PHASE A) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Number of repositionings required in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in static mode (PHASE A) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in static mode (PHASE A) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B) measure: Sex measure: Age measure: Height measure: Weight measure: Body mass index sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351176 id: 2024-6819 briefTitle: Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes acronym: DenSiFy cohort overallStatus: ENROLLING_BY_INVITATION date: 2023-07-04 date: 2024-12-22 date: 2025-08-29 date: 2024-04-08 date: 2024-04-08 name: CHU de Quebec-Universite Laval class: OTHER name: Diabetes Canada briefSummary: Background : Type 1 diabetes (T1D) is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. As T1D is often diagnosed in childhood or early adulthood, the lower bone mineral density (BMD) and deteriorated bone microarchitecture observed in T1D may reflect changes in the bone that occurred before or at the time of peak bone mass achievement. There is a lack of high-quality prospective studies to determine whether adults with T1D continue to lose BMD or deteriorate bone quality compared with controls. Moreover, while chronic hyperglycemia is a risk factor for fracture in T1D, it is unknown if better glycemic control affects bone outcomes.

This prospective multicenter cohort study aims: (1) To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age, sex and body-mass index distribution: BMD by dual-energy X-ray absorptiometry (DXA) at the femoral neck, hip, spine, and radius, trabecular bone score (TBS) by DXA, and serum biochemical markers of bone turnover (BTMs); (2) To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D. conditions: Diabetes Mellitus, Type 1 conditions: Bone Health conditions: Bone Loss conditions: Bone Diseases, Metabolic conditions: Hyperglycaemia Due to Type 1 Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 163 type: ESTIMATED name: Clinical tests name: Biochemical tests name: DXA scan with TBS and VFA name: AGEReader measure: Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2 measure: Change in areal bone mineral density (aBMD) at the spine in g/cm2 measure: Change in areal bone mineral density (aBMD) at the total hip in g/cm2 measure: Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2 measure: Change in Trabecular bone score (TBS) (unitless) measure: Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years measure: Glycemic control, assessed with skin advanced glycation end products (AGEs) measure: Presence of a microvascular complication (neuropathy, nephropathy, retinopathy) measure: Areal bone mineral density at the femoral neck, g/cm2 measure: Areal bone mineral density at the femoral neck, T-Score measure: Areal bone mineral density at the femoral neck, Z-Score measure: Areal bone mineral density at the total hip, g/cm2 measure: Areal bone mineral density at the total hip, T-score measure: Areal bone mineral density at the total hip, Z-score measure: Areal bone mineral density at the spine, g/cm2 measure: Areal bone mineral density at the spine, T-Score measure: Areal bone mineral density at the spine, Z-score measure: Areal bone mineral density at the distal third of radius, g/cm2 measure: Areal bone mineral density at the distal third of radius, T-score measure: Areal bone mineral density at the distal third of radius, Z-score measure: Trabecular bone score (TBS) at the lumbar spine (L1-L4) (unitless) measure: Vertebral Fracture Assessment (VFA) from the T4 to L5 vertebrae to detect the presence of vertebral fracture measure: Lean mass (arm, leg, trunk, android, gynoid and total) (g) measure: Fat mass (arm, leg, trunk, android, gynoid and total) (g) measure: C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL) measure: Procollagen type 1 N-terminal propeptide (P1NP) (ng/mL) measure: Osteocalcin (ng/mL) measure: Sclerostin (pmol/mL) measure: Change in C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL) measure: Change in osteocalcin (ng/mL) measure: Change in procollagen type 1 N-terminal propeptide (P1NP) (ng/mL) measure: Change in sclerostin (pmol/mL) measure: Skin advanced glycation end-products (AGEs) (arbitrary units) measure: Glycated hemoglobin (HbA1c, %) measure: Fasting glucose (mmol/L) measure: Complete blood count measure: Thyroid-stimulating hormone (TSH) (mU/L) measure: Lipid panel (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol/HDL-cholesterol ratio, triglycerides, in mmol/L) measure: Creatinine (umol/L) measure: Microalbuminuria (mg/mmol) measure: Liver enzymes (AST, ALT) (U/L) measure: Calcium (mmol/L) measure: Albumine (g/L) measure: Phosphate (mmol/L) measure: 25-hydroxyvitamin D3 (nmol/L) measure: Parathormone (PTH) (ng/L) measure: Antitransglutaminase antibodies (U/mL) measure: Immunoglobulin A (IgA) (g/L) measure: Insulin like growth factor-1 (IGF-1) (ng/mL) measure: Follicle stimulating hormone (FSH, women) (U/L) measure: Total testosterone (men) (nmol/L) measure: Sex hormone-binding globulin (SHBG, men) (nmol/L) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut de recherches cliniques de Montréal (IRCM) city: Montréal state: Quebec zip: H2W 1R7 country: Canada lat: 45.50884 lon: -73.58781 facility: Centre de recherche du CHU de Québec-Université Laval city: Quebec City state: Quebec zip: G1V 4G2 country: Canada lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06351163 id: 1451_03/BVNTW-VNCSKTE briefTitle: Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study overallStatus: COMPLETED date: 2016-01 date: 2020-12 date: 2024-03 date: 2024-04-08 date: 2024-04-08 name: National Children's Hospital, Vietnam class: OTHER name: Vinmec Research Institute of Stem Cell and Gene Technology briefSummary: Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Surgical intervention becomes necessary if pneumatic reduction fails or is not recommended. Traditionally, manual reduction required a large incision on the right side of the abdomen. However, the advancement of minimally invasive techniques, such as the laparoscopic approach (LAP), has become increasingly popular for managing intussusception. LAP offers benefits such as reduced surgical trauma and shorter operative times compared to open procedures. Nevertheless, the adoption of LAP remains controversial due to challenges like limited working space in children and variability in the affected bowel segment. This study aims to investigate the safety and feasibility of LAP and mini-open reduction (MOR) techniques in treating idiopathic intussusception in pediatric patients. conditions: Intussusception studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 181 type: ACTUAL name: Laparoscopic reduction name: Transumbilical mini-open reduction measure: Operating time measure: Intraoperative complications measure: Immediate postoperative complications measure: Time to feed measure: Hospital stays measure: Recurrence rate measure: Long-term complication rate sex: ALL minimumAge: 2 Months maximumAge: 12 Years stdAges: CHILD facility: The National Hospital of Pediatrics city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 facility: Vinmec Research Institute of Stem Cell and Gene Technology city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False

 nctId: NCT06351150 id: TQG3902-III-01 briefTitle: Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-06 date: 2027-12 date: 2024-04-08 date: 2024-04-08 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group. conditions: Vasodilatory Shock studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 214 type: ESTIMATED name: Angiotensin II Injection name: 0.9% sodium chloride injection measure: Proportion of subjects with blood pressure response at 3 hours after administration of study drug measure: Sequential Organ Failure Assessment (SOFA) total score measure: Cardiovascular SOFA subscore measure: Mortality at Day 7 measure: Mortality at Day 28 measure: Proportion of subjects with blood pressure response at 1 hour after administration measure: Proportion of subjects with blood pressure response at 2 hours after administration measure: Change in background vasoactive agent dose from 0 to 48 hours measure: Absolute change in blood lactate from 0 to 3 hours measure: Absolute change in blood lactate from 3 to 48 hours measure: Absolute change in heart rate from 0 to 3 hours measure: Absolute change in heart rate from 3 to 48 hours measure: Adverse events (AE) measure: Serious adverse events (SAE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China name: Yun Long, M.D. role: CONTACT phone: 13911608699 email: yunlongxh@163.com lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Sun Yat sen University city: Guangzhou state: Guangdong zip: 510062 country: China name: Xiangdong Guan, M.D. role: CONTACT phone: 13802925067 email: guanxiangdong1962@163.com lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong zip: 510260 country: China name: Zhanguo Liu, M.D. role: CONTACT phone: 18520711669 email: zhguoliu@163.com lat: 23.11667 lon: 113.25 facility: Qingyuan Hospital Affiliated to Guangzhou Medical University city: Qingyuan state: Guangdong zip: 511518 country: China name: Jingwen Yang, M.D. role: CONTACT phone: 13542498765 email: 00655@qyry.com lat: 23.7 lon: 113.03333 facility: The First Affiliated Hospital of Shantou University Medical College city: Shantou state: Guangdong zip: 515041 country: China name: Yongru Chen, M.D. role: CONTACT phone: 13411969797 email: ongruchen@126.com lat: 23.36814 lon: 116.71479 facility: Liuzhou General Hospital city: Liuzhou state: Guangxi zip: 545026 country: China name: Guangyu Lv, M.D. role: CONTACT phone: 13977210130 email: lgy197823@163.com facility: The Affiliated Hospital of Hebei University city: Baoding state: Hebei zip: 050031 country: China name: Zhanbiao Yu, M.D. role: CONTACT phone: 15188655821 email: daxiang285@sina.com lat: 38.85111 lon: 115.49028 facility: The First Affiliated Hospital of Harbin Medical University city: Harbin state: Heilongjiang zip: 150007 country: China lat: 45.75 lon: 126.65 facility: The First Affiliated Hospital of Bengbu Medical College city: Bengbu state: Henan zip: 233099 country: China name: Yongsheng Zheng, M.D. role: CONTACT phone: 13955252796 email: zsy0916@163.com lat: 32.94083 lon: 117.36083 facility: The First Affiliated Hospital of Henan University of Science and Technology city: Luoyang state: Henan zip: 450052 country: China name: Qizhi Fu, M.D. role: CONTACT phone: 13837944687 email: fuqizhi33@sina.com lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Zhengzhou University city: Zhengzhou state: Henan zip: 450052 country: China name: Tongwen Sun, M.D. role: CONTACT phone: 13838516916 email: suntongwen@163.com lat: 34.75778 lon: 113.64861 facility: Union Hospital, Tongji Medical College of huazhong university of science and technology city: Wuhan state: Hubei zip: 430022 country: China name: You Shang, M.D. role: CONTACT phone: 15972127819 email: you_shanghust@163.com lat: 30.58333 lon: 114.26667 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 140008 country: China name: Lina Zhang, M.D. role: CONTACT phone: 15874875763 email: zln7095@163.com lat: 28.19874 lon: 112.97087 facility: Jiangsu Province Hospital city: Nanjing state: Jiangsu zip: 210029 country: China name: Quan Cao, M.D. role: CONTACT phone: 13851992695 email: 2004caoquan@163.com lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'an state: Shaanxi zip: 710004 country: China name: Xiaochuang Wang, M.D. role: CONTACT phone: 13772152935 email: 1585431074@qq.com lat: 34.25833 lon: 108.92861 facility: The First Hospital of Shanxi Medical University city: Taiyuan state: Shanxi zip: 030001 country: China name: Jing Cao, M.D. role: CONTACT phone: 13834691242 email: 13834691242@163.com lat: 37.86944 lon: 112.56028 facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610044 country: China name: Yan Kang, M.D. role: CONTACT phone: 13808041931 email: kangyan_hx@163.com lat: 30.66667 lon: 104.06667 facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 610072 country: China name: Xiaobo Huang, M.D. role: CONTACT phone: 18140049936 email: drhuangxb@163.com lat: 30.66667 lon: 104.06667 facility: The First Affiliated Hospital of Xinjiang Medical University city: Ürümqi state: Xinjiang zip: 830054 country: China name: Xiangyou Yu, M.D. role: CONTACT phone: 13009681003 email: yu2796@163.com lat: 43.80096 lon: 87.60046 hasResults: False

 nctId: NCT06351137 id: INIV2023 briefTitle: Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain overallStatus: RECRUITING date: 2024-03-13 date: 2024-06-01 date: 2024-06-01 date: 2024-04-08 date: 2024-04-08 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: Prehospital treatment of acute traumatic pain is common in military practice. Analgesics are usually administered intravenously (IV). Research from the civil prehospital environment shows that obtaining IV access can be difficult and time consuming, delaying onset of treatment. The challenges for obtaining IV access in the military prehospital setting are even bigger, for example in combat environments. However, this has not been assessed.

Current guidelines also offer alternative routes of administration for analgesics, for example intranasal (IN) administration. IN administration is a fast, easy and effective route of administration. This study determines whether IN administration of analgesia is faster and leads to increased healthcare provider satisfaction compared to IV administration in patients with acute traumatic pain in a simulated military prehospital environment. conditions: Acute Pain Due to Trauma conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Intravenous administration name: Intranasal administration measure: Time required for administration of analgesic (minutes) measure: Total time spent on scene (minutes) measure: Time required for obtaining IV access measure: Time required preparing IN administration measure: Satisfaction of the navy nurse regarding the used route of administration. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: Midas N de Grunt, MD role: CONTACT phone: +31205669111 email: m.n.degrunt@amsterdamumc.nl name: Markus W Hollmann, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06351124 id: 00005294 briefTitle: Beta-Hydroxybutyrate Feasibility Treating IBS acronym: BHB overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: University of Texas at Austin class: OTHER briefSummary: This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease.

The main questions it aims to answer are:

* BHB supplementation will be feasible and acceptable to patients.
* BHB supplementation will be associated with a reduction in systemic inflammation.
* BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies.

Participants will:

* Take 3 capsules x 3 times per day for 4 weeks.
* Document food consumption using a 24-hour food recall questionnaire.
* Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark.

Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease. conditions: Crohn's Disease conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a prospective, open-label, randomized, two-arm pilot trial of adults primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Eligible consenting patients will be randomized to either standard of care therapy (control) vs standard of care therapy plus BHB supplementation (intervention). BHB will be supplemented as a capsule taken orally three times daily for four weeks for those randomized to the intervention arm. count: 12 type: ESTIMATED name: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Inflammatory Bowel Disease measure: Ability to enroll patients who meet the inclusion criteria within the target time frame measure: Adherence to proposed study timelines and anticipated study costs measure: Patient adherence to the intervention measure: Microbial Diversity measure: BHB Blood Levels measure: Gastrointestinal Symptoms measure: Quality of Life measure: Clinical Response measure: Systemic Inflammation measure: Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas at Austin city: Austin state: Texas zip: 78712 country: United States name: Michelle Stickler, Associate Vice President, DEd role: CONTACT phone: 512-475-6323 email: m.stickler@austin.utexas.edu name: Thomas Street, Executive Director role: CONTACT phone: 512 495 5142 email: thomas.street@austin.utexas.edu lat: 30.26715 lon: -97.74306 hasResults: False

 nctId: NCT06351111 id: IRB-24-240 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-08 date: 2024-04-08 name: [Redacted] hasResults: False

 nctId: NCT06351098 id: 2024579 briefTitle: Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition acronym: HSR overallStatus: RECRUITING date: 2023-11-05 date: 2028-06 date: 2028-06 date: 2024-04-08 date: 2024-04-08 name: University of Maryland, College Park class: OTHER name: University of Massachusetts, Amherst briefSummary: To examine the relations between sleep (nap transitions, sleep physiology), memory, and brain development longitudinally, the researchers will assess n=180 children (in order to acquire n=152 usable data sets) who are 36-54 months of age and habitual nappers at enrollment. In each wave, the researchers will assess memory, memory change over a nap and equivalent waking interval, sleep physiology of the nap, and brain structure and function (using Magnetic Resonance Imagining or MRI). Additionally, overnight sleep physiology will be assessed in all participants. Waves will take place approximately every 6 months. For all children, three waves will be collected. With these data, the researchers will address the following aims:

* Examine neural markers that predict the sleep transition (Aim 1);
* Examine changes in sleep-dependent memory processing (mnemonic discrimination) over both nap and overnight sleep intervals, across the sleep transition (Aim 2);
* Examine changes in sleep microstructure in both nap and overnight sleep across the sleep transition (Aim 3)
* Examine interrelations among brain, memory and sleep microstructure across the sleep transition (Aim 4) conditions: Memory studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: nap measure: Memory sex: ALL minimumAge: 36 Months maximumAge: 60 Months stdAges: CHILD facility: University of Maryland status: RECRUITING city: College Park state: Maryland zip: 20742 country: United States name: Tracy Riggins, Ph.D. role: CONTACT phone: 301-405-5905 email: riggins@umd.edu name: Postdoctoral Fellow role: CONTACT phone: 301-405-5922 email: napstudy@umd.edu lat: 38.98067 lon: -76.93692 facility: University of Massachusetts status: RECRUITING city: Amherst state: Massachusetts zip: 01003 country: United States name: Rebecca MC Spencer, PhD role: CONTACT phone: 413-577-6128 email: rspencer@umass.edu name: Postdoctoral Fellow role: CONTACT phone: 413-545-4831 email: preschoolnapstudy@gmail.com lat: 42.36723 lon: -72.51852 hasResults: False

 nctId: NCT06351085 id: 1937769-1 briefTitle: Enhancing Lung Cancer Screening Through Human-Centered Intervention acronym: ELFE overallStatus: RECRUITING date: 2022-11-10 date: 2025-04-14 date: 2025-04-14 date: 2024-04-08 date: 2024-04-08 name: University of California, Davis class: OTHER briefSummary: The purpose of this study is to further understand the factors involved in increasing lung cancer screening. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients of the intervention clinics will be assigned one of two interventions: 1) Pre Visit Planner (PVP) or 2) PVP + patient education delivered via the MyUCDHealth patient web portal. primaryPurpose: SCREENING masking: SINGLE maskingDescription: Biostatistician created a randomized table to allocate patient in either intervention 1 or 2. whoMasked: PARTICIPANT count: 2869 type: ESTIMATED name: Pre-Visit Planner name: Pre-Visit Planner + MyChart measure: Lung Cancer Screening measure: Completion of Interviews with Staff and Patients sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Davis status: RECRUITING city: Sacramento state: California zip: 95817 country: United States name: Moon Chen, M.P.H, Ph.D role: CONTACT phone: 916-548-3928 email: mschenjr@ucdavis.edu name: Moon Chen, M.P.H, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False

 nctId: NCT06351072 id: NOXANI briefTitle: Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia acronym: ANI overallStatus: RECRUITING date: 2024-04-02 date: 2024-09-01 date: 2024-10-01 date: 2024-04-08 date: 2024-04-26 name: University of Padova class: OTHER briefSummary: qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.

No trials have compared them, so with this trial authors want to explore the correlations between them. conditions: Analgesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Correlation between qNOX and ANI values measure: Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain measure: Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Treviso Regional Hospital status: RECRUITING city: Treviso state: TV zip: 31100 country: Italy name: Federico Linassi role: CONTACT email: federico.linassi@gmail.com lat: 45.66673 lon: 12.2416 hasResults: False

 nctId: NCT06351059 id: UE-0083 briefTitle: Acoustic Emission Biomarkers for the Detection and Monitoring of Early Knee Osteoarthritis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-07-31 date: 2024-12-31 date: 2024-04-08 date: 2024-04-19 name: Schulthess Klinik class: OTHER name: Ecole Polytechnique Fédérale de Lausanne briefSummary: The aim of this exploratory study is to further investigate the potential of acoustic emission biomarkers, assessed by the inmodi knee brace, to diagnose osteoarthritis (OA) at earlier stages. Therefore, 20 healthy participants and 100 patients with increased risk of knee OA will be recruited from the Schulthess Klinik in Zurich and examined twice with 9 ± 3 months' time interval. Anthropometric data, EOS radiographs and MR images of both knees, PROMs and acoustic emission data will be collected and evaluated. Artificial Intelligence algorithm will then be used to identify and validate the most promising acoustic emission biomarkers with a prognosis value in the prediction of knee osteoarthritis progress. conditions: Osteoarthritis, Knee conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ACTUAL name: InModi acoustic emission analysis measure: acoustic emissions measure: kinematic data measure: MRI / MOAKS measure: EOS / leg alignment measure: PROMS sex: ALL minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Schulthess Klinik city: Zürich state: ZH zip: 8008 country: Switzerland lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06351046 id: NCT05178082_WP3 briefTitle: Preventive Interventions for Chronic Pain Worsening overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-07-30 date: 2027-01-30 date: 2024-04-08 date: 2024-04-08 name: Rigshospitalet, Denmark class: OTHER name: The Novo Nordic Foundation briefSummary: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): Mindfulness Based Stress Reduction (MBSR) group, Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 78 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck. conditions: Chronic Non-Cancer Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): MBSR group, VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention. primaryPurpose: PREVENTION masking: NONE maskingDescription: The statistical analysis of the data will be blinded count: 78 type: ESTIMATED name: Online Mindfullness Based Stress Reduction Program name: Virtual Reality-based Pain Self-management program measure: Pain intensity measure: Pain intensity and interference in daily activities measure: Pain catastrophizing measure: Pain acceptance measure: Health status measure: Health related quality of life measure: Anxiety measure: Depression measure: Use of medication measure: Use of healthcare system measure: Number of absent days at work measure: Satisfaction with the intervention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351033 id: ADP_012023 briefTitle: Ozonized Oil as Dietary Supplement in Macular Degeneration overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-31 date: 2024-12 date: 2024-12 date: 2024-04-08 date: 2024-04-08 name: Alba Di Pardo class: OTHER briefSummary: Macular degeneration, also called age-related macular degeneration (AMD), is a leading cause of visual impairment and severe vision loss.

AMD is a disease with a multifactorial etiology. The main factors which, associated with the genetic ones, increase the risk of WMD onset are represented by smoking, obesity, hypertension, cardio-vascular diseases, a diet rich in dietary fat and alcohol intake. From an organic point of view, AMD is a disease that affects the macular region of the retina, causing progressive loss of central vision.

Retinal cells are characterized by high oxygen consumption. Reactive oxygen species (ROS), such as superoxide anion, hydrogen peroxide and hydroxyl radical are the standard product of cellular metabolism within the mitochondria. Under physiological conditions, ROS are neutralized by a system of antioxidants. In case of cellular metabolism disturbances or insufficiency of the antioxidant system, an excess of ROS can be produced which contributes to oxidative stress, widely described as exerting deleterious effects on cells. The high oxygen requirement and low levels of antioxidant enzymes make the retina extremely sensitive to oxidative stress and more susceptible to cell death. Prevention of neuronal death in the retina becomes a crucial aspect for the management of WMD.

The treatment of choice for AMD today is the use of anti-VEGF (Vascular Endothelial Growth Factor) drugs, they are effective for neo-vascular AMD, acting on the inhibition of the angiogenic protein VEGF, which is produced in the retina and induced by hypoxia and other conditions. It is practice, however, to support the integration of nutritional supplements such as zinc, resveratrol, carotenoids such as lutein and zeaxanthin, vitamin E and Omega-3 fatty acids.

The aim of this study is to evaluate the efficacy of ozonated oil with high ozonides (HOO) administered orally as gastro-resistant capsules (O3Zone, GS Pharma, Malta), as an integrative and complementary treatment in patients affected by macular degeneration in the possible slowing of disease progression. conditions: Maculopathy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: High ozonide (HOO) ozonated oil measure: evaluation of any slowing down of the maculopathy measure: evaluation of any slowing down of the maculopathy measure: evaluation of any slowing down of the maculopathy measure: evaluation of any slowing down of the maculopathy and closure of the study sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Neuromed city: Pozzilli country: Italy lat: 41.51142 lon: 14.06252 hasResults: False

 nctId: NCT06351020 id: LM302-03-101 briefTitle: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-08-10 date: 2026-12-15 date: 2024-04-08 date: 2024-04-08 name: LaNova Medicines Zhejiang Co., Ltd. class: INDUSTRY briefSummary: This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy conditions: Locally Advanced or Metastatic GC and GCJ Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: experimental arm:LM-302 control arm:Apatinib or Irinotecan primaryPurpose: TREATMENT masking: NONE count: 375 type: ESTIMATED name: LM-302 name: Apatinib name: Irinotecan measure: Overall Survival (OS) measure: Progression Free Survival (PFS) measure: Objective response rate (ORR) measure: Duration of response (DoR) measure: Disease control rate (DCR) measure: AE and SAE measure: Evaluate the immunogenicity of LM-302 measure: Evaluation of pharmacokinetic characteristics of LM-302 measure: Evaluation of pharmacokinetic characteristics of LM-302 measure: Evaluation of pharmacokinetic characteristics of LM-302 measure: Evaluation of pharmacokinetic characteristics of total antibody measure: Evaluation of pharmacokinetic characteristics of total antibody measure: Evaluation of pharmacokinetic characteristics of total antibody measure: Evaluation of pharmacokinetic characteristics of MMAE measure: Evaluation of pharmacokinetic characteristics of MMAE measure: Evaluation of pharmacokinetic characteristics of MMAE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06351007 id: NMM-4650-23-24-1 briefTitle: Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) acronym: EPAK overallStatus: RECRUITING date: 2023-09-19 date: 2024-07 date: 2024-07 date: 2024-04-08 date: 2024-04-08 name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran class: OTHER briefSummary: A fundamental strategy to improve adherence to nutritional treatment in patients with chronic kidney disease is the implementation of educational programs. The aim of this study is to evaluate the effect of a multidisciplinary educational program on dietary adherence, nutritional knowledge, nutritional status, metabolic control and quality of life in patients with chronic kidney disease, predialysis, peritoneal dialysis and hemodialysis.

A randomized clinical trial will be carried out, in which patients who meet the inclusion criteria will be randomly assigned to three possible groups: predialysis educational intervention, dialysis educational intervention and control group. At the initial visit, the nutritional status will be evaluated by means of anthropometric parameters, screening and dynamometry, the biochemical parameters of interest will be extracted from the clinical record, nutritional knowledge and quality of life will be evaluated, and the diet will be explained. In the second visit, adherence to the diet will be evaluated and the food registry will be carried out. In the intervention groups, the educational program will begin with a duration of five months. Patients will come twice a month to the hospital to participate in the educational sessions and attend group psychology sessions. After completion of the educational program, the same measurements as at the beginning of the study will be carried out in the three groups. conditions: Chronic Kidney Disease conditions: Predialysis conditions: Peritoneal Dialysis conditions: Hemodialysis conditions: Educational Activities conditions: Adherence conditions: Nutritional Status studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 63 type: ESTIMATED name: Nutritional education and psychological intervention name: Standard care measure: Patients´ dietary attitude measure: Dietary adherence measure: Nutritional knowledge measure: Muscle status measure: Muscle functionality measure: Nutritional status of predialysis patients measure: Nutritional status of dialysis patients measure: Patients´ quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán status: RECRUITING city: Mexico City zip: 14080 country: Mexico name: Ximena Atilano Carsi, PhD role: CONTACT phone: 00 52 55 56 17 65 42 email: ximena.atilanoc@incmnsz.mx lat: 19.42847 lon: -99.12766 hasResults: False

 nctId: NCT06350994 id: APHP230625 id: IDRCB 2023-A01957-38 type: OTHER domain: ANSM briefTitle: Early Assessment of Cardiac Function After Treatment With CAR-T Cells acronym: Cardio CAR-T overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-10 date: 2027-01 date: 2024-04-08 date: 2024-04-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.

Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease.

This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells.

The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5). conditions: Car T- Cell conditions: Hematologic Malignancy conditions: Acute Lymphoblastic Leukemia conditions: Lymphoma, B-Cell conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity measure: Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations measure: Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Critical care medicine department city: Paris zip: 75012 country: France name: Jérémie JOFFRE, MD, PhD role: CONTACT phone: +33 1 49 28 21 45 email: Jeremie.joffre@aphp.fr name: Hafid AIT-OUFELLA, Professor role: CONTACT phone: +33 1 49 28 21 45 email: hafid.ait-oufella@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06350981 id: FORE813 briefTitle: Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-03-01 date: 2024-04-08 date: 2024-04-08 name: Foundation for Orthopaedic Research and Education class: OTHER name: Pacira Pharmaceuticals, Inc briefSummary: The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores. conditions: Back Pain conditions: Surgery-Complications conditions: Narcotic Use conditions: Physical Stress conditions: Post Operative Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Study subjects will be randomized to either Group 1 or Group 2 in a 1:1 ratio based on the randomization scheme in sealed envelopes maintained by the study coordinator. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 76 type: ESTIMATED name: Exparel name: Bupivacain measure: Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion. measure: Total Postsurgical opioid consumption measure: Time to discharge measure: Time to ambulation measure: Maximum ambulated distance measure: Numeric Rating Pain Scale (Physical Therapy) measure: Numeric Rating Pain Scale measure: Oswestry Disability Index (ODI) measure: Pain Catastrophizing Scale (PCS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation for Orthopaedic Research and Education city: Tampa state: Florida zip: 33607 country: United States name: Deborah H Warren role: CONTACT phone: 813-910-3688 email: dwarren@foreonline.org lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06350968 id: MEC-2023-0151 id: 10200012110003 type: OTHER_GRANT domain: ZonMw briefTitle: Implementation of Online Advance Care Planning Tool for (Hemato-)Oncological Patients Within the Cancer Network Concord acronym: INDEED overallStatus: RECRUITING date: 2023-10-01 date: 2026-06-30 date: 2026-12-31 date: 2024-04-08 date: 2024-04-08 name: Erasmus Medical Center class: OTHER name: Maasstad Hospital name: Spijkenisse Medical Center name: Franciscus &Vlietland name: IJsselland name: Ikazia Hospital, Rotterdam name: Van Weel-Bethesda hospital name: Albert Schweitzer Hospital name: Beatrix hospital briefSummary: The aim of this mixed-methods study is to describe both the implementation process and outcomes of the online module Advance Care Plan for (hemato-)oncology patients within the oncology-network CONCORD.

The main question is: How is implementation and assurance of the advance care plan in daily care for (hemato-)oncological patients within CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed?

Healthcare providers and patients are asked to use the module and share their experiences with it. conditions: Oncology conditions: Advance Care Planning conditions: Implementation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Implementation outcome measure: Intervention outcome measure: Implementation outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Joica Benschop status: RECRUITING city: Rotterdam zip: 3023TB country: Netherlands name: Joica Benschop, MSc role: CONTACT phone: +31622586583 email: j.benschop@erasmusmc.nl name: Wendy Oldenmenger, PhD role: CONTACT phone: +31651072608 email: w.h.oldenmenger@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06350955 id: 2022-01389 briefTitle: IV Iron-induced Hypophosphatemia After RYGB acronym: IVORY overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-06 date: 2026-06 date: 2024-04-08 date: 2024-04-08 name: Lucie Favre class: OTHER briefSummary: The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®). conditions: Hypophosphatemia conditions: Roux-en-Y Gastric Bypass studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 94 type: ESTIMATED name: Iron isomaltoside name: Iron Carboxymaltose measure: incidence of hypophosphatemia in RYGB patients treated with intravenous iron sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350942 id: 1451_01/BVNTW-VNCSKTE briefTitle: One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication overallStatus: COMPLETED date: 2016-09 date: 2020-12 date: 2024-02 date: 2024-04-08 date: 2024-04-08 name: National Children's Hospital, Vietnam class: OTHER name: Vinmec Research Institute of Stem Cell and Gene Technology briefSummary: Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children. conditions: Ureteral Duplication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU) measure: Mean operating time measure: Intraoperative complications measure: Conversion to open measure: Early postoperative complications measure: Median length of hospital stays measure: Mean UPM renal pelvis' APD measure: Mean SFU of UPM renal pelvis measure: Mean UPM ureter's diameter measure: Mean UPM DRF measure: Mean DRF of operated side sex: ALL minimumAge: 1 Month maximumAge: 10 Years stdAges: CHILD facility: The National Hospital of Pediatrics city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 facility: Vinmec Research Institute of Stem Cell and Gene Technology city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False

 nctId: NCT06350929 id: RC31/24/0017 briefTitle: Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients acronym: NORAFLOW overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-05 date: 2024-04-08 date: 2024-04-08 name: University Hospital, Toulouse class: OTHER briefSummary: Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.

The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction. conditions: Hypotension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Cardiac output monitoring by the Starling™ SV Sebac® measure: Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction. measure: Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus. measure: Evaluation of the impact of the norepinephrine bolus on blood pressure correction. measure: Evaluation of the impact of the norepinephrine bolus on heart rate. measure: Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Toulouse Rangueil city: Toulouse zip: 31400 country: France name: François LABASTE, Dr role: CONTACT phone: 0561322822 phoneExt: +33 email: labaste.f@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06350916 id: IRB00082594 id: LCI-GI-CRC-SEAMLESS-2020 type: OTHER domain: Atrium Health briefTitle: Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery overallStatus: COMPLETED date: 2021-01-28 date: 2021-07-30 date: 2021-10-01 date: 2024-04-08 date: 2024-04-08 name: Wake Forest University Health Sciences class: OTHER name: Atrium Health Levine Cancer Institute briefSummary: The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery. conditions: Colorectal Surgery studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 75 type: ACTUAL name: SeamlessMD® Mobile Application measure: Perioperative ERAS metric completion rate measure: Postoperative hospital length of stay measure: Postoperative complications measure: 30-day readmission measure: Postoperative Opioid Consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States lat: 35.22709 lon: -80.84313 hasResults: False

 nctId: NCT06350903 id: ICM 2024-3356 briefTitle: Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging acronym: SWEET-HEART overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-08 date: 2024-04-09 name: Matthieu Pelletier-Galarneau, MD MSc class: OTHER briefSummary: The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies. conditions: Myocardial Suppression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Fast + High-fat low-carbohydrate diet name: Fast + Empagliflozin measure: Levels of serum Beta-hydroxybutyrate (BHB) mmol/L measure: Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L measure: Proportions of glycemia levels (mmol/L) <3.5 mmol/L measure: Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350890 id: HTD1801.PCT105 briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-11-05 date: 2025-03 date: 2025-09 date: 2024-04-08 date: 2024-04-18 name: HighTide Biopharma Pty Ltd class: INDUSTRY briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of Berberine Ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone. conditions: T2DM (Type 2 Diabetes Mellitus) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 405 type: ESTIMATED name: HTD1801 name: Placebo measure: Primary Endpoint: Mean Change in HbA1c measure: Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose measure: DB Phase: Mean Change in 2-Hour Postprandial Glucose measure: DB Phase: Proportion of patients achieving HbA1c <7.0% measure: DB Phase: Proportion of patients achieving HbA1c <6.5% measure: DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR) measure: DB Phase: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C) measure: Open Label Extension (OLE) Phase: Mean Change in HbA1c measure: OLE Phase: Mean change in 2-Hour Postprandial Glucose measure: OLE Phase: Proportion of patients achieving HbA1c <7.0% measure: OLE Phase: Proportion of patients achieving HbA1c <6.5% measure: OLE Phase: Mean Change in Insulin Sensitivity (HOMA-IR) measure: OLE Phase: Mean Change in LDL-C sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuancheng People's Hospital status: RECRUITING city: Xuancheng state: Anhui country: China lat: 25.40949 lon: 116.3841 facility: Beijing Pinggu Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Fuwai Hospital, CAMS & PUMC status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Chongqing University Three Gorges Hospital status: RECRUITING city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Huizhou Municipal Central Hospital status: RECRUITING city: Huizhou state: Guangdong country: China lat: 23.11147 lon: 114.41523 facility: Shenzhen People's Hospital status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: Liuzhou People's Hospital status: RECRUITING city: Liuzhou state: Guangxi country: China facility: Cangzhou Central Hospital status: RECRUITING city: Cangzhou state: Hebei country: China lat: 38.31667 lon: 116.86667 facility: Handan First Hospital status: RECRUITING city: Handan state: Hebei country: China lat: 36.60056 lon: 114.46778 facility: Hengshui People's Hospital (Harrison International Peace Hospital) status: RECRUITING city: Hengshui state: Hebei country: China lat: 37.73222 lon: 115.70111 facility: Hebei Petro China Center Hospital status: RECRUITING city: Langfang state: Hebei country: China lat: 39.50972 lon: 116.69472 facility: The First Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei country: China lat: 38.04139 lon: 114.47861 facility: The Fourth Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang country: China lat: 45.75 lon: 126.65 facility: The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: The Third Affiliated Hospital of Qiqihar Medical College status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua) status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan) status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Nanyang Medical College status: RECRUITING city: Nanyang state: Henan country: China lat: 32.99472 lon: 112.53278 facility: Zhumadian Central Hospital status: RECRUITING city: Zhumadian state: Henan country: China lat: 32.97944 lon: 114.02944 facility: Huangshi Central Hospital status: RECRUITING city: Huangshi state: Hubei country: China lat: 30.24706 lon: 115.04814 facility: Jingzhou Central Hospital status: RECRUITING city: Jingzhou state: Hubei country: China lat: 30.35028 lon: 112.19028 facility: The Central Hospital of Wuhan status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: The First People's Hospital of Changde City status: RECRUITING city: Changde state: Hunan country: China lat: 29.04638 lon: 111.6783 facility: Hunan Provincial People's Hospital status: RECRUITING city: Changsha state: Hunan country: China lat: 28.19874 lon: 112.97087 facility: Yueyang People's Hospital status: RECRUITING city: Yueyang state: Hunan country: China lat: 29.37455 lon: 113.09481 facility: Baotou City Central Hospital status: RECRUITING city: Baotou state: Inner Mongolia country: China lat: 40.65222 lon: 109.82222 facility: Inner Mongolia Autonomous Region People's Hospital status: RECRUITING city: Hohhot state: Inner Mongolia country: China lat: 40.81056 lon: 111.65222 facility: The First People's Hospital of Changzhou status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: Huai'an First People's Hospital status: RECRUITING city: Huai'an state: Jiangsu country: China lat: 33.50389 lon: 119.14417 facility: The Second People's Hospital of Lianyungang status: RECRUITING city: Lianyungang state: Jiangsu country: China lat: 34.59845 lon: 119.21556 facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Nanjing Jiangning Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Sir Run Run Hospital Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou state: Jiangsu country: China lat: 34.18045 lon: 117.15707 facility: Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: Pingxiang People's Hospital status: RECRUITING city: Pingxiang state: Jiangxi country: China lat: 27.61672 lon: 113.85353 facility: The Second Norman Bethune Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: Tonghua Central Hospital status: RECRUITING city: Tonghua state: Jilin country: China lat: 41.71972 lon: 125.92639 facility: Panjin Liaohe Oilfield Gem Flower Hospital status: RECRUITING city: Panjin state: Liaoning country: China lat: 41.121 lon: 122.0739 facility: The Sixth People's Hospital of Shenyang status: RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: Qinghai Provincial People's Hospital status: RECRUITING city: Xining state: Qinghai country: China lat: 36.62554 lon: 101.75739 facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine status: RECRUITING city: Xianyang state: Shaanxi country: China lat: 34.33778 lon: 108.70261 facility: Jinan Central Hospital status: RECRUITING city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 facility: Liaocheng People's Hospital status: RECRUITING city: Liaocheng state: Shandong country: China lat: 36.45596 lon: 115.97766 facility: Shanghai East Hospital of Tongji University status: RECRUITING city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: The Third People's Hospital of Datong status: RECRUITING city: Datong state: Shanxi country: China lat: 40.09361 lon: 113.29139 facility: Yuncheng Central Hospital status: RECRUITING city: Yuncheng state: Shanxi country: China lat: 35.02306 lon: 110.99278 facility: People's Hospital of Tianjin status: RECRUITING city: Tianjin state: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: The First People's Hospital of Kashgar status: RECRUITING city: Kashgar state: Xinjiang country: China lat: 39.47066 lon: 75.98951 facility: The Second Affiliated Hospital of Kunming Medical University status: RECRUITING city: Kunming state: Yunnan country: China lat: 25.03889 lon: 102.71833 facility: Huzhou Central Hospital status: RECRUITING city: Huzhou state: Zhejiang country: China lat: 30.8703 lon: 120.0933 hasResults: False

 nctId: NCT06350877 id: PA RCT briefTitle: 1:1 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being overallStatus: RECRUITING date: 2024-01-08 date: 2025-01 date: 2025-01 date: 2024-04-08 date: 2024-04-08 name: University of Toronto class: OTHER briefSummary: Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses.

Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress) and secondary (i.e., social support, social connectedness) outcomes. Secondly, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. Lastly, limited research has explored contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of physical activity programs for student mental health. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 1:1 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health. The main questions include:

* Are there group differences between 1:1, group-based delivery, and waitlist control in the immediate (post-intervention) and follow-up (1-month) maintenance effects on the primary and secondary outcomes?
* Grounded in recommendations for process evaluation of complex interventions, what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination?

Trial participants will be randomly assigned to one of the following groups:

1. 1:1 physical activity training;
2. Group-based physical activity training consisting of small 5-8 person groups; or
3. Waitlist control. Students will participate in the physical activity intervention after the intervention and follow-up period (10 weeks); however, their participation will not be monitored or evaluated.

The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions. Each session involves: (1) 30-minutes of behaviour change coaching (e.g., goal setting, action-planning, brainstorming strategies to overcome barriers to engaging in physical activity); and (2) 30-minutes of supervised and structured physical activity training. To address the aims of the study, participants will complete self-report questionnaires at baseline, post-intervention (following completion of the 6-week physical activity intervention), and 1-month following completion of the physical activity intervention. Questionnaires will assess demographic characteristics, primary outcomes (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress), secondary outcomes (i.e., social support, social connectedness, physical activity behaviour) and contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes. conditions: Physical Activity conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A 3-arm parallel Randomized Controlled Trial (RCT) assessing the immediate (post-intervention) and short-term (1-month) impact of the experimental arms (1:1 physical activity delivery and group-based physical activity delivery) compared to a 10-week control arm (wait-list control) will be conducted. A parallel arm design will be implemented, whereby participants will be randomized to a study arm and each study arm will be allocated a different intervention. The protocol adheres to CONSORT guidelines and SPIRIT recommendations for reporting of clinical trial protocols. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Following completion of the baseline assessment (T1), students will be randomly assigned to an experimental arm or the control arm by a program coordinator for the study. To prevent care provider bias, the physical activity coaches will remain blind to the purpose of group allocation and hypotheses of the study. Research Randomizer (www.randomizer.org) will be used to allocate participants into three equal groups using a blocked design (with an allocation ratio of 1:1:1). whoMasked: CARE_PROVIDER count: 93 type: ESTIMATED name: Physical Activity Intervention measure: Depression measure: Anxiety measure: Psychological distress measure: Social Support measure: Social Connectedness measure: Physical Activity Behaviour measure: Intervention Reach measure: Therapeutic Alliance measure: Intervention Satisfaction measure: Coach Perceptions sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Toronto, Mental Health and Physical Activity Research Centre status: RECRUITING city: Toronto state: Ontario zip: M5S 2W6 country: Canada name: Melissa L deJonge, Msc role: CONTACT phone: 9059739414 email: melissa.dejonge@utoronto.ca name: Catherine M Sabiston, PhD role: CONTACT phone: 416-978-5837 email: catherine.sabiston@utoronto.ca name: Melissa L deJonge, Msc role: SUB_INVESTIGATOR name: Delaney E Thibodeau, Msc role: SUB_INVESTIGATOR name: Sandra Yeun, PhD role: SUB_INVESTIGATOR name: Luc Simard role: SUB_INVESTIGATOR name: Catherine M Sabiston, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06350864 id: FMASU R11/2024 briefTitle: HFNC Versus Conventional Oxygen Therapy in Prolonged Upper Gastrointestinal Endoscopy in the ICU overallStatus: RECRUITING date: 2024-01-20 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-05 name: Ain Shams University class: OTHER briefSummary: Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) . conditions: Upper Gastrointestinal Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, randomized, comparative, controlled clinical trial study primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The patients and anesthesiologists in charge of the case will be unmasked as High-flow nasal cannula HFNC) shape,setting and preparation are completely different from the Conventional nasal oxygen therapy (COT), so masking both of them is impossible. whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: High-flow nasal cannula (HFNC) name: Conventional nasal oxygen therapy (COT) name: Upper gastrointestinal endoscopy (UGE) including gastroscopy name: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA) measure: Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure. measure: The median lowest SpO2 -Any episode of hypoxia -Clinically significant hypoxia -Sedation and procedure related adverse effects -Endoscopy procedure time -Anesthetic time -Propofol total used doses measure: Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes measure: Clinically significant hypoxia measure: Sedation related adverse effects (SRAEs) measure: Procedure-related adverse events (PRAEs) measure: Endoscopy procedure time measure: Anesthetic time sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Ain Shams University-Faculty of Medicine status: RECRUITING city: Cairo country: Egypt name: Ahmed M Mohamed, MD role: CONTACT phone: 002 01121318459 email: drahmed.mostafa.mohamed@med.asu.edu.eg name: Wessam Z Selima, MD role: CONTACT phone: 002 01001958858 email: w.z.selima@med.asu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06350851 id: BA161WP1 briefTitle: Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination acronym: Obi1 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-04 date: 2024-04-05 date: 2024-04-05 name: Bioaster class: OTHER briefSummary: Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.

To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected.

At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs. conditions: Onchocerciasis conditions: Loiasis conditions: Mansonelliasis conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 400 type: ESTIMATED name: Biological samples collection (blood drawing + feces) measure: Evaluation of the performance of the prototype diagnostic test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Higher Institute for Scientific and Medical Research city: Yaounde zip: 5797 country: Cameroon name: Joseph KAMGNO role: CONTACT phone: +237 6 75 06 91 58 email: contact@ismcm.org name: Joseph KAMGNO role: PRINCIPAL_INVESTIGATOR lat: 3.86667 lon: 11.51667 hasResults: False

 nctId: NCT06350838 id: KN-BCG-I briefTitle: Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC) overallStatus: COMPLETED date: 2022-11-11 date: 2023-02-13 date: 2023-02-13 date: 2024-04-05 date: 2024-04-05 name: Chengdu CoenBiotech Co., Ltd class: INDUSTRY name: Hunan Cancer Hospital briefSummary: Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC) conditions: Non-muscular Invasive Bladder Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: BCG for Therapeutic Use measure: Incidence of Treatment-Emergent Adverse Events(TEAE) and serious Treatment-Emergent Adverse Events; measure: Effects on clinical laboratory tests index of blood biochemistry, such as the concentration of alanine aminotransferase (ALT). measure: Effects on clinical laboratory tests index of blood routine, such as white blood cell count, red blood cell count, platelet count. measure: Effects on clinical laboratory tests index of coagulation function, such as activated partial thromboplastin time (APTT). measure: Effects on clinical laboratory tests index of urine routine, such as white urine albumin count, urine red blood cell count. measure: Effects on vital signs,such as temperature. measure: Effects on P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram. measure: Effects on the periodic activity of echocardiography，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure. measure: Effects on physical examination, refers to the detection and measurement of the development level of human form, structure and function. measure: Exposure condition of the test drug in the blood, refer to plasma concentration of the test drug(BCG). measure: Shedding condition of the test drug in urine. measure: To investigate the immune response characteristics of therapeutic BCG in patients with moderate and high- risk non-invasive bladder cancer after surgery. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 415000 country: China lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06350825 id: 2023-SR-543 briefTitle: Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients overallStatus: RECRUITING date: 2016-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-04-05 date: 2024-04-05 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP) conditions: Metastatic Prostate Cancer conditions: Therapy, Directly Observed studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Cytoreductive prostatectomy or brachytherapy name: ADT+second-generation antiandrogens ± chemotherapy measure: rPFS measure: Safety of CRP in mHSPC patients sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Shangqian Wang, M.D. role: CONTACT phone: 13770561625 email: wsq5501@126.com name: Lixin Hua, M.D. role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2024-03-20 uploadDate: 2024-03-20T11:18 filename: Prot_ICF_000.pdf size: 125657 hasResults: False

 nctId: NCT06350812 id: PB119110 briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-04-29 date: 2025-04-29 date: 2024-04-05 date: 2024-04-05 name: PegBio Co., Ltd. class: OTHER briefSummary: The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: PB-119 name: Placebo measure: Incidence of Treatment-Emergent Adverse Events measure: Pharmacokinetic profile measure: Pharmacokinetic profile measure: Pharmacokinetic profile measure: Pharmacokinetic profile measure: Effectiveness index measure: Effectiveness index sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06350799 id: 01741 briefTitle: Chronic Obstructive Pulmonary Disease and Community Health Worker Home-visits overallStatus: COMPLETED date: 2019-03-14 date: 2021-05-27 date: 2023-04-28 date: 2024-04-05 date: 2024-04-05 name: VA Puget Sound Health Care System class: FED name: Public Health - Seattle and King County name: University of Washington briefSummary: We examined a Community Health Worker (CHW) program for Chronic Obstructive Pulmonary Disease (COPD) in Veteran Participants. The goal of this study was to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention, explore participants' COPD health outcomes, and gather insights from participants and CHWs to inform potential improvements.

Veteran participants enrolled in the 12-week intervention and received a series of 9 CHW home, phone, or video visits. These visits provided education and chronic disease self-management practices to improve COPD health.

Researchers examined the participant and CHW perception of the intervention through qualitative interviews and surveys. conditions: COPD studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 9 type: ACTUAL measure: Acceptability, Appropriateness, Feasibility sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Puget Sound Health Care System city: Seattle state: Washington zip: 98108 country: United States lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06350786 id: ROM Study id: PZ00P1_201972 type: OTHER_GRANT domain: Swiss National Science Foundation briefTitle: Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Chronic Non-cancer Pain acronym: ROM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-07 date: 2024-04-05 date: 2024-04-05 name: Cosima Locher class: OTHER name: Brown University name: University of Basel briefSummary: This study aims to evaluate whether the reduction of the daily morphine equivalent dose (MED) in patients with chronic non-cancer pain (CNCP) can be decreased with an open-label placebo (OLP) intervention in comparison to an electronic monitoring (EM) control group. The participants will receive the intervention (OPL or EM) over the duration of six weeks. Diverse psychological and health measures will be assessed with questionnaires over the course of the intervention. Furthermore, evaluation outcomes, qualitative outcomes and safety outcomes will be assessed. It is hypothesized that the OLP-intervention group in comparison to the EM-control group will have a significantly lower consumption of MED over the course of the study. Furthermore, this study aims to evaluate whether the OLP intervention can reduce opioid withdrawal symptoms in comparison to the control group. conditions: Chronic Non-cancer Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 86 type: ESTIMATED name: P-Dragees blue Lichtenstein, Placebo dragees name: Control group (EM) measure: Daily opioid consumption (MED): measure: Subjective opioid withdrawal symptoms measure: Pain severity measure: Pain disability measure: Anxiety measure: Depression measure: Pain Opioid Analgesics Beliefs Scale - Cancer measure: Treatment Expectancy measure: Placebo pill count measure: Opioid adherence measure: Rationale credibility measure: Placebo understanding measure: Patient Provider Connection measure: Medication history measure: Primary treating physicians' acceptability of the OLP approach: measure: Primary treating physicians' treatment expectancies measure: Qualitative Outcomes measure: Safety Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350773 id: FMBSUREC/06122022/ Zaher briefTitle: Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension overallStatus: RECRUITING date: 2023-01-10 date: 2024-07 date: 2024-11 date: 2024-04-05 date: 2024-04-08 name: Beni-Suef University class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of tadalafil in patients with group II pulmonary hypertension with elevated pulmonary vascular resistance (PVR). The main question it aims to answer is:

• Can tadalafil improve patients with group II pulmonary hypertension with elevated PVR? Participants will undergo right heart catheterization (RHC) to make sure they are fulfilling the inclusion criteria, then will be asked to take tadalafil 20 mg for two weeks then 40 mg if tolerated for 12 weeks, then participants will be followed up. Investigators will compare the drug group with another age- and sex- matched control placebo group. conditions: Group 2 Pulmonary Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: tadalafil 20 mg then 40 mg if tolerated measure: Functional capacity of the patients measure: heart failure symptoms measure: right ventricular function measure: right ventricular function measure: right ventricular function measure: right ventricular function measure: right ventricular function sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beni Suef University status: RECRUITING city: Cairo state: Beni Suef zip: 62511 country: Egypt name: Hesham Boshra Mahmoud, Doctorate role: CONTACT phone: 201001402250 email: heshamboshra@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06350760 id: UJA_PROCARE-I+ briefTitle: Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules acronym: PROCARE-I+ overallStatus: RECRUITING date: 2023-03-15 date: 2024-07-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-05 name: University of Jaén class: OTHER name: Universidad Miguel Hernandez de Elche name: University Rovira i Virgili name: University of Miami briefSummary: PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population, with the following objectives: 1) provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I+; and 2) evaluate if there is any risk factor that predicts anxiety-depressive symptoms and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or depression and a high risk of developing an emotional disorder and who benefited from the preventive, transdiagnostic, online and personalized intervention called PROCARE-I+. After the analysis of the data collected at the pre-intervention and post-intervention time, the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology, quality of life and emotional regulation. On the other hand, the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression; In contrast, predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty. conditions: Anxiety Disorders and Symptoms conditions: Depressive Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Active control condition name: PROCARE-I+ 8-session measure: Self-reported anxiety and mood symptomatology measure: Factors associated with adolescents' mental health measure: Resilience measure measure: Health-related quality of life measure: Absence of emotional disorders measure: Economic evaluations measure: Psychological flexibility measure: Emotional regulation measure: Bullying measure: Expressed Emotion measure: Ecoanxiety measure: Exam anxiety measure: Videogames addiction measure: Smartphone addiction sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universidad Miguel Hernández status: RECRUITING city: Elche state: Alicante zip: 03202 country: Spain name: José Antonio Piqueras, Ph. D. role: CONTACT phone: 966658343 email: jpiqueras@umh.es name: José Antonio Piqueras, Ph. D. role: SUB_INVESTIGATOR lat: 38.26218 lon: -0.70107 facility: University of Jaén status: RECRUITING city: Jaén state: Jaen zip: 23071 country: Spain name: Luis Joaquín García-López, Ph. D. role: CONTACT phone: 953213412 email: ljgarcia@ujaen.es name: Luis Joaquín García-López, Ph. D. role: PRINCIPAL_INVESTIGATOR name: José Antonio Muela-Martínez, Ph. D. role: PRINCIPAL_INVESTIGATOR name: Lourdes Espinosa-Fernández, Ph. D. role: PRINCIPAL_INVESTIGATOR name: Laura Zafra-Palomino, Ph. D. stud role: PRINCIPAL_INVESTIGATOR name: David Jiménez-Vázquez, Ph. D. stud role: PRINCIPAL_INVESTIGATOR lat: 37.76922 lon: -3.79028 facility: Universitat Rovira i Virgili status: RECRUITING city: Tarragona zip: 43003 country: Spain name: Josefa Canals, M.D. role: CONTACT phone: 977257895 email: josefa.canals@urv.cat name: Josefa Canals, M.D. role: SUB_INVESTIGATOR lat: 41.11667 lon: 1.25 hasResults: False

 nctId: NCT06350747 id: CelalBayarU-SBF-OT-02 briefTitle: The Effect of Laughter Yoga on Nurses' Perceived Stress, Sleep Quality, and Burnout Levels overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-07-30 date: 2024-04-05 date: 2024-04-18 name: Celal Bayar University class: OTHER briefSummary: The aim of the study was to investigate the effects of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels. conditions: Healthy Participants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pretest-posttest with control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 64 type: ESTIMATED name: Laughter Yoga measure: Perceived Stress Scale measure: Jenkins Sleep Scale measure: Maslach Burnout Scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi status: RECRUITING city: Manisa zip: 45060 country: Turkey name: Özge Topsakal, PhD role: CONTACT phone: 05549165599 email: ozgebydr_19@hotmail.com lat: 38.61202 lon: 27.42647 hasResults: False

 nctId: NCT06350734 id: 18-004675 id: NCI-2024-00973 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 18-004675 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study overallStatus: RECRUITING date: 2018-10-12 date: 2029-01-31 date: 2029-01-31 date: 2024-04-05 date: 2024-04-05 name: Mayo Clinic class: OTHER briefSummary: This study evaluates the effect of bladder cancer treatment on quality of life. conditions: Stage 0a Bladder Cancer AJCC v8 conditions: Stage 0is Bladder Cancer AJCC v8 conditions: Stage I Bladder Cancer AJCC v8 conditions: Stage II Bladder Cancer AJCC v8 conditions: Stage IIIA Bladder Cancer AJCC v8 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 704 type: ESTIMATED name: Non-Interventional Study measure: Change in quality of life outcomes - PROMIS-29 measure: Change in quality of life outcomes - Bladder Cancer Index measure: Patient level characteristics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Mark D. Tyson, M.D., M.P.H. role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Paul R. Young, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Matthew T. Gettman, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06350721 id: DizzyVR briefTitle: Feasibility, Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR acronym: DizzyVR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-10-01 date: 2024-04-05 date: 2024-04-05 name: Universidad Loyola Andalucia class: OTHER name: University of Seville name: Universitat Politècnica de València name: Universidad de Zaragoza briefSummary: The goal of this pilot study is to assess the safety and feasibility of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. The main questions it aims to answer are:

* To assess the feasibility, usability and safety of the system DizzyVR for the vestibular rehabilitation in participants with vestibular disorders.
* To detect and record possible adverse events due to the use of DizzyVR.
* To examine the degree of adherence of the participants to the intervention.
* To know the average success rate of the different games in each session.
* To evaluate the average difficulty levels overcome throughout the intervention.
* To know the usability and satisfaction with the system reported by participants and therapists.

Participants will receive the vestibular rehabilitation based on the novel immersive virtual systema, DizzyVR. conditions: Vestibular Disorder conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: DizzyVR measure: Retention rate of participants measure: User Satisfaction Evaluation Questionnaire (USEQ) measure: Register of risk and number of adverse events experimented by the stakeholders measure: Adherence rate measure: Dropout rates sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350708 id: 2024-18304-33663 id: 336664 type: OTHER domain: Integrated Research Application System (IRAS) briefTitle: Virtual Reality (VR) Paediatric Tracheostomy Training overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-10 date: 2024-07-10 date: 2024-04-05 date: 2024-04-05 name: University of Manchester class: OTHER briefSummary: This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children. conditions: Educational Study studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 69 type: ESTIMATED name: Virtual reality (VR) tracheostomy educational tool measure: Performance in simulation (time to key specific intervention, time to completion of scenario, and number of correct interventions completed) measure: Knowledge using a bespoke knowledge multiple choice questionnaire adapted from a validated question bank. measure: Participant satisfaction measured using a bespoke data collection tool. measure: Virtual Reality Sickness measure: Usability using the validated system usability scale sex: ALL minimumAge: 18 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Manchester city: Manchester state: Greater Manchester zip: M13 9PL country: United Kingdom name: Jonathan R Abbas, MBChB role: CONTACT email: jonathan.abbas@postgrad.manchester.ac.uk lat: 53.48095 lon: -2.23743 hasResults: False

 nctId: NCT06350695 id: HP-00103478 id: 1R21AG080424-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AG080424-01 briefTitle: The ROle of Compression StocKings in Heart Failure Patients acronym: ROCK-HF overallStatus: RECRUITING date: 2024-01-17 date: 2025-06-01 date: 2026-01-01 date: 2024-04-05 date: 2024-04-05 name: University of Maryland, Baltimore class: OTHER name: National Institute on Aging (NIA) briefSummary: Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months. conditions: Heart Failure，Congestive conditions: Leg Edema conditions: Venous Insufficiency conditions: Venous Ulcers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective randomized-control 1:1 single blind study primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: low grade compression stockings (10-15 mmHg) name: high grade compression stockings (20-30 mmHg) measure: Incidence of adverse events. measure: Change in symptoms of heart failure. measure: Change in kidney function. measure: Change in venous reflux. measure: Change in C Class from the CEAP classification for venous insufficiency. measure: Mobility of the patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Maryland status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Rydica Newton, Research Coordinator role: CONTACT phone: 410-706-3941 email: RNewton@som.umaryland.edu name: Kim Nordstrom role: CONTACT email: knordstrom@som.umaryland.edu name: Rafael S Cires-Drouet, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06350682 id: HP-00107323 briefTitle: Resilient HIV Implementation Science With SGM Youths Using Evidence acronym: RISE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-09 date: 2028-06 date: 2024-04-05 date: 2024-04-05 name: University of Maryland, Baltimore class: OTHER name: University of Florida briefSummary: The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group. conditions: Hiv studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: HealthMPowerment (HMP) measure: PrEP initiation for HIV seronegative seropositive measure: Viral load suppression for HIV measure: RE-AIM measure: HIV testing cascade measure: PrEP continuum measure: HIV care and treatment continuum measure: Implementation effectiveness sex: MALE minimumAge: 15 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06350669 id: 9576-22-SMC briefTitle: App-supported Vestibular Rehabilitation (RCT) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-03 date: 2024-04-05 date: 2024-04-22 name: University of Haifa class: OTHER name: Sheba Medical Center name: Ben-Gurion University of the Negev briefSummary: A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes conditions: Vestibular Disorder conditions: Vestibular Diseases conditions: Vestibular Abnormality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients will be randomly assigned to either the intervention group (app-assisted vestibular rehabilitation) or the control group ("standard" vestibular rehabilitation/no app) primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Vestibular rehabilitation phone application measure: Adherence measures measure: Timed up and go (TUG) measure: Demographics and medical history intake measure: Vestibular functions- physical examination measure: Oculomotor functions- physical examination measure: Visual Analogue Scale (VAS) measure: Dizziness Handicap Inventory (DHI) measure: Activities-specific Balance Confidence Scale (ABC) measure: Dynamic Gait Index (DGI) measure: 10-Meters Walk Test (10MWT) measure: 2-Minute Walk Test (2MWT) measure: Dynamic Visual Acuity (DVA) measure: Video Head Impulse Test (vHIT) measure: Suppression Head Impulse Test (SHIMP) measure: Exercise difficulty levels and symptoms severity measure: Cognitive reserve index questionnaire (CRIQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sheba Medical Center city: Ramat Gan country: Israel name: Yoav Gimmon, PT, Ph.D role: CONTACT email: yoavgimmon@gmail.com name: Amit Wolfovitz, M.D role: PRINCIPAL_INVESTIGATOR name: Shelly Levy-Tzedek, PhD role: PRINCIPAL_INVESTIGATOR name: Liran Kalderon, M.Sc.PT role: PRINCIPAL_INVESTIGATOR lat: 32.08227 lon: 34.81065 hasResults: False

 nctId: NCT06350656 id: IRBN282022/CHUSTE briefTitle: Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2) acronym: EC2 overallStatus: RECRUITING date: 2023-03-31 date: 2024-04 date: 2024-04 date: 2024-04-05 date: 2024-04-05 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy.

In treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box. conditions: Cerebrospinal; Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Clinical data collection name: Therapeutic data collection name: IntraCranial Pression (ICP) values collection measure: Intracranial pressure (mmHg) measure: Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CENTRE HOSPITALIER Charponnay status: RECRUITING city: Chaponnay zip: 69970 country: France name: PIERRE-HENRI MURGAT, MD role: PRINCIPAL_INVESTIGATOR lat: 45.63097 lon: 4.94299 facility: CENTRE HOSPITALIER UNIVERSITAIRE Grenoble status: RECRUITING city: Grenoble zip: 38000 country: France name: JEAN FRANCOIS PAYEN, MD role: PRINCIPAL_INVESTIGATOR lat: 45.16667 lon: 5.71667 facility: HOPITAL NORD La Tronche status: RECRUITING city: La Tronche zip: 38170 country: France name: KEVIN LAGARDE, MD role: PRINCIPAL_INVESTIGATOR lat: 45.20429 lon: 5.73645 facility: APHP status: RECRUITING city: Paris zip: 75010 country: France name: SAMUEL GAUGUIN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hopital Lariboisiere - Ahph status: RECRUITING city: Paris zip: 75010 country: France name: JEROME CARTAILLIER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CENTRE HOSPITALIER UNIVERSITAIRE Rennes status: RECRUITING city: Rennes zip: 35000 country: France name: YOANN LAUNEY, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 facility: CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: CLEMENT MAGAND, MD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06350643 id: 287064 id: P50MD017319-03S1 type: NIH link: https://reporter.nih.gov/quickSearch/P50MD017319-03S1 briefTitle: The Black Health Block Quit and Screen Project overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2024-12 date: 2024-04-05 date: 2024-04-05 name: University of Arkansas class: OTHER name: Virginia Commonwealth University name: Coalition for a Tobacco Free Arkansas name: National Institute on Minority Health and Health Disparities (NIMHD) name: National Medical Association briefSummary: The Black Health Block Quit and Screen Project seeks to engage Black health care providers in helping Black smokers quit tobacco use, including menthol cigarettes and flavored cigars, and screen for lung cancer early as strategies to reduce multiple chronic disease disparities.

The goal of this clinical trial is to test the feasibility and impact of the Black Health Block Culturally Tailored Training alone versus the Health Disparities and Lung Cancer Screening Training + the Black Health Block Culturally Tailored training modules on changes in knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition. Participants will complete the training modules and complete pre- and post-tests to assess these outcomes. conditions: Knowledge conditions: Attitudes conditions: Behavioral Intention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Black Health Block Culturally Tailored training name: Health Disparities and Lung Cancer Screening training measure: Familiarity with treatment guidelines for tobacco and nicotine treatment measure: Weaver et al. 2012 Provider Attitudes and Perceptions about smoking cessation measure: Weaver et al. 2012 Provider Perceptions about provider barriers to providing smoking cessation interventions to patients measure: Provider Perceptions about patient barriers to smoking cessation measure: Behavioral intentions to screen and advise patients about smoking cessation measure: Familiarity with lung cancer screening guidelines measure: Knowledge about low dose computed tomography for lung cancer screening measure: Perceptions about shared decision-making for low dose computed tomography for lung cancer screening measure: Perceptions about provider barriers to referring patients to low dose computed tomography for lung cancer screening measure: Provider Perceptions about patient barriers to get screened for lung cancer measure: Behavioral intentions to advise patients to get screened for lung cancer via low dose computed tomography measure: Diversity of enrolled healthcare providers measure: Retention: Percent of providers complete the training after enrolling measure: Adherence to completing training modules: Percent of modules completed measure: Preferences regarding training measure: Satisfaction with training sex: ALL minimumAge: 21 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth Univesity city: Richmond state: Virginia zip: 23284 country: United States name: Mignonne Guy, PhD role: CONTACT phone: 804-828-1731 email: mguy@vcu.edu name: Mignonne Guy, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06350630 id: 20PH284 id: 2024-512653-25-00 type: CTIS briefTitle: Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study acronym: QUIgAN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-12-31 date: 2030-12-31 date: 2024-04-05 date: 2024-04-05 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER name: Ministry of Health, France briefSummary: immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity.

In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced.

One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group).

Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study. conditions: IgA Nephropathy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double blind trial randomized primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 334 type: ESTIMATED name: Hydroxychloroquine Oral Tablet name: Placebo oral tablet measure: Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution measure: nephrological follow-up: proteinuria measure: nephrological follow-up: albuminuria measure: nephrological follow-up: GFR measure: nephrological follow-up: hematuria measure: nephrological follow-up: systolic and diastolic blood pressure measure: nephrological follow-up: proteinuria measure: nephrological follow-up: albuminuria measure: nephrological follow-up: GFR measure: nephrological follow-up: hematuria measure: nephrological follow-up: systolic and diastolic blood pressure measure: nephrological follow-up: proteinuria measure: nephrological follow-up: albuminuria measure: nephrological follow-up: hematuria measure: nephrological follow-up: systolic and diastolic blood pressure measure: end stage renal disease (GFR< 15mL/min/1.73m²) measure: death measure: adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Gabriel Montpied city: Clermont-Ferrand zip: 63000 country: France lat: 45.77966 lon: 3.08628 facility: Hospices Civils de Lyon city: Lyon zip: 69437 country: France lat: 45.74848 lon: 4.84669 facility: AP-HM Hôpital de la Conception city: Marseille zip: 13385 country: France name: Thomas ROBERT, MD role: CONTACT phone: 0662426166 phoneExt: +33 email: thomas.robert@ap-hm.fr lat: 43.29551 lon: 5.38958 facility: APHP Hôpital Bichat city: Paris zip: 75018 country: France name: Eric DAUGAS, PU-PH role: CONTACT phone: 0140257101 phoneExt: +33 email: eric.daugas@aphp.fr lat: 48.85341 lon: 2.3488 facility: APHP Hôpital de Tenon city: Paris zip: 75020 country: France name: Khalil EL KAROUI, PU-PH role: CONTACT phone: 0156016317 phoneExt: +33 email: khalil.el-karoui@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU Lyon Sud city: Pierre-Bénite zip: 69495 country: France name: Sarah MEZAACHE, MD role: CONTACT phone: 0478863712 phoneExt: +33 email: sarah.mezaache@chu-lyon.fr lat: 45.7009 lon: 4.82511 facility: CHU de Saint-Etienne city: Saint-Étienne zip: 42055 country: France name: Nicolas MAILLARD, MD role: CONTACT phone: 0477828127 phoneExt: +33 email: nicolas.maillard@chu-st-etienne.fr name: Carine LABRUYERE role: CONTACT phone: 0477120469 phoneExt: +33 email: carine.labruyere@chu-st-etienne.fr lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06350617 id: 2023-12-028 briefTitle: Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients overallStatus: RECRUITING date: 2024-02-20 date: 2025-09-30 date: 2025-09-30 date: 2024-04-05 date: 2024-04-05 name: Samsung Medical Center class: OTHER name: National Research Foundation of Korea name: Ministry of Food and Drug Safety, Korea name: Seoul National University Hospital name: Bucheon St. Mary's Hospital name: Saint Vincent's Hospital, Korea name: Severance Hospital name: Kumoh National Institute of Technology name: NEUROPHET briefSummary: The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves. conditions: Parkinson's Disease and Parkinsonism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: High-Frequency, ipsilateral M1 name: High-Frequency, bilateral M1 name: High-Frequency, Lt. DLPFC name: High-Frequency, bilateral M1 measure: Differences of Timed Up and Go Test (TUG) measure: Differences of Timed Up and Go Test (TUG) measure: Differences of Timed Up and Go Test (TUG) measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog) measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog) measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog) measure: Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III measure: Differences of MDS-UPDRS, Part III measure: Differences of New Freezing of Gait Questionnaire (FoG-Q) measure: Differences of New Freezing of Gait Questionnaire (FoG-Q) measure: Differences of Digit span Test measure: Differences of Digit span Test measure: Differences of Trail making Test measure: Differences of Trail making Test measure: Differences of Gait lab parameter (Gait speed) measure: Differences of Gait lab parameter (Gait speed) measure: Differences of Gait lab parameter (Stride length) measure: Differences of Gait lab parameter (Stride length) measure: Differences of Gait lab parameter (Step count) measure: Differences of Gait lab parameter (Step count) measure: Differences of Gait lab parameter (Cadence) measure: Differences of Gait lab parameter (Cadence) measure: Differences of Gait lab parameter (Swing ratio) measure: Differences of Gait lab parameter (Swing ratio) measure: Differences of Gait lab parameter (Stride time) measure: Differences of Gait lab parameter (Stride time) measure: Differences of Gait lab parameter (Pressure distribution) measure: Differences of Gait lab parameter (Pressure distribution) sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Won Hyuk Chang, PhD role: CONTACT phone: +82-2-3410-6068 email: wh.chang@samsung.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06350604 id: PRO-2023-355 briefTitle: Project WHADE: A Partner-Based Physical Activity Program for Women overallStatus: RECRUITING date: 2024-01-02 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-05 name: Rowan University class: OTHER briefSummary: This study is designed to test the feasibility and acceptability of a new method for supporting physical activity among women ages 40-65 who have risk factors for cardiovascular disease. Each participant receives a trained physical activity coach and a physical activity partner; the partner is another woman in the program. Partners communicate with each other between weekly coaching sessions to provide support for physical activity behavior change. conditions: Hypertension conditions: Type 2 Diabetes conditions: Metabolic Syndrome conditions: Smoking conditions: High Cholesterol conditions: PreDiabetes conditions: Prehypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants receive the same intervention primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Project WHADE: A Partner-Based Physical Activity Program for Women measure: Frequency of partner communication measure: Satisfaction with partner communication measure: Physical activity behavior - steps measure: Physical activity behavior - active minutes sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rowan University status: RECRUITING city: Glassboro state: New Jersey zip: 08028 country: United States name: Sofia Gular, B.A. role: CONTACT phone: 856-256-4872 email: projectwhade@rowan.edu name: Danielle Arigo, Ph.D. role: CONTACT phone: 8562564500 phoneExt: 53775 email: arigo@rowan.edu lat: 39.70289 lon: -75.11184 hasResults: False

 nctId: NCT06350591 id: 6038674 briefTitle: Evaluating Changes in Skeletal Muscle Proteins Following Resistance Exercise and Single-Leg Disuse overallStatus: RECRUITING date: 2024-04-01 date: 2024-08 date: 2024-08 date: 2024-04-05 date: 2024-04-05 name: Queen's University class: OTHER briefSummary: Skeletal muscle plays a critical role in supporting human health. Beyond its role in providing the force to move, skeletal muscle accounts for a large proportion of metabolic rate, glucose disposal, and amino acid storage. Skeletal muscle is dynamically regulated by environmental stimuli, such as loading (i.e., resistance training\]) and unloading (i.e., disuse atrophy) as well as the intake of essential amino acids (EAAs). However, the precise mechanisms that regulate skeletal muscle mass in response to various conditions (e.g., EAA supplementation, resistance training, and unloading) are not completely understood. Therefore, concerted efforts to better understand the mechanisms regulating skeletal muscle size are needed that aid in the development of therapeutic interventions to combat age, disease, and disuse related muscular atrophy. conditions: Healthy conditions: Skeletal Muscle Atrophy conditions: Skeletal Muscle Hypertrophy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel, within-subject design primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: Immobilization name: Resistance training measure: Changes in average rates of muscle synthesis measure: Dynamic proteomic profiling measure: Protein expression (phosphorylation and content) of novel and known targets implicated in protein translation and mitochondrial-related protein expression measure: Muscle torque measure: Quadriceps skeletal muscle volume sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: School of Kinesiology and Health Studies status: RECRUITING city: Kingston state: Ontario zip: K7L 3N6 country: Canada name: Chris McGlory, PhD role: CONTACT phone: 6135336000 phoneExt: 75410 email: chris.mcglory@queensu.ca name: Kristine Boileau, BSc role: CONTACT email: 22kb15@queensu.ca name: Chris McGlory, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.22976 lon: -76.48101 hasResults: False

 nctId: NCT06350578 id: BUHOOTH-D-23-00073 briefTitle: A Randomized Clinical Trial Comparing Hall vs. Conventional Technique in Primary Molars. overallStatus: RECRUITING date: 2023-12-06 date: 2025-03 date: 2025-06 date: 2024-04-05 date: 2024-04-05 name: Primary Health Care Corporation, Qatar class: OTHER_GOV briefSummary: This study aims to assess the comparative effectiveness of the Hall technique (HT) and the conventional technique (CT) for placing Stainless Steel Crowns (SSCs) in primary molars with approximal caries. conditions: Dental Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A binary outcome non-inferiority randomized trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single-blind whoMasked: CARE_PROVIDER count: 80 type: ESTIMATED name: Hall Crown Technique name: Conventional SSC Technique measure: Restoration survival at 12 months measure: Occlusal vertical dimension (OVD) resolution measure: Tooth survival measure: Procedural time measure: Participant's cooperation measure: Participant's pain perception measure: Treatment perceptions and opinions of the parents sex: ALL minimumAge: 3 Years maximumAge: 9 Years stdAges: CHILD facility: Primary Healthcare Corporation status: RECRUITING city: Doha country: Qatar name: Research Section role: CONTACT phone: +97444069917 email: researchsection@phcc.gov.qa lat: 25.28545 lon: 51.53096 hasResults: False

 nctId: NCT06350565 id: DEX20240104 briefTitle: A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+) overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-12-31 date: 2024-04-05 date: 2024-04-16 name: Peking University Third Hospital class: OTHER briefSummary: This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus. conditions: Respiratory Distress Syndrome of Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Dexamethasone measure: Respiratory distress syndrome measure: PK parameters (analysed in conjunction with population pharmacokinetic (PPK) modelling): area under the blood concentration curve, Cmax, Tmax, Kel, t1/2, CL, VZ measure: Pharmacodynamics measure: Measurability indicators measure: Blood biochemistry findings in newborns measure: DEX potential safety marker test sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06350552 id: PA224ES-1-03 briefTitle: Prevalence of Postural Abnormalities in Dialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2024-04 date: 2024-04-05 date: 2024-04-23 name: Pardis Specialized Wellness Institute class: OTHER briefSummary: The goal of this observational study is to investigate and compare the prevalence of forward head , hyper kyphosis and balance in hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are:

What is the prevalence of forward head posture in hemodialysis and peritoneal dialysis patients? What is the prevalence of hyper kyphosis in hemodialysis and peritoneal dialysis patients? Is there any relation between postural abnormalities and physical function in hemodialysis and peritoneal dialysis patients?

Participants will answer 2 questionnaires and will do some functional tests. conditions: End Stage Renal Disease conditions: Hemodialysis Complication conditions: Peritoneal Dialysis Complication studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 390 type: ESTIMATED measure: Prevalence of thoracic hyper kyphosis measure: Prevalence of forward head measure: Balance level measure: Cardiopulmonary function's level measure: Fall risk level sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Khorshid Dialysis Center city: Isfahan country: Iran, Islamic Republic of lat: 32.65246 lon: 51.67462 hasResults: False

 nctId: NCT06350539 id: 10-007 briefTitle: Personalized Models for Cancer Research overallStatus: RECRUITING date: 2024-02-15 date: 2034-02-15 date: 2034-02-15 date: 2024-04-05 date: 2024-04-05 name: New York Stem Cell Foundation Research Institute class: OTHER name: Stevens Institute of Technology briefSummary: The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate cancer research ranging from disease mechanisms to personalized medicine approaches that will help to realize the promise of precision medicine for oncology. conditions: Solid Tumor, Adult studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 500 type: ESTIMATED name: Biological Sample Collection measure: Implement organoid culture technologies. measure: Validate genotypic and phenotypic relevance of tumor-derived organoids for biobanking. measure: Establish functional testing using organoid cultures alone or in combination with additional cell types. measure: Perform drug testing and screens to identify new targets and/or new therapeutic strategies to effectively treat cancer. measure: Develop a Laboratory Developed Test (LDT) for CLEP/FDA approval that will inform clinicians of each patient's tumor responses to FDA approved drugs. measure: Develop stem cells from individual patient samples to study tumor evolution. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New York Stem Cell Foundation Research Institute status: RECRUITING city: New York state: New York zip: 10019 country: United States name: Becca Wood role: CONTACT phone: 212-927-1801 email: clinicalresearch@nyscf.org name: Lisa Voltolina role: CONTACT phone: 6462133911 email: lvoltolina@nyscf.org name: Laura Andres-Martin, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06350526 id: PULMHEMA briefTitle: Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2025-06-01 date: 2024-04-05 date: 2024-04-05 name: New Valley University class: OTHER briefSummary: Hematologic malignancies are heterogeneous groups of neoplasia, with frequent pulmonary complications. These complications may be secondary to the patient's comorbidities, to the hemopathy itself, or its treatments. Divided into infectious and non-infectious complications, the etiologies are numerous and varied. This makes the diagnostic approach complex for the clinicians conditions: Hematologic Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Complete Blood Count name: C-reactive protein name: O2 saturation name: Serum ferritin and D-dimer name: Liver and renal function tests name: Lactate dehydrogenase name: coronavirus (SARS-CoV-2) swab name: CT chest measure: Number of patients who had certain radiological patterns associated with pulmonary complications in patients diagnosed with various hematological diseases measure: Number of patients who developed complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350513 id: NecmettinE briefTitle: The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-09-25 date: 2025-02-25 date: 2024-04-05 date: 2024-04-05 name: Selverhan Yurttutan class: OTHER briefSummary: This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes. conditions: Diabetes Mellitus, Type 1 conditions: Child, Only conditions: Anxiety conditions: Fear conditions: Nurse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Group (Experiment-Control) Randomized Controlled Experimental primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Animation movie, story book measure: State Anxiety Inventory for Children (STAI-C) measure: State Anxiety Inventory for Children (STAI-C) measure: State Anxiety Inventory for Children (STAI-C) measure: Children's Fear Scale measure: Children's Fear Scale measure: Children's Fear Scale sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Semra Köse city: Konya state: Meram country: Turkey lat: 37.87135 lon: 32.48464 facility: Necmettin Erbakan Üniversity city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06350500 id: I-3858823 briefTitle: A Patient Navigation Program for Addressing Disparities in Breast Cancer Care overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-01-01 date: 2026-01-01 date: 2024-04-05 date: 2024-04-09 name: Roswell Park Cancer Institute class: OTHER briefSummary: This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients. conditions: Breast Carcinoma conditions: Breast Ductal Carcinoma in Situ studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 126 type: ESTIMATED name: Patient Navigation name: Questionnaire measure: Enrollment rate measure: Reasons for refusal measure: Retention Rate measure: Reasons for discontinuation measure: European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30) measure: Social Determinates of health measure: Barriers to care measure: Use of supportive services measure: Patient Satisfaction survey sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350487 id: SMC2024-01-089-003 briefTitle: The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction acronym: ENRICH-PEF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-06-30 date: 2024-04-05 date: 2024-04-08 name: Samsung Medical Center class: OTHER briefSummary: The aim of prospective, open label, single center, randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance, diastolic dysfunction, and quality of life in patients with heart failure with preserved ejection fraction (HFpEF). conditions: Heart Failure, Preserved Ejection Fraction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, open label, single center, randomized controlled trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group. whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: SGLT2 inhibitor measure: Change in peak oxygen consumption (VO2) measure: Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope) measure: Change in Left atrial volume index (LAVI) before and after maximal exercise measure: Change in Lateral Early diastolic transmitral filling velocity over early diastolic relaxation velocity at mitral annulus (E/e') before and after maximal exercise measure: Change in Left ventricular mass index (LVMI) before and after maximal exercise measure: Change in LV wall thickness before and after maximal exercise measure: Change in LV global longitudinal strain before and after maximal exercise measure: Change in LA strain before and after maximal exercise measure: Change in right ventricular (RV) free wall strain before and after maximal exercise measure: Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) measure: Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) level measure: Change in chronotropic response reserve assessed by change in heart rate from rest to peak exercise measure: Change in serum iron measure: Change in ferritin measure: Change in total iron binding capacity measure: Change in hemoglobin measure: All-cause death measure: Hospitalization for heart failure sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center city: Seoul zip: 06351 country: Korea, Republic of name: Jeong Hoon Yang, MD, PhD role: CONTACT phone: 82-2-3410-3419 email: jhysmc@gmail.com name: David Hong, MD role: CONTACT phone: 82-2-3410-3419 email: hongdawi@naver.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06350474 id: SIMPLIFY-IP-19 Dnase briefTitle: Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study acronym: SIMPLIFY-DN overallStatus: COMPLETED date: 2020-08-25 date: 2022-07-11 date: 2022-07-11 date: 2024-04-05 date: 2024-04-05 name: Nicole Hamblett class: OTHER name: Cystic Fibrosis Foundation name: Dartmouth-Hitchcock Medical Center name: University of Washington briefSummary: Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking dornase alfa (Dnase) in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).

ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.

Dornase alfa (Dnase) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. Dnase is considered to be relatively burdensome and it is not known whether Dnase can improve or maintain lung function above what is already gained through ETI use.

The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop Dnase by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking Dnase as compared to those who are assigned to keep taking Dnase while continuing to take ETI.

This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.

The sub study investigating the impact of discontinuing and continuing hypertonic saline is registered under NCTXXXXXXX (will add once available). conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 477 type: ACTUAL name: Discontinuation of dornase alfa (Dnase) name: Continuation of dornase alfa (Dnase) measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 6 measure: Absolute Change in LCI 2.5 From Baseline to Week 6 measure: Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6 measure: Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6 measure: Absolute Change in FEV1 % Predicted From Week -2 to Week 0 measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 2 measure: Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6 measure: Number and Percent of Participants Hospitalized From Week 0 to Week 6 measure: Number and percent of participants Experiencing Pulmonary Exacerbations from Week 0 to Week 6 measure: Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6 measure: Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms measure: Number and Percent of Participants with Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6 sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States lat: 33.52066 lon: -86.80249 facility: Providence Alaska Medical Center city: Anchorage state: Alaska zip: 99508 country: United States lat: 61.21806 lon: -149.90028 facility: Tucson Cystic Fibrosis Center city: Tucson state: Arizona zip: 85724 country: United States lat: 32.22174 lon: -110.92648 facility: Arkansas Children's Hospital city: Little Rock state: Arkansas zip: 72202 country: United States lat: 34.74648 lon: -92.28959 facility: Miller Children's and Women's Hospital Long Beach city: Long Beach state: California zip: 90806 country: United States lat: 33.76696 lon: -118.18923 facility: CHOC Children's Hospital city: Orange state: California zip: 92868 country: United States lat: 33.78779 lon: -117.85311 facility: Stanford University Medical Center city: Palo Alto state: California zip: 94304 country: United States lat: 37.44188 lon: -122.14302 facility: Rady Children's Hospital and Health Center at the University of California San Diego city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco - Adult Center city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 facility: University of California, San Francisco - Peds Center city: San Francisco state: California zip: 94158 country: United States lat: 37.77493 lon: -122.41942 facility: Children's Hospital Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States lat: 39.73915 lon: -104.9847 facility: Yale University School of Medicine city: New Haven state: Connecticut zip: 06520 country: United States lat: 41.30815 lon: -72.92816 facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States lat: 29.65163 lon: -82.32483 facility: Nemours Children's Clinic - Jacksonville city: Jacksonville state: Florida zip: 32207 country: United States lat: 30.33218 lon: -81.65565 facility: Central Florida Pulmonary Group city: Orlando state: Florida zip: 32803 country: United States lat: 28.53834 lon: -81.37924 facility: The Nemours Children's Clinic - Orlando city: Orlando state: Florida zip: 32827 country: United States lat: 28.53834 lon: -81.37924 facility: Nemours Children's Clinic - Pensacola city: Pensacola state: Florida zip: 32514 country: United States lat: 30.42131 lon: -87.21691 facility: All Children's Hospital city: Saint Petersburg state: Florida zip: 33701 country: United States lat: 27.77086 lon: -82.67927 facility: Tampa General Hospital city: Tampa state: Florida zip: 33606 country: United States lat: 27.94752 lon: -82.45843 facility: Emory University city: Atlanta state: Georgia zip: 30324 country: United States lat: 33.749 lon: -84.38798 facility: Saint Luke's Cystic Fibrosis Center of Idaho city: Boise state: Idaho zip: 83702 country: United States lat: 43.6135 lon: -116.20345 facility: Northwestern University city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: OSF Saint Francis Medical Center city: Peoria state: Illinois zip: 61637 country: United States lat: 40.69365 lon: -89.58899 facility: Riley Hospital for Children city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: University of Iowa city: Iowa City state: Iowa zip: 52242 country: United States lat: 41.66113 lon: -91.53017 facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 facility: University of Kentucky city: Lexington state: Kentucky zip: 40506 country: United States lat: 37.98869 lon: -84.47772 facility: University of Louisville city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: Tulane University city: Metairie state: Louisiana zip: 70001 country: United States lat: 29.98409 lon: -90.15285 facility: Maine Medical Partners Pediatric Specialty Care city: Portland state: Maine zip: 04102 country: United States lat: 43.66147 lon: -70.25533 facility: John Hopkins Hospital city: Baltimore state: Maryland zip: 21205 country: United States lat: 39.29038 lon: -76.61219 facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: University of Michigan, Michigan Medicine city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: Wayne State University Harper University Hospital city: Detroit state: Michigan zip: 48201 country: United States lat: 42.33143 lon: -83.04575 facility: Corewell Health Helen DeVos city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: Children's Hospitals and Clinics of Minnesota city: Minneapolis state: Minnesota zip: 55404 country: United States lat: 44.97997 lon: -93.26384 facility: The Minnesota Cystic Fibrosis Center city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: Children's Mercy Kansas City city: Kansas City state: Missouri zip: 64108 country: United States lat: 39.09973 lon: -94.57857 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States lat: 38.62727 lon: -90.19789 facility: Billings Clinic city: Billings state: Montana zip: 59101 country: United States lat: 45.78329 lon: -108.50069 facility: Dartmouth Hitchcock Medical Center city: Lebanon state: New Hampshire zip: 03756 country: United States lat: 43.64229 lon: -72.25176 facility: Monmouth Medical Center city: Eatontown state: New Jersey zip: 07724 country: United States lat: 40.29622 lon: -74.05097 facility: Morristown Medical Center city: Morristown state: New Jersey zip: 07960 country: United States lat: 40.79677 lon: -74.48154 facility: Rutgers - Robert Wood Johnson Medical School city: New Brunswick state: New Jersey zip: 08903 country: United States lat: 40.48622 lon: -74.45182 facility: Cohen Children's Medical Center of New York city: New Hyde Park state: New York zip: 11042 country: United States lat: 40.7351 lon: -73.68791 facility: Beth Israel Medical Center city: New York state: New York zip: 10003 country: United States lat: 40.71427 lon: -74.00597 facility: Lenox Hill Hospital Cystic Fibrosis Center city: New York state: New York zip: 10028 country: United States lat: 40.71427 lon: -74.00597 facility: Columbia University Cystic Fibrosis Program city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: University of Rochester Medical Center Strong Memorial city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 facility: SUNY Upstate Medical University city: Syracuse state: New York zip: 13210 country: United States lat: 43.04812 lon: -76.14742 facility: New York Medical College at Westchester Medical Center city: Valhalla state: New York zip: 10595 country: United States lat: 41.07482 lon: -73.77513 facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27517 country: United States lat: 35.9132 lon: -79.05584 facility: Atrium Health Wake Forest Baptist city: Winston-Salem state: North Carolina zip: 27157 country: United States lat: 36.09986 lon: -80.24422 facility: Children's Hospital Medical Center of Akron city: Akron state: Ohio zip: 44308 country: United States lat: 41.08144 lon: -81.51901 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States lat: 39.12713 lon: -84.51435 facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center city: Cleveland state: Ohio zip: 44146 country: United States lat: 41.4995 lon: -81.69541 facility: Cleveland Clinic Cystic Fibrosis Program city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43205 country: United States lat: 39.96118 lon: -82.99879 facility: Dayton Children's Hospital city: Dayton state: Ohio zip: 45404 country: United States lat: 39.75895 lon: -84.19161 facility: Oregon Health & Sciences University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Hershey Medical Center Pennsylvania State University city: Hershey state: Pennsylvania zip: 17033 country: United States lat: 40.28592 lon: -76.65025 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15224 country: United States lat: 40.44062 lon: -79.99589 facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Dell Children's Medical Center of Central Texas city: Austin state: Texas zip: 78723 country: United States lat: 30.26715 lon: -97.74306 facility: University of Texas Southwestern / Children's Health city: Dallas state: Texas zip: 75207 country: United States lat: 32.78306 lon: -96.80667 facility: University of Texas Southwestern city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: Cook Children's Medical Center city: Fort Worth state: Texas zip: 76104 country: United States lat: 32.72541 lon: -97.32085 facility: University of Texas Health Center at Tyler city: Tyler state: Texas zip: 75708 country: United States lat: 32.35126 lon: -95.30106 facility: Primary Children's Cystic Fibrosis Center city: Salt Lake City state: Utah zip: 84113 country: United States lat: 40.76078 lon: -111.89105 facility: University of Vermont Medical Center city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 facility: University of Virginia city: Charlottesville state: Virginia zip: 22904 country: United States lat: 38.02931 lon: -78.47668 facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23219 country: United States lat: 37.55376 lon: -77.46026 facility: Seattle Children's Hospital city: Seattle state: Washington zip: 98105 country: United States lat: 47.60621 lon: -122.33207 facility: University of Washington Medical Center city: Seattle state: Washington zip: 98195 country: United States lat: 47.60621 lon: -122.33207 facility: Providence Medical Group, Cystic Fibrosis Center city: Spokane state: Washington zip: 99204 country: United States lat: 47.65966 lon: -117.42908 facility: West Virginia University - Morgantown city: Morgantown state: West Virginia zip: 26506 country: United States lat: 39.62953 lon: -79.9559 facility: University of Wisconsin city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 facility: Children's Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States lat: 43.0389 lon: -87.90647 facility: Froedtert & Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06350461 id: SIMPLIFY-IP-19 HS briefTitle: Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study acronym: SIMPLIFY-HS overallStatus: COMPLETED date: 2020-08-25 date: 2022-07-11 date: 2022-07-11 date: 2024-04-05 date: 2024-04-05 name: Nicole Hamblett class: OTHER name: Cystic Fibrosis Foundation name: Dartmouth-Hitchcock Medical Center name: University of Washington briefSummary: Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).

ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.

Inhaled hypertonic saline (HS) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. HS is considered to be relatively burdensome and it is not known whether HS can improve or maintain lung function above what is already gained through ETI use.

The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop hypertonic saline by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking HS as compared to those who are assigned to keep taking HS while continuing to take ETI.

This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.

The sub study investigating the impact of discontinuing and continuing dornase alfa is registered under NCTXXXXXXX (will add once available). conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 370 type: ACTUAL name: Discontinuation of hypertonic saline (HS) name: Continuation of hypertonic saline (HS) measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 6 measure: Absolute Change in LCI 2.5 From Baseline to Week 6 measure: Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6 measure: Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6 measure: Absolute Change in FEV1 % Predicted From Week -2 to Week 0 measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 2 measure: Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6 measure: Number and Percent of Participants Hospitalized From Week 0 to Week 6 measure: Number and percent of participants Experiencing Pulmonary Exacerbations from Week 0 to Week 6 measure: Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6 measure: Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms measure: Number and Percent of Participants with Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6 sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States lat: 33.52066 lon: -86.80249 facility: Providence Alaska Medical Center city: Anchorage state: Alaska zip: 99508 country: United States lat: 61.21806 lon: -149.90028 facility: Tucson Cystic Fibrosis Center city: Tucson state: Arizona zip: 85724 country: United States lat: 32.22174 lon: -110.92648 facility: Arkansas Children's Hospital city: Little Rock state: Arkansas zip: 72202 country: United States lat: 34.74648 lon: -92.28959 facility: Miller Children's and Women's Hospital Long Beach city: Long Beach state: California zip: 90806 country: United States lat: 33.76696 lon: -118.18923 facility: CHOC Children's Hospital city: Orange state: California zip: 92868 country: United States lat: 33.78779 lon: -117.85311 facility: Stanford University Medical Center city: Palo Alto state: California zip: 94304 country: United States lat: 37.44188 lon: -122.14302 facility: Rady Children's Hospital and Health Center at the University of California San Diego city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco - Adult Center city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 facility: University of California, San Francisco - Peds Center city: San Francisco state: California zip: 94158 country: United States lat: 37.77493 lon: -122.41942 facility: Children's Hospital Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States lat: 39.73915 lon: -104.9847 facility: Yale University School of Medicine city: New Haven state: Connecticut zip: 06520 country: United States lat: 41.30815 lon: -72.92816 facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States lat: 29.65163 lon: -82.32483 facility: Nemours Children's Clinic - Jacksonville city: Jacksonville state: Florida zip: 32207 country: United States lat: 30.33218 lon: -81.65565 facility: Central Florida Pulmonary Group city: Orlando state: Florida zip: 32803 country: United States lat: 28.53834 lon: -81.37924 facility: The Nemours Children's Clinic - Orlando city: Orlando state: Florida zip: 32827 country: United States lat: 28.53834 lon: -81.37924 facility: Nemours Children's Clinic - Pensacola city: Pensacola state: Florida zip: 32514 country: United States lat: 30.42131 lon: -87.21691 facility: All Children's Hospital city: Saint Petersburg state: Florida zip: 33701 country: United States lat: 27.77086 lon: -82.67927 facility: Tampa General Hospital city: Tampa state: Florida zip: 33606 country: United States lat: 27.94752 lon: -82.45843 facility: Emory University city: Atlanta state: Georgia zip: 30324 country: United States lat: 33.749 lon: -84.38798 facility: Saint Luke's Cystic Fibrosis Center of Idaho city: Boise state: Idaho zip: 83702 country: United States lat: 43.6135 lon: -116.20345 facility: Northwestern University city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: OSF Saint Francis Medical Center city: Peoria state: Illinois zip: 61637 country: United States lat: 40.69365 lon: -89.58899 facility: Riley Hospital for Children city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: University of Iowa city: Iowa City state: Iowa zip: 52242 country: United States lat: 41.66113 lon: -91.53017 facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 facility: University of Kentucky city: Lexington state: Kentucky zip: 40506 country: United States lat: 37.98869 lon: -84.47772 facility: University of Louisville city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: Tulane University city: Metairie state: Louisiana zip: 70001 country: United States lat: 29.98409 lon: -90.15285 facility: Maine Medical Partners Pediatric Specialty Care city: Portland state: Maine zip: 04102 country: United States lat: 43.66147 lon: -70.25533 facility: Johns Hopkins University city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: University of Michigan, Michigan Medicine city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: Wayne State University Harper University Hospital city: Detroit state: Michigan zip: 48201 country: United States lat: 42.33143 lon: -83.04575 facility: Corewell Health Helen DeVos city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: Children's Hospitals and Clinics of Minnesota city: Minneapolis state: Minnesota zip: 55404 country: United States lat: 44.97997 lon: -93.26384 facility: The Minnesota Cystic Fibrosis Center city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: Children's Mercy Kansas City city: Kansas City state: Missouri zip: 64108 country: United States lat: 39.09973 lon: -94.57857 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States lat: 38.62727 lon: -90.19789 facility: Billings Clinic city: Billings state: Montana zip: 59101 country: United States lat: 45.78329 lon: -108.50069 facility: Dartmouth Hitchcock Medical Center city: Lebanon state: New Hampshire zip: 03756 country: United States lat: 43.64229 lon: -72.25176 facility: Monmouth Medical Center city: Eatontown state: New Jersey zip: 07724 country: United States lat: 40.29622 lon: -74.05097 facility: Morristown Medical Center city: Morristown state: New Jersey zip: 07960 country: United States lat: 40.79677 lon: -74.48154 facility: Rutgers - Robert Wood Johnson Medical School city: New Brunswick state: New Jersey zip: 08903 country: United States lat: 40.48622 lon: -74.45182 facility: Cohen Children's Medical Center of New York city: New Hyde Park state: New York zip: 11042 country: United States lat: 40.7351 lon: -73.68791 facility: Beth Israel Medical Center city: New York state: New York zip: 10003 country: United States lat: 40.71427 lon: -74.00597 facility: Lenox Hill Hospital Cystic Fibrosis Center city: New York state: New York zip: 10028 country: United States lat: 40.71427 lon: -74.00597 facility: Columbia University Cystic Fibrosis Program city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: University of Rochester Medical Center Strong Memorial city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 facility: SUNY Upstate Medical University city: Syracuse state: New York zip: 13210 country: United States lat: 43.04812 lon: -76.14742 facility: New York Medical College at Westchester Medical Center city: Valhalla state: New York zip: 10595 country: United States lat: 41.07482 lon: -73.77513 facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27517 country: United States lat: 35.9132 lon: -79.05584 facility: Atrium Health Wake Forest Baptist city: Winston-Salem state: North Carolina zip: 27157 country: United States lat: 36.09986 lon: -80.24422 facility: Children's Hospital Medical Center of Akron city: Akron state: Ohio zip: 44308 country: United States lat: 41.08144 lon: -81.51901 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States lat: 39.12713 lon: -84.51435 facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center city: Cleveland state: Ohio zip: 44146 country: United States lat: 41.4995 lon: -81.69541 facility: Cleveland Clinic Cystic Fibrosis Program city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43205 country: United States lat: 39.96118 lon: -82.99879 facility: Dayton Children's Hospital city: Dayton state: Ohio zip: 45404 country: United States lat: 39.75895 lon: -84.19161 facility: Oregon Health & Sciences University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Hershey Medical Center Pennsylvania State University city: Hershey state: Pennsylvania zip: 17033 country: United States lat: 40.28592 lon: -76.65025 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15224 country: United States lat: 40.44062 lon: -79.99589 facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Dell Children's Medical Center of Central Texas city: Austin state: Texas zip: 78723 country: United States lat: 30.26715 lon: -97.74306 facility: University of Texas Southwestern / Children's Health city: Dallas state: Texas zip: 75207 country: United States lat: 32.78306 lon: -96.80667 facility: University of Texas Southwestern city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: Cook Children's Medical Center city: Fort Worth state: Texas zip: 76104 country: United States lat: 32.72541 lon: -97.32085 facility: University of Texas Health Center at Tyler city: Tyler state: Texas zip: 75708 country: United States lat: 32.35126 lon: -95.30106 facility: Primary Children's Cystic Fibrosis Center city: Salt Lake City state: Utah zip: 84113 country: United States lat: 40.76078 lon: -111.89105 facility: University of Vermont Medical Center city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 facility: University of Virginia city: Charlottesville state: Virginia zip: 22904 country: United States lat: 38.02931 lon: -78.47668 facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23219 country: United States lat: 37.55376 lon: -77.46026 facility: Seattle Children's Hospital city: Seattle state: Washington zip: 98105 country: United States lat: 47.60621 lon: -122.33207 facility: University of Washington Medical Center city: Seattle state: Washington zip: 98195 country: United States lat: 47.60621 lon: -122.33207 facility: Providence Medical Group, Cystic Fibrosis Clinic city: Spokane state: Washington zip: 99204 country: United States lat: 47.65966 lon: -117.42908 facility: West Virginia University - Morgantown city: Morgantown state: West Virginia zip: 26506 country: United States lat: 39.62953 lon: -79.9559 facility: University of Wisconsin city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 facility: Children's Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States lat: 43.0389 lon: -87.90647 facility: Froedtert & Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06350448 id: WMT-CN-RH briefTitle: Washed Microbiota Transplantation for Rhinitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2029-08-01 date: 2024-04-05 date: 2024-04-05 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: The common symptoms of rhinitis include nasal itching, sneezing, anterior or posterior nasal leakage, and nasal congestion. Rhinitis can be classified as allergic rhinitis (AR) and non-allergic rhinitis (NAR) based on the presence of a specific allergen. Increasing evidence showed that gut microbiota can influence the development of AR. Although few studies have reported the association between NAR and gut microbiota, we found that washed microbiota transplantation (WMT) could improve nasal symptoms, whether it is AR or NAR. This clinical trial aims to evaluate the efficacy and safety of WMT for rhinitis. conditions: Rhinitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Washed Microbiota Transplantation measure: Changes in the reflective total nasal symptom score (rTNSS) measure: Changes in the combined symptoms and medication score (CSMS) measure: Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score measure: Changes in the single reflective nasal symptoms score measure: Specific IgE measure: Inflammatory factors measure: Flow cytometric analysis of lymphocyte clusters measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210011 country: China name: Faming Zhang, MD,PhD role: CONTACT phone: 086-25-58509883 email: fzhang@njmu.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06350435 id: CUHK 2023.569 briefTitle: Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-18 date: 2024-04-26 date: 2024-05-31 date: 2024-04-05 date: 2024-04-05 name: Chinese University of Hong Kong class: OTHER name: Pamela Youde Nethersole Eastern Hospital briefSummary: Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia. conditions: Metatarsalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: Prefabricated foot orthoses (PFO) with metatarsal pads name: Prefabricated foot orthoses (PFO) without metatarsal pads measure: Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale measure: Foot and Ankle Outcome Score measure: Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamela Youde Nethersole Eastern Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06350422 id: Microgravity-ChinaPLAGH briefTitle: Neuroimage Genome Study of Neuroplasticity Associated With Microgravity overallStatus: ACTIVE_NOT_RECRUITING date: 2022-01-01 date: 2024-10-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-05 name: Chinese PLA General Hospital class: OTHER briefSummary: This clinical trial investigates the neuroplasticity and cognitive status changes of the human brain in microgravity. To explore the relationship between cognitive status changes and brain functional activities, gray matter and white matter changes under microgravity exposure, screen and identify representative image markers, so as to provide decision-making information for the cognitive status changes of relevant personnel under microgravity environment. conditions: Microgravity conditions: Neuroplasticity conditions: MRI conditions: Repeatable Battery for the Assessment of Neuropsychological Status studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 26 type: ACTUAL name: Head-Down tilt Bed Rest test measure: Local brain functional activity measure: Brain functional connectivity measure: Brain structure - Morphology measure: Brain fiber bundle and brain Diffusion index measure: Brain blood flow measure: Imaging indexes and clinical scale scores sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Chinese PLA General Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06350409 id: CTN-0146 id: UG1DA015831-22S4 type: NIH link: https://reporter.nih.gov/quickSearch/UG1DA015831-22S4 briefTitle: Adolescent Outcomes of Post-operative Opioid EXposure acronym: APEX overallStatus: NOT_YET_RECRUITING date: 2024-08-10 date: 2026-09-10 date: 2026-10-10 date: 2024-04-05 date: 2024-04-10 name: Sharon Levy class: OTHER name: National Institute on Drug Abuse (NIDA) name: National Institutes of Health (NIH) briefSummary: The goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with "signposts" of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations. conditions: Opioid Use Disorder conditions: Pain, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20000 type: ESTIMATED measure: Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery. measure: Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery. measure: Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery. measure: Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery. measure: Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery. sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Boston Childrens Hopsital - Division of Addiction Medicine city: Boston state: Massachusetts zip: 02115 country: United States name: Melissa Brogna, MSW role: CONTACT phone: 857-218-4311 email: Melissa.Brogna@childrens.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06350396 id: CPLTRDDM2024 briefTitle: pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12-30 date: 2025-06-30 date: 2024-04-05 date: 2024-04-05 name: Changping Laboratory class: OTHER briefSummary: This study is a multicenter, randomized, double-blind, placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression. conditions: Treatment Resistant Depression conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 270 type: ESTIMATED name: active rTMS treatment name: sham rTMS treatment measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment measure: Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS) measure: Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17) measure: Changes in the MADRS from baseline to each visit measure: Changes in the HAMD-17 from baseline to each visit measure: cognitive change in Digit Symbol Substitution Test (DSST) measure: cognitive change in continuous performance test (CPT) measure: cognitive change in Trail-Making Test (TMT) measure: cognitive change in Digit Span Test (DST) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hebei Mental Health Center city: Hebei state: Baoding country: China name: Lili Zhang role: CONTACT facility: West China Hospital, Sichuan University city: Chengdu country: China name: Qiyong Gong role: CONTACT lat: 30.66667 lon: 104.06667 facility: Inner Mongolia Mental Health Center city: Hohhot country: China name: Dongsheng Lv role: CONTACT lat: 40.81056 lon: 111.65222 facility: Shandong Daizhuang Hospital city: Jining country: China name: Zhonggang Wang role: CONTACT lat: 35.405 lon: 116.58139 facility: The Second Affiliated Hospital of Xinxiang Medical University city: Xinxiang country: China name: Yongfeng Yang role: CONTACT lat: 35.19033 lon: 113.80151 hasResults: False

 nctId: NCT06350383 id: K01TW011775 type: NIH link: https://reporter.nih.gov/quickSearch/K01TW011775 briefTitle: Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-01-06 date: 2025-01-06 date: 2024-04-05 date: 2024-04-05 name: Columbia University class: OTHER name: Drexel University name: Africa Mental Health Research and Training Foundation briefSummary: The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic. conditions: Violence, Domestic conditions: Psychological Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-arm, parallel-group design primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participants will not be told which arm they have been randomized to. Additionally, to reduce contamination, community health volunteers (CHVs) will either carry out assessment or intervention, not both. Assessors will not be told to which arm participants they are assessing have been assigned. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 260 type: ESTIMATED name: WINGS+PM+ name: PM+-only measure: World Health Organization (WHO) Violence Against Women (VAW) diagnostic instrument measure: Receipt of violence services measure: Domestic Violence Coping Self-efficacy Scale (DVCSE) measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: Safety Behavior Checklist measure: Psychological distress (GHQ-12) measure: Functioning (WHODAS 2.0) measure: Short form of the Posttraumatic Stress Disorder Checklist (PCL-5) measure: Personalized outcomes (PSYCHLOPS) measure: Quality control/intervention fidelity measure: Facilitator Satisfaction and ease of intervention delivery (EBPAS-36) measure: Adverse events measure: Participant satisfaction with intervention measure: Number of participants in attendance at sessions measure: Retention Rate sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350370 id: NCC3489 briefTitle: Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study overallStatus: RECRUITING date: 2019-01-01 date: 2023-01-01 date: 2028-01-01 date: 2024-04-05 date: 2024-04-05 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8000 type: ESTIMATED name: Natural orifice specimen extraction measure: Rate of short-term complication measure: Operative duration measure: Intraoperative blood loss measure: Time to first flatus after surgery measure: Time to first stool after surgery measure: Length of stay after surgery measure: 3-year disease free survival measure: 3-year overall survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Xishan Wang role: CONTACT phone: 13261967603 email: wxshan_cams@163.com name: Mingguang Zhang role: CONTACT phone: +8613261967603 email: zmgslimshady@163.com name: Xishan Wang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06350357 id: 2024B014 briefTitle: Conventional Clipping Versus Punching Closure overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-05 date: 2024-04-05 name: Ningbo No. 1 Hospital class: OTHER briefSummary: Endoscopic submucosal dissection (ESD) is an important minimally invasive treatment method for early digestive tract tumors, with a high cure rate, and it is widely used in clinical practice. And wound closure after ESD is a great challenge, which is closely related to postoperative perforation bleeding. Clip closure is one of the most commonly used closure methods. However, when the wound is large or when the wound is located more difficult to operate, conventional closure may lead to delayed perforation, and postoperative clips may be prone to early spontaneous shedding. The authors have recently reported a method that may be able to close larger and difficult wounds because the grooves can better fix the metal clips. The latest study suggests that this approach may be safe and effective, but the study has a small sample size and has no controls. Therefore, high-quality clinical study evidence related to punch closure is required in the strategy of defect closure after ESD, in order to better evaluate the feasibility and safety of this new endoscopic closure method. conditions: the Rate of Complete Closure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: punching closure name: Conventional clipping measure: Completely closed measure: delayed hemorrhage sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ningbo first hospital status: RECRUITING city: Ningbo state: Zhejiang country: China name: Lei Xu role: CONTACT phone: +86-13486659126 email: xulei22@163.com lat: 29.87819 lon: 121.54945 hasResults: False

 nctId: NCT06350344 id: HZKY-PJ-2024-8-2 briefTitle: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management acronym: SmaVTE-COR overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2026-10-31 date: 2027-10-31 date: 2024-04-05 date: 2024-04-11 name: Navy General Hospital, Beijing class: OTHER briefSummary: Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.

The objective of this study is to observe the long-term effect of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on thromboprophylaxis, and establish a foundation of evidence for managing patients with high-risk VTE. conditions: Venous Thromboembolism conditions: Digital Health conditions: Health Education studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 2353 type: ESTIMATED name: mobile venous thromboembolism application (mVTEA) measure: VTE-related composite event measure: VTE-KAP questionnaire score measure: Generic quality of life measure: VTE events measure: Major bleeding measure: VTE-related hospitalization measure: New-onset of atrial fibrillation or atrial flutter measure: Death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sixth Medical Center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100048 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06350331 id: HZKY-PJ-2024-8-1 briefTitle: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management acronym: SmaVTE-RCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-10-31 date: 2024-04-05 date: 2024-04-11 name: Navy General Hospital, Beijing class: OTHER briefSummary: Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.

The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE. conditions: Venous Thromboembolism conditions: Digital Health conditions: Health Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 256 type: ESTIMATED name: mobile venous thromboembolism application (mVTEA) measure: VTE-KAP questionnaire score measure: Knowledge, attitude, and practice scores in the VTE-KAP questionnaire measure: Generic quality of life measure: VTE events measure: Chronic thromboembolic pulmonary hypertension (CTEPH) measure: Chronic thromboembolic pulmonary disease (CTEPD) measure: Post-pulmonary embolism syndrome (PPES) measure: Major bleeding measure: VTE-related hospitalization measure: VTE-related rehospitalization measure: New-onset of atrial fibrillation or atrial flutter measure: Death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sixth Medical Center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100048 country: China name: ZHI-GENG JIN, Doctor role: CONTACT phone: 8615801402223 email: lwgjzg@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06350318 id: MCC-22005 briefTitle: Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas overallStatus: RECRUITING date: 2024-03-13 date: 2029-03 date: 2029-03 date: 2024-04-05 date: 2024-04-23 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: BeiGene, Ltd. briefSummary: The purpose of the study is to establish the safety and efficacy of zanubrutinib in combination with rituximab for people with untreated B-cell lymphomas (marginal zone lymphoma and follicular lymphomas). conditions: Follicular Lymphoma conditions: Marginal Zone Lymphoma conditions: B-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 43 type: ESTIMATED name: Zanubrutinib name: Rituximab measure: Overall Response Rate: Cohort A measure: Overall Response Rate: Cohort B measure: Efficacy of Zanubrutinib and Rituximab measure: Safety and tolerability of combination Zanubrutinib and Rituximab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Richard Corona role: CONTACT phone: 813-745-3465 email: Richard.Corona@moffitt.org name: Sameh Gaballa, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06350305 id: Screening for high-risk COPD briefTitle: Screening for High-risk Chronic Obstructive Pulmonary Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-10-31 date: 2024-04-05 date: 2024-04-11 name: Henan University of Traditional Chinese Medicine class: OTHER briefSummary: This study is a multicenter cross-sectional study design aimed at screening risk factors for the combination of disease and syndrome in high-risk individuals with chronic obstructive pulmonary disease (COPD). conditions: High-risk COPD studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 3600 type: ESTIMATED name: questionnaire survey measure: COPD screening questionnaire from Terrassa (EGARPOC) measure: COPD assessment in primary care to identify undiagnosed respiratory disease and exacerbation risk questionnaire (CAPTURE) measure: COPD Assessment Test (CAT) measure: COPD screening questionnaire (COPD-Q) measure: chronic obstructive pulmonary disease diagnostic questionnaire (CDQ) measure: modified chronic obstructive pulmonary disease diagnostic questionnaire (mCDQ) measure: Simple screening questionnaire measure: lung function questionnaire (LFQ) measure: chronic obstructive pulmonary disease screening questionnaire (COPD-SQ) measure: chronic obstructive pulmonary disease population screener questionnaire (COPD-PS) measure: Chronic Obstructive Pulmonary Disease Risk Scale (COPDRS) measure: Standardised Scale of Physical Fitness in Chinese Medicine measure: Syndrome therapeutic evaluation scale of chronic obstructive pulmonary disease (COPD-STES) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Henan University of Chinese Medicine city: Zhengzhou state: Henan zip: 450000 country: China name: yang Xie, doctor role: CONTACT phone: 0371-66248624 email: xieyanghn@163.com lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06350292 id: 0161464 briefTitle: SLEEP-COPE: Sleep Intervention for Oppositional Children overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-02-01 date: 2024-04-05 date: 2024-04-05 name: University of South Florida class: OTHER briefSummary: Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents. conditions: Insomnia Chronic conditions: Oppositional Defiant Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: SLEEP: COPE measure: Child Daily Sleep Diaries measure: Parent Daily Sleep Diaries measure: Child Actigraphy measure: Parent Actigraphy measure: Child Salivary Cortisol measure: Child Hair Cortisol measure: The Revised Childhood Anxiety and Depression Scale measure: PROMIS Child Sleep Disturbance measure: Alabama Parenting Questionnaire measure: Perceived Stress Scale measure: Child Disruptive Behavior Disorders Checklist measure: Beck Depression Inventory-II measure: State-Trait Anxiety Inventory measure: PROMIS Adult Sleep Disturbance measure: Pediatric Sleep Questionnaire measure: Epworth Sleepiness Scale sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06350279 id: HSK39297-101 briefTitle: A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects overallStatus: RECRUITING date: 2023-12-25 date: 2024-05-31 date: 2024-07-31 date: 2024-04-05 date: 2024-04-05 name: Haisco Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 96 type: ESTIMATED name: HSK39297 measure: The number and severity of treatment emergent adverse events (TEAEs) . measure: AUC measure: Cmax measure: Tmax measure: t1/2 measure: AP change measure: Bb sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Beijing Tongren Hospital status: RECRUITING city: Beijing country: China name: Laichun Lu role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06350266 id: 2024-0183 briefTitle: Informing Low-acuity Emergency Department Patients of Non-emergent Resources overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-12 date: 2024-12 date: 2024-04-05 date: 2024-04-05 name: Geisinger Clinic class: OTHER briefSummary: The goal of this campaign is to reduce unnecessary ED visits/encourage patients with low acuity visits to follow up with an appropriate provider and/or to seek care outside of the ED in the future. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message, as well as information added to the patient's after visit summary, and will include one or more calls to action that make patients aware of other Geisinger resources and avenues through which they can seek care outside of the ED. These may include, but are not limited to, walk-in urgent care, virtual urgent care, PCP appointments, and/or other ways in which to contact Geisinger. We will measure whether ED use differs across patients in different outreach conditions. We will also examine whether patients followed through on the message-specific calls to action in the messages differently across conditions. conditions: Emergency Service, Hospital studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: Patients will be aware of their own messages but not of messages sent to other patients or in other arms. count: 8300 type: ESTIMATED name: Information about healthcare resources measure: Return to ED measure: PCP appointment scheduled measure: PCP visit measure: Telehealth appointment scheduled measure: Telehealth appointment attended measure: Urgent care visit measure: Call made to PCP measure: Any of the suggested actions taken sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350253 id: 22-X-187 briefTitle: Comparison Of Measured To Predicted Resting Metabolism overallStatus: RECRUITING date: 2023-03-14 date: 2024-12-31 date: 2025-12-31 date: 2024-04-05 date: 2024-04-05 name: Ohio University class: OTHER briefSummary: The purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry. conditions: Body Weight studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: Metabolic cart name: MedGem name: BIA measure: Resting metabolic rate sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ohio University Exercise Physiology Lab status: RECRUITING city: Athens state: Ohio zip: 45701 country: United States name: Angela Hillman, PhD role: CONTACT phone: 740-593-0153 email: hillman@ohio.edu lat: 39.32924 lon: -82.10126 hasResults: False

 nctId: NCT06350240 id: KUzunAkkaya briefTitle: Effects of Textured Insoles and Exercise in Children With Joint Hypermobility overallStatus: RECRUITING date: 2023-11-01 date: 2024-11-01 date: 2024-11-30 date: 2024-04-05 date: 2024-04-05 name: Gazi University class: OTHER name: TÜBİTAK briefSummary: Joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. In children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. It is very important to support children with joint hypermobility with intervention programs that are rich in both motor and sensory aspects. The aim of this project is to create an exercise protocol rich in tactile, proprioceptive senses for children with joint hypermobility and to examine the effects of using textured insoles in addition to exercise on tactile sense, balance, foot load distribution and quality of life in children. conditions: Child, Only conditions: Joint Laxity conditions: Exercise conditions: Textured Insoles studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Exercise name: Exercise+texture insoles measure: Tactile sense measure: Foot load distribution measure: Balance measure: Foot posture measure: Quality of life assessment sex: ALL minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Gazi University status: RECRUITING city: Ankara country: Turkey name: Kamile Uzun Akkaya, Phd role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06350227 id: WestChinaSU briefTitle: Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst overallStatus: RECRUITING date: 2024-01-04 date: 2026-01 date: 2026-06 date: 2024-04-05 date: 2024-04-05 name: West China Second University Hospital class: OTHER briefSummary: The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts. conditions: Ovarian Cyst Benign studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 165 type: ESTIMATED name: the absorbable hemostat and suture name: electrocoagulation and suture name: suture measure: Antral Follicle Count (AFC) measure: Anti-Mullerian hormone (AMH) sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: West China Second University Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Yanru Long role: CONTACT phone: 86-13550169017 email: 2801443341@qq.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06350214 id: #2005-06; #2011-17; #2018-01 briefTitle: Physical Activity and Nutrition in Cancer Survivors overallStatus: COMPLETED date: 2007-01-01 date: 2018-12-31 date: 2018-12-31 date: 2024-04-05 date: 2024-04-05 name: West China Hospital class: OTHER briefSummary: This study aims to investigate the independent and combined associations between physical activity and nutrition condition with mortality among cancer survivors. conditions: Cancer conditions: Nutrition, Healthy conditions: Physical Inactivity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3100 type: ACTUAL name: physical activity and nutrition assessment measure: All-cause mortality measure: Cause-specific mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350201 id: KY2024.0124.02 briefTitle: Machine Learning-based Classification of Symptom Clusters and Online CBT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-01 date: 2024-12-01 date: 2024-04-05 date: 2024-04-09 name: Wuhan Mental Health Centre class: OTHER briefSummary: To breakthrough the bottleneck identified, we will conduct a cross-sectional study to develop a symptom clustering model for depression and anxiety. A wide range of statistical methods as well as machine learning approaches were explored, and a cohesive hierarchical clustering algorithm will be used. After developing the model, a symptom-matched intervention program based on problem solving therapy will be formulated. We are supposed to examine whether its use for personalizing symptom-matched psychological treatment can lead to improved patient outcomes, compared with usual care. This project is expected to provide a new and precise method for the emotion management, which will provide a standardized intervention pathway combining screening with treatment for the management of depression symptom and anxiety symptom. A preciser intervention matched to individual symptoms may provide important insight in improving patient outcome as well as a standardized mood management pathway targeting to the early detection and intervention for community residents. conditions: Depression and Anxiety Symptom studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: cognitive behavior therapy name: control group measure: The Patient Health Questionnaire (PHQ-9) measure: 7-tiem Generalized Anxiety Disorder Scale,GAD-.7 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350188 id: ECM#2024-506 briefTitle: Efficacy of Kinesiotape on Treatment of Nonspecific Cardiac Chest Pain overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-22 date: 2024-06-22 date: 2024-07-22 date: 2024-04-05 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: purpose of the study To investigate the effect of Kinesio-tape on treatment of nonspecific cardiac chest pain conditions: Nonspecific Cardiac Chest Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: experimental name: traditional measure: PAIN USING VIISUSL ANALOGE SCALE measure: PERSSURE PAIN THRESHOLD measure: SHOULDER RANGE OF MOTION measure: shoulder pain and disability sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Huda Badr Abd Elhamed city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06350175 id: 2212697123 briefTitle: Emergency Department Management of Tobacco Use Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-06 date: 2024-04-05 date: 2024-04-16 name: West Virginia University class: OTHER briefSummary: The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy. conditions: Tobacco Use Disorder conditions: Tobacco Use Cessation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Nicotine Replacement Therapy Agent name: West Virginia Quit Line measure: Percentage of Continued Abstinence Rate (2 weeks) measure: Percentage of Continued Abstinence Rate (1 month) measure: Percentage of Continued Abstinence Rate (3 months) measure: Patient Health Questionnaire 2 (Baseline) measure: Patient Health Questionnaire 2 (3 months from baseline) measure: Heaviness of Smoking Index (Baseline) measure: Heaviness of Smoking Index (3 months from baseline) measure: Richmond Test (Baseline) measure: Richmond Test (3 months from baseline) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West Virginia University city: Morgantown state: West Virginia zip: 26505 country: United States lat: 39.62953 lon: -79.9559 hasResults: False

 nctId: NCT06350162 id: ASTRUM-LC12 briefTitle: Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC overallStatus: RECRUITING date: 2023-10-18 date: 2024-12-31 date: 2025-12-31 date: 2024-04-05 date: 2024-04-05 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer . conditions: Extensive Stage Lung Small Cell Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Serplulimab name: Chest Radiation measure: 1-year Progression-free survival rate measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Duration of response (DOR) measure: Disease control rate (DCR) measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou country: China name: jing Qin role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06350149 id: STUDY00004637 id: 1R21DK128731-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R21DK128731-01A1 briefTitle: A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis overallStatus: RECRUITING date: 2024-03-22 date: 2025-09 date: 2025-09 date: 2024-04-05 date: 2024-04-05 name: Emory University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are:

* Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible.
* What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF

Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Sugar Sweetened Beverages (SSB) name: Hi GI name: Lo GI measure: Recruitment Rate measure: Refusal Rate measure: Investigator Fidelity measure: Participant Fidelity measure: Acceptability measure: Retention Rates measure: Recruitment measure: Change in plasma Cysteine (Cys) measure: Change in plasma Cystine (CySS) measure: Change in plasma Glutathione (GSH) measure: Change in plasma Glutathione Disulfide (GSSG) measure: Change in redox potentials (EhCys/ CySS and EhGSH/GSSG) measure: Insulinogenic index measure: Whole body insulin sensitivity index (WBISI-Matsuda) measure: Disposition Index measure: Change in plasma Eh Cys/CySS measure: Change in incremental glucose AUC measure: Changes in Plasma insulin measure: Changes in Plasma C-peptide measure: Changes in Plasma Glucagon measure: Changes in Plasma Incretins: glucagon-like peptide-1 (GLP-1) measure: Changes in Plasma Incretins: total glucose-dependent insulinotropic polypeptide (GIP) sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Center for Advanced Pediatrics: Emory Healthcare status: RECRUITING city: Atlanta state: Georgia zip: 30329 country: United States name: Tanicia Daley, MD role: CONTACT phone: 404-785-5437 email: tanicia.daley@emory.edu name: Arlene Stecenko, MD role: CONTACT phone: 404-727-1460 email: astecen@emory.edu name: Tanicia Daley, MD role: PRINCIPAL_INVESTIGATOR name: Jessica Alvarez, PhD role: SUB_INVESTIGATOR name: Arlene Stecenko, MD role: SUB_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06350136 id: 2024/05-37 briefTitle: The Effect of Self-Management Support Provided to Hypertension Patients Affected by the Earthquake Via Tele-Nursing on Patients' Treatment Compliance and Self-Care Management overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-01 date: 2025-06-01 date: 2024-04-05 date: 2024-04-08 name: Firat University class: OTHER briefSummary: This important research includes a randomized controlled trial evaluating the potential of self-management support provided via telenursing to earthquake-affected hypertension patients to improve patients' treatment adherence and overall self-care management. This study will be carried out at Fırat University Hospital and will cover a wide range of effects on health outcomes in individuals receiving hypertension treatment. The sample selected from hypertension patients, which constitute the population of the research, was based on predetermined power analysis criteria. It has been determined that at least 51 hypertension patients should be included in each of the intervention and control groups, and accordingly, a total of 150 hypertension patients will be included in the study.

. The results obtained within this framework may provide guidance in the development and implementation of Turkey's health policies, and may also shed light on strategies for the management of other similar health problems. On the other hand, strengthening the digital health infrastructure and effective management of chronic diseases, which are among the health-related targets of the Development Plan, further emphasize the importance of this research. The success of the self-management model supported by tele-nursing can serve as an example in the integration of digital health technologies into Turkey's healthcare system and be an important step towards achieving strategic goals in this field. conditions: With Tele-Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: With Tele-Nursing measure: Hill-Bone Hypertension Treatment Compliance Scale measure: Self-Care Management Scale in Chronic Diseases; measure: Psychological Impact of Earthquake Scale: measure: Earthquake Stress Coping Strategies Scale sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350123 id: D6405C00002 briefTitle: Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease. acronym: MIRO-CKD overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2026-01-13 date: 2026-01-13 date: 2024-04-05 date: 2024-04-05 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD. conditions: Chronic Kidney Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentre, randomised, double-blind, dose-finding, parallel group, double-dummy primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg name: Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg name: Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin measure: Relative change in UACR from baseline to Week 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: San Carlos state: California zip: 94070 country: United States lat: 37.50716 lon: -122.26052 facility: Research Site city: Waterbury state: Connecticut zip: 06708 country: United States lat: 41.55815 lon: -73.0515 facility: Research Site city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Research Site city: Salt Lake City state: Utah zip: 84124 country: United States lat: 40.76078 lon: -111.89105 facility: Research Site city: Norfolk state: Virginia zip: 23504 country: United States lat: 36.84681 lon: -76.28522 facility: Research Site city: Linz zip: 4021 country: Austria lat: 48.30639 lon: 14.28611 facility: Research Site city: St. Pölten zip: 3100 country: Austria lat: 48.2 lon: 15.63333 facility: Research Site city: Vienna zip: A-1090 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wels zip: 4600 country: Austria lat: 48.16667 lon: 14.03333 facility: Research Site city: Wien zip: 1030 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wien zip: 1130 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wien zip: 1190 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Burgas zip: 8018 country: Bulgaria lat: 42.50606 lon: 27.46781 facility: Research Site city: Dobrich zip: 9300 country: Bulgaria lat: 43.56667 lon: 27.83333 facility: Research Site city: Pleven zip: 5800 country: Bulgaria lat: 43.41667 lon: 24.61667 facility: Research Site city: Plovdiv zip: 4000 country: Bulgaria lat: 42.15 lon: 24.75 facility: Research Site city: Sofia zip: 1680 country: Bulgaria lat: 42.69751 lon: 23.32415 facility: Research Site city: London state: Ontario zip: N6A 5A5 country: Canada lat: 42.98339 lon: -81.23304 facility: Research Site city: Waterloo state: Ontario zip: N2T 0C1 country: Canada lat: 43.4668 lon: -80.51639 facility: Research Site city: Montreal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Quebec zip: G1R 2J6 country: Canada lat: 46.81228 lon: -71.21454 facility: Research Site city: Bari zip: 70124 country: Italy lat: 41.11148 lon: 16.8554 facility: Research Site city: Bologna zip: 40138 country: Italy lat: 44.49381 lon: 11.33875 facility: Research Site city: Genoa zip: 16132 country: Italy lat: 44.40478 lon: 8.94438 facility: Research Site city: Parma zip: 43126 country: Italy lat: 44.79935 lon: 10.32618 facility: Research Site city: Pavia zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 facility: Research Site city: Ipoh zip: 30990 country: Malaysia lat: 4.5841 lon: 101.0829 facility: Research Site city: Kota Bahru zip: 15586 country: Malaysia lat: 6.13328 lon: 102.2386 facility: Research Site city: Kuala Lumpur zip: 59100 country: Malaysia lat: 3.1412 lon: 101.68653 facility: Research Site city: Białystok zip: 15-481 country: Poland lat: 53.13333 lon: 23.16433 facility: Research Site city: Gdańsk zip: 80-546 country: Poland lat: 54.35205 lon: 18.64637 facility: Research Site city: Grodzisk Mazowiecki zip: 05-825 country: Poland lat: 52.10387 lon: 20.6337 facility: Research Site city: Leżajsk zip: 37-300 country: Poland lat: 50.26257 lon: 22.41932 facility: Research Site city: Ruda Śląska zip: 41-709 country: Poland lat: 50.2584 lon: 18.85632 facility: Research Site city: Szczecin zip: 70-111 country: Poland lat: 53.42894 lon: 14.55302 facility: Research Site city: Warszawa zip: 02-798 country: Poland lat: 52.22977 lon: 21.01178 facility: Research Site city: Łódź zip: 92-213 country: Poland lat: 51.75 lon: 19.46667 facility: Research Site city: Żywiec zip: 34-300 country: Poland lat: 49.68529 lon: 19.19243 facility: Research Site city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Barcelona zip: 8035 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Cordoba zip: 14004 country: Spain lat: 37.89155 lon: -4.77275 facility: Research Site city: Palma de Mallorca zip: 07010 country: Spain lat: 39.56939 lon: 2.65024 facility: Research Site city: Sevilla zip: 41013 country: Spain lat: 37.38283 lon: -5.97317 facility: Research Site city: Valencia zip: 46026 country: Spain lat: 39.46975 lon: -0.37739 facility: Research Site city: Kaohsiung zip: 80756 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site city: New Taipei City zip: 220 country: Taiwan lat: 25.01111 lon: 121.44583 facility: Research Site city: Taichung zip: 40201 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site city: Tainan zip: 710 country: Taiwan lat: 22.99083 lon: 120.21333 facility: Research Site city: Taipei City zip: 110 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei City zip: 11217 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 11490 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06350110 id: ESBI202492 briefTitle: Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE) acronym: BAH242 overallStatus: NOT_YET_RECRUITING date: 2024-11-10 date: 2025-12-10 date: 2025-12-28 date: 2024-04-05 date: 2024-04-05 name: Essen Biotech class: OTHER briefSummary: This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate. conditions: Systemic Lupus Erythematosus conditions: Lupus Nephritis conditions: Autoimmune Diseases conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis conditions: Granulomatous Polyangiitis conditions: Microscopic Polyangiitis conditions: Systemic Sclerosis conditions: Idiopathic Inflammatory Myopathies conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment

Patients enrolled in this clinical trial will receive a carefully designed treatment regimen. Prior to the infusion of CD19 and BCMA CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for the CAR-T cell therapy to effectively target and eliminate malignant B cells. Following chemotherapy, participants will receive the infusion of CD19 and BCMA CAR-T cells.

Monitoring and Follow-up:

Following the CAR-T cell infusion, patients will be subjected to rigorous monitoring to assess safety and treatment response. primaryPurpose: TREATMENT masking: NONE maskingDescription: Open-label clinical trials are a category of clinical research where the masking is minimal or nonexistent. In such trials, both the participants and the researchers are fully aware of the treatment assignments, which means participants know the treatment they are receiving, and researchers are aware of each participant's treatment group. count: 75 type: ESTIMATED name: CD19- BCMA CAR-T cells measure: Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells measure: Rate of successful manufacture and expansion of the CD19/BCMA chimeric antigen receptor (CAR) T cells sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: District one hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06350097 id: D516NC00001 briefTitle: Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer acronym: TROPION-Lung14 overallStatus: NOT_YET_RECRUITING date: 2024-05-16 date: 2028-03-21 date: 2032-05-25 date: 2024-04-05 date: 2024-04-10 name: AstraZeneca class: INDUSTRY name: Daiichi Sankyo briefSummary: The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Datopotamab Deruxtecan (i.v. infusion) compared with osimertinib (tablet) monotherapy as a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC.

Study details include:

1. The study duration will be event-driven, with an estimated duration of approximately 9 years.
2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met.
3. The visit frequency will be every 3 weeks during the treatment period.

Note: Participants on osimertinib treatment (osimertinib only arm or who have discontinued Datopotamab Deruxtecan while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression, IP discontinuation or primary PFS DCO. Participants who are receiving osimertinib + Datopotamab Deruxtecan are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 582 type: ESTIMATED name: Osimertinib name: Datopotamab Deruxtecan measure: To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by BICR in all randomised participants. measure: To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of OS in all randomised participants. measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS on CNS metastases in participants with CNS metastases at baseline measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by investigator in all randomised participants. measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of ORR in all randomised participants with measurable disease at baseline. measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of DoR in all randomised participants with measurable disease at baseline. measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib on the prevention of CNS metastases measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS2 in all randomised participants measure: To assess the PK of osimertinib and Datopotamab Deruxtecan measure: To investigate the immunogenicity of Datopotamab Deruxtecan measure: To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumour samples measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan vs. osimertinib monotherapy based on the cobas® EGFR Mutation Test v2 plasma screening test result for Ex19del or L858R EGFR mutations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Clayton zip: 3168 country: Australia lat: -37.91667 lon: 145.11667 facility: Research Site city: Kogarah zip: 2217 country: Australia lat: -33.98333 lon: 151.11667 facility: Research Site city: Changchun zip: 130000 country: China lat: 43.88 lon: 125.32278 facility: Research Site city: Chongqing zip: 400030 country: China lat: 29.56278 lon: 106.55278 facility: Research Site city: Jinan zip: 250021 country: China lat: 36.66833 lon: 116.99722 facility: Research Site city: Jinan zip: 250117 country: China lat: 36.66833 lon: 116.99722 facility: Research Site city: Kunming zip: 650118 country: China lat: 25.03889 lon: 102.71833 facility: Research Site city: Linhai zip: 318000 country: China lat: 28.85535 lon: 121.14469 facility: Research Site city: Shanghai zip: 200030 country: China lat: 31.22222 lon: 121.45806 facility: Research Site city: Seoul zip: 06351 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 120-752 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 13620 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Taipei City zip: 106 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taoyuan zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06350084 id: 2023/381 briefTitle: Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection overallStatus: RECRUITING date: 2023-09-04 date: 2024-07-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-08 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Mother's Touch and Nurse's Therapeutic Touch on pain levels and crying times by newborns during heel blood collection. conditions: Pain, Acute conditions: Newborn conditions: Crying studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Mother's Touch name: Nurse's Therapeutic Touch measure: NIPS (Neonatal Infant Pain Scale) measure: Crying times measure: Processing time sex: ALL minimumAge: 2 Days maximumAge: 4 Days stdAges: CHILD facility: Burdur Bucak State Hospital status: RECRUITING city: Burdur state: Bucak zip: 15030 country: Turkey name: Selda Ateş Beşirik, PhD. role: CONTACT phone: +905076228189 email: seldaates07@gmail.com name: Selda Ateş Beşirik, PhD. role: PRINCIPAL_INVESTIGATOR name: Emine Geçkil, Prof. role: SUB_INVESTIGATOR lat: 37.72028 lon: 30.29083 hasResults: False

 nctId: NCT06350071 id: 2023/06 briefTitle: Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection overallStatus: RECRUITING date: 2023-06-19 date: 2024-07-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-08 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection. conditions: Pain, Acute conditions: Newborns conditions: Crying studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Kangaroo Care name: Swaddling measure: NIPS (Neonatal Infant Pain Scale) measure: Crying times measure: Processing time sex: ALL minimumAge: 1 Day maximumAge: 4 Days stdAges: CHILD facility: Burdur Bucak State Hospital status: RECRUITING city: Burdur state: Bucak zip: 15030 country: Turkey name: Selda Ateş Beşirik, PhD. role: CONTACT phone: +905076228189 email: seldaates07@gmail.com name: Selda Ateş Beşirik, PhD. role: PRINCIPAL_INVESTIGATOR name: Emine Geçkil, Prof. role: SUB_INVESTIGATOR lat: 37.72028 lon: 30.29083 hasResults: False

 nctId: NCT06350058 id: 202012005 briefTitle: Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old overallStatus: ACTIVE_NOT_RECRUITING date: 2021-08-03 date: 2023-11-30 date: 2024-10-31 date: 2024-04-05 date: 2024-04-05 name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd class: INDUSTRY briefSummary: The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 375 type: ACTUAL name: Inactivated rotavirus vaccine (low dose) name: Inactivated rotavirus vaccine (high dose) name: Placebo measure: Incidence rate of AE measure: Incidence rate of SAE sex: ALL minimumAge: 6 Weeks maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: Hebei Provincial Center for Disease Control and Prevention city: Shijiangzhuang state: Hebei zip: 050021 country: China lat: 34.61038 lon: 113.58554 hasResults: False

 nctId: NCT06350045 id: supra 11th puncture PCNL briefTitle: High Supracostal Versus Subcostal Puncture in Adult PCNL overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2028-04-01 date: 2028-04-01 date: 2024-04-05 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one conditions: Urolithiasis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: closed envelop whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 162 type: ACTUAL name: PCNL measure: Rate of complications measure: Stone free rate measure: duration of Hospital stay. measure: Operative time sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut University Hospital city: Assiut zip: 11751 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06350032 id: TREPaed id: 2023-505082-91-00 type: CTIS briefTitle: Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-11 date: 2028-11 date: 2024-04-05 date: 2024-04-05 name: AOP Orphan Pharmaceuticals AG class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate safety and tolerability of preservative-free parenteral treprostinil in paediatric patients with PAH (PH Group 1) who are below 18 years of age. The main question it aims to answer is:

• if preservative-free parenteral treprostinil is safe and tolerable in the treatment of paediatric PAH in patients who are either treatment-naïve or have been previously treated with commercially available parenteral treprostinil formulations.

Participants will receive either subcutaneous (SC) or intravenous (IV) preservative-free treprostinil and will be observed for 5 months (20 weeks ± 1 week). conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: preservative-free parenteral treprostinil measure: Frequency and seriousness of adverse events and adverse drug reactions measure: Change from baseline in quality of Life (QoL) measure: Change from baseline in 6-minute walk distance (6MWD) measure: Change from baseline in World Health Organization Functional Class (WHO FC) measure: Change from baseline in echocardiography (ECHO) parameters - RA/RV enlargement measure: Change from baseline in echocardiography (ECHO) parameters - RV systolic dysfunction measure: Change from baseline in echocardiography (ECHO) parameters - RV/LV end-systolic ratio (PSAX) measure: Change from baseline in echocardiography (ECHO) parameters - tricuspid annular plane systolic excursion (TAPSE) measure: Change from baseline in echocardiography (ECHO) parameters - S/D ratio (TR jet) measure: Change from baseline in echocardiography (ECHO) parameters - Pulmonary Artery Acceleration Time (PAAT) measure: Change from baseline in echocardiography (ECHO) parameters - pericardial effusion measure: Change from baseline in echocardiography (ECHO) parameters - eccentricity index measure: Change from baseline in echocardiography (ECHO) parameters - acceleration time measure: Change from baseline in plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) levels measure: Treprostinil plasma concentration sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Medizinische Universität Wien city: Vienna zip: 1090 country: Austria name: Sulaimi Albinni, MD role: PRINCIPAL_INVESTIGATOR lat: 48.20849 lon: 16.37208 facility: Necker-Enfants Malades Hospital, Paris city: Paris zip: 75015 country: France name: Damien Bonnet, Prof role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Gottsegen National Cardiovascular Center city: Budapest zip: H-1096 country: Hungary name: Laszlo Ablonczy, MD role: PRINCIPAL_INVESTIGATOR lat: 47.49801 lon: 19.03991 facility: Ramón y Cajal University Hospital city: Madrid zip: 28034 country: Spain name: Maria J del Cerro, Prof role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06350019 id: 26379996/91 briefTitle: Vascular Effects of Penil revascularızatıon overallStatus: COMPLETED date: 2013-01-01 date: 2014-08-15 date: 2014-12-25 date: 2024-04-05 date: 2024-04-05 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: Purpose: The aim of this study is to measure the effects of penile revascularization surgery performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to determine the importance of vascular parameters in postoperative patient follow-up.

Methods: A total of 35 participants who underwent penile revascularization surgery due to vascular ED were included in this study. In the preoperative period and at the 3rd postoperative month, penile color doppler ultrasonography (PCDU) was performed to evaluate cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery (IEA) separately. During this evaluation, peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) were measured. The International Index of Erectile Function questionnaire (IIEF) was applied to all patients in the preoperative period and at the 3rd postoperative month. The relationship between changes in (IIEF) questionnaire score and penile vascular hemodynamic changes in the postoperative period was evaluated. conditions: Erectile Dysfunction conditions: Erectile Dysfunction Due to Arterial Disease conditions: Erectile Dysfunction Due to Venous Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ACTUAL name: Penile revascularızation measure: The importance of resistive index in evaluating the postoperative success of penile revascularization sex: MALE minimumAge: 23 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06350006 id: SHR-A1904-301 briefTitle: SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor overallStatus: RECRUITING date: 2024-05-30 date: 2027-12-30 date: 2028-12-30 date: 2024-04-05 date: 2024-04-26 name: Shanghai Hengrui Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This study consists of two research phases:

Phase Ib (includes dose escalation phase and efficacy extension phase): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.

Phase III: A randomized, double-blind, multicenter clinical study of SHR-1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors. conditions: Cldn18.2-positive Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a multicenter Phase Ib/III clinical study. Phase Ib consists of two phases, IB-A for dose escalation and IB-B for efficacy extension. The Phase III multi-center, randomized controlled, double-blind study was designed to evaluate the efficacy and safety of SHR-A1904 combined chemotherapy and immunotherapy versus chemotherapy combined immunotherapy in first-line treatment of CLDN18.2-positive solid tumors patients. primaryPurpose: TREATMENT masking: NONE count: 924 type: ESTIMATED name: SHR-A1904; Adebrelimab name: SHR-A1904; CAPOX; Adebrelimab measure: Incidence and severity of AE measure: Dose Limiting Toxicity (DLT) measure: Maximal Tolerable Dose (MTD) measure: Phase III Recommended Dose (RP3D) measure: Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria measure: SHR-A1904 toxin binding antibody measure: SHR-A1904 Total antibody measure: Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb) measure: Expression level of CLDN18.2 in tumor tissues measure: Overall survival (OS) measure: Incidence and severity of AE sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Ruihua Xu role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06349993 id: pd003 briefTitle: Digital Intervention for Depression and Anxiety in Adolescents overallStatus: RECRUITING date: 2024-04-17 date: 2024-12-30 date: 2025-07-01 date: 2024-04-05 date: 2024-04-22 name: Adai Technology (Beijing) Co., Ltd. class: OTHER briefSummary: The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.

Participants will be asked to engage with the digital intervention platform for a period of two months. conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Digital Intervention name: Health Education measure: Hamilton Depression Rating Scale measure: Hamilton Anxiety Rating Scale measure: ADHD(attention deficit hyperactivity disorder) Rating Scale-IV measure: PHQ-9 (Patient Health Questionnaire-9) measure: GAD-7 (Generalized Anxiety Disorder-7) sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: West China Hospital status: RECRUITING city: Chengdu state: Sichuang country: China name: Liqun Zhang role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06349980 id: HLX53-HCC201 briefTitle: A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 With or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-02-10 date: 2027-02-10 date: 2024-04-05 date: 2024-04-09 name: Shanghai Henlius Biotech class: INDUSTRY briefSummary: The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. conditions: Carcinoma, Hepatocellular studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 117 type: ESTIMATED name: HLX53 (1000mg) name: HLX53 (2000mg) name: HLX10 name: HLX04 name: Placebo measure: ORR measure: PFS measure: ORR measure: PFS measure: OS measure: Incidence and severity of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349967 id: WCH-2023-1592 briefTitle: Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-04-30 date: 2027-05-30 date: 2024-04-05 date: 2024-04-05 name: West China Hospital class: OTHER briefSummary: Currently, standard treatment options for gastric cancer failed to first-line treatment include monotherapy with paclitaxel/irinotecan/docetaxel/albumin paclitaxel, or paclitaxel combined with ramucirumab. However, the efficacy of these regimens is still far from satisfactory. The aim of the study is to evaluate the efficacy and safety of nab-paclitaxel combined with cadonilimab for the second-line treatment of advanced gastric cancer. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 59 type: ESTIMATED name: Nab-paclitaxel Combined With Cadonilimab (AK104) measure: overall response rate (ORR) measure: disease control rate (DCR) measure: overall survival (OS) measure: progression-free survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349954 id: BFHHZS20240064 briefTitle: Effectiveness and Safety of Single-session Endoscopic Stone Extraction overallStatus: RECRUITING date: 2024-04-15 date: 2024-12-01 date: 2024-12-01 date: 2024-04-05 date: 2024-04-18 name: Beijing Friendship Hospital class: OTHER briefSummary: This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction. conditions: Choledocholithiasis With Acute Cholangitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All patients will be randomly allocated into single-session group or two-session group. primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: single-session ERCP name: two-session ERCP measure: Success rate of complete stone removal measure: ERCP-related complication rate measure: Length of stay measure: Hospital expenses sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Wei Jiang role: CONTACT phone: 18663186116 email: jfw899w@outlook.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06349941 id: STU-2023-0745 briefTitle: Telemedicine in Rural Patients With Heart Failure acronym: RURAL-HF overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-12-01 date: 2024-12-01 date: 2024-04-05 date: 2024-04-05 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: We propose a pilot trial examining the effectiveness of a mHealth-based home cardiac rehabilitation program using a telemedicine platform for the identification, recruitment, and retention of an underserved rural population with heart failure with reduced ejection fraction.(HFrEF). The goal of the pilot trial will be to demonstrate the feasibility of a telemedicine platform for the recruitment and retention of underserved rural patients in clinical trials. Participants will participate in a cardiac rehabilitation program delivered through a smartphone application called Movn. They will be monitored for 14 weeks. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot trial primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Movn app measure: Physical activity levels measure: Quality of life using KCCQ score measure: Enrollment rate measure: Loss to follow up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349928 id: MASF_Dancers01 briefTitle: "The Show Must go on" : The Experience of Injuries Among Dancers: Fears, Thoughts, and Beliefs. A Qualitative Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-30 date: 2025-04-01 date: 2024-04-05 date: 2024-04-05 name: University of Siena class: OTHER briefSummary: This qualitative, cross-sectional study aims at describing the experience of Italian dancers with injury.

Dancers face a high risk of sustaining one or more injuries during their career (87-94%), which may lead to physical, psychological, and socioeconomic consequences affecting dancer's lives and careers both short and long-term.

Dancers report fearing injury and its consequences and believing in the existence of a stigma around injury and injured colleagues; many of them also try to self-manage pain and delay reporting injuries to healthcare professionals, possibly making its outcomes worse.

This study will collect data from dancers via focus groups and individual interviews, investigating dancers' experiences, thoughts, and beliefs about injury. Records from the interviews will be transcribed ad verbatim and analyzed using the framework method to synthetize the data and highlight the most meaningful content.

Understanding dancers' thoughts and behaviors regarding past or possible future injuries may be beneficial in improving treatment efficacy and designing adequate education and prevention strategies. It may also help raise awareness of dancers' complex and unique needs, and the importance of having accessible, specialized professionals around dance companies and schools. conditions: Injuries conditions: Dancing conditions: Injury;Sports conditions: Stress, Psychological studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Focus group or interview measure: Experience and perception of injury amongst dancers measure: Understanding of injury prevention and pain management amongst dancers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349915 id: 2023-15217 briefTitle: A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents acronym: SWEEP overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-04 date: 2026-04 date: 2024-04-05 date: 2024-04-05 name: Albert Einstein College of Medicine class: OTHER name: American Foundation for Suicide Prevention name: Yeshiva University briefSummary: Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, NY. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents. conditions: Suicide studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The first 6 participants will serve as a brief pilot to validate outcomes and the acceptability of the intervention. The study team may make slight changes to the intervention (e.g., time of day the suicide recovery narratives are administered, or which narratives are presented) before recruiting the remaining 40 participants. primaryPurpose: PREVENTION masking: NONE count: 46 type: ESTIMATED name: Supporting Wellbeing with Everyday Experiences of Peers (SWEEP) measure: Suicidal Thoughts measure: Suicidal Urge Resistance measure: Social Connectedness measure: Optimism measure: Social Support measure: Intervention Acceptability measure: Emotions measure: Treatment Readiness sex: ALL minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06349902 id: Pro00077561 briefTitle: Re-link HCV in Substance-Use Telemedicine Program overallStatus: RECRUITING date: 2024-03-12 date: 2024-08-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-05 name: trueNorth Medical Centres class: OTHER name: Gilead Sciences briefSummary: This is an observational, retrospective \& prospective cohort study. The retrospective element of the study is a chart review to identify people with diagnosed but untreated HCV and re-link them to care. The observational prospective cohort element of the study will examine the HCV linkage to care, treatment initiation, treatment completion \& cure rates of these HCV clients achieved through this chart review and re-linking approach. conditions: Hepatitis C studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 5000 type: ESTIMATED name: Re-Link measure: number of patients identified as having diagnosed but untreated HCV measure: percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care measure: treatment initiation rates measure: treatment completion dates measure: cure rates sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: trueNorth Medical Centre status: RECRUITING city: Toronto state: Ontario zip: M5B 2A5 country: Canada name: Hannah O'Reilly, BSc role: CONTACT phone: 8888783563 phoneExt: 6452 email: hannah.oreilly@truenorthmedical.com role: CONTACT phoneExt: Cavacuiti email: drccavacuiti@truenorthmedical.com name: Chris Cavacuiti, BA, MD, MHSc role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06349889 id: MA-NPC-II-004 briefTitle: Adebrelimab and Chemoradiotherapy in High-risk Locoregionally Advanced Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-05-01 date: 2024-04-05 date: 2024-04-09 name: Sun Yat-sen University class: OTHER name: Nanfang Hospital, Southern Medical University name: West China Hospital briefSummary: This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC). conditions: Nasopharyngeal Carcinoma conditions: Nasopharyngeal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Adebrelimab measure: Failure-free survival (FFS) measure: Overall survival (OS) measure: Distant metastasis-free survival (DMFS) measure: Locoregional recurrence-free survival (LRRFS) measure: Adverse events (AEs) and serious adverse events (SAEs) measure: Quality of life (QoL) measure: Failure-free survival (FFS) within different subgroups sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong zip: 510000 country: China name: Jian Guan, M.D. role: CONTACT lat: 23.11667 lon: 113.25 facility: West China Hospital, Sichuan University city: Chengdu state: Sichuan zip: 610000 country: China name: Lei Liu, M.D. role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06349876 id: SUEZ MED - IRB Approval NO: 6 briefTitle: Cholecystectomy in Patients With Silent Common Bile Duct Stones overallStatus: COMPLETED date: 2023-02-15 date: 2023-07-15 date: 2024-01-15 date: 2024-04-05 date: 2024-04-23 name: Suez University class: OTHER briefSummary: Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones conditions: Performing Cholecystectomy in Patients With Chronic Calcular Choleycystits studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ACTUAL name: laparoscopic cholecystectomy measure: number of patients developed jaundice post cholecystectomy sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Qeft Teatching Hospital city: Qinā country: Egypt lat: 26.16418 lon: 32.72671 facility: Qena Faculty of Medicine city: Qinā country: Egypt lat: 26.16418 lon: 32.72671 facility: Suez Faculty of Medicine city: Suez zip: 43221 country: Egypt lat: 29.97371 lon: 32.52627 hasResults: False

 nctId: NCT06349863 id: W23.225 briefTitle: Dutch CHolEcystitis Snapshot Study acronym: Dutch-CHESS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-31 date: 2025-04-30 date: 2024-04-05 date: 2024-04-11 name: St. Antonius Hospital class: OTHER name: St. Antonius Onderzoeksfonds name: Dutch Snapshot Research Group name: Nederlandse Leverpatientenvereniging briefSummary: Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes.

Purpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome.

Methods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a \>7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded.

Conclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands. conditions: Cholecystitis conditions: Cholecystitis; Gallstone conditions: Cholecystitis; Choledocholithiasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED measure: Total hospital stay sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349850 id: Soh-Med-24-03-06MS briefTitle: Predictive Value of Serum Uric Acid to High Density Lipoprotein Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-05 date: 2024-04-05 name: Sohag University class: OTHER briefSummary: An prospective observetional study to asses the predictive value of serum uric acid to high density lipoprotein cholesterol ratio for diabetic kidney injury in type 2 diabetes conditions: Diabetic Kidney Disease studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: serum uric acid level to plasma HDL-c level ratio (UHR) measure: Uric acid to HDL-c ratio (UHR) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349837 id: ECLIPSE-02 briefTitle: Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-03-31 date: 2026-03-31 date: 2024-04-05 date: 2024-04-05 name: Sichuan University class: OTHER briefSummary: This is a 3+3 dose escalation phase I study which aims to evaluate the safety and tolerability of low dose radiotherapy (LDRT) plus concurrent partial Stereotactic Ablative Radiotherapy (SBRT) and Tislelizumab in Patients with bulky tumors who have failed standard therapy. At least 9 participants will be enrolled in this study. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Tislelizumab name: Low Dose Radiotherapy name: Stereotactic Ablative Radiotherapy measure: Dose Limiting Toxicities measure: Objective Response Rate (ORR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349824 id: 004AEstb/EC/01/2022 briefTitle: Dextrose, Steroid, PRP: Choosing the Right Injection for CRS Relief; a RCT overallStatus: COMPLETED date: 2023-10-10 date: 2024-03-30 date: 2024-03-30 date: 2024-04-05 date: 2024-04-05 name: Sheikh Zayed Medical College class: OTHER_GOV briefSummary: USG guided injections to relieve carpal tunnel syndrome with dextrose water or steroid or PRP conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: injection Dextrose water name: USG machine measure: VAS sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sheikh Zayed Medical College city: Rahim yar khan state: Punjab zip: 64200 country: Pakistan lat: 28.41987 lon: 70.30345 hasResults: False

 nctId: NCT06349811 id: BL-M05D1-101 briefTitle: A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-05 date: 2024-04-09 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors. conditions: Locally Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: BL-M05D1 measure: Phase Ia: Dose limiting toxicity (DLT) measure: Phase Ia: Maximum tolerated dose (MTD) measure: Phase Ib: Recommended Phase II Dose (RP2D) measure: Treatment-Emergent Adverse Event (TEAE) measure: Cmax measure: Tmax measure: T1/2 measure: AUC0-t measure: CL (Clearance) measure: Ctrough measure: ADA (anti-drug antibody) measure: Phase Ib: Objective Response Rate (ORR) measure: Phase Ib: Disease Control Rate (DCR) measure: Phase Ib: Duration of Response (DOR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing country: China name: Lin Shen role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06349798 id: DR200177 briefTitle: Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO) acronym: NEFARTHRO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-04 date: 2024-04-05 date: 2024-04-05 name: University Hospital, Tours class: OTHER briefSummary: NEFARTHRO is a multicentric randomized controlled trial comparing the effects of discontinuous infusions of nefopam (bolus) versus continuous infusion of intravenous nefopam (via an infusion pump) versus placebo on the opioid-request during the first 24 hours following a Total Hip arthroplasty, as part of multimodal analgesia including at least paracetamol and a Non-Steroidal Anti-Inflammatory Drug (NSAID).

The primary endpoint is cumulative morphine consumption for the first postoperative 24 hours, expressed in mg of iv equivalent morphine, including titration in the Post Anesthesia Care Unit (PACU).

Patients will be followed during 6 months. conditions: Total Hip Arthroplasty studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter, double-blind, randomized controlled trial in 3 parallel groups (placebo group, nefopam bolus group and nefopam Continuous Intra-Venous Infusion CIVI group). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Patient, investigator and outcome assessor will be blind., A nurse anesthetist who will not be involved in the follow up of the patient will receive the kit and prepare the syringes. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 546 type: ESTIMATED name: Nefopam name: Nefopam name: NaCl 0.9% measure: Cumulative morphine consumption from the end of surgery (Day 0 - Hour 0) to the first 24 hours after surgery, expressed in mg of intravenous morphine (including titration in the Post-Anesthesia care Unit PACU). measure: Maximum self-assessed pain using the Numeric Rating Scale ranging from 0 (no pain) to 10 (maximum pain) at rest in the PACU, at rest and on walking between PACU discharge and Hour 24, at Hour 24, and at hospital discharge. measure: Time to return to walking. measure: Time to leave room. measure: Time to climb stairs. measure: Length of stay. measure: Time to abandon canes/crutches. measure: Opioid analgesic consumption between days 1 and 5 or at hospital discharge measure: Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire. measure: Neuropathic pain score (DN2)The DN2 is a simplified version of the DN4, with 7 items: burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching (scored 0=absent, 1=present). measure: Incidence of all serious AEs during patient follow-up and non-serious AEs. measure: Incidence of patients with morphine side effects measure: Financial impact of spreading the recommended strategy following the results of the clinical study, estimated per year and over a 5-year period, from the point of view of the French Health Insurance and from the hospital perspective. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anaesthesia - Intensive care city: Angers zip: 49933 country: France name: Emmanuel RINEAU, MD role: CONTACT phone: 02 41 35 39 51 phoneExt: +33 email: Emmanuel.Rineau@chu-angers.fr name: Emmanuel RINEAU, MD role: PRINCIPAL_INVESTIGATOR lat: 47.46667 lon: -0.55 facility: Anaesthesia - Intensive care city: Blois zip: 41016 country: France name: Raphaël DARMON, MD role: CONTACT phone: 02 54 55 66 33 phoneExt: +33 email: darmonr@ch-blois.fr name: Raphaël DARMON, MD role: PRINCIPAL_INVESTIGATOR lat: 47.58333 lon: 1.33333 facility: Anaesthesia - Intensive care city: Chartres zip: 28018 country: France name: Elias CHADDOUK, MD role: CONTACT phone: 02 37 30 30 30 phoneExt: +33 email: echaddouk@ch-chartres.fr name: Elias CHADDOUK, MD role: PRINCIPAL_INVESTIGATOR lat: 48.44685 lon: 1.48925 facility: Anaesthesia - Intensive care city: Nantes zip: 44000 country: France name: Raphaël CINOTTI, MD role: CONTACT phone: 02 53 48 22 30 phoneExt: +33 email: Raphael.CINOTTI@chu-nantes.fr name: Raphaël CINOTTI, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 facility: Anaesthesia - Intensive care city: Orléans zip: 45067 country: France name: Léa PARCOT, MD role: CONTACT phone: 02 38 22 97 17 phoneExt: +33 email: lea.pascot@chr-orleans.fr name: Léa PARCOT, MD role: PRINCIPAL_INVESTIGATOR lat: 47.90289 lon: 1.90389 facility: Anaesthesia - Intensive care city: Poitiers zip: 86021 country: France name: Denis FRASCA, MD role: CONTACT phone: 05 49 44 38 95 phoneExt: +33 email: denis.frasca@univ-poitiers.fr name: Denis FRASCA, MD role: PRINCIPAL_INVESTIGATOR lat: 46.58333 lon: 0.33333 facility: Anesthesia - intensive care city: Tours zip: 37044 country: France name: Francis REMERAND, MD role: CONTACT phone: 02 47 47 84 80 phoneExt: +33 email: F.REMERAND@chu-tours.fr name: Francis REMERAND, MD role: PRINCIPAL_INVESTIGATOR lat: 47.38333 lon: 0.68333 hasResults: False

 nctId: NCT06349785 id: P.T.REC/012/003858 briefTitle: Manual Hyperinflation and Physical Therapy Program on Lung Recruitment Mechanically Ventilated Pediatric Patients acronym: MHI overallStatus: COMPLETED date: 2023-12-20 date: 2024-03-01 date: 2024-03-29 date: 2024-04-05 date: 2024-04-05 name: New Ismailia National University class: OTHER briefSummary: The purpose of this study is to investigate the immediate combined effects of Manual Hyperinflation and standard Physical therapy program on lung recruitment and secretion mass in mechanically ventilated pediatric patients aged between 10-15 years 'old conditions: Mechanical Ventilation Complication conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: using sealed envelopes, whoMasked: PARTICIPANT count: 32 type: ACTUAL name: rehabilitation of mechanically ventilated patients name: supportive care measure: change the respiratory functions measure: change the respiratory mechanics measure: change the bronchospasm measure: change the amount of ventilation measure: decreasing the amount of secretions measure: weaning from mechanical ventilator sex: ALL minimumAge: 10 Years maximumAge: 15 Years stdAges: CHILD facility: College of Medicine city: Ismailia zip: 41522 country: Egypt lat: 30.60427 lon: 32.27225 hasResults: False

 nctId: NCT06349772 id: FY2024-203 briefTitle: Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-05 date: 2024-04-08 name: Texas Tech University Health Sciences Center class: OTHER briefSummary: The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only. conditions: Post Operative Pain studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: Zynrelef name: Exparel measure: postoperative pain score measure: Total postoperative opioid use measure: Proportion of total rescue medication use sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349759 id: OPI-NYXDLD-302 briefTitle: Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances acronym: LYNX-2 overallStatus: RECRUITING date: 2024-04-01 date: 2025-09 date: 2025-11 date: 2024-04-05 date: 2024-04-08 name: Ocuphire Pharma, Inc. class: INDUSTRY name: Viatris Inc. briefSummary: Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances. conditions: Mesopic Vision conditions: Night Vision Loss studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist name: Placebo measure: Percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 15 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United States, California status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 facility: United States, North Carolina status: RECRUITING city: Garner state: North Carolina zip: 27529 country: United States lat: 35.71126 lon: -78.61417 facility: United States, Rhode Island status: RECRUITING city: Warwick state: Rhode Island zip: 02888 country: United States lat: 41.7001 lon: -71.41617 hasResults: False

 nctId: NCT06349746 id: collage of physical therapy briefTitle: Cervical Unilateral Antero-posterior Mobilization and Thoracic Central Postro-anterior Mobilization in Treatment of Shoulder Impingement Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05 date: 2024-06 date: 2024-04-05 date: 2024-04-05 name: Egyptian Chinese University class: OTHER name: Benha University briefSummary: Shoulder impingement syndrome (SIS) is a complex, multi-factorial problem that is treated with a variety of different conservative options. The conservative option that has shown effectiveness is manual therapy of the cervical and thoracic spine conditions: Shoulder Impingement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: this study will be conducted to compare one group receiving selected therapeutic exercises and other group recieve cervical and thoracic mobilization added to selected therapeutic exercise Program on pain intensity, Pain-free shoulder flexion and scaption active ROM, muscle strength of external rotator and abductors, shoulder functional status in patients with Shoulder Impingement Syndrome. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: patients and outcomes assessor will be masked about the grouping of the study whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: therapeutic exercises name: mobilization exercise measure: pain intensity measure: shoulder flexion and abduction range of motion measure: muscle strength sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06349733 id: MR-37-23-008382 briefTitle: Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration" overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-23 date: 2023-11-10 date: 2024-04-10 date: 2024-04-05 date: 2024-04-05 name: Qilu Hospital of Shandong University class: OTHER briefSummary: Each year, millions of burn, trauma, or surgical patients worldwide suffer from scarring that severely affects their quality of life and social functioning. In order to prevent and treat diseases related to abnormal scar hyperplasia, clinicians and researchers have adopted various methods, such as scar grinding, surgical resection, drug injection in scar tissue, cryotherapy, laser and so on. However, these methods can not effectively inhibit the abnormal proliferation of scars and improve the adverse effects of existing scars on patients. To date, there is no accepted gold standard for the effective treatment and improvement of abnormal scar tissue. conditions: Scar studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: Botulinum toxin type A measure: The modified Stony Brook Scar Evaluation Scale measure: Patient satisfaction sex: ALL minimumAge: 12 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University Dezhou Hospital city: Dezhou state: Shandong zip: 253000 country: China lat: 37.45127 lon: 116.31046 hasResults: False

 nctId: NCT06349720 id: KF-2023-355 briefTitle: Investigating Long-term Health Effects and Complications in COVID-19 Recoveries overallStatus: RECRUITING date: 2023-06-07 date: 2024-06-07 date: 2024-06-07 date: 2024-04-05 date: 2024-04-05 name: Zhaohui Tong class: OTHER briefSummary: Clarify the incidence of functional impairments in cured COVID-19 patients and identify influencing factors. Build a multi-omics database for COVID-19 patients in the recovery period to elucidate the biological biomarkers and targets associated with functional impairments. Comprehensive exploration of the long-term prognosis, complications, sequelae, and risk factors of COVID-19 patients after Omicron infection, as well as their immune characteristics. Compare the impact of different strains of the COVID-19 virus on prognosis and immune response. Develop comprehensive rehabilitation intervention strategies for COVID-19 patients with functional impairments and evaluate the impact of different intervention methods on their prognosis. Based on clinical data, multi-omics data, and precise rehabilitation assessment data, construct predictive models for prognosis and rehabilitation effectiveness in COVID-19, providing scientific evidence for the implementation of effective COVID-19 rehabilitation measures. conditions: COVID-19 Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 17000 type: ESTIMATED name: respiratory rehabilitation measure: Immunological characteristics associated with functional impairments in COVID-19 convalescent patients measure: Changes in laboratory examination indicators measure: High-resolution CT of the chest measure: Pulmonary function test measure: Multi-omics changes and characteristics associated with functional impairments in COVID-19 convalescent patients measure: Inflammatory factors related to body dysfunction in COVID-19 rehabilitation patients measure: Regular rehabilitation assessment following respiratory rehabilitation intervention in COVID-19 patients sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Institute of Respiratory Medicine status: RECRUITING city: Beijing state: Beijing zip: 100027 country: China name: Zhaohui Tong, Dr role: CONTACT phone: +86 010 8523 1000 email: 13910930309@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06349707 id: 2023PI112 briefTitle: Multiplex PCR for Severe Respiratory Infections During the COVID-19 Pandemic acronym: VirCoV+ overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-06 date: 2024-04-05 date: 2024-04-05 name: Central Hospital, Nancy, France class: OTHER briefSummary: The hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge. conditions: Viral Pneumonia studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 18 type: ESTIMATED name: other: Observational measure: Occurrence of positive viral PCR assays (not COVID-19) from hospitalizations for respiratory infections. measure: Real-life features of patients in Intensive care (from the whole population - Outcome 1) with positive viral PCR during infectious pneumonia. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Schvoerer city: Vandoeuvre Les Nancy zip: 54511 country: France lat: 48.65 lon: 6.18333 hasResults: False

 nctId: NCT06349694 id: PamukkaleU.ftr-NYıldız-001 briefTitle: Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-01-31 date: 2025-02-28 date: 2024-04-05 date: 2024-04-05 name: Pamukkale University class: OTHER briefSummary: Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.

The main questions we aim to answer are:

Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied. conditions: Urinary Bladder, Overactive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Transcutaneous MPN stimulation (T-MPNS) name: Transcutaneous tibial nerve stimulation (TTNS) name: BT (Control group) measure: Improvement in incontinence episodes (positive response rate) measure: The severity of incontinence measure: Symptom severity measure: Frequency of voiding, nocturia, number of pads measure: Quality of life (IIQ7) measure: The Hospital Anxiety and Depression Scale (HAD) measure: FSFI measure: Cure-improvement rates measure: Treatment satisfaction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University city: Denizli country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False

 nctId: NCT06349681 id: CONOXBird briefTitle: Describe Relations Between qCON and qNOX Indicies During Propofol-Remifentanil General Anesthesia overallStatus: RECRUITING date: 2024-04-01 date: 2024-09-01 date: 2024-10-01 date: 2024-04-05 date: 2024-04-25 name: University of Padova class: OTHER briefSummary: CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.

It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies. conditions: Anesthesia Brain Monitoring studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 14 type: ESTIMATED measure: Correlation between qCON and qNOX measure: Correlation between qCON and concentrations of Propofol(CeP) measure: Correlation between qNOX and concentrations of Remifentanil (CeR) sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Treviso Regional Hospital status: RECRUITING city: Treviso state: TV zip: 31100 country: Italy name: Federico Linassi role: CONTACT email: federico.linassi@gmail.com lat: 45.66673 lon: 12.2416 hasResults: False

 nctId: NCT06349668 id: 2023-505941-21-00 briefTitle: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery acronym: SMILe overallStatus: RECRUITING date: 2024-04-09 date: 2026-10-01 date: 2026-12-01 date: 2024-04-05 date: 2024-04-11 name: Hans Bahlmann class: OTHER name: Linkoeping University briefSummary: The goal of this clinical trial is to learn whether the addition of spinal analgesia leads to superior recovery in patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. The main questions it aims to answer are:

* Is the decrease in wellbeing as quantified by the patient-centered outcome scale "Quality of Recovery 15" (QoR-15), from baseline to the first day after surgery (POD 1), at least 8.0 points less in patients receiving spinal analgesia in addition to general anesthesia?
* Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications?
* Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery?
* Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery?

Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively.

QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary.

In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction. conditions: Other Specified Disorders of Kidney and Ureter conditions: Benign Neoplasm of Ureter conditions: Calculus of Kidney and Ureter conditions: Ureter Cancer conditions: Ureteric Reflux conditions: Congenital Ureteric Anomaly conditions: Benign Renal Neoplasm conditions: Renal Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: spinal analgesia with morphine and bupivacaine name: lidocaine infusion measure: QoR-15 score at postoperative day 1 measure: QoR-15 score preoperatively measure: QoR-15 score at postoperative day 7 measure: Pain (NRS) in rest and during motion 2hrs after arrival to the PACU measure: Pain (NRS) on POD 1-3 measure: Pain (NRS) in rest and during motion at POD 7 measure: Time from arrival in the OR to start of surgery measure: Time from end of surgery until leaving the OR measure: Incidence of unplanned termination of the lidocaine infusion measure: Amount of remifentanil in patients given remifentanil measure: Amount of intraoperative opioids in patients not receiving remifentanil measure: Length of stay at the PACU measure: Amount of opioids administred at the PACU measure: Percentage of patients with PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay measure: "Time out-of-bed" on POD 1-3 measure: Amount of opioids administered during the first 24 hours at the ward measure: First POD passing gases measure: First POD passing stool measure: Incidence of pruritus measure: Length of stay measure: DAOH30 measure: Postoperative complications untill POD 30 measure: Requirement for opioids after discharge measure: Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia measure: Intraoperative fluid balance measure: Time with low blood pressure during anesthesia measure: Lowest MAP within 10 minutes after induction of anesthesia measure: Highest MAP within 10 minutes of abdominal insufflation measure: Fraction of patients needing norepinephrine before start of surgery measure: Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of surgery) measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, before start of surgery measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, after start of surgery measure: Intraoperative Cardiac Index measure: Intraoperative Stroke Volume Index measure: Intraoperative Cardiac Power Index measure: Intraoperative dPmx measure: Intraoperative Pulse Pressure Variation measure: Intraoperative Stroke Volume Variation measure: Intraoperative Systemic Vascular Resistance Index measure: Intraoperative heart rate measure: Biochemical markers of inflammation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Linköping status: RECRUITING city: Linköping country: Sweden name: Martin Holmberg, MD role: CONTACT phone: +46101033932 email: martin.holmberg@regionostergotland.se lat: 58.41086 lon: 15.62157 hasResults: False

 nctId: NCT06349655 id: 2023-KY-0865-001 briefTitle: The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19 overallStatus: COMPLETED date: 2023-12-05 date: 2024-01-15 date: 2024-03-10 date: 2024-04-05 date: 2024-04-05 name: The First Affiliated Hospital of Zhengzhou University class: OTHER name: Henan Provincial Chest Hospital name: The Affiliated Infectious Disease Hospital of Zhengzhou University name: The Fifth People's Hospital of Anyang name: Shangqiu Municipal Hospital name: Nanyang Central Hospital name: Luoyang Central Hospital name: Guangshan County People's Hospital name: Fengqiu County People's Hospital briefSummary: To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection. conditions: COVID-19 conditions: Azvudine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 32864 type: ACTUAL name: Azvudine name: Paxlovid measure: All-cause death measure: Composite disease progression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Zhengzhou University city: Zhengzhou state: Henan zip: 450052 country: China lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06349642 id: MC230901 id: 23-008413 type: OTHER domain: Mayo Clinic Institutional Review Board id: NCI-2024-02979 type: REGISTRY domain: CTRP (Clinical Trials Reporting Program) briefTitle: Predicting Response to Immune Checkpoint Inhibitors Across Solid Tumors Using a Live Tumor Diagnostic Platform acronym: CYBRID-04 overallStatus: RECRUITING date: 2024-04-24 date: 2027-05 date: 2027-05 date: 2024-04-05 date: 2024-04-26 name: Mayo Clinic class: OTHER briefSummary: The primary purpose of this study is to determine the sensitivity of CYBRID Score for predicting in-vivo clinical response based on surgical response or RECIST 1.1 for neoadjuvant and locally advanced/metastatic patients, respectively. The secondary purposes is to determine the sensitivity of the CYBRID Score for predicting in-vivo clinical response based on surgical response or RECIST 1.1 for neoadjuvant and locally advanced/metastatic patients, respectively. conditions: Early Stage Triple-Negative Breast Carcinoma conditions: Locally Advanced Bladder Urothelial Carcinoma conditions: Locally Advanced Cervical Carcinoma conditions: Locally Advanced Clear Cell Renal Cell Carcinoma conditions: Locally Advanced Colorectal Carcinoma conditions: Locally Advanced Endometrial Carcinoma conditions: Locally Advanced Esophageal Carcinoma conditions: Locally Advanced Liver Carcinoma conditions: Locally Advanced Lung Non-Small Cell Carcinoma conditions: Locally Advanced Malignant Skin Neoplasm conditions: Locally Advanced Triple-Negative Breast Carcinoma conditions: Metastatic Bladder Urothelial Carcinoma conditions: Metastatic Cervical Carcinoma conditions: Metastatic Clear Cell Renal Cell Carcinoma conditions: Metastatic Colorectal Carcinoma conditions: Metastatic Endometrial Carcinoma conditions: Metastatic Esophageal Carcinoma conditions: Metastatic Liver Carcinoma conditions: Metastatic Lung Non-Small Cell Carcinoma conditions: Metastatic Malignant Skin Neoplasm conditions: Metastatic Malignant Solid Neoplasm conditions: Metastatic Triple-Negative Breast Carcinoma conditions: Resectable Bladder Urothelial Carcinoma conditions: Resectable Colorectal Carcinoma conditions: Resectable Lung Non-Small Cell Carcinoma conditions: Resectable Malignant Liver Neoplasm conditions: Resectable Skin Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 324 type: ESTIMATED name: Biospecimen Collection name: Tissue Collection measure: Accuracy of cytoplasmic hybrid (Cybrid) Score for predicting in-vivo clinical response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Dev Mukhopadhyay, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06349629 id: 20240401 briefTitle: The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects overallStatus: RECRUITING date: 2023-01-01 date: 2025-01-01 date: 2027-01-01 date: 2024-04-05 date: 2024-04-05 name: Peking University Third Hospital class: OTHER briefSummary: Perimarticular fracture bone defect is a common and complicated clinical disease. The current treatment for this type of injury is anatomical reduction of the fracture, where the bone defect is filled with artificial, autologous or allogeneic bone in granular form, and then fixed with plates and screws. However, these bone filler materials exist in a loose accumulation state and cannot form an effective overall support force for the joint. The applicant realized three dimensional (3D) printing of WE43 magnesium alloy with personalized design and porous overall structure, and developed high-temperature heat treatment technology to slow its degradation, which effectively realized the dual stability of degradation rate of magnesium alloy support body and overall structure during the bone repair period. This project will optimize the design of 3D printed WE43 magnesium alloy full-structure in-bone support, and establish a metamaterial pore structure design platform that regulates the physical properties and degradation behavior of porous implants. Fracture from proximal humerus, distal radius and tibial plateau conditions: Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: 3D printed WE43 magnesium alloy measure: Detection of Magnesium alloy metabolism measure: Degradation of 3D printed magnesium alloy prosthesis measure: New bone regeneration measure: Evaluation of shoulder joint function measure: Evaluation of wrist joint function measure: Evaluation of knee joint function sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Haidian country: China name: Bingchuan Liu role: CONTACT phone: +86 18310188678 email: liubc@bjmu.edu.cn lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospita status: RECRUITING city: Beijing zip: 100083 country: China name: Yun Tian, M.D role: CONTACT phone: +8613701053505 email: tiany@bjmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06349616 id: STUDY24458 briefTitle: Cooling Strategies for Older Adults in the Heat overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-05 date: 2024-04-05 name: Penn State University class: OTHER briefSummary: The earth's climate is warming, and the number of heat waves has increased in recent years. At the same time, the number of adults over the age of 65 is growing. Humans sweat and increase blood flow to the skin to cool their body when they get hot. Older adults do not do this as well as young adults. This makes it harder to safely be in warm and/or humid conditions. It is important to learn about cooling strategies for older adults to safely be in warm and/or humid conditions.

There is compelling evidence that intermittent hand and forearm cold-water immersion effectively reduces the rise of core temperature during heat stress in older adults. However, it is still unknown if this is an effective cooling strategy for older adults. Furthermore, our laboratory has shown that folic acid supplementation improves blood flow responses in older adults. This may be beneficial to older adults during heat stress. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Subjects participate in 4 experiments, 2 for each treatment (folic acid supplementation and placebo). The order of treatment is random. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Intermittent cold-water hand and forearm immersion name: No intermittent cold-water hand and forearm immersion measure: Core temperature measure: Heart rate measure: Blood Pressure measure: Body Mass measure: Skin Temperature sex: ALL minimumAge: 65 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: Noll Laboratory city: University Park state: Pennsylvania zip: 16802 country: United States name: W. Larry Kenney, Ph.D. role: CONTACT phone: 814-863-1672 email: w7k@psu.edu name: Rachel Cottle, MS role: CONTACT email: rmc5808@psu.edu lat: 40.80201 lon: -77.85639 hasResults: False

 nctId: NCT06349603 id: S2023 briefTitle: Physiotherapy Approach for Susac Syndrome overallStatus: COMPLETED date: 2023-02-13 date: 2023-04-01 date: 2023-04-06 date: 2024-04-05 date: 2024-04-05 name: Rehabilitation Centre Zivot class: OTHER briefSummary: Susac's syndrome is a rare autoimmune disorder characterised by a triad of encephalopathy (brain dysfunction), branch retinal artery occlusion (loss of vision) and sensorineural hearing loss. This study presents the case of a patient undergoing intensive physiotherapy intervention following an injury, focusing on assessments such as volume and range of motion measurements, manual muscle tests, and pain intensity evaluations using various scales. conditions: Susac Syndrome studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 1 type: ACTUAL measure: Mobility and Muscle Strength Improvement measure: Muscle Strength Improvement Outcome Measure measure: Pain Intensity Outcome Measure sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rehabilitation centre Život city: Mostar zip: 88000 country: Bosnia and Herzegovina lat: 43.34333 lon: 17.80806 hasResults: False

 nctId: NCT06349590 id: IRB24-0373 briefTitle: Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery acronym: DIET overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-04 date: 2029-04 date: 2024-04-05 date: 2024-04-05 name: University of Chicago class: OTHER briefSummary: A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized plant-based low fat/ high-fiber meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Plant-Based Meals measure: Change of the presence of active-urokinase-type plasminogen activation (uPA) stool samples before and after diet intervention using western blot and zymography. measure: Change of the presence of active- Matrix Metalloproteinase-9 (MMP9) in stool samples before and after diet intervention using western blot and zymography. measure: Change of the presence of plasminogen in stool samples before and after diet intervention using western blot and zymography. measure: Change of the stool associated metagenomics in subjects before and after intervention. measure: Change of the levels of short-chain fatty acids and bile acids between pre- and post- intervention stool samples. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago city: Chicago state: Illinois zip: 60637 country: United States name: Benjamin Shogan, MD role: CONTACT phone: 773-732-2260 email: bshogan@bsd.uchicago.edu name: Leila Yazdanbakhsh role: CONTACT phone: 773-834-6087 email: leila.yazdanbakhsh@bsd.uchicago.edu name: Benjamin Shogan, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06349577 id: 23-0921 id: 5K23HL151882 type: NIH link: https://reporter.nih.gov/quickSearch/5K23HL151882 briefTitle: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-10 date: 2024-04-05 date: 2024-04-05 name: University of Colorado, Denver class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass. conditions: Acute Kidney Injury conditions: Hemolysis conditions: Thrombocytopenia conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1100 type: ESTIMATED name: Non-pulsatile blood flow name: Pulsatile blood flow measure: Acute kidney injury measure: Acute kidney injury risk score measure: Red blood cell units transfused measure: Platelet nadir measure: Discontinuation rate of cardiopulmonary bypass mode measure: 30-day mortality measure: Myocardial infarction measure: Stroke measure: Renal failure requiring renal replacement therapy measure: Re-exploration for bleeding measure: Sepsis measure: New onset atrial fibrillation measure: Duration of mechanical ventilation measure: Post-operative delirium measure: Post-operative hospital length of stay measure: New requirement for mechanical circulatory support measure: Intra-operative red blood cell transfusion in units measure: Post-operative red blood cell transfusion in units measure: Post-operative platelet transfusion in units measure: Post-operative plasma transfusion in units measure: Post-operative cryoprecipitate transfusion in units measure: Intra-operative platelet transfusion in units measure: Intra-operative plasma transfusion in units measure: Intra-operative cryoprecipitate transfusion in units measure: New onset of acute lung injury measure: New onset of left ventricular systolic dysfunction measure: New onset of right ventricular systolic dysfunction sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Hospital city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06349564 id: 23-01443 briefTitle: Implementing Virtual Reality (VR) to Reduce Sedation overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-05 date: 2024-04-05 name: NYU Langone Health class: OTHER briefSummary: The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time. conditions: Sedative During Endoscopy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Pico 4 Enterprise headset with noise cancelling headphones measure: Total amount of sedative drugs administered during the procedure measure: Patient-reported discomfort or pain (using 0-10 pain scale) measure: Duration of the procedure measure: Overall patient satisfaction scores measure: Number of events of complications from VR measure: Number of technical failures measure: Troubleshooting time measure: PACU length of stay sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Brooklyn city: Brooklyn state: New York zip: 11220 country: United States lat: 40.6501 lon: -73.94958 hasResults: False

 nctId: NCT06349551 id: RC23_0586 briefTitle: Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling. acronym: SECU-BIO2 overallStatus: RECRUITING date: 2024-04-17 date: 2025-03-20 date: 2025-03-20 date: 2024-04-05 date: 2024-04-18 name: Nantes University Hospital class: OTHER briefSummary: After blood sampling from an arterial catheter, the reinjection of the clearing fluid (a mixture of saline solution and blood) is proposed to limit blood loss. However, the status of coagulation in this clearing liquid remains poorly documented. conditions: Intensive Care Units conditions: Arterial Lines studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 211 type: ESTIMATED name: Patients of intensive care unit measure: Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter measure: Concentration of prothrombin over time in the clearing fluid during blood sampling from an arterial catheter measure: Concentration of factor II over time in the clearing fluid during blood sampling from an arterial catheter measure: Concentration of factor V over time in the clearing fluid during blood sampling from an arterial catheter measure: Concentration of fibrin monomer over time in the clearing fluid during blood sampling from an arterial catheter sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes university hospital status: RECRUITING city: Nantes state: Loire-atlantique zip: 44093 country: France name: Jerôme Dauvergne role: CONTACT phone: +33240165289 email: jerome.dauvergne@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: Hospital center status: NOT_YET_RECRUITING city: Saint-Nazaire zip: 44606 country: France name: Damien Muller, Dr role: CONTACT phone: 02 72 27 89 89 email: dmuller.med@gmail.com lat: 47.28333 lon: -2.2 hasResults: False

 nctId: NCT06349538 id: 35-435 ex 22/23 briefTitle: Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor overallStatus: ENROLLING_BY_INVITATION date: 2024-04-04 date: 2026-04-30 date: 2034-04-30 date: 2024-04-05 date: 2024-04-16 name: Medical University of Graz class: OTHER briefSummary: The goal of this observational study is to learn about epidemiology, biologic markers, disease subtypes and possible prognostic factors in essential tremor (ET) patients. The main question\[s\] it aims to answer are:

* The prevalence of ET-plus compared to ET in a prospectively collected ET population.
* To assess in detail the heterogenous group of ET patients using comprehensive clinical (motor and non-motor scales, questionnaires), imaging \[magnetic resonance imaging (MRI), sonography of substantia nigra and cerebral vessels\], neurophysiological (tremor analysis, digital spiral drawing) and laboratory markers (sGFAP, sNfL, routine laboratory parameters).
* To assess possible non-invasive markers of neurodegeneration in ET patients (optic coherence tomography, alpha-synuclein in olfactory mucosa)

Participants will be asked to undergo the above mention evaluation at baseline and at follow-up approx. 5 years later.

Researchers will compare the findings within the ET group to independently existing cohorts of healthy controls and/or patients with other movement disorders like Parkinson's disease. conditions: Essential Tremor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab. measure: Prevalence of ET-plus measure: Age of ET patients measure: Sex of ET patients measure: Family history measure: Symptom leading to ET-plus classification measure: current and former medication for essential tremor measure: subjective disease course of ET measure: responsivity to alcohol measure: presence of cardiovascular risk factors measure: MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease Rating Scale) parts I-IV measure: modified Essential Tremor Rating Assessment Scale (mTETRAS) measure: Scale for the assessment and rating of ataxia (SARA) measure: Verbal fluency animals (part of the CERAD-plus test battery) measure: Boston Naming Test (part of the CERAD-plus test battery) measure: Mini Mental State Examination Test (MMSE; part of the CERAD-plus test battery) measure: word list learning (part of the CERAD-plus test battery) measure: constructive praxis (part of the CERAD-plus test battery) measure: word list recall (part of the CERAD-plus test battery) measure: word list recognition (part of the CERAD-plus test battery) measure: constructive praxis recall (part of the CERAD-plus test battery) measure: Trail Making Test A (part of the CERAD-plus test battery) measure: Trail Making Test B (part of the CERAD-plus test battery) measure: s-words (part of the CERAD-plus test battery) measure: Frontal Assessment Battery (FAB) measure: Geriatric Depression Scale (GDS) measure: Hospital Anxiety and Depression Scale (HADS) measure: Non-Motor Symptoms Scale for Parkinson's Disease (NMSS) measure: RBD Screening Questionnaire measure: Global Physical Activity Questionnaire (GPAQ) measure: Quality of Life in Essential Tremor Questionnaire (QUEST) measure: University of Pennsylvania Smell Identification Test (UPSIT) measure: Montreal Cognitive Assessment (MOCA) measure: Auditory verbal learning test measure: Symbol Digit Modalities Test (SDMT) measure: Brief Visuospatial Memory Test measure: Comprehensive trail making test 4 measure: Comprehensive trail making test 5 measure: Regensburg word fluency test measure: EQ-5D measure: resilience scale (RS-13) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Digital Spiral Drawing measure: Schellong Test measure: serum glial fibrillary acidic protein (sGFAP) measure: serum neurofilament light (sNfL) measure: Transcranial sonography measure: tremor analysis measure: cerebral MRI measure: cerebral MRI measure: cerebral MRI measure: cerebral MRI measure: cerebral MRI measure: cerebral MRI measure: optic coherence tomography (OCT) measure: optic coherence tomography (OCT) measure: optic coherence tomography (OCT) measure: optic coherence tomography (OCT) measure: Olfactory mucosa swab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz city: Graz zip: 8036 country: Austria lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06349525 id: DU-2021-00103 briefTitle: Retention of Telescopic Versus Locator Attachments overallStatus: COMPLETED date: 2021-04-01 date: 2023-07-05 date: 2023-10-01 date: 2024-04-05 date: 2024-04-09 name: Delta University for Science and Technology class: OTHER briefSummary: Forty patients ( 24female and16 male )with completely edentulous maxilla and mandible . All patients received implant supported mandibular and maxillary overdentures. The patients were randomly divided into two groups according to attachments retaining Max IOD that supported by four axial implants in maxilla . The TA was used to retain group I (GrI) MaxIOD , while that of group II (Gr II) was retained by LA. MaxIOD retention and MBL(vertical and horizontal) around implants of both groups was recorded at time of insertion (R0) ,then twelve(R12)and (R24) months following insertion of the prosthesis. conditions: Jaw, Edentulous studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: telescopic overdenture name: Locator overdenture measure: Retention measure: Marginal bone loss sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Delta University for Science & Technology city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06349512 id: IC 2022-07 id: 2023-507860-37-00 type: CTIS briefTitle: 68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT) acronym: FAP-IT overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2027-07-30 date: 2027-07-30 date: 2024-04-05 date: 2024-04-05 name: Institut Curie class: OTHER briefSummary: Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC. conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC. primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: 68Ga-FAPI-46 PET/CT imaging measure: Area under the ROC curve measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances measure: Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349499 id: CIIPCL-AMD-MAG-23 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-05 date: 2024-04-05 name: [Redacted] hasResults: False

 nctId: NCT06349486 id: KMUHIRB-F(II)-20230179 briefTitle: Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication overallStatus: RECRUITING date: 2023-11-28 date: 2026-12-31 date: 2026-12-31 date: 2024-04-05 date: 2024-04-05 name: Kaohsiung Medical University class: OTHER briefSummary: 1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments. conditions: Helicobacter Pylori Eradication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. bismuth-amoxicillin-vonoprazan triple therapy
2. vonoprazan-amoxicillin dual therapy
3. proton pump inhibitor-based standard triple therapy primaryPurpose: TREATMENT masking: NONE count: 780 type: ESTIMATED name: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate name: vonoprazan, amoxicillin name: rabeprazole, amoxicillin, clarithromycin measure: the eradication rate of Helicobacter pylori measure: genotype analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Hospital status: RECRUITING city: Kaohsiung zip: 807 country: Taiwan name: Deng-Chyang Wu, MD,PHD role: CONTACT phone: 886-7-3121101 phoneExt: 7451 email: dechwu@yahoo.com lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06349473 id: SR604-1 briefTitle: A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B) overallStatus: RECRUITING date: 2024-04-15 date: 2025-09-27 date: 2025-09-27 date: 2024-04-05 date: 2024-04-23 name: Equilibra Bioscience LLC class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with severe Hemophilia A or Hemophilia B, with or without inhibitors (Part B). conditions: Healthy Participants conditions: Hemophilia A conditions: Hemophilia B studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: SR604 name: Placebo measure: Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) measure: Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations Markers measure: Part A: Area Under the Serum Concentration-time Curve from time Zero to the Last Quantifiable Time Point (AUC[0-t]) measure: Part A: Area Under the Serum Concentration-time Curve from time Zero Extrapolated to Infinity (AUC[0-inf]) measure: Parts A and B: Maximum Concentration (Cmax) of SR604 measure: Parts A and B: Time to Maximum Concentration (tmax) of SR604 measure: Parts A and B: Terminal Half-life (T1/2) of SR604 measure: Part A: Clearance Following Extravascular Administration (CL/F) of SR604 measure: Part A: Volume of Distribution in Terminal Phase Following Extravascular Administration (Vz/F) of SR604 measure: Parts B: Concentration before the next dose administration (Ctrough) measure: Parts B: Area Under the Serum Concentration-time Curve within One Dosing Interval (AUCtau) measure: Parts B: Accumulation Ratio (R) of SR604 measure: Parts B: Number of Bleeding Events measure: Parts B: Annualized Bleeding Rate (ABR) in Body and Targeted Joints measure: Parts A and B: Number of Participants with Positive Antidrug Antibodies (ADAs) sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: California Clinical Trials Medical Group (CCTMG) status: RECRUITING city: Glendale state: California zip: 91206 country: United States name: Esther Yoon, M.D. role: PRINCIPAL_INVESTIGATOR lat: 34.14251 lon: -118.25508 hasResults: False

 nctId: NCT06349460 id: STU00216998 id: R01DK133300 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK133300 briefTitle: A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors overallStatus: RECRUITING date: 2024-03-21 date: 2026-09-30 date: 2026-12-31 date: 2024-04-05 date: 2024-04-05 name: Northwestern University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence. conditions: Binge Eating conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: In this micro-randomized trial, participants will have 2 consecutive, independent micro-randomizations at the time of target selection each week for 16 weeks: namely, 1 of 5 treatment targets will be randomly delivered, either as a recommended or assigned target, to each user, of equal probability per randomization. primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: FoodSteps behavioral intervention measure: Weekly change in binge eating sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University Feinberg School of Medicine status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Andrea K Graham, PhD role: CONTACT phone: 312-503-5266 email: andrea.graham@northwestern.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06349447 id: KY2021-771 briefTitle: Pilot Study of LED for PIE and PIH overallStatus: RECRUITING date: 2024-04-10 date: 2024-05-10 date: 2024-06-01 date: 2024-04-05 date: 2024-04-05 name: Yanjun Dan class: OTHER briefSummary: The aim of this study is to explore the effect of medical LEDs (830 nm and 590 nm) in the prevention and treatment of PIE and PIH. conditions: Hyperpigmentation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 308 nm LED light was utilized to induce an vivo PIE/PIH model on the thigh of subjects. The irradiation dose was 1.5 MED. Five circular experimental lesions measuring 1.5 × 1.5 cm were selected on the thighs, categorizing into five groups: control group, 830 nm LED treatment group, 590 nm LED treatment group, 830 nm LED prevention group and 590 nm LED prevention group. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: LED name: without any LED exposition measure: melanin index measure: erythema index measure: transepidermal water loss (TEWL) measure: elasticity sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huashan Hospital status: RECRUITING city: Shanghai country: China name: Yanjun Dan role: CONTACT phone: +86 159 0194 0897 email: danyanjun@126.com name: Leihong Xiang role: CONTACT phone: +86 13818252671 email: flora_xiang@vip.163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06349434 id: R-1215-23 briefTitle: The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI overallStatus: RECRUITING date: 2023-10-15 date: 2028-10-01 date: 2028-10-01 date: 2024-04-05 date: 2024-04-15 name: Kessler Foundation class: OTHER briefSummary: To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study. conditions: SCI - Spinal Cord Injury conditions: Upper Extremity Dysfunction conditions: Upper Extremity Problem studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Randomized Clinical Trial primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: MyoMo name: conventional therapy measure: GRASSP measure: Range of motion of hands and arms measure: Muscle strength measurement measure: Spasticity measurement measure: Brain signals measurement measure: CUE-Q sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kessler Foundation status: RECRUITING city: West Orange state: New Jersey zip: 07052 country: United States name: Ghaith J Androwis, Ph.D. role: CONTACT phone: 201-968-6110 email: gandrowis@kesslerfoundation.org lat: 40.79871 lon: -74.23904 hasResults: False

 nctId: NCT06349421 id: 202401078RINE briefTitle: Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-05-31 date: 2024-10-31 date: 2024-04-05 date: 2024-04-05 name: National Taiwan University Hospital class: OTHER briefSummary: Bone quality stands as a crucial determinant impacting the success rate of dental implants, exerting influence on both implant primary stability and the efficacy of osseointegration. While radiographic images can partially reveal bone quality, experienced surgeons often rely on tactile sensation during bone drilling to assess it. Subsequently, based on the diagnosed bone quality, distinct implant designs and surgical protocols have been invented to enhance survival rates.

Technological advancements now enable the preoperative design of implant placement through a comprehensive guide, merging CBCT DICOM files with digital oral scanning data. This "fully guided" approach enhances the precision, stability, and safety of implant placement surgery. However, the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeon's tactile feedback.

This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide, using test blocks of different bone density. The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment. conditions: Dentistry conditions: Education studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED measure: VAS scale at the same density of sawbone sex: ALL minimumAge: 24 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06349408 id: CIBI3001A101 briefTitle: IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2026-05-30 date: 2027-05-30 date: 2024-04-05 date: 2024-04-05 name: Innovent Biologics (Suzhou) Co. Ltd. class: INDUSTRY briefSummary: This is a Phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. It includes a Phase 1 section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3001, and a Phase 2 section to explore and confirm the efficacy, safety and tolerability of IBI3001 at its RP2D. conditions: Locally Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: IBI3001 measure: Number of subjects with adverse events measure: Number of subjects with clinically significant changes in physical examination results measure: Number of subjects with clinically significant changes in vital signs measure: MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs) measure: Plasma concentration (Cmax) of IBI3001 measure: Area under the curve (AUC) of IBI3001 measure: Time to maximum concentration (Tmax) of IBI3001 measure: Clearance (CL) of IBI3001 measure: Volume of distribution (V) of IBI3001 measure: Half-life (T1/2) of IBI3001 measure: Immunogenicity of IBI3001 measure: Objective response rate (ORR) measure: Duration of response (DoR) measure: Disease control rate (DCR) measure: Time to response (TTR) measure: Progression free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wollongong Public city: Wollongong state: New South Wales zip: 2500 country: Australia name: Daniel Brungs role: CONTACT email: Daniel.brungs@health.nsw.gov.au lat: -34.424 lon: 150.89345 hasResults: False

 nctId: NCT06349395 id: NisantasiU briefTitle: The Effect of Mindfulness-Based Stress Reduction Training Before Mastectomy on Postoperative Pain in Early Period overallStatus: RECRUITING date: 2023-05-01 date: 2024-06-29 date: 2024-07-29 date: 2024-04-05 date: 2024-04-05 name: Istanbul Nisantasi University class: OTHER briefSummary: This research aims to investigate the effect of mindfulness-based stress reduction training given before mastectomy on postoperative early period pain and the fear of movement caused by pain. According to the World Health Organization, 18.1 million new cancer diagnoses are made each year, with breast cancer being the most common type among women, accounting for 24.2% of all cancers diagnosed. In Turkey, the incidence of breast cancer was determined as 22,345 in 2018. Breast cancer significantly affects women's quality and length of life. Surgical intervention is the most commonly chosen treatment method for cases of localized breast cancer. Pain and limited movement are among the most common problems encountered after surgery. Non-pharmacological methods have been shown to be effective in pain management, with the mindfulness-based stress reduction technique being one of these methods. This technique is described as an effective treatment for conditions such as pain, depression, and addiction, with high levels of mindfulness being associated with greater self-esteem, optimism, and empathy, whereas low levels of mindfulness are linked to depression, anxiety, chronic pain, and acute pain. conditions: Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 parallel groups randomized controlled study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: MBSR surgical nursing care measure: Visual analog scale measure: The Tampa Scale of Kinesiophobia sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa status: RECRUITING city: Istanbul zip: 34160 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06349382 id: CALAS briefTitle: CArbohydrate Loading in Aortic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-11-01 date: 2024-04-05 date: 2024-04-08 name: University of Belgrade class: OTHER briefSummary: The adverse effects of overnight fasting before surgery have been well-documented in the contemporary literature. Still, due to the possibility of pulmonary aspiration of gastric contents, many clinicians worldwide still employ this practice. On the other hand, the benefits of preoperative oral carbohydrate loading (OCHL) have been shown in various patient groups. Studies examining the usefulness of preoperative OCHL in aortic surgery are lacking. In particular, no randomized control trials have specifically examined the impact of preoperative OCHL on the postoperative course in patients undergoing open abdominal aortic surgery. conditions: Abdominal Aortic Aneurysm conditions: Leriche Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to receive preoperative OCHL (the experimental group) or no intervention (the control group) in a 1:1 ratio. Randomization will be performed using computer-generated randomization codes, which will be held in sealed envelopes. Patients in the experimental group (OCHL group) will receive a high-carbohydrate beverage (12.6% carbohydrates, 50 kcal/100 mL, 285 mOsm/kg; PreOp®, Nutricia, Zoetermeer, The Netherlands) 800 mL on the evening before surgery (between 9 p.m. and 11 p.m.), and 400 mL 2 hours before the induction of anesthesia. Participants in the no-intervention (control) group will be fasted from midnight until surgery. All other aspects of perioperative patient care will be the same for all participants, as per the standardized Institutional protocol for the treatment of abdominal aortic aneurysms and Leriche Syndrome. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: carbohydrate-rich beverage measure: The ICU length of stay measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measure: Insulin sensitivity index (HOMA-ISI) measure: Homeostasis model assessment of β-cell function (HOMA-β) measure: Six aspects of subjective well-being according to the visual analog scale measure: Length of hospital stay measure: 30-day mortality rate measure: The incidence of local wound infections measure: The incidence of postoperative surgical complications measure: The incidence of postoperative non-surgical complications sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia city: Belgrade zip: 11000 country: Serbia name: Igor Koncar, MD, Ph.D. role: CONTACT phone: +381668300290 email: dr.koncar@gmail.com name: Igor Koncar, MD, Ph.D. role: SUB_INVESTIGATOR name: Ksenija Jovanovic, MD, Ph.D. role: SUB_INVESTIGATOR name: Ranko Trailovic, MD role: SUB_INVESTIGATOR lat: 44.80401 lon: 20.46513 hasResults: False

 nctId: NCT06349369 id: PG Thesis/2023-24/105 briefTitle: Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia acronym: tDCS overallStatus: RECRUITING date: 2024-04-08 date: 2025-12-09 date: 2026-04-09 date: 2024-04-05 date: 2024-04-25 name: All India Institute of Medical Sciences, Bhubaneswar class: OTHER briefSummary: The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia over 10 days of treatment. The primary objective is to assess changes in IL-6 levels, while secondary objectives include evaluating changes in TNF-alpha, symptom scales, and adverse events. The study will be conducted at the psychiatry department of AIIMS Bhubaneswar, with 60 patients aged 18-60 years with moderate-to-severe schizophrenia symptoms randomized to receive either active tDCS (cathode over left temporo-parietal junction, anode over left dorsolateral prefrontal cortex) or sham stimulation. The researchers hope to elucidate the potential immunomodulatory effects of tDCS and its impact on symptoms in chronic schizophrenia, which may lead to more targeted, multifaceted interventions to improve patient outcomes. conditions: Chronic Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: transcranial direct current stimulation measure: Change in the IL-6 levels measure: Change in the TNF alpha levels. measure: Change in the Positive and Negative syndrome Scale measure: Change in the Auditory hallucination rating scale measure: Change in the Clinical global impression- Schizophrenia scale measure: Change in the Global Assessment of Functioning scale measure: To compare the adverse events reported in both control and intervention groups. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: AIIMS Bhubaneswar status: RECRUITING city: Bhubaneswar state: Odisha zip: 751019 country: India name: Ashutosh Biswas role: CONTACT lat: 20.27241 lon: 85.83385 hasResults: False

 nctId: NCT06349356 id: FDACSTIM0012023 id: IRB00000533 type: OTHER domain: WCG IRB briefTitle: Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease" overallStatus: RECRUITING date: 2023-03-28 date: 2024-09-30 date: 2024-12-31 date: 2024-04-05 date: 2024-04-08 name: Quantel Medical class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of C.STIM, an intense pulsed light device to treat signs and symptoms of dry eye disease. The main question it aims to answer is:

• Difference of the evolution of Tear Break-Up time (TBUT) between the 2 arms of the study (placebo and treated).

Researchers will compare treated group and placebo to respond to the main question.

Participants will assess to an inclusion visit (disease evaluation purpose) and then four IPL treatment visit to finish with the last visit (disease evaluation purpose). conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SHAM-CONTROLLED, SUPERIORITY, NON-SIGNIFICANT RISK primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Intense pulsed light with C.STIM device measure: Tear Break-Up Time evolution measure: dry eye signs and symptoms measure: dry eye signs and symptoms measure: dry eye signs and symptoms measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Meibum quality measure: Meibum Expressibility measure: Use of artificial tear drops measure: Use of artificial tear drops measure: Glaucoma sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Visionary Consultants Inc. status: RECRUITING city: Lexington state: Kentucky zip: 40517 country: United States name: Dr. KARPECKI role: CONTACT phone: 463-210-6618 email: karpecki@karpecki.com lat: 37.98869 lon: -84.47772 facility: Triangle Eye Consultants status: ACTIVE_NOT_RECRUITING city: Raleigh state: North Carolina zip: 27617 country: United States lat: 35.7721 lon: -78.63861 facility: Toyos Clinic status: RECRUITING city: Nashville state: Tennessee zip: 37215 country: United States name: Dr. TOYOS role: CONTACT phone: 615-327-4015 email: rostar80@gmail.com lat: 36.16589 lon: -86.78444 facility: Eye Centers of Racine & Kenosha status: RECRUITING city: Kenosha state: Wisconsin zip: 53142 country: United States name: Dr SINGH role: CONTACT phone: 312-371-4335 email: ipsingh@amazingeye.com lat: 42.58474 lon: -87.82119 hasResults: False

 nctId: NCT06349343 id: UHCT230949 briefTitle: CD19/BCMA HLA-independent TCR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2026-01 date: 2024-04-05 date: 2024-04-05 name: Wuhan Union Hospital, China class: OTHER briefSummary: The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) human leukocyte antigen (HLA)-independent T cell receptor (TCR) -T therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE). conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: CD19/BCMA Hi-TCR-T cell therapy measure: Safety and tolerability measure: Proportion of subjects with SRI-4 response measure: Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline measure: Changes in the BILAG-2004 score from baseline measure: Changes in the Physician Global Assessment (PGA) score from baseline measure: Pharmacokinetics (PK) measure: Pharmacodynamics (PD) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349330 id: 2022/00908 briefTitle: The Immediate Effectiveness of a 3D Intraoral Scanner as an Oral Hygiene Educational Tool acronym: 3D scanner overallStatus: RECRUITING date: 2023-11-07 date: 2024-07-31 date: 2024-07-31 date: 2024-04-05 date: 2024-04-24 name: National University Hospital, Singapore class: OTHER briefSummary: The goal of this randomized controlled clinical trial is to compare the immediate effectiveness of 3D intra-oral scanners and standard oral hygiene instructions in improving the oral hygiene of 52 subjects. The main question\[s\] it aims to answer are:

* Does a 3D intra-oral scanner facilitate the improvement of oral hygiene in subjects?
* Does a 3D-rendered image of plaque-stained teeth confer better visualization to subjects?

Prospective Open Cohort study: Patients referred to NUCOHS Periodontology Department will be invited to participate in the study. Included participants will be randomized into the 3D scanner (test) and standard oral hygiene (control) group. Subsequently, both groups will receive personalized oral hygiene instructions before brushing their teeth. The participants will receive plaque disclosing again to compare the differences between baseline and post-intervention.

Routine periodontal parameters will be recorded at baseline and researchers will compare the percentage improvement in full mouth plaque scores to see if the test group performed better than the control group.

A questionnaire will be given to subjects in the test and control group for qualitative analysis.

The study will require 1 visit. conditions: Periodontal Diseases conditions: Plaque Induced Gingival Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a parallel-arm randomized controlled trial and subjects are randomized into test and control groups via block randomization.

To investigate the immediate effectiveness on the use of 3D intraoral scanner in the improvement of oral hygiene in two (2) parallel arm study with 52 subjects (n=52). The study will take place over 1 visit. primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 52 type: ESTIMATED name: Test: 3D intra-oral scanner name: Control: Standard oral hygiene measure: Full mouth plaque score (%) measure: Patient's satisfaction of 3D scanner and standard oral hygiene group based on 5-point Likert Scale sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University Hospital, Singapore status: RECRUITING city: Singapore country: Singapore name: Xiao Tong, Jacinta Lu, BDS role: CONTACT phone: 6716 2233 email: jacinta_lu@nuhs.edu.sg name: Xiao Tong, Jacinta Lu, MDS role: PRINCIPAL_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06349317 id: 2024-005 briefTitle: Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-06 date: 2024-04-05 date: 2024-04-05 name: Yongyi Zeng class: OTHER briefSummary: This study is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib measure: 1-year Event-Free Survival (EFS) rate measure: Event-Free Survival (EFS) measure: Overall Survival (OS) measure: Disease-Free Survival (DFS) measure: R0 resection rate measure: Overall Objective Response of primary liver tumor and PVTT measure: Surgical safety measure: Safety of radiotherapy, camrelizumab and apatinib treatment measure: Exploratory Endpoints sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349304 id: S25 briefTitle: Impact of Grape Powder Consumption on Eye Health and Glycemic Status in Singapore Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-08-01 date: 2025-08-01 date: 2024-04-05 date: 2024-04-05 name: National University of Singapore class: OTHER name: California Table Grape Commission briefSummary: The purpose of this study is to understand the impacts of regular consumption of freeze-dried table grape powder on eye health and regulation of advanced glycation end products in Singapore older adults. The investigators hypothesize that regular consumption of freeze-dried table grape powder will promote improvements in eye health and lower levels of advanced glycation end products when compared to the placebo group. conditions: Macula; Degeneration conditions: Aging conditions: Advanced Glycation End Products studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Freeze-dried table grape powder name: Placebo grape powder measure: Macular pigment optical density measure: Visual acuity measure: Photostress recovery time measure: Visual function questionnaire 25 measure: Skin advanced glycation end products levels measure: Dietary advanced glycation end products level measure: Blood advanced glycation end products levels measure: Contrast sensitivity measure: Concentration of tumour necrosis factor-α measure: Concentration of interleukin-6 measure: Concentration of high-sensitivity C-reactive protein measure: Concentration of fasting blood glucose measure: Concentration of malondialdehyde measure: Concentration of 8-isoprostaglandin-F2α measure: Skin carotenoid status measure: Concentration of insulin measure: Percentage of glycated hemoglobin measure: Measurement of height measure: Measurement of blood pressure measure: Measurement of weight measure: Measurement of waist circumference sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349291 id: 0074-24-MMC briefTitle: Venous Thrombosis After Removal of Central Venous Catheter overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08-01 date: 2025-08-01 date: 2024-04-05 date: 2024-04-05 name: Meir Medical Center class: OTHER briefSummary: Insertion of intravenous catheter is a very common operation in patients in the general intensive care unit. These catheters are used for a variety of purposes - administration of inotropics/pressors, intravenous nutrition, concentrated electrolytes and performing dialysis.There are several known complications of central venous catheter insertion, such as thrombosis and pulmonary embolism. In a literature review, there are no clear data regarding the rate of intravenous thrombosis in patients after removal of a central venous catheter. These findings are often discovered randomly, when the patient undergoes imaging for a different indication. There is no recommendation for an active search for intravenous thrombi at the catheter insertion sites in these patients, and it is not entirely clear whether it is mandatory to administer anticoagulant treatment in these patients if thrombi are randomly discovered at the catheter insertion sites.

In this study, we aim to check the proportion of patients who developed thrombosis at the central catheter insertion sites after its removal, to check whether there are catheter insertion sites that are at a higher risk of developing thrombosis than other sites, and to check whether there are predictive characteristics for the development of this type of thrombosis. conditions: Thrombosis, Venous studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Detection of venous thrombosis via US measure: Rate of DVT after removal of central venous catheter sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Meir Medical Center city: Kfar Saba country: Israel lat: 32.175 lon: 34.90694 hasResults: False

 nctId: NCT06349278 id: 2024-7276 briefTitle: Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX acronym: PDAC-LIV overallStatus: RECRUITING date: 2024-01-16 date: 2026-01-16 date: 2029-01-16 date: 2024-04-05 date: 2024-04-16 name: Laval University class: OTHER briefSummary: This is a prospective, pilot study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough, standard of care assessment for both pancreatic primary and liver metastases resectability with blood tumor markers (CEA, CA 19-9 and CA-125), triphasic CT-scan and liver magnetic resonance imaging (MRI), patients with resectable pancreatic ductal adenocarcinoma primary and three or less resectable liver metastases will be prospectively included in the study. PET-scan may be added to the investigation depending on CT-scan or MRI results to prove metastatic disease or rule out extrahepatic metastases. Patients will receive a total of 12 cycles of perioperative FOLFIRINOX (FFX), with first reassessment with triphasic CT-scan to monitor tumor response after the first six cycles. Every patient will receive at least 6 cycles of FFX before surgery. The remaining six cycles will be received either preoperatively or postoperatively, depending on patient tolerance and tumor response at reassessment. Patients with liver metastases only visible on MRI will also have liver MRI at reassessment, which is also standard of care. Patients with evidence of tumor response on both imaging using RECIST V.1.1 criteria (stable disease or partial response), and blood tumor markers (≥ 80% decrease and/or normalization of all tumor markers) will then undergo pancreatic resection, either distal pancreatectomy or pancreatoduodenectomy depending on tumor side, with liver metastases excision. Each case will be followed with blood tumor markers and CT-scan every three months for two years, and every four months afterwards or until recurrence, which is standard of care for patients with metastatic PDAC. For patients without evidence of tumor response on imaging, or \< 80% decrease of all tumor markers, the standard palliative systemic treatment will be continued. conditions: Pancreas Adenocarcinoma conditions: Pancreas Metastases conditions: Pancreas Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One group will undergo intervention prospectively. primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Pancreatic resection and non-anatomic liver resections. measure: Morbidity and mortality measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Québec status: RECRUITING city: Quebec City state: Quebec zip: G1R 2J6 country: Canada name: Alexandre Brind'Amour role: CONTACT phone: +14185254444 phoneExt: 15925 email: godonco@chudequebec.ca name: Jean-François Ouellet, MD role: SUB_INVESTIGATOR name: Jean-François Berthin Ouellet, MD role: SUB_INVESTIGATOR name: Isabelle Deshaies, MD role: SUB_INVESTIGATOR name: Carl Daigle, MD role: SUB_INVESTIGATOR name: Félix Couture, MD role: SUB_INVESTIGATOR name: Maxime Chénard-Poirier, MD role: SUB_INVESTIGATOR name: Anne-Julie Simard role: SUB_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06349265 id: 02 briefTitle: Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome overallStatus: COMPLETED date: 2023-10-02 date: 2024-02-02 date: 2024-03-02 date: 2024-04-05 date: 2024-04-05 name: Kastamonu University class: OTHER briefSummary: This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models. conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 33 type: ACTUAL name: Carpal Tunnel Hydrodissection with %5 dextrose in water injection measure: Visual Analogue Scale(VAS) measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) measure: Dolour Neuropathique en 4 Questions (DN4) questionnaire sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gamze Gül Güleç city: Kastamonu zip: 37150 country: Turkey lat: 41.37805 lon: 33.77528 hasResults: False

 nctId: NCT06349252 id: LUNGTNM briefTitle: Survival Validation and Gene Mutations of N Descriptors in the Ninth Edition of the TNM Classification for Lung Cancer overallStatus: RECRUITING date: 2021-01-01 date: 2024-08-01 date: 2025-01-01 date: 2024-04-05 date: 2024-04-05 name: Fudan University class: OTHER briefSummary: The International Association for the Study of Lung Cancer Staging Committee recently unveiled the ninth edition of TNM staging system for lung cancer. This study aims to explore survival outcomes, stage grouping, and gene mutations in N descriptors of this new classification system. conditions: Non-small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1263 type: ESTIMATED name: Radical resection measure: Overall Survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Chen Haiquan, MD role: CONTACT phone: +86-21 64175590 phoneExt: 1707 email: hqchen1@yahoo.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06349239 id: 24Hemato01 briefTitle: Oral Azacitidine Maintenance Post-CPX 351 acronym: ORAZ-351 overallStatus: RECRUITING date: 2020-01-01 date: 2025-01-01 date: 2025-01-01 date: 2024-04-05 date: 2024-04-05 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Approximately 10% of patient develop AML after chemotherapy or radiation for unrelated disease (t-AML) and 20% have AML with an antecedent hematologic disorder (AML-MRC). CPX-351 (Vyxeos), a liposomal formulation of a fixed molar ratio (1:5) daunorubicin and cytarabine, has been approved for treatment of adults with newly diagnosed t-AML or AML-MRC. CPX-351 significantly improved median overall survival.

Although induction chemotherapy results in remission in many older patients with AML, relapse is common and overall survival is poor. For patients not eligible for HSCT, maintenance therapies are needed to reduce the risk of relapse and prolong overall survival without causing undue adverse effects or compromising health-related quality of life. Oral azacitidine (ONUREG) has been approved by FDA on September, 2020, to treat adult patients with AML who achieved CR or CRi following intensive induction chemotherapy with or without consolidation and who are not able to complete intensive curative therapy (not candidate to HSCT).

The use of oral azacitidine maintenance is an integral part of clinical practice for AML patients who have achieved a first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after intensive ""3+7"" induction chemotherapy and who are unable to complete intensive curative therapy.

But there are few data on its efficacy as a post-CPX-351 maintenance agent in patients with newly diagnosed t-AML or AML-MRC or de novo AML.THe aim of this study is to show the improvement of overall survival with use of oral Azacitidine as maintenance for patients with de novo AML including t-AML or AML-MRC who achieved complete remission or complete remission with incomplete blood count recovery after CPX-351. Long-term product safety is also being studied conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: overall survival measure: Safety and tolerance sex: ALL minimumAge: 64 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Nice status: RECRUITING city: Nice country: France name: CLUZEAU thomas role: CONTACT lat: 43.70313 lon: 7.26608 hasResults: False

 nctId: NCT06349226 id: DISCOLAB briefTitle: Identification of Biomarkers and Molecular Targets Involved on Intervertebral Disc Degeneration and Discogenic Pain overallStatus: RECRUITING date: 2018-05-22 date: 2025-05-21 date: 2025-05-21 date: 2024-04-05 date: 2024-04-05 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Low back pain, associated with intrinsic disorders of the spine, is a very frequent clinical condition that is accompanied by high morbidity with effects both on psychosocial aspects, and health care system. It occurs in approximately 80% of the population throughout their lives. Most low back pain is associated with intervertebral disc degeneration (IDD) associated with neuroinflammation and pain. In this context, the study of sphingolipid metabolism can play an important role in the identification of new molecules responsible for the degenerative process. Sphingolipids, in fact, are a class of molecules that are implicated in multiple signal pathways, such as proliferation, degradation of the extracellular matrix, inflammatory state, apoptosis and migration. In particular, sphingosine-1-phosphate (S1P), an intermediate of sphingolipid metabolism, acts as a pro-inflammatory mediator, predominantly in the extracellular environment, regulating important cellular properties related to inflammatory potential and pain. The objective of this study is to characterize the degenerative process in cells isolated from degenerated human intervertebral discs from both at cellular and molecular levels in order to identify new targets implicated in degenerative processes, including sphingolipid signaling pathway. conditions: Intervertebral Disc Degeneration conditions: Discogenic Pain conditions: Discogenic Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 160 type: ESTIMATED name: cell isolation from intervertebral disc tissue and biomarker investigation measure: Characterization of degenerated intervertebral disc cells measure: Development of cellular model platform sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Giovanni Marfia, MD, Phd role: CONTACT phone: 0255035502 phoneExt: +39 email: giovanni.marfia@policlinico.mi.it name: Stefania E Navone, PhD role: CONTACT phone: 0255034268 phoneExt: +39 email: stefania.navone@policlinico.mi.it name: Mauro Pluderi, MD role: PRINCIPAL_INVESTIGATOR name: Giovanni Marfia, MD, PhD role: SUB_INVESTIGATOR name: Stefania E Navone, PhD role: SUB_INVESTIGATOR name: Laura Guarnaccia, PhD role: SUB_INVESTIGATOR name: Laura Begani, MSc role: SUB_INVESTIGATOR name: Marco Locatelli, MD, PhD role: SUB_INVESTIGATOR name: Stefano Borsa, MD role: SUB_INVESTIGATOR name: Giulio Bertani, MD role: SUB_INVESTIGATOR name: Claudia Fanizzi, MD role: SUB_INVESTIGATOR name: Giorgio Fiore, MD role: SUB_INVESTIGATOR name: Luigi Schisano, MD role: SUB_INVESTIGATOR name: Manuela Caroli, MD role: SUB_INVESTIGATOR name: Antonella Ampollini, MD role: SUB_INVESTIGATOR name: Elena Pirola, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06349213 id: C23-19 id: 2023-A02263-42 type: OTHER domain: Secondary ID briefTitle: Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time acronym: TIMES overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-11-01 date: 2030-11-01 date: 2024-04-05 date: 2024-04-10 name: Institut National de la Santé Et de la Recherche Médicale, France class: OTHER_GOV briefSummary: Time processing, the ability to process and encode temporal information, is essential for cognitive functioning and for a large number of daily life activities. In particular, the processing of durations of several seconds is central to cognition, impaired in several pathologies, and has been associated with cognitive changes with advancing age. While behavioral studies have been conducted to specify the neural bases of temporal cognition and their association with other cognitive functions, the mechanisms underlying age-related changes, and individual differences, remain unknown. The project will characterize ageing effects on timing mechanisms and their neural underpinnings. Building on recent advances from neuroscience and age-related cognitive changes, the project focuses on the precision of duration processing, that declines with age, and the associated neural bases. Participants will perform a duration judgement task while (a) electroencephalography, and (b) functional magnetic resonance imaging activity are simultaneously recorded to investigate age effects on structural and functional network connectivity. In addition, striatal dopamine will be measured using a FDOPA PETscan. Evaluation of other temporal cognition processes and general cognition will also be performed. This combination offers a unique opportunity to accurately specifying the neurophysiological underpinning of aging effects on time processing changes. This project will further our understanding of the variability of cognitive performance with advancing age, and contribute to identifying new measures of temporal impairments. conditions: Healthy Aging studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 130 type: ESTIMATED name: FDOPA injection before PET imaging name: Time perception tasks name: fMRI imaging name: EEG imaging name: 3 year follow-up measure: EEG phase lag index differences between group sex: ALL minimumAge: 20 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349200 id: 3197 briefTitle: Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients overallStatus: RECRUITING date: 2024-03-27 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-12 name: Dow University of Health Sciences class: OTHER briefSummary: Many patients suffer from dental anxiety and don't go to dentists for regular checkups. This can lead to the initiation and progression of dental caries, which, if not controlled at the right time, can lead to the loss of the tooth itself. Many forms of distraction have been used to overcome this; music is also one of them. The main objective of this study is to compare the effectiveness of binaural beats and 432 Hz music in reducing preoperative dental unease and anxiety among adult patients undergoing root canal treatment in a dental teaching hospital. The null hypothesis is that both binaural beats and 432 Hz-frequency music are not effective in reducing preoperative dental anxiety among patients undergoing routine endodontic therapy in a dental teaching hospital. A total of three groups will be a part of this study, with a total sample size of 99 participants (33 participants in each group). Group A will listen to 432 Hz music for 10 minutes before the procedure, Group B will listen to binaural beats for 10 minutes before the procedure; and Group C (active control group) will listen to white noise for 10 minutes before the procedure. The Visual Analog Scale for Anxiety will be used to assess the anxiety levels before local anesthesia administration, after local anesthesia administration, and 10 minutes after listening to sounds. Then root canal treatment will be completed as a routine procedure. conditions: Dental Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 99 type: ESTIMATED name: 432 Hz music name: Binaural beats name: White noise measure: Change in Pre-operative Dental Anxiety score using Visual Analog Scale for Anxiety sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Dow University of Health Sciences status: RECRUITING city: Karachi state: Sindh zip: 74200 country: Pakistan name: Dr. Hafsa Zaki role: CONTACT phone: +923462746052 email: hafsazaki99@hotmail.com name: Dr. Shahbaz Ahmed role: CONTACT phone: +923212000873 email: saj119@googlemail.com lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06349187 id: dsc002 briefTitle: Digital Competencies of the Doctors overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-05-10 date: 2024-06-10 date: 2024-04-05 date: 2024-04-05 name: Limited Liability Company "Docstarclub" class: OTHER briefSummary: The role of digital technologies in healthcare is growing. Therefore, the roles and responsibilities of medical professionals are constantly changing and there is a need for continuous professional development. However, according to some authors, today's generation of doctors can be considered as "digital aborigines" \[Aungst, Patel, 2020\]. Low literacy in the field of e-health has become a major obstacle to digital transformation in developed countries, so digital skills training for healthcare professionals has gradually been introduced in the USA \[Adler-Milstein, et al., 2014\], Europe \[Schreiweis, et al., 2019\], Australia \[Evolution of eHealth in Australia, 2016\].

The most common methodologies for determining a doctor's digital literacy level are HITCOMP and TIGER. In particular, HITCOMP includes 5 areas of expertise: administration, research/biomedicine, direct patient care, computer science, engineering/information systems/information and communication technologies, as well as several levels: basic, basic, intermediate, advanced, expert \[EU\*US eHealth Work Project, 2020\].

However, in our opinion, the digital competence of a doctor is not only the ability to work at a computer and use software. The successful development of the digital world is preceded by some psychological and emotional processes.

It all starts with digital trust, that is, with people's confidence in the reliability and security of digital systems, processes and technologies. Without the conviction that the implementation and active use of certain IT services will be useful and will not bring harm, the successful launch of such technologies will be impossible.

Provided that there is digital trust, a person in his daily life gradually gets experience using various technologies: payments, appointments with specialists, purchases, etc. Thus, basic digital literacy appears in conjunction with the rules of behavior in the online space (digital culture). And only after that, having skills positively supported by experience, the doctor begins to master digital competencies in his workplace.

Computerization and automation of the healthcare system began relatively recently, traditional (paper) document management in medicine is familiar to everyone, but not optimal from the point of view of system management. Therefore, universal digitalization is perceived as something artificially imposed, increasing the workload of doctors, distracting from their main work and shifting the focus from truly therapeutic activities to filling out documentation. As a result, doctors have a range of negative emotions: fear, annoyance, anxiety, despondency, refusal of further contacts, etc., which lead to an aggravation of emotional burnout. The ability to recognize and live through these states, to come to an inner balance, to accumulate an internal resource for further development of new technologies - all this is possible under the condition of the development of emotional intelligence. By developing so-called soft skills, the doctor will be emotionally stable, capable of further advancement and learning new skills, and will easily cope with temporary difficulties and setbacks.

And the final stage, having gained the opportunity to overcome internal obstacles, the doctor is ready to begin mastering specialized digital skills directly related to medical activities: work in medical information systems, remote monitoring, artificial intelligence, medical decision support systems.

The result of the development of a doctor within this model will be not only digital literacy, but also the development of an internally stable personality that easily overcomes any obstacles not only in training, but also in communication with patients and colleagues. conditions: Digital Competences conditions: Emotional Intelligence conditions: Emotional Burnout conditions: Doctor Patient Relation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: Interview measure: Completing the survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349174 id: 2024-valve-1 briefTitle: Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: A Prospective Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2025-03-20 date: 2025-03-31 date: 2024-04-05 date: 2024-04-05 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:

Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?

Participants will:

undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.

receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery. conditions: Emphysema conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: bronchoscopic lung volume reduction surgery using endobronchial valve measure: Percentage change in FEV1 relative to baseline measure: Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators measure: Percentage change in RV relative to baseline measure: Percentage change in TLC relative to baseline measure: Percentage change in DLCO relative to baseline measure: Percentage change in SGRQ score relative to baseline measure: Percentage change in mMRC grade relative to baseline measure: Percentage change in 6MWD relative to baseline measure: the incidence of surgical-related adverse events sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital city: BeiJing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06349161 id: 1451_02/BVNTW-VNCSKTE briefTitle: Long-term Outcome of Retroperitoneoscopic One-trocar-assisted Pyeloplasty: A Single-center and Single-surgeon Experience overallStatus: COMPLETED date: 2011-05 date: 2013-06 date: 2024-03 date: 2024-04-05 date: 2024-04-05 name: National Children's Hospital, Vietnam class: OTHER briefSummary: Open surgical dismembered pyeloplasty has traditionally been the preferred method for treating ureteropelvic junction obstruction (UPJO), with a success rate exceeding 94%. However, it is associated with drawbacks such as increased postoperative pain, extended hospital stays, and visible scarring. Minimally invasive alternatives, including laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP), have gained popularity since their introduction in 1993, offering comparable success rates to open surgery while providing cosmetic benefits and shorter hospital stays. Nevertheless, these techniques present challenges in pediatric patients, including limited working space, technical complexities, and prolonged operative times. The retroperitoneoscopic one-trocar-assisted pyeloplasty (OTAP) method, introduced in 2007, combines the advantages of minimally invasive surgery with the success rates of standard dismembered pyeloplasty. Despite favorable outcomes reported by several researchers, comprehensive studies regarding long-term follow-up and clinical outcomes are lacking. This study aims to evaluate the long-term outcomes of OTAP, addressing this gap in the medical literature. conditions: Ureteropelvic Junction Obstruction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 70 type: ACTUAL name: One-trocar-assisted pyeloplasty measure: Operative time measure: Conversion to open measure: Extension of skin incision measure: Postoperative complications measure: Median length of hospital stays measure: Median follow up length measure: Post-operative mean APD measure: Post-operative mean DRF measure: Mean incision length measure: Recurrence sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD facility: The National Hospital of Pediatrics city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False

 nctId: NCT06349148 id: NESTLE2022QN-0007 briefTitle: The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients overallStatus: RECRUITING date: 2024-01-01 date: 2025-08 date: 2025-12 date: 2024-04-05 date: 2024-04-05 name: SHUANGZHENGJIA class: OTHER briefSummary: The goal of this open-label randomized control trial is to study the effect of immunonutrition in locally advanced cervical cancer (LACC) with standard concurrent chemoradiotherapy. LACC patients undergoing radical synchronous chemoradiotherapy will be randomized into the experimental group receiving enteral immunonutrition therapy and the control group receiving standard enteral nutrition support.The main purpose it aims to answer are:1）Can immunonutrition therapy improve patients' dose-limiting toxicity(DLT) and DLT-free survival? 2）Can immunonutrition therapy improve patients' nutritional status and quality of life? conditions: Cervical Cancers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: enteral immunonutrition name: standard oral enteral nutrition measure: Dose-limiting toxicity measure: DLT-free survival measure: compliance measure: Prevalence of malnutrition measure: Prevalence of sarcopenia measure: QoL (Quality of life) measure: Objective response rate (ORR) measure: laboratory tests measure: 2-year overall survival measure: 2-year progression-free survival sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijing zip: 100021 country: China name: SHUANGZHENG JIA, PhD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06349135 id: A.Ayman OMFS briefTitle: Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-04-15 date: 2025-12-15 date: 2024-04-05 date: 2024-04-05 name: Aya Ayman Ahmed class: OTHER briefSummary: Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study conditions: Mandibular Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2 type: ESTIMATED name: Open Reduction & Internal Fixation measure: IL-17 measure: OPG measure: Blood Loss measure: Operative time sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06349122 id: 2023-509421-41-00 briefTitle: Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth acronym: AUTOP2 overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-03 date: 2028-01 date: 2024-04-05 date: 2024-04-05 name: Assistance Publique Hopitaux De Marseille class: OTHER briefSummary: Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis.

The main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth.

The hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%. conditions: Bacterial Vaginosis conditions: Vaginal Dysbiosis conditions: Premature Delivery studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1292 type: ESTIMATED name: Vaginal flora abnormalities screening and quantification using molecular biology technique name: Azithromycine name: Ceftriaxone name: Metronidazole name: Clotrimazole, Vaginal name: Usual Care measure: The rate of preterm birth sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06349109 id: PA-WPW briefTitle: Physical Activity in Children With Wolff-Parkinson-White Syndrome overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-01 date: 2024-04-05 date: 2024-04-09 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: The aim of this study was to investigate the level of physical activity and its determinants in children with WPW. conditions: Wolff-Parkinson-White Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Cardiopulmonary exercise test name: Atrial-Ventricular Strain Analysis name: Arterial Stiffness Measurement name: Physical Activity Level name: Physical Activity Barriers Assesment measure: The Physical Activity Questionnaire for Older Children Score measure: VO2peak measure: aPWV measure: GLS measure: LASr measure: LASct measure: LAScd measure: Physical activity barriers (Parent) scale score measure: Physical Activity Outcome Expectancies (Child) scale score measure: Physical Activity Home Environment (Child) scale score sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hacettepe University status: RECRUITING city: Ankara country: Turkey name: Haluk Tekerlek, PhD role: CONTACT phone: +905355915009 email: haluktekerlek@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06349096 id: ALM-HAR-CLL-23-01 briefTitle: Safety And Efficacy Investigation Of The Effects Of ClearLift Q-Switched Nd:Yag 1064nm Laser Module In The Treatment Of Facial Skin Wrinkles overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2024-10 date: 2024-10 date: 2024-04-05 date: 2024-04-05 name: Alma Lasers class: INDUSTRY briefSummary: Alma Lasers ClearLift is a fractional non-ablative Q-Switched laser, allowing practitioners to use the benefits of a high intensity QS laser for the treatment of aged skin. Alma Harmony ClearLift uses a fractional QS laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. This creates a controlled dermal wound while leaving the epidermis intact. The wound healing process stimulates growth of new collagen, skin contracture and tightening. This procedure is virtually painless with no downtime and is safe for all skin types.

Based on this background, we have considered an interest to design a study aimed at assessing the efficacy and safety of a treatment course with ClearLift Module in patients with facial skin wrinkles conditions: Facial Skin Wrinkles studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Alma Harmony measure: Primary endpoint measure: Secondary endpoint measure: Secondary endpoint measure: Secondary endpoint measure: Safety & Tolerability measure: Safety & Tolerability sex: FEMALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: San Luca Medical Clinic city: Tirana country: Albania name: Arminda Avdulaj, MD role: CONTACT phone: 694488000 phoneExt: +355 email: avdulajarminda@gmail.com name: Arminda Avdulaj, MD role: PRINCIPAL_INVESTIGATOR lat: 41.3275 lon: 19.81889 hasResults: False

 nctId: NCT06349083 id: 23-01227 briefTitle: Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2029-01 date: 2029-01 date: 2024-04-05 date: 2024-04-05 name: NYU Langone Health class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 200 type: ESTIMATED name: Psilocybin name: Inactive Placebo name: Supportive therapy sessions measure: Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC) measure: Percent change in the alcohol cue-induced BOLD signal change in the caudate measure: Percent change in alcohol cue-induced BOLD signal change in the ventromedial PFC (vmPFC) measure: Percent change in alcohol cue-induced BOLD signal change in the insula measure: Percent change in negative affective cue-induced BOLD signal change in the dorsomedial PFC (dmPFC) measure: Percent change in negative affective cue-induced BOLD signal change in the supramarginal gyrus measure: Percent change in negative affective cue-induced BOLD signal change in the amygdala measure: Percent change in negative affective cue-induced BOLD signal change in the insula measure: Percent change in alcohol cue-induced functional connectivity in prespecified regions of interest (ROI) measure: Percent change in negative affective cue-induced functional connectivity in prespecified regions of interest (ROI) measure: Percent change in the frequency of failed response inhibition measure: Change in discounting rate (log(k)) measure: Change in number of set-shifting errors measure: Average number of no heavy drinking days measure: Change in phosphatidyl ethanol (PEth) blood levels measure: Change in carbohydrate-deficient transferrin (CDT) blood levels measure: Change in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score measure: Change in PSQI global score measure: Change in patient's self-assessed quality of life (by the SF-36 Questionnaire) measure: Change in Alcohol craving score measure: Change in negative affect score measure: Change in impulsivity score (Barratt impulsivity scale by the subscales and by the total score) measure: Average number of no drinking days measure: Percentage of heavy drinking days measure: Average number of drinks per day measure: Percentage of abstinent days sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06349070 id: 23-00404 briefTitle: RESTORE - Phase II overallStatus: RECRUITING date: 2024-01-26 date: 2027-01-30 date: 2027-03-30 date: 2024-04-05 date: 2024-04-05 name: NYU Langone Health class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies. conditions: Maternal Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The study is a hybrid type III implementation-effectiveness trial using a longitudinal cluster-randomized trial with a modified stepped wedge design. In Year 1, all 10 clinics start with the low touch strategy, followed by randomization of clinics in Year 2 to either low touch (5 clinics) or high touch (5 clinics), and finally in Year 3, all 10 clinics will transition to the high touch strategy. Starting in Year 2, we will enroll a subsample of subjects into the a prospective cohort of pregnant persons who will participate in surveys at baseline and postpartum. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 900 type: ESTIMATED name: Low Touch - Text Messaging Implementation Strategy name: High Touch - Community Health Worker (CHW) Implementation Strategy measure: Percent adoption of the program measure: Mean number of videos viewed measure: Mean number of sessions completed measure: Level of adherence measure: Adequacy of Prenatal Care Utilization Index Score measure: Number of postpartum follow-up visits attended measure: Number of subjects who had a pre-term delivery measure: Number of subjects with post-partum depression measure: Mean gestational weight gain measure: Percent sustainability (continued adoption) following the M-CHW implementation period measure: Program Costs sex: FEMALE minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYC Health + Hospitals/Bellevue status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06349057 id: AnkaraCHBilkent.1 briefTitle: The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-01 date: 2024-12-30 date: 2024-04-05 date: 2024-04-05 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Many drugs have anticholinergic activity. This means that it blocks the muscarinic binding of the neurotransmitter acetylcholine.

In this study, the anticholinergic burden of the patients in the perioperative period will be calculated with the Anticholinergic Cognitive Burden Scale (ACBS) and patients with a score of 1 or above will be included in the study. Anticholinergic load of drugs used in the intraoperative period; Its effect on postoperative hospital stay, morbidity and mortality following elective heart surgery will be investigated. conditions: Mortality conditions: Postoperative Complications studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: reducing anticholinergic burden measure: Mortality measure: Effects on postoperative recovery measure: Effects on postoperative recovery measure: Postoperative complication measure: Length of stay in hospital and intensive care unit sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seda Kurtbeyoğlu status: RECRUITING city: Çankaya state: Ankara zip: 06800 country: Turkey name: Seda Kurtbeyoğlu role: CONTACT phone: +905388342776 email: kurtbeyogluseda@gmail.com lat: 39.9179 lon: 32.86268 hasResults: False

 nctId: NCT06349044 id: BASIMA briefTitle: A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy/Stereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +/- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies. overallStatus: RECRUITING date: 2024-03-20 date: 2025-12-31 date: 2025-12-31 date: 2024-04-05 date: 2024-04-05 name: Zhejiang Cancer Hospital class: OTHER briefSummary: Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors. conditions: Gastroesophageal Junction Adenocarcinoma conditions: Liver Cancer Stage IV conditions: Biliary Tract Cancer conditions: Pancreatic Adenocarcinoma conditions: Colorectal Cancer conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: Hypofractionated radiotherapy/SBRT（5-8 Gy/fx，3-5 fx） name: Anti-PD-1 monoclonal antibody name: Oxaliplatin and Capecitabine name: Anti-VEGF 15mg/kg name: Anti-VEGF 7.5mg/kg name: Gemcitabine and Cisplatin name: Gemcitabine and Albumin paclitaxel measure: ORR measure: ORR measure: adverse effects rate measure: Qol measure: PFS measure: OS measure: Qol sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhengjiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Ji Zhu role: CONTACT phone: 13501978674 email: zhuji@zjcc.org.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06349031 id: IEC/IMS.SH/SOA/2024/683 briefTitle: Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-15 date: 2024-09-15 date: 2024-04-05 date: 2024-04-12 name: Institute of Medical Sciences and SUM Hospital class: OTHER briefSummary: Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide. In 90-95% of children, it is of functional origin. Thirty to seventy-five percent of children with functional constipation also have fecal impaction. The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements.

Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents. The commonly used formulations are PEG 3350 with a molecular weight between 3200- 3700 g/mol and PEG 4000 with molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. PEG 3350 + Electrolyte (E) is more widely used than PEG 4000 for the management of constipation. This might be because of the perception that PEG 3350 + E is safer in terms of preventing electrolyte imbalance. However, because of the inclusion of electrolytes, PEG 3350+ E solution taste saltier than PEG 4000. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance. To date, no pediatric trials have compared PEG 4000 versus PEG 3350+E for management of Fecal disimpaction.

Present study has been planned to evaluate the efficacy \& tolerability of PEG 4000 versus PEG 3350+ E for fecal disimpaction in pediatric functional constipation. Patients between age 1-16 years having functional constipation (as per ROME IV criteria) with fecal impaction will be included. Subjects will be randomly assigned to either PEG 4000 or PEG 3350+E at a ratio of 1:1. They will be stratified into 3 different age groups: 1-5 years, 6-11 years, and 12-16 years. They will receive either of the PEG solutions (as per allocation) at a dose of 1.5 gm/kg/day for 6 consecutive days or till the resolution of fecal impaction whichever is earlier. The resolution of fecal impaction is defined as the passage of clear liquid stool and the disappearance of palpable abdominal fecolith.

Primary outcome is defined as the proportion of subjects achieving fecal disimpaction in each arm.

Secondary outcomes are defined as follows:

1. Total no of Days required to achieve fecal disimpaction in each arm
2. Cumulative dose of PEG required for fecal disimpaction in each arm
3. Proportion of subjects (\> 5 years age) reporting palatability issues in each arm
4. Proportion of subjects discontinuing the treatment due to palatability issues in each arm conditions: Functional Constipation conditions: Fecal Impaction conditions: Constipation - Functional conditions: Constipation Chronic Idiopathic conditions: Pediatric Functional Constipation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: One member of the research group will do the treatment allocation and will not be involved in clinical evaluation and collection of outcome data. Both study medications will be provided by him/her in opaque bottles with identical packaging and labeling. Neither the participants nor the rest of the study personnel will be aware of the treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Administration of Polyethylene Glycol (PEG) 4000 as per treatment allocation to participants name: Administration of Polyethylene Glycol (PEG) 3350 + Electrolyte as per treatment allocation to participants measure: Proportion of subjects achieving fecal disimpaction in Each Arm measure: Total no of Days required to achieve fecal disimpaction in each arm measure: Cumulative PEG dose required for fecal disimpaction in each arm measure: Proportion of subjects reporting palatability issues in each arm measure: Proportion of subjects discontinuing the treatment due to palatability issues in each arm sex: ALL minimumAge: 1 Year maximumAge: 16 Years stdAges: CHILD facility: Institute of Medical Sciences (IMS) and SUM Hospital city: Bhubaneswar state: Odisha zip: 751003 country: India name: Kalpana Panda, MD, DM role: CONTACT phone: 91-9717133189 email: drkalpanapanda@gmail.com name: J Bikrant kumar Prusty, MD role: CONTACT phone: 91-9090205041 email: princejammy142@gmail.com name: Mrutunjay Dash, MD role: SUB_INVESTIGATOR name: Basudev Biswal, MD role: SUB_INVESTIGATOR name: Mamta Devi Mohanty, MD role: SUB_INVESTIGATOR name: Prasant Saboth, MD role: SUB_INVESTIGATOR lat: 20.27241 lon: 85.83385 hasResults: False

 nctId: NCT06349018 id: IRB-2023-972 briefTitle: Effects of Isotonic Beetroot Supplementation on Sprint Interval Exercise Performance overallStatus: RECRUITING date: 2024-02-20 date: 2025-02-28 date: 2025-02-28 date: 2024-04-05 date: 2024-04-09 name: Nanyang Technological University class: OTHER briefSummary: This study aims to examine the effects of dietary nitrate supplementation via beetroot juice on sprint interval cycling exercise performance. Twenty-four participants (male or female) will undertake a randomized, crossover trial where they consume either (i) an isotonic beetroot juice drink containing nitrate (12.9 mmol) for 5 days or (ii) an isotonic sports drink (no nitrate) for 5 days. On Day 5 of each trial, participants will come to the laboratory and 2 hours after consuming their allocated drink will complete a 6 bouts of sprint interval exercise. Power output during cycling will be measured as the primary outcome measure. Salivary and plasma measures of nitrate and nitrite will be taken over the course of the morning on Day 5. After a 5-day washout period participants will crossover and begin their second trial. conditions: Exercise Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: DOUBLE maskingDescription: Both isotonic drinks (high nitrate or no nitrate) are deidentified and labelled (coded) by a third party not involved with the research. Randomization and allocation are completed by a third party not involved in the testing. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 24 type: ESTIMATED name: Dietary Supplement: High nitrate isotonic drink name: Dietary Supplement: No nitrate isotonic drink measure: Power output during maximal sprint cycling measure: Salivary nitrate measure: Plasma nitrate and nitrite measure: Muscle oxygenation measure: Sensory evaluation (Acceptance and Preference Test Evaluation by Meilgaard et al 2007) measure: Stroop test sex: ALL minimumAge: 21 Years maximumAge: 40 Years stdAges: ADULT facility: Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University status: RECRUITING city: Singapore zip: 637616 country: Singapore name: Stephen Burns, PhD role: CONTACT phone: 65 67903354 email: stephen.burns@nie.edu.sg lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06349005 id: 111 briefTitle: Laryngoscopy and Coronary Artery Bypass Graft Surgery acronym: VL overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-08-01 date: 2024-09-01 date: 2024-04-05 date: 2024-04-05 name: Konya Meram State Hospital class: OTHER briefSummary: In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG). conditions: Videolaryngoscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 112 type: ESTIMATED name: Tracheal intubation using Storz VL name: Tracheal intubation using Macintosh laryngoscopy name: Tracheal intubation using MacGrath VL name: Tracheal intubation using EzVision VL measure: Hemodynamic response measure: Hemodynamic response measure: Intubation time measure: Visualization of the glottis sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Betul Kozanhan city: Konya zip: 42005 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06348992 id: HMUDQ20240318001 briefTitle: ACT Combined Yoga for Parental Burnout in Parents With Autistic Children overallStatus: RECRUITING date: 2023-09-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-05 name: Harbin Medical University class: OTHER briefSummary: OBJECTIVE: To explore the intervention effect of ACT combined with a yoga intervention program on parenting burnout in parents with ASD.

METHODS: This study used a combination of qualitative research and quantitative analysis to examine the intervention effects of an ACT-centered intervention program on parenting burnout in parents of children with ASD, and to clarify the evaluations and perceptions of parents with ASD about the research program through qualitative research.

RESULTS AND CONCLUSION: To clarify the intervention effect of ACT combined with yoga intervention program on parenting burnout of ASD parents. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Acceptance commitment therapy and yoga name: Active Comparator: Mental Health Education Group measure: Measuring parental Burnout Levels measure: Measuring parenting stress Levels measure: Patient-Reported Outcomes Measurement Information System adult profile-57, PROMIS-57 measure: Medical Outcomes Study 36-Item Short-Form Health Survey, MOS SF-36 measure: Acceptance and Action Questionnaire-II, AAQ-II measure: Cognitive Fusion Questionnaire，CFQ-F sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Harbin Medical University Hospital status: RECRUITING city: Daqing state: None Selected zip: 043300 country: China name: Jiayi Chen, Master role: CONTACT phone: 15765962070 email: cjy071949@163.com lat: 46.58333 lon: 125.0 hasResults: False

 nctId: NCT06348979 id: CEBD 5/2021 briefTitle: Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns overallStatus: COMPLETED date: 2022-01-01 date: 2023-12-30 date: 2024-01-30 date: 2024-04-05 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area. conditions: Dental Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 110 type: ACTUAL name: Fiber flowable (SFRC) support below hybrid nanoceramic endocrowns name: all ceramic Endocrowns (emax) measure: clinical Fracture measure: clinical performance marginal adaptation sex: ALL minimumAge: 18 Years maximumAge: 38 Years stdAges: ADULT facility: Cairo University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06348966 id: predictors of readmission briefTitle: Predictors of Hospital Readmission for Chronic Obstructive Pulmonary Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05 date: 2026-06 date: 2024-04-05 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: This study is aimed to determine the risk factors for hospital readmission within 6 months in COPD patients conditions: Hospital Radmission for COPD Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 188 type: ESTIMATED measure: assessment of potential predictors of readmission among COPD patients measure: development of early warning model for hospital readmission in COPD patients sex: ALL minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06348953 id: Bioactive restorative system briefTitle: Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-11 date: 2025-11 date: 2024-04-05 date: 2024-04-09 name: Cairo University class: OTHER briefSummary: This research study delves into the effectiveness of bioactive and non-bioactive restorative systems in deep carious permanent molars treated with selective caries removal. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue. The study investigates how the choice of restorative material influences the outcomes of selective caries removal procedures in deep carious lesions. By assessing factors such as restoration integrity, pulpal response, and long-term success rates, the research seeks to provide evidence-based insights into the comparative performance of bioactive and non-bioactive restorative systems in this clinical context. conditions: Dental Caries conditions: Dental Diseases conditions: Deep Caries conditions: Tooth Diseases conditions: Tooth Decay conditions: Teeth; Lesion conditions: Caries; Dentin conditions: Dental Restoration Failure of Marginal Integrity conditions: Tooth Demineralization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: selective caries removal and conventional non-bioactive restorative system name: selective caries removal and bioactive restorative system measure: Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5 measure: Functional properties - fracture&retention-marginal adaptation-Radiographic Examination"when applicable"-Scoring system Ordinal 1-5 measure: Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5) measure: Success or Failure sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06348940 id: 83242392 briefTitle: Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-12 date: 2024-06-12 date: 2024-06-12 date: 2024-04-05 date: 2024-04-08 name: Anhui Medical University class: OTHER briefSummary: The majority of cancer patients experience varying degrees of psychological distress and physical symptoms due to the presence of cancer or the process of treatment. These symptoms are closely associated with inflammatory markers and patient prognosis, highlighting the urgent need for effective psychological intervention methods. Behavioral activation, an emerging psychological intervention approach, requires further investigation regarding its potential in alleviating negative emotions among cancer patients. Therefore, the investigators conducted a randomized controlled trial (RCT) to investigate whether (1) behavioral activation can ameliorate negative emotions and physical symptoms in cancer patients; (2) behavioral activation can contribute to improved survival outcomes for these patients; and (3) behavioral activation can enhance NLR levels and other clinical indicators among individuals with cancer.

The investigators aimed to recruit a total of 390 cancer patients, comprising 170 individuals diagnosed with esophageal and gastric cancer, 100 individuals with colorectal cancer, and 120 individuals with lung cancer. These patients were recruited from the Department of Oncology at the Second Affiliated Hospital of Anhui Medical University between March 2023 and November 2023. They were randomly allocated into two groups: an intervention group (behavioral activation+care as usual, BA+CAU) and a control group (care as usual, CAU). The intervention group underwent an eight-week behavioral activation program (see Detailed Description) designed to promote engagement in meaningful activities that are physically and emotionally rewarding while reducing involvement in maladaptive emotional cycles. Both the intervention group and the control group received standard care along with conventional treatment for their respective cancers.

This study aims to demonstrate the significant efficacy of behavioral activation in improving negative emotions, somatic symptoms, quality of life, and clinical inflammatory indicators among cancer patients. Furthermore, it may potentially enhance patient survival rates, thereby offering a novel approach for psychological intervention in cancer patients and contributing to multidisciplinary treatment and management strategies. The intervention measures employed in this study do not involve any pharmacological treatments or hazardous activities. For illiterate or less educated patients, the informed consent process and questionnaire collection will be conducted using methods that ensure their full comprehension (e.g., verbal explanations, visual aids). Additionally, patients with evident cognitive impairments were excluded from the study.

The investigators have implemented a questionnaire system on the WJX website (https://www.wjx.cn/) to collect patient information through both paper and electronic questionnaires. The psychological measurement questionnaires are stored electronically, while socio-demographic data and clinical indicators are collected in the hospital's medical record management system. Subsequently, all data is summarized and saved in local Excel files and SPSS files for specialized analysis by data analysts. Patient names are anonymized within the database, ensuring strict confidentiality of personal information such as contact details and home address.

Possible statistical methods include descriptive statistical analysis, generalized estimating equation or repeated measures analysis of variance, structural equation modeling, correlation analysis and regression, survival analysis, etc. conditions: Cancer Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 390 type: ESTIMATED name: behavioral activation measure: Sociodemographic data measure: Status of Tumor measure: Body Mass Index, BMI measure: Biochemical index measure: Blood Pressure, BP measure: Nutritional Risk Screening, NRS measure: Visual Analogue Scale, VAS measure: Karnofsky Performance Status Scale, KPS measure: Psychological Distress Thermometer (DT) measure: Hospital anxiety and depression scale (HADS) measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) measure: Pittsburgh sleep quality index (PSQI) measure: Revised Piper Fatigue Scale (PFS-R) measure: International physical activity questionnaire (IPAQ) measure: Brief Resilient Coping Scale (BRCS) measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: General Self-Efficacy Scale (GSES) measure: The activation subscale of Behavioral Activation for Depression Scale (BADS-A) measure: Social Impact Scale (SIS) measure: Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF) measure: The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) measure: Time of Progression-free survival (PFS) measure: Time of Time to progression (TTP) measure: Concentration of C-reactive protein (CRP) measure: Value of Neutrophils to lymphocytes ratio (NLR) measure: Value of Platelet-lymphocyte ratio (PLR) measure: Value of Monocyte-lymphocyte ratio (MLR) measure: Value of Systemic immune inflammation index (SII) measure: Value of Pan-immune inflammation value (PIV) measure: Concentration of Carcinoembryonic antigen (CEA) measure: Concentration of Carbohydrate antigen 19-9 (CA19-9) measure: Concentration of Carbohydrate antigen 72-4 (CA72-4) measure: Concentration of Neuron-specific enolase (NSE) measure: Concentration of Squamous cell carcinoma associated antigen (SCC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital of Anhui Medical University city: Hefei state: Anhui country: China lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06348927 id: DZ2023EI004 briefTitle: Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC acronym: WUKONG-32 overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-10-31 date: 2027-04-30 date: 2024-04-05 date: 2024-04-05 name: Hunan Province Tumor Hospital class: OTHER briefSummary: This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.

Condition or disease Intervention/treatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2 conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: sunvozertinib in combination with Anlotinib measure: Progression-free survival (PFS) measure: Objective Response Rate (ORR) measure: Overall survival (OS) measure: Duration of Response (DoR) measure: Adverse events (AEs) according to CTCAE 5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410013 country: China lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06348914 id: 6991 briefTitle: Knowledge of Vital Pulp Therapy in Permanent Teeth Among a Group of Dental Students in Egypt overallStatus: NOT_YET_RECRUITING date: 2024-09-10 date: 2024-11-10 date: 2024-12-30 date: 2024-04-05 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: Conducting this questionnaire will help in collecting information about the extent of knowledge of vital pulp therapy in permanent teeth among dental students in Egypt. This will aid in identifying the knowledge gap, interest, and challenges regarding utilization of vital pulp therapy in permanent teeth. conditions: Vital Pulp Therapy studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 323 type: ESTIMATED name: Knowledge assessment name: Educational Material measure: Knowledge of vital pulp therapy measure: Knowledge after awareness about vital pulp therapy sex: ALL minimumAge: 15 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06348901 id: 2021-09-001 briefTitle: Clinical Utility of Oxford Cognitive Screen Test to Screen Cognitive Impairment in Post Stroke Patients overallStatus: RECRUITING date: 2021-09-01 date: 2025-02-28 date: 2025-02-28 date: 2024-04-05 date: 2024-04-05 name: Bundang CHA Hospital class: OTHER briefSummary: The goal of this type of study: clinical trial is to assess K-OCS clinical utility in participant population. The main aims:

validate the reliability and validity of the Korean version of the Oxford Cognitive Screen (K-OCS) analyze its sensitivity, specificity, and diagnostic accuracy, and compare its examination participation rates with existing assessment tools to determine the effectiveness of K-OCS in detecting post-stroke cognitive impairment. conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Measurement of K-OCS measure: Measurement of Korean version of mini-mental state examination (K-MMSE) measure: Measurement Korean Version of the Oxford cognitive screen (K-OCS) measure: Measurement of national institute of health care stroke scale (NIHSS) measure: Measurement of fuctional independence meausure (FIM) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center status: RECRUITING city: Seongnam-si state: Gyeonggi-do zip: 13496 country: Korea, Republic of name: Eunyoung Cho role: CONTACT phone: +82-10-2753-0285 email: a220242@chamc.co.kr lat: 37.43861 lon: 127.13778 hasResults: False

 nctId: NCT06348888 id: 22250 briefTitle: A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-05-30 date: 2024-05-30 date: 2024-04-05 date: 2024-04-05 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations.

Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.

In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.

BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.

BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced.

The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine

* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time
* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood

The study will have 2 treatment groups.

In Group 1, participants will take:

* BAY2927088 as a single dose on Days 1 and 8.
* Itraconazole once daily on Days 5 to 11.

In Group 2, participants will take:

* BAY2927088 as a single dose on Days 1 and 14.
* Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2.

Participants will visit the study clinic:

* at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study
* on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2
* once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up

During the study, the doctors and their study team will:

* perform physical examinations
* collect blood samples from the participants to measure the levels of BAY2927088
* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. conditions: Advanced Non-small Cell Lung Cancer conditions: EGFR Mutation conditions: HER2 Mutation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: BAY2927088 name: Itraconazole name: Carbamazepine measure: AUC of BAY2927088 with and without itraconazole measure: Cmax of BAY2927088 with and without itraconazole measure: AUC of BAY2927088 with and without carbamazepine measure: Cmax of BAY2927088 with and without carbamazepine measure: Number of participants with TEAEs measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06348875 id: CLN-PLAN-102v1 briefTitle: Clinical Evaluation of Radiation Reduction for Optimized Safety acronym: CERROS overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-07-15 date: 2024-07-31 date: 2024-04-05 date: 2024-04-05 name: Angiowave Imaging class: INDUSTRY briefSummary: The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques. conditions: Coronary Artery Disease conditions: Myocardial Infarction conditions: Coronary Disease conditions: Coronary Stenosis conditions: Angina Pectoris conditions: Chest Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Segment-level percent diameter stenosis (%DS) measure: Stenosis severity measure: Diagnostic quality measure: Radiation dose - SOC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Corewell Health West city: Grand Rapids state: Michigan zip: 49503 country: United States name: Ryan Madder, MD role: CONTACT phone: 616-391-4327 email: Ryan.Madder@corewellhealth.org name: Timothy Joseph, MD role: CONTACT phone: 616-391-4327 email: stacie.vanoosterhout@corewellhealth.org name: Ryan Madder, MD role: PRINCIPAL_INVESTIGATOR name: Timothy Joseph, MD role: PRINCIPAL_INVESTIGATOR lat: 42.96336 lon: -85.66809 hasResults: False

 nctId: NCT06348862 id: 323/REC/2023 briefTitle: Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-06-30 date: 2024-06-30 date: 2024-04-05 date: 2024-04-05 name: Al-Quds University class: OTHER briefSummary: The aim of the current study is to analyze the effect of listening to Quran or music or natural sounds on anxiety and stress level among patients undergoing MRI. conditions: Anxiety conditions: Stress conditions: MRI Contrast Media Adverse Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 400 type: ESTIMATED name: Listening to either Quran, Music, and or Natural sound measure: Level of Anxiety among patients who underwent MRI measure: Level of Stress measure: Sociodemographic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06348849 id: 0797-11/2023 briefTitle: The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-05 name: Alexandria University class: OTHER briefSummary: The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy. conditions: Molar Incisor Hypomineralization conditions: Hypersensitivity studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED measure: Desensitising effect in hypersensitive MIH molars measure: Change in the plaque index scores measure: Change in children's frequency of toothbrushing sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD hasResults: False

 nctId: NCT06348836 id: 2123624-1/2 briefTitle: The Effects of Open Chain Versus Closed Chain Strengthening on Dynamic Valgus During a Step Down Test overallStatus: RECRUITING date: 2024-03-22 date: 2025-02-28 date: 2025-02-28 date: 2024-04-05 date: 2024-04-05 name: Alvernia University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of different exercises programs in individuals with abnormal knee motion. The main question it aims to answer are:

* In individuals with abnormal knee motion and without knee pain, does a weight-bearing exercise program reduce abnormal knee motion during a step-down test better than a non weight-bearing exercise program? Participants will
* Perform a stepdown test while undergoing motion analysis and electromyograph (EMG) recording.
* Participants will then be placed either into a weight-bearing or non weight-bearing exercise group. Exercises will be performed 3 times per week for 6 weeks.
* Further motion analysis and EMG data will be collected to test for differences. Researchers will compare individual results before and after exercise, and between-group results before and after exercise to see if one exercise program helps improved abnormal knee motion more than the other. conditions: Dynamic Knee Valgus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either a closed-chain (weightbearing) exercise group or an open-chain (non-weightbearing) exercise group primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Exercise measure: Electromyographic activity of gluteus medius muscle during step-down test measure: Electromyographic activity of quadriceps muscle during step-down test measure: Electromyographic activity of hamstring muscles during step-down test measure: Amount of dynamic knee valgus during step-down test measured with motion analysis sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alvernia University status: RECRUITING city: Reading state: Pennsylvania zip: 19607 country: United States name: James M O'Donohue, DPT role: CONTACT phone: 610-334-1162 email: jim@odfamily.com lat: 40.33565 lon: -75.92687 hasResults: False

 nctId: NCT06348823 id: BritishUE briefTitle: Relationship Between Soft Tissue Volume and Gingival Phenotype: A Novel Classification System overallStatus: RECRUITING date: 2024-02-25 date: 2024-06 date: 2024-10 date: 2024-04-05 date: 2024-04-09 name: Ain Shams University class: OTHER name: British University In Egypt briefSummary: Different classifications to describe alveolar ridge defects have been published over the past years but no single classification has been developed concerning soft tissue volume around teeth or dental implants. Moreover, while several studies investigated the effect of various augmentation techniques and materials on soft tissue volume change and volume stability there is a real gap of knowledge regarding how to evaluate the available soft tissue volume and when to consider it sufficient or deficient which would definitely improve clinical decision making and treatment planing. Therefore, our primary aim was to assess the application of a novel classification system based on the correlation between buccal soft tissue volume and gingival biotypes and, also to assess the sensitivity of such novel method. conditions: Gingival Biotype conditions: Soft Tissue studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 56 type: ESTIMATED name: volume survey measure: soft tissue volume - biotype correlation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahmed Hamdy status: RECRUITING city: Cairo zip: 11234 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06348810 id: DTT2024 briefTitle: Dual-Task Training for People With Mild Cognitive Impairment and Mild Dementia acronym: DTT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-15 date: 2025-01-15 date: 2024-04-05 date: 2024-04-05 name: Taipei Medical University class: OTHER briefSummary: Evidence shows that people with dementia have a higher prevalence of sleep disturbance, cognitive decline, behavioral disturbance, and experience motor dysfunction. These symptoms are interrelated. However, few randomized controlled trial (RCT) studies implement dual-task training for mild cognitive impairment and mild dementia, especially for those who experience sleep problems and behavioral disturbances.

Therefore, this study aims to analyze the effect of dual-task training in improving global cognitive function, executive function, working memory, sleep, behavioral disturbances, balance, and flexibility among people with mild cognitive impairment and mild dementia.

The main questions it aims to answer are:

1. . Does dual-task training affect primary outcomes (global cognitive function, executive function, and working memory)
2. . Does dual-task training affect secondary outcomes (including sleep quality, behavioral disturbances, balance, and flexibility) for people with mild cognitive impairment and mild dementia?"

The length of dual-task training is 6 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 18. While the control group receives the usual care. Researchers will compare the experiment and control groups to see the effect of the dual-task training. conditions: Dementia conditions: Mild Cognitive Impairment conditions: Older Adult studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: eksperimental group receive dual-task training, while control group receive usual care and both conduct at the same time primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Outcomes Assessor will be blind, so they didnt know which is intervention group or control group whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dual-task training name: Usual care measure: Global cognitive function measure: Executive function measure: Working memory measure: Sleep Quality measure: Behavioral disturbance measure: Balance measure: Flexibility sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nursing Home city: Malang state: Jawa Timur zip: 65216 country: Indonesia name: Nur Aini, MSc role: CONTACT phone: +6285234727354 email: d432110003@tmu.edu.tw lat: -7.9797 lon: 112.6304 hasResults: False

 nctId: NCT06348797 id: BHP01-01 briefTitle: Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-31 date: 2026-12-31 date: 2024-04-05 date: 2024-04-05 name: Sichuan University class: OTHER name: Chengdu Brilliant Pharmaceutical Co., Ltd. briefSummary: A study to evaluate the safety and feasibility of α-PD-L1/4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with/without bridge radiotherapy. conditions: Small Cell Lung Cancer Extensive Stage studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: α-PD-L1/4-1BB DLL3 CAR-T (BHP01) measure: Dose-limiting toxicity (DLT) measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Overall-Survival (OS) measure: CAR-T cell numbers sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06348784 id: 11 briefTitle: Screening for Ovarian Malignancy overallStatus: COMPLETED date: 2022-01-01 date: 2023-01-01 date: 2023-01-01 date: 2024-04-05 date: 2024-04-05 name: Ain Shams Maternity Hospital class: OTHER briefSummary: Ovarian cancer is the second most common gynecologic malignancy. In 2008, it was the seventh leading cause of cancer deaths in women worldwide. Estimating the risk of malignancy is essential in the management of adnexal masses and several mathematical models and scoring systems have been developed to be used for discrimination between benign and malignant adnexal masses. Knowledge of the specific type of adnexal pathology before surgery is likely to improve patient triage with high accuracy, and it also makes it possible to optimize treatment. The correct identification of stage I cancer is particularly important conditions: Early Detection of Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ACTUAL name: Assesment of Different NEoplasias in the adenexa model name: Risk of malignancy index name: Histopathologic examination measure: Sensitivity, specificity, positive predictive, and negative predictive value of Assessment of Different NEoplasias in the adneXa model for differentiating between benign and malignant ovarian tumors sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AinShams university maternity hospital city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06348771 id: Pro2023001579 briefTitle: Postprandial Inflammation and Nuts (PIN) in Older Adults acronym: PIN overallStatus: RECRUITING date: 2024-03-25 date: 2024-10-30 date: 2025-01-30 date: 2024-04-05 date: 2024-04-05 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice, but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain and inflammation. Given these findings, this study will examine the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and this will be compared to a high SFA meal. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults. conditions: Healthy Aging conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Higher SFA meal vs higher MUFA (nut) meal in individuals with overweight and obese primaryPurpose: PREVENTION masking: NONE count: 18 type: ESTIMATED name: monounsaturated fatty acids (MUFA) peanut meal measure: Concentration of Endotoxin measure: Concentration of Interleukin-6 measure: Concentration of Glucose and Insulin measure: Concentration of Triglyceride measure: Appetite measure: Concentration of Inflammatory markers measure: Concentration of zonulin measure: Lipid Profile measure: Characterization of the Microbiome measure: Concentration of incretin hormones measure: Concentration of Bone regulating markers sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foran Hall status: RECRUITING city: New Brunswick state: New Jersey zip: 08901 country: United States name: Sue Shapses, PhD role: CONTACT phone: 848-932-9403 email: shapses@rutgers.edu name: Rebecca Serrano, RD MPH role: CONTACT phone: 848-932-9403 email: rcjs@cinj.rutgers.edu lat: 40.48622 lon: -74.45182 facility: Rutgers University - NJ Inst Food Nutrition & Health status: RECRUITING city: New Brunswick state: New Jersey zip: 08901 country: United States name: Sue A Shapses role: CONTACT phone: 848-932-9403 email: shapses@rutgers.edu lat: 40.48622 lon: -74.45182 hasResults: False

 nctId: NCT06348758 id: KAP towards AI briefTitle: Knowledge, Attitudes, And Perceptions of a Group of Egyptian Dental Students Towards Artificial Intelligence acronym: AIKnowledge overallStatus: ENROLLING_BY_INVITATION date: 2024-02-11 date: 2024-06-07 date: 2024-08-07 date: 2024-04-05 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: In the context of this ongoing AI revolution, it is essential to ensure that current and future clinical practitioners are up to date regarding this technology's current state and potential. It is valuable to assess the current attitude of clinical dentists and undergraduate students in dentistry regarding the future role of AI.

To the best of the author's knowledge, there is no study about Egyptian dental students' views and attitudes regarding the application of AI in dental practice. Therefore, this study aimed to evaluate the attitudes and perceptions of a group of dental students in Egypt towards AI. conditions: Health Knowledge, Attitudes, Practice studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 384 type: ESTIMATED name: questionnaire measure: knowledge, attitudes, and perceptions about artificial intelligence in Dentistry sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Cairo University- Faculty of Dentistry city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06348745 id: diaphragmatic ultrasound briefTitle: Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-05-01 date: 2024-04-05 date: 2024-04-08 name: Assiut University class: OTHER briefSummary: * Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
* Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function.
* Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator. conditions: Diaphragm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: ultrasound measure: diaphragmatic function measure: pulmonary function . sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06348732 id: biomarkers in cardiomyopathy briefTitle: Diagnostic and Prognostic Role of Troponin and Brain Natriuretic Peptide in Pediatric Patients With Cardiomyopathy in Correlation to Echocardiography Findings overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-09 date: 2025-11 date: 2024-04-05 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: This study aims to assess the the role of cardiac biomarkers (troponin and ProBNP) in pediatric Patients with all types of cardiomyopathy in correlation with echocardiography findings . conditions: Cardiomyopathies studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 65 type: ESTIMATED measure: Diagnostic and Prognostic Role of Troponin and Pro BNP in Pediatric Patients with Cardiomyopathy in correlation to Echocardiography findings . sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06348719 id: 35RC21_9732_ROBOT-ECO-GYN briefTitle: Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer. acronym: ROBOT-ECO-GYN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-10 date: 2027-10 date: 2024-04-05 date: 2024-04-05 name: Rennes University Hospital class: OTHER briefSummary: The standard treatment for endometrial cancer is surgery, as long as the stage of the disease and the patient's condition allow. It consists of hysterectomy (TSH) with bilateral adnexectomy. The recommended surgical approach is the minimally invasive or laparoscopic route, whose oncological safety has been demonstrated by the LAP2 study.

Since 2010 and the arrival of robotic surgery in gynaecology, the robot-assisted laparoscopic approach has gradually been used for endometrial cancer Hysterectomy.

Several studies have suggested that the cost and effectiveness of laparoscopy may vary according to the age and body mass index of the patient.

The investigators therefore hypothesise that robot-assisted laparoscopy may be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France.

The investigators therefore hypothesise that robot-assisted laparoscopy could be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators will also test the efficiency of the surgical technique as a function of age and Body mass Index. conditions: Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: As part of this project, we are proposing an original approach by combining a randomized controlled trial with a prospective observational cohort and a retrospective cohort.

This research will therefore consist of 3 complementary studies :

A multicenter, parallel-group, open-label, randomized controlled superiority trial (ratio 1:1) comparing two groups:

* Group 1: laparoscopic robot-assisted hysterectomy
* Group 2: conventional laparoscopic hysterectomy A prospective cohort based on the randomized controlled trial A retrospective cohort primaryPurpose: OTHER masking: NONE count: 1680 type: ESTIMATED name: Robot-assisted laparoscopy name: conventional laparoscopy name: Prospective cohort study name: Retrospective cohort study name: information and consent name: randomization name: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence name: Surgical data collection name: Biological data collection name: Collection of histological data from the surgical specimen name: Phone calls name: Pain assessment name: Collect of data on non-reimbursed transport name: Collect of everyday help name: Collection of the business resumption date name: SF36 questionnaire name: Questionnaire EQ5D-5L name: FIGO Stadium name: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) name: Collection of adjuvant treatments name: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one name: Collection of data measure: Cost-utility ratio expressed in terms of costs / QALY measure: Operating time measure: Conversion rate measure: Rate and nature of intraoperative complications measure: Post-operative complication rate and nature at D42 (Clavien-Dindo classification) measure: Post-operative complication rate and nature at M6 (Clavien-Dindo classification) measure: Volume of intraoperative blood loss measure: Number of RBC, FFP, PC transfused during hospital stay measure: Visual analogue scale (VAS) of pain 6h after surgery measure: Visual analogue scale (VAS) of pain 24h after surgery measure: Visual analogue scale (VAS) of pain D3 after surgery measure: Analgesic consumption at D1 after surgery measure: Analgesic consumption at D3 after surgery measure: Analgesic consumption at D7 after surgery measure: Analgesic consumption at D42 after surgery measure: EQ-5D-5L at inclusion after surgery measure: EQ-5D-5L at D1 after surgery measure: EQ-5D-5L at D3 after surgery measure: EQ-5D-5L at D7 after surgery measure: EQ-5D-5L at D14 after surgery measure: EQ-5D-5L at D21 after surgery measure: EQ-5D-5L at D42 after surgery measure: EQ-5D-5L at M3 after surgery measure: EQ-5D-5L at M6 after surgery measure: SF-36 at baseline after surgery measure: SF-36 at D3 after surgery measure: SF-36 at D7 after surgery measure: SF-36 at D42 after surgery measure: SF-36 at M6 after surgery measure: Consumption of care: average length of hospital stay measure: Consumption of care: average of number of re-hospitalizations, measure: Consumption of care: average of emergency room visits measure: Consumption of care: average of number of gynecologist consultations measure: Consumption of care: quantity of analgesic(s) measure: Consumption of care: measure: Consumption of care: average of number of work stoppage(s). measure: Time to initiate adjuvant treatment when indicated measure: Vital status at 6 months measure: Gas recovery time measure: QALYs from a collective perspective at D42 measure: QALYs from a collective perspective at M6. measure: Number of patients who underwent each approach measure: QALYs and average costs in relation to care consumption of patients included in the prospective cohort and in the randomized controlled trial according to the approach used and subgroups defined by age (<or> to 75 years) and BMI <or> to 30 kg/m2). measure: Surgical teams' perception of the benefits and limitations of robotic surgery in this indication, as well as perceived barriers and levers to the deployment of robot-assisted surgery in low- or intermediate-risk endometrial cancer. measure: Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale measure: Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX measure: Total annual costs of the foreseeable spread of robot-assisted surgery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Lille, Hôpital Jeanne de Flandre city: Lille zip: 59000 country: France name: Yohan Kerbage role: CONTACT lat: 50.63297 lon: 3.05858 facility: CHU LIMOGES, Hôpital Mère-Enfant city: Limoges zip: 87042 country: France lat: 45.83153 lon: 1.25781 facility: Hôpital Lariboisière/Hôpital Saint Louis city: Paris zip: 75010 country: France name: Cyrille Huchon role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Cochin city: Paris zip: 75014 country: France name: Bruno Borghese role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Européen Georges Pompidou city: Paris zip: 75015 country: France name: Henri Azaïs role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Bichat city: Paris zip: 75018 country: France name: Martin Koskas role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Tenon AP-HP city: Paris zip: 75020 country: France name: Yohann Dabi role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Pitié Salpêtrière city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Lyon Sud - Hospices Civils de Lyon city: Pierre-Bénite zip: 69495 country: France name: Pierre-Adrien Bolze role: CONTACT lat: 45.7009 lon: 4.82511 facility: Hôpital privé des côtes d'Armor city: Plerin zip: 22190 country: France name: Isabelle Jaffré role: CONTACT lat: 48.54249 lon: -2.77983 facility: CHU de Rennes, Hôpital Sud city: Rennes zip: 35200 country: France name: Vincent Lavoue role: CONTACT lat: 48.11198 lon: -1.67429 facility: CHU de Rouen city: Rouen zip: 76031 country: France name: Morgane Perrin role: CONTACT lat: 49.44313 lon: 1.09932 facility: CHU de Saint Etienne city: Saint Etienne zip: 42055 country: France name: Céline Chauleur role: CONTACT lat: 45.43389 lon: 4.39 facility: CHU de Strasbourg - Hôpital de Hautepierre city: Strasbourg zip: 67200 country: France lat: 48.58392 lon: 7.74553 facility: CHU de Tours - Hôpital Bretonneau city: Tours zip: 37044 country: France name: Lobna OULDAMER role: CONTACT lat: 47.38333 lon: 0.68333 hasResults: False

 nctId: NCT06348706 id: Ain Shams University25032024 briefTitle: Effect of Dipeptidyl Peptidase- 4 Inhibitors on Non-Alcoholic Steatohepatitis and Type 1 Diabetes overallStatus: COMPLETED date: 2022-11-10 date: 2023-12-01 date: 2024-01-15 date: 2024-04-05 date: 2024-04-05 name: Ain Shams University class: OTHER briefSummary: Background: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that can precipitate to advanced fibrosis and leads to cardiovascular morbidity and mortality. Many patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and met the histological criteria for NASH. Matrix metalloproteinase-14 (MMP-14) is a type 1 transmembrane proteinase expressed in liver fibrosis and is involved in the development of atherosclerosis and cardiovascular disease. Hepatic dipeptidyl peptidase-4 (DPP-4) expression in NAFLD may be directly associated with hepatic lipogenesis and liver injury. Some studies showed the beneficial effect of dipeptidyl peptidase-4 (DDP-4) inhibitors in NAFLD/NASH for their role in improving hepatic glucose metabolism. Vildagliptin, a DPP-4 inhibitor, could be promising therapeutic agents for NAFLD/NASH.

To the best of our knowledge, no previous study assessed the role of DPP-4 inhibitors in adolescent patients with T1DM and NASH.

Objectives: This randomized-controlled clinical trial assessed the impact of the oral DPP-4 inhibitor, vildagliptin, as an add-on therapy on NASH in adolescents with T1DM as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis.

Methods: This study included 60 adolescents with T1DM and NASH with a mean age 15.6 ± 2.08 years and disease duration ≥ 5 years. Forty age- and sex-matched healthy subjects with a mean age 14.9 ± 3.2 years were enrolled as healthy controls to compare MMP-14 levels. T1DM patients were randomly assigned to receive oral vildagliptin (50 mg daily) with lunch meal for six months or not. Fasting and 2 hours post-prandial blood glucose levels, HbA1c, liver function tests, fasting lipid profile, hepatic steatosis index and triglyceride glucose (TyG) index were assessed. MMP-14 levels were measured by enzyme-linked immunosorbent assay among all patients and healthy controls. CIMT was assessed using Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) was performed to assess liver stiffness and steatosis stage. conditions: Diabetes Mellitus, Type 1 conditions: NASH studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Dipeptidyl peptidase 4 (DPP-4) inhibitor measure: Number of participants with treatment-related effect on NASH status in adolescents with type 1 diabetes mellitus measure: Number of participants with treatment-related Matrix metalloproteinase-14 (MMP-14) level change measure: Number of participants with treatment-related Glycemic control (HbA1c%) level change sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nancy Elbarbary city: Cairo zip: 11361 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06348693 id: Gliotherapy briefTitle: Development of Therapeutic Approaches Modulating Molecular Targets Implicated on Cancer Stem Cell-related Aggressiveness overallStatus: RECRUITING date: 2017-04-19 date: 2025-11-21 date: 2025-11-21 date: 2024-04-05 date: 2024-04-05 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. In fact, due to the hypoxic tumor microenvironment, these cells are able to create compensatory pathways that confer stem-like, angiogenic and pro-tumoral functions. Furthermore, it has been demonstrated that brain tumor stem cells are radio- and chemo-resistant and therefore not treatable with the therapeutic protocols currently in use. To date, in fact, there are no definitive treatments for the eradication of brain tumors. In this scenario, sphingolips, a class of lipid deputized to several physiological functions, are also involved in tumor onset, progression, drug resistance, and aggressiveness. In hypoxic tumor microenvironment, CSCs present a modified rheostat in the metabolism of sphingolipid, in favor of Sphingosine-1-phosphate (S1P).

S1P is an intermediate of sphingolipid metabolism, formed from sphingosine through the action of sphingosine kinases (SK). Increasing evidence suggests that S1P acts as a tumor-promoting signal, predominantly in the extracellular environment, regulating important cellular properties correlated with tumor potential.

The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment. conditions: Glioblastoma conditions: Glioma conditions: Glioma Glioblastoma Multiforme studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: cell isolation from tumor biopsies and biomarker investigation measure: Investigation of molecular and metabolic signature of cancer stem cells to assess specific markers related to gliomagenesis and cancerogenesis. measure: Biomarker investigation measure: Cellular response to pharmacological treatments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Stefania E Navone, PhD role: CONTACT phone: 0255034268 phoneExt: +39 email: stefania.navone@policlinico.mi.it name: Giovanni Marfia, MD, PhD role: CONTACT phone: 0255034268 phoneExt: +39 email: giovanni.marfia@policlinico.mi.it name: Stefania Navone, PhD role: PRINCIPAL_INVESTIGATOR name: Giovanni Marfia, MD, PhD role: SUB_INVESTIGATOR name: Laura Guarnaccia, PhD role: SUB_INVESTIGATOR name: Laura Begani, MSc role: SUB_INVESTIGATOR name: Marco Locatelli, Md, PhD role: SUB_INVESTIGATOR name: Claudia Fanizzi, MD role: SUB_INVESTIGATOR name: Luigi Schisano, MD role: SUB_INVESTIGATOR name: Antonella Ampollini, MD role: SUB_INVESTIGATOR name: Manuela Caroli, MD role: SUB_INVESTIGATOR name: Giulio Bertani, MD role: SUB_INVESTIGATOR name: Giorgio Fiore, MD role: SUB_INVESTIGATOR name: Antonio D Ammando, MD role: SUB_INVESTIGATOR name: Elena Scagliotti, MSc role: SUB_INVESTIGATOR name: Giorgia Abete Fornara, MSc role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06348680 id: AmasyaU-betuluzun-004 briefTitle: The Effect of Video-assisted Episiotomy Repair Training on Anxiety and Self-efficacy Levels in Midwifery Students overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-04-05 date: 2024-05-15 date: 2024-04-05 date: 2024-04-05 name: Amasya University class: OTHER briefSummary: The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training. conditions: Episiotomy Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 31 type: ESTIMATED name: Video assisted episiotomy repair training measure: State Anxiety Scale measure: Episiotomy Skills Self-Efficacy Scale sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06348667 id: 3184794 briefTitle: Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability in Older Adults overallStatus: RECRUITING date: 2024-03-07 date: 2024-06-10 date: 2024-06-10 date: 2024-04-05 date: 2024-04-05 name: University of Valencia class: OTHER briefSummary: The goal of this clinical trial is to assess the effectiveness of adding specific Blackboard Training (BB) exercises to conventional physiotherapy in improving foot and ankle parameters essential for fall prevention among older adults.

The main questions it aims to answer are:

1. Can the addition of BB exercises improve ankle dorsiflexion mobility?
2. Can the addition of BB exercises enhance single-leg stability and control of mediolateral displacement of the center of pressure?

Participants will be divided into control and intervention groups. Both groups will receive their usual conventional physiotherapy exercises. The intervention group will undergo a 5-week program comprising 10 sessions of BB exercises targeting ankle mobility and balance.

Participants will be asked to:

* Perform 3 sets of 15 repetitions for assisted ankle dorsiflexion mobility.
* Engage in 5 rounds of 40-second balance exercises using the BB.

Researchers will compare the intervention group's outcomes with those of the control group to determine the effectiveness of adding BB exercises in improving foot and ankle parameters related to fall prevention. conditions: Fall studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Specific ankle stability exercises name: Conventional physiotherapy exercises program measure: Foot and ankle pain measure: Foot and ankle strength measure: Foot and ankle ROM measure: Ankle dorsiflexion under load measure: Center of pressures variations (anteroposterior and mediolateral center of pressure displacement, velocity, and total surface) measure: Monopodal stability measure: Functional stability sex: ALL minimumAge: 75 Years maximumAge: 95 Years stdAges: OLDER_ADULT facility: Rodrigo Martin-San Agustin status: RECRUITING city: Valencia country: Spain name: Rodrigo Martin-San Agustin role: CONTACT phone: +34 963 983 853 email: rodrigo.martin@uv.es lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06348654 id: 6392 briefTitle: New Digital Person-based Care Model in Patients With HER2-negative Advanced Breast Cancer acronym: InPERSON overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-12-01 date: 2025-01-01 date: 2024-04-05 date: 2024-04-05 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of the InPerson study is to employ all resources in a digital listening platform to benefit the quality of life of patients (QoL) with advanced HER2-negative breast cancer.

The care pathway of patients with this type of disease represents an optimal setting for the implementation of an innovative narrative medicine pathway that, aided by integrative therapies, aims to support and accompain them in their treatment journey with a continuum of care. Moreover, the narrative medicine platform will implement the actual "static" way to define QoL with the classic Patient-Reported Outcomes (PROs) questionnaires, that reflect the patient status at a certain time point and not as a dinamic entity. It is on the basis of these assumptions that the present application project on the use of the DNMLAB digital narrative diary in the oncology department of the Fondazione Policlinico Gemelli was born. conditions: Breast Cancer conditions: Narrative Medicine conditions: HER2-negative Breast Cancer conditions: Patient Satisfaction studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: introduction of digital listening may improve the quality of life of patients withe breast cancer measure: Standardized quality-of-life measurement measure: Perceived quality of life measure: Personalization of the care pathway measure: Quality of the patient-physician relationship. measure: Interaction between multidisciplinary teams measure: Patient involvement and compliance in the care pathway measure: lifestyles best suited to positively affect quality of life measure: Awareness of disease condition sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06348641 id: 2011-KAEK-25 2022/12-11 briefTitle: Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-04-20 date: 2025-04-20 date: 2024-04-05 date: 2024-04-05 name: Nurgül Tekin class: OTHER briefSummary: The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn.

This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.

Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist.

The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.

Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant.

The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines. conditions: Pain conditions: Retinopathy of Prematurity conditions: Premature Baby 26 to 32 Weeks conditions: Premature Baby 33 to 36 Weeks studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: baby massage measure: Pain during examination for retinopathy of prematurity measure: Comfort during retinopathy of prematurity examination sex: ALL minimumAge: 1 Day maximumAge: 40 Days stdAges: CHILD hasResults: False

 nctId: NCT06348628 id: P/38/04/2021 briefTitle: Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2022-05-31 date: 2025-01 date: 2025-07 date: 2024-04-05 date: 2024-04-05 name: Madunil Anuk Niriella class: OTHER briefSummary: The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD). conditions: Non-Alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 231 type: ACTUAL name: Motivational Interview name: Placebo measure: Change in weight after 1 year compared to baseline measure: Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline measure: Change in platelet count after 1 year compared to baseline measure: Change in waist circumference and hip circumference after 1 year compared to baseline measure: Change in total fat percentage and visceral fat percentage after 1 year compared to baseline measure: Change in motivation for weight loss after 1 year compared to baseline measure: Change in depression, anxiety and stress after 1 year compared to baseline measure: Change in quality of life after 1 year compared to baseline sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Medicine, University of Kelaniya city: Ragama state: Western Province zip: 11010 country: Sri Lanka lat: 7.0292 lon: 79.917 hasResults: False

 nctId: NCT06348615 id: DEFBODY briefTitle: Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device acronym: DEFBODY overallStatus: RECRUITING date: 2024-01-23 date: 2024-04-23 date: 2024-06-07 date: 2024-04-05 date: 2024-04-08 name: ICIM International S.r.l. a socio unico class: INDUSTRY briefSummary: Post-marketing clinical study conducted on a CE medical device, named Defense Body, cellulite treatment, edematous fibrosclerotic panniculopathy (2nd and 3rd stage pathology), reducing draining cream-gel, to verify its effectiveness and tolerability on a panel of 56 subjects females affected by 2nd and 3rd degree PEF. The effectiveness of the device is measured in terms of reduction in thigh circumference, improvement in the appearance of the skin with reduction of the orange peel appearance and improvement in skin smoothness. conditions: Cellulite studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Anti-cellulite cream-gel Medical Device (DEFBODY) measure: First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments measure: First day of study initiation: BMI measure: First day of study initiation: Measurement of waist circumference, hip circumference and thigh circumference measure: First day of study initiation: digital photographs of the area to be treated measure: First day of study initiation: skin profilemetry of the thigh measure: First day of study initiation: pinch test measure: After 28 days of treatment: recording of any concomitant pharmacological treatments that have occurred. measure: After 28 days of treatment: BMI measure: After 28 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference measure: After 28 days of treatment: digital photographs of the area to be treated measure: After 28 days of treatment: skin profilemetry of the thigh measure: After 28 days of treatment: pinch test measure: After 28 days of treatment: AE or AED or Drop-off measure: After 28 days of treatment: satisfaction evaluation and compliance measure: After 56 days of treatment: recording of any concomitant pharmacological treatments that have occurred. measure: After 56 days of treatment: BMI measure: After 56 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference measure: After 56 days of treatment: digital photographs of the area to be treated measure: After 56 days of treatment: skin profilemetry of the thigh measure: After 56 days of treatment: pinch test measure: After 56 days of treatment: AE or AED or Drop-off measure: After 56 days of treatment: evaluation of compliance measure: After 56 days of treatment: overall rating of product satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Dermatology Unit - I.R.C.C.S. Ospedale San Raffaele status: RECRUITING city: Milano country: Italy name: Santo Raffaele Mercuri role: CONTACT name: Vittoria Giulia Bianchi role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06348602 id: PI23-00201 briefTitle: Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT overallStatus: RECRUITING date: 2023-08-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-08 name: Hospital Universitario Dr. Jose E. Gonzalez class: OTHER briefSummary: Chronic GVHD (cGVHD) is a predominant cause of mortality and disability not related to relapse; it occurs in 30 to 70% of patients. The majority of patients with cGVHD present with ocular involvement with a reported incidence of 40-60%. Symptoms can range from mild dry eye syndrome to severe epithelial defects that can generate corneal perforation and loss of vision. The most accepted pharmacological modality is the topical application of cyclosporine A; on the other hand, tacrolimus has shown greater immunosuppressive power when used in ocular GVHD. However, this effectiveness is limited since by the time the manifestations appear, there is already permanent damage to the lacrimal gland due to the lymphocytic infiltration; so it is necessary to use a prevention strategy before these manifestations appear. Previously, the employment of ocular cyclosporine drops as ocular GVHD prophylaxis was assessed to evaluate safety and effectiveness, showing that it is well tolerated and can limit the appearance of severe dry eye manifestations in a small group of patients. The purpose of this work is to compare the two modalities currently accepted for the treatment of the disease, but in a prophylactic way; topical ciclosporin A against topical tacrolimus, to determine the safety and efficiency of each of them as a preventive measure to limit the risk of developing the appearance of ocular cGVHD and the permanent consequences that this generates. conditions: Ocular Graft-versus-host Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental, prospective, randomized, unblinded. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Cyclosporine ophthalmic solution 0.1% name: Tacrolimus ophthalmic ointment 0.03% measure: Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease. measure: Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the National Institutes of Health Consensus Development Projects on Chronic GVHD scoring system. measure: Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease measure: Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease. measure: Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system. measure: Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system. measure: Number of participants requiring adjuvant treatment for ocular GVHD in patients receiving prophylactic tacrolimus or cyclosporine for ocular GVHD. measure: Prevalence of Dry Eye Disease prior to the HSCT. measure: Subtypes of Dry Eye Disease prior to the HSCT measure: Number of participants requiring adjuvant treatments for the Dry Eye Disease measure: Incidence of other manifestations of acute and chronic GVHD, local or systemic, in patients receiving prophylactic treatment for ocular GVHD. measure: Number of participants with topical tacrolimus related adverse events as assessed by a questionnaire for evaluation of adverse drug events measure: Number of participants with topical cyclosporine related adverse events as assessed by a questionnaire for evaluation of adverse drug events measure: Incidence of ocular GVHD in patients receiving prophylactic treatment for ocular GVHD. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario de la U.A.N.L. status: RECRUITING city: Nuevo León state: Monterrey zip: 66640 country: Mexico name: Olga Graciela Cantú Rodriguez, MD role: CONTACT phone: 8186939257 email: ogcantur@yahoo.com.mx name: David Gómez Almaguer, MD role: CONTACT phone: 8186756718 email: dgomezalmaguer@gmail.com hasResults: False

 nctId: NCT06348589 id: 2023-05959-01 briefTitle: Orthostatic Hypotension and Blood Pressure Variability in Persons Undergoing Hemodialysis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-04 date: 2024-04-04 name: Vrinnevi Hospital class: OTHER name: Linkoeping University briefSummary: High blood pressure is a risk factor for end-stage renal disease and is common in patients undergoing maintenance hemodialysis. Intradialytic hypotension is associated with an adverse prognosis. More knowledge is needed to identify patients at high risk for intradialytic hypotension and dialysis-associated hypotensive episodes. The aim of this observational single-center pilot study is to evaluate whether point-of-care ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure falls, in patients with chronic kidney disease who undergo maintenance hemodialysis. conditions: Chronic Kidney Disease Requiring Chronic Dialysis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED measure: Intra-dialytic systolic blood pressure fall of 20 mmHg or larger measure: Post-dialytic orthostatic systolic blood pressure fall of 20 mmHg or larger sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06348576 id: AD-209P3 briefTitle: Phase III Study to Evaluate the Efficacy and Safety of AD-209 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-02 date: 2024-04-04 date: 2024-04-04 name: Addpharma Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of AD-209 conditions: Hypertension,Essential studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 280 type: ESTIMATED name: AD-209 name: AD-2091 name: AD-209 Placebo name: AD-2091 Placebo measure: Change rate of MSSBP sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Korea University Guro Hospital city: Seoul country: Korea, Republic of name: Chang Gyu Park, M.D., Ph.D role: CONTACT name: Chang Gyu Park, M.D., Ph.D role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06348563 id: 7437787981 briefTitle: AGED Diagnostics Liver Disease Assessment acronym: AGEDDX overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-09-15 date: 2024-04-04 date: 2024-04-04 name: Active Genomes Expressed Diagnostics, Corp class: INDUSTRY name: Arizona Clinical Trials name: Walter Reed National Military Medical Center briefSummary: Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. The first assessment is to conduct test method verification to expand sample size to several hundred samples through whole genome sequencing methods. The second assessment is focused on biomarker validation by comparing targeted sequencing from patient plasma. Several sub- assessments will be conducted to support overall biomarker development efforts. conditions: NASH With Fibrosis conditions: NAFLD conditions: Healthy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 400 type: ESTIMATED name: AGED Multiple Target Assay in Healthy Controls name: AGED Multiple Target Assay in NAFLD Participants name: AGED Multiple Target Assay in Fibrosis Participants measure: Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma measure: Biomarker Validation, Targeted Epigenetic Sequencing Assessment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AGED Diagnostics city: Bethesda state: Maryland zip: 20002 country: United States name: Rachel Zayas role: CONTACT phone: 617-777-7971 email: rachel@ageddiagnostics.com lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06348550 id: BFMKP 01 briefTitle: Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients. overallStatus: RECRUITING date: 2023-11-30 date: 2024-07 date: 2024-09 date: 2024-04-04 date: 2024-04-04 name: University of Pavia class: OTHER name: Foundation IRCCS San Matteo Hospital briefSummary: The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl. conditions: Dyslipidemias conditions: Dysglycemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Berberol® K name: Placebo measure: Variation of LDL cholesterol measure: Variation of lipid profile measure: Change in glycemic status sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Policlinico S. Matteo Foundation status: RECRUITING city: Pavia zip: 27100 country: Italy name: Giuseppe Derosa, MD, PhD role: CONTACT email: giuseppe.derosa@unipv.it name: Pamela Maffioli, MD role: CONTACT email: p.maffioli@smatteo.pv.it name: Giuseppe Derosa, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Pamela Maffioli, MD role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06348537 id: Polyphenol-Fibromyalgia briefTitle: Effects of Olive Polyphenols in Fibromyalgia Patients overallStatus: COMPLETED date: 2021-01-20 date: 2021-04-01 date: 2023-09-01 date: 2024-04-04 date: 2024-04-04 name: Universidad de Granada class: OTHER name: Solvitae Medical, S.L name: University of Jaén briefSummary: To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Olive Polyphenols name: Placebo measure: Plasma proteome measure: Lipid peroxidation measure: Aldolase measure: C-reactive protein (CRP) measure: Impact of fibromyalgia measure: Quality of Life measure: Red blood cells measure: Haemoglobin measure: Fibrinogen measure: Total cholesterol measure: Cholesterol ratio measure: LDL cholesterol measure: Cortisol sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Jaén city: Jaén zip: 23071 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False

 nctId: NCT06348524 id: ferumoxytol_2015 briefTitle: Ferumoxytol-enhanced Magnetic Resonance Imaging overallStatus: NOT_YET_RECRUITING date: 2024-08-03 date: 2024-12-30 date: 2025-12-30 date: 2024-04-04 date: 2024-04-04 name: Transmed Solutions class: OTHER briefSummary: There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR \<30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Ferumoxytol injection measure: Detect the absence of ≥50% stenosis in the coronary artery tree measure: Detect stenosis in proximal and distal segments of the coronary artery tree measure: Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06348511 id: 0165-22-TLV briefTitle: XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders overallStatus: COMPLETED date: 2022-07-01 date: 2022-12-31 date: 2022-12-31 date: 2024-04-04 date: 2024-04-04 name: Tel-Aviv Sourasky Medical Center class: OTHER_GOV briefSummary: The investigators developed a neuroscientifically-informed gamified tic-therapy platform. The investigators previously identified tic-triggering elements in movies and video games. Next, the investigators employed these elements to generate and validate a gamified intervention protocol, which is based on a video game the investigators designed (called XTics). The study tests the efficacy of the gamified tool integrated in an exposure and response prevention (ERP) protocol to enhance both patient's compliance and clinical outcome. conditions: Tic Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study tested the impact of contingent and immediate reward (ICR) given by the game in respect to the participant's tic frequency relative to a random and non-contingent delayed reward (DR) provided by the end of the training day. Each participant underwent three training days in each of the the modes during one week. The training days included 3 (first day) or 4 (second and third days) game sessions. The order of the training modes was random. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Personnel who interact directly with the study subjects were not aware of the assigned treatments. Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group. whoMasked: INVESTIGATOR count: 35 type: ACTUAL name: XTics measure: The Tic Yale Global Tic Severity Scale (YGTSS) measure: The Parent Tic Questionnaire (PTQ) measure: Premonitory Urge for Tic Scale (PUTS) measure: The Subjective Units of Distress Scale (SUDS) measure: The "Urge Thermometer" measure: Rush Videotape Protocol measure: Tic-to-tic interval measure: The Screen for Child Anxiety Related Emotional Disorders (SCARED) measure: The Children Depression Inventory (CDI) measure: The Conners' Parent Rating Scale-Revised Long Form (CRS:RL) measure: Obsessive Compulsive Inventory-Child Version (OCI-CV) measure: The Behavior Rating Inventory of Executive Function (BRIEF) measure: The Emotion Regulation Questionnaire (ERQ) measure: User Engagement Scale (UES) sex: ALL minimumAge: 7 Years maximumAge: 15 Years stdAges: CHILD facility: Sagol Brain Institute, Tel Aviv Sourasky Medical Center city: Tel Aviv country: Israel lat: 32.08088 lon: 34.78057 hasResults: False

 nctId: NCT06348498 id: TSL-TCM-JSP-Ⅰb briefTitle: Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2026-06-30 date: 2026-06-30 date: 2024-04-04 date: 2024-04-04 name: Tasly Pharmaceutical Group Co., Ltd class: INDUSTRY briefSummary: Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure. conditions: Heart Failure studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Jia Shen Tablet measure: Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax) measure: Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (Tmax) measure: Plasma PK analysis: Area under curve at steady state (AUCss) measure: NT-proBNP measure: 6-Minutes-Walking-Test (6MWT) measure: Echocardiogram results measure: NYHA classification measure: AEs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine city: Tianjin state: Tianjin country: China name: Yuhong Huang role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06348485 id: VGHTCCTC_NPCbleeding001 briefTitle: Massive Nasal Bleeding in Patients With NPC Received Curative RT overallStatus: COMPLETED date: 1994-12-01 date: 2019-04-30 date: 2024-02-29 date: 2024-04-04 date: 2024-04-04 name: Taichung Veterans General Hospital class: OTHER briefSummary: To investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (NPC) patients who received curative radiotherapy (RT) with/without chemotherapy. A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. Investigators analyzed the occurrence rates of massive nasal bleeding between different characteristics and tried to identify important predictive factors. Investigators compared overall survival between patients with and without massive nasal bleeding by Kaplan-Meier method. conditions: Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1327 type: ACTUAL name: Patients without massive nasal bleeding name: Patients with massive nasal bleeding measure: Massive Nasal Bleeding Rate measure: Overall Survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Veterans General Hospital city: Taichung zip: 407 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06348472 id: 0004-24-SHA briefTitle: The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness overallStatus: RECRUITING date: 2024-03-14 date: 2028-03-01 date: 2028-03-01 date: 2024-04-04 date: 2024-04-04 name: Shalvata Mental Health Center class: OTHER briefSummary: Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions. conditions: Posttraumatic Stress Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Oxytocin Secretion measure: Inflammatory Response: IL-1β measure: Inflammatory Response: IL-6 measure: Inflammatory Response: TNF-α measure: Posttraumatic stress disorder symptoms measure: Depression severity measure: General anxiety symptoms measure: Psychological resilience measure: Working Alliance sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shalvata Mental health Center status: RECRUITING city: Hod HaSharon country: Israel name: Omer Sedoff, MA role: CONTACT email: omerse@clalit.org.il lat: 32.15934 lon: 34.8932 hasResults: False

 nctId: NCT06348459 id: 18/010-E briefTitle: Registry of Catheter Intervention in Pulmonary Embolism acronym: RiTEP overallStatus: RECRUITING date: 2018-09-18 date: 2029-12-31 date: 2030-12-31 date: 2024-04-04 date: 2024-04-04 name: Hospital San Carlos, Madrid class: OTHER name: Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología briefSummary: Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism. conditions: Pulmonary Embolism conditions: Pulmonary Embolism Acute Massive conditions: Pulmonary Embolism Acute conditions: Pulmonary Embolism and Thrombosis conditions: Pulmonary Thromboembolisms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: All cause-death measure: all cause-death measure: all cause-death measure: all cause-death measure: procedural success measure: in-hospital complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clinico San Carlos status: RECRUITING city: Madrid zip: 28040 country: Spain name: Pablo Salinas, MD, PhD role: CONTACT phone: +34913303000 email: salinas.pablo@gmail.com lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06348446 id: FY20-2963 briefTitle: Tacrolimus Exposure in Kidney Transplantation overallStatus: RECRUITING date: 2022-02-01 date: 2024-07-30 date: 2024-08-30 date: 2024-04-04 date: 2024-04-04 name: Seoul National University Hospital class: OTHER name: Astellas Pharma Inc briefSummary: Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation. conditions: Kidney Transplant Rejection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 12000 type: ESTIMATED measure: relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes measure: relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Asan medical center, Seoul, Korea status: RECRUITING city: Seoul country: Korea, Republic of name: Young Hoon Kim, MD role: CONTACT phone: 82-10-2705-6998 email: kyh-001@hanmail.net lat: 37.566 lon: 126.9784 facility: Samsung medical center, Seoul, Korea status: RECRUITING city: Seoul country: Korea, Republic of name: Jae Berm Park, MD role: CONTACT phone: 82-10-8971-1953 email: jbparkmd@gmail.com lat: 37.566 lon: 126.9784 facility: Seoul St. Mary's hospital, Seoul, Korea status: RECRUITING city: Seoul country: Korea, Republic of name: Sun Cheol Park, MD role: CONTACT phone: 82-10-6310-2847 email: sun60278@catholic.ac.kr lat: 37.566 lon: 126.9784 facility: Severance hospital, Seoul, Korea status: RECRUITING city: Seoul country: Korea, Republic of name: kyuha Hur, MD role: CONTACT phone: 82-10-2043-9947 email: KHHUH@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06348433 id: QL000003 briefTitle: Efficacy Evaluation and Mechanism Study of Ketogenic Diet on Autism Spectrum Disorder in Children overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Qilu Hospital of Shandong University class: OTHER briefSummary: Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, which is characterized by social interaction and communication defects, rigid repetitive behaviors, and often accompanied by speech development retardation. According to the report released by the Morbidity and Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC), according to the statistical data analysis in 2020, one out of every 36 8-year-old children (2.76%) was confirmed to have autism spectrum disorder (ASD). This ratio is higher than that published in December 2021, when the prevalence rate of 8-year-old children was 1/44 (2.3%) according to the statistics in 2018. Although ASD has a high incidence, there is still a lack of effective treatment measures for autism at present. Drug treatment can only partially alleviate some related symptoms, such as irritability and aggressiveness. Other interventions mainly focus on behavioral and educational interventions, which have limited help to patients. The high cost also leads to a huge burden on families and health care systems. Therefore, finding targeted treatment measures and treatment mechanisms for ASD as soon as possible has become an urgent problem for us to solve.Faced with limited treatment options, as many as a third of parents try various dietary pattern interventions to help their autistic children. In recent years, ketogenic diet, as a diet mode with extremely low carbohydrate, high fat, proper amount of protein and other nutrients, has attracted wide attention. In this mode, increased lipolysis puts the body in a ketosis state, thus ensuring energy supply.Although ketogenic diet (KD) has been proved to be effective in reducing the core symptoms in autistic patients and mouse models, the specific mechanism of KD in autism spectrum disorder (ASD) is still not completely clear.This study aims to evaluate the efficacy of ketogenic diet in improving core symptoms, sleep disorders and gastrointestinal symptoms of ASD children, explore the changes of excitation/inhibition (dorsolateral prefrontal cortex) in prefrontal cortex of ASD children before and after ketogenic diet intervention, and try to reveal the mechanism of ketogenic diet in treating ASD. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Ketogenic diet measure: Autism Behavior Checklist（ABC） measure: Childhood Autism Rating Scale(CARS) measure: Gastrointestinal Symptom Scale（GSRS) measure: Children's Sleep Habits Questionnaire（CSHQ) measure: MRS sex: ALL minimumAge: 18 Months maximumAge: 10 Years stdAges: CHILD facility: Yu Wang city: Jinan state: Shandong zip: 274400 country: China lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06348420 id: 2023-QILU-LU 03 briefTitle: Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment acronym: ARMV overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2027-04-20 date: 2027-08-13 date: 2024-04-04 date: 2024-04-04 name: Qilu Hospital of Shandong University class: OTHER name: Shandong University briefSummary: The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs). conditions: Gastroesophageal Reflux Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: anti-reflux mucosal valvuloplasty (ARMV) measure: The total score of the GERD-HRQL questionnaire measure: Number of Participants with PPI usage measure: Appearance of the mucosal flap measure: Presence of reflux esophagitis measure: Safety evaluation indicators measure: Total score of GERD GerdQ questionnaire measure: DeMeester score sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06348407 id: 2024-BA-001 briefTitle: A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE) acronym: ESSENCE overallStatus: RECRUITING date: 2023-12-01 date: 2024-11-30 date: 2024-11-30 date: 2024-04-04 date: 2024-04-04 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.Previous studies have reported that nearly 90% of patients with severe asthma were cases of allergic asthma, in which Immunoglobulin E (IgE) plays a critical role.Omalizumab was approved as an anti-IgE humanized monoclonal antibody for the treatment of patients with poorly controlled moderate-to-severe asthma, and was the first targeted drug used in the field of asthma treatment.The drug was launched in mainland China in August 2017.whereas,the clinical application experience, effects, and relevant data in the domestic population still lacking.The aim of this study was to observe the efficacy and safety of omalizumab, and to investigate whether baseline clinical characteristics and biomarkers can predicted response and adherence to treatment. conditions: Moderate to Severe Allergic Asthma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: IgE monoclonal antibody measure: Change in Asthma Control Test (ACT) measure: Global Evaluation of Treatment Effectiveness (GETE) measure: Forced Expiratory Volume in 1 second（FEV1) measure: FEV1/predicted%. measure: Forced Vital Capacity （FVC） measure: FEV1/FVC. measure: Number of Acute Exacerbations（AE） measure: Oral glucocorticoid dosage measure: Good adherence measure: Poor adherence measure: Adverse events sex: ALL minimumAge: 14 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Linfu zhou status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Xuejun Zhang, Master role: CONTACT phone: 86+13704726254 email: zxj1301@163.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06348394 id: 023-318 briefTitle: Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion acronym: ICETEE overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-14 date: 2025-12-14 date: 2025-12-30 date: 2024-04-04 date: 2024-04-04 name: Baylor Research Institute class: OTHER briefSummary: This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach. conditions: Left Atrial Appendage Closure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, parallel controlled, open-label, single center study primaryPurpose: OTHER masking: NONE count: 444 type: ESTIMATED name: Intracardiac Echocardiography measure: Procedural success following implantation of the left atrial appendage occlusion (LAAO) device. measure: Periprocedural complications measure: Procedural characteristics measure: Patient satisfaction measure: Periprocedural complications measure: Periprocedural complications measure: Procedural characteristics measure: Procedural characteristics measure: Procedural characteristics sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor Scott and White Heart Hospital city: Plano state: Texas zip: 75093 country: United States lat: 33.01984 lon: -96.69889 hasResults: False

 nctId: NCT06348381 id: IS24030 briefTitle: Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: Shanghai Chest Hospital class: OTHER briefSummary: Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury. conditions: Esophageal Neoplasm conditions: Anastomotic Leak conditions: Recurrent Laryngeal Nerve Injuries conditions: Anastomotic Stenosis conditions: Endoscopic Evaluation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: No intervention measure: anastomotic leak measure: anastomotic stenosis measure: laryngeal nerve injury sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital, Shanghai Jiao Tong University status: RECRUITING city: Shanghai zip: SH 21 country: China name: Zhigang Li, Doctor role: CONTACT phone: 86-18930619260 email: zhigang.li@shchest.org lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06348368 id: Soh-Med-23-01-29 briefTitle: Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder overallStatus: COMPLETED date: 2023-01-01 date: 2024-01-30 date: 2024-02-01 date: 2024-04-04 date: 2024-04-09 name: Sohag University class: OTHER briefSummary: Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study conditions: Corneal Ectasia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 4000 type: ACTUAL name: Pentacam and autorefractometry measure: Values anterior and posterior corneal elevation values by pentacam. sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Elshimaa A.Mateen city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06348355 id: D5084C00016 id: 2023-508334-34-00 type: OTHER domain: EMA-CTIS briefTitle: A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-28 date: 2024-06-28 date: 2024-04-04 date: 2024-04-04 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to measure brain exposure of \[11C\]savolitinib in healthy volunteers.

This study will determine brain exposure of \[11C\]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when the BBB is intact. The study design allows up to 3 site visits. Two PET examinations will be performed for each healthy volunteer. The first PET examination will use IV administration of \[11C\]savolitinib. The second PET examination using \[11C\]savolitinib will occur after a single oral dose of 300 mg of savolitinib. PET image analysis will include kinetic compartment modelling using arterial input function, and will generate a set of brain exposure parameters (eg, maximum %ID, maximum \[11C\]savolitinib concentration in brain, partition coefficients between brain and plasma). conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 8 type: ESTIMATED name: [11C]savolitinib name: Savolitinib measure: Percentage of injected radioactivity entering the brain (%ID) as %IDmax_brain measure: The following endpoint: Cmax_brain SUV measure: The following endpoint: Tmax brain measure: The following endpoint: AUCbrain 0-90 measure: The following endpoint: AUCplasma 0-90 measure: The following endpoint: Kp measure: The following endpoint: Kp,uu measure: The following endpoint: VT measure: The following endpoint: Cmax_brain SUV measure: The following endpoint: Tmax brain measure: The following endpoints: AUCbrain 0-90 measure: The following endpoints: AUCplasma 0-90 measure: The following endpoints: Kp measure: The following endpoints: Kp,uu measure: The following endpoints: VT measure: Number of participants with safety findings, AEs sex: ALL minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Solna zip: 171 64 country: Sweden lat: 59.36004 lon: 18.00086 hasResults: False

 nctId: NCT06348342 id: TÜTF-GOBAEK 2023/24 briefTitle: Pelvic Floor Muscle Exercises and Core Exercises in Menopausal Women overallStatus: ENROLLING_BY_INVITATION date: 2023-10-15 date: 2024-04-20 date: 2024-06-30 date: 2024-04-04 date: 2024-04-04 name: Trakya University class: OTHER briefSummary: The prospective and four-arm randomized controlled study was conducted on n = 136 (34 = control, 34 = kegel, 34 = core, 34 = kegel+ core group) menopausal women at Trakya University Health Research and Application Center Urology Polyclinic between Oct 2023 and June 2024. In the first interview, the researcher will apply an information form to all four groups, asking about personal information, habits, bladder irritants and fluid intake-related features, obstetric, gynecological and systemic disease-related features, and stress urinary incontinence-related features. This form will only be filled at the beginning. In addition, the \&amp;#34;Pelvic Floor Distress Scale (PFDI)\&amp;#34; and \&amp;#34;Pelvic Floor Impact Questionnaire (PFIQ)\&amp;#34; will be applied and will be repeated by the executive researcher at the 1st, 2nd and 3rd controls. It will be terminated at the 3rd follow-up. Descriptive statistics, Pearson, Spearman\&amp;#39;s correlation, and regression analyzes will be used in the analysis of research data. conditions: Menopause conditions: Stress Urinary Incontinence conditions: Kegel Exercises conditions: Core Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Before starting the research, four groups of mothers will be randomly formed. As a randomization method, mothers who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumbergenerator.aspx). primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 136 type: ESTIMATED name: Pelvic Floor Muscle Exercise name: Core Exercise measure: Pelvic floor evaluated using the Pelvic Floor Distress Inventory (PFDI - Pelvic Floor Distress Inventionary) measure: Pelvic floor impact evaluated using the Pelvic Floor Impact Questionnaire (PFIQ Pelvic Floor Impact Questionnaire) measure: Urinary incontinence evaluated using the Stress Test measure: Urinary incontinence evaluated using the Uroflowmetry measure: Urinary incontinence evaluated using the Pelvic Floor Muscle Strength Measurement measure: Urinary incontinence evaluated using the Digital Palpation sex: FEMALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bartın University city: Bartin zip: 78100 country: Turkey lat: 41.63583 lon: 32.3375 hasResults: False

 nctId: NCT06348329 id: TÜTF-GOBAEK 2023/41 briefTitle: Pregnant Women Participating in Birth Preparation Training With Their Spouses on the Parenting Role, Attitudes of Their Spouses Towards Participating in the Birth, and Birth Self-Efficacy overallStatus: RECRUITING date: 2023-06-29 date: 2023-10-15 date: 2024-04-15 date: 2024-04-04 date: 2024-04-04 name: Trakya University class: OTHER briefSummary: In this prospective, randomized controlled study, it was aimed to examine the effect of pregnant women participating in birth preparation training together with their partners on the parenting role, spouses' attitudes towards participation in birth, and birth self-efficacy.

The study was shared via the web on social media (Facebook, Instagram, Twitter, Telegram) forum pages between 25.09.2023-25.03.2025, and n=158 pregnant women who met the inclusion criteria and volunteered to participate in the study (79= education without spouse participation, 79= spouse Participatory education) will be conducted randomly in two groups: case and control.

Before starting the research, two groups will be randomly formed among pregnant women. As a randomization method, pregnant women who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx). conditions: Birth Order conditions: Parenting conditions: Self Efficacy conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 158 type: ESTIMATED name: Birth Preparation Training measure: Parenting behavior evaluated using the Postpartum Parenting Behavior Scale measure: Parenting self-efficacy in labor evaluated using the Self-Efficacy in Labor Scale measure: Spouse support evaluated using the Spouse Support Scale measure: Father candidates towards participating in the birth evaluated using the Attitude Scale for Father Candidates Towards Participating in the Birth sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Trakya University status: RECRUITING city: Edirne zip: 22030 country: Turkey name: Burcu Küçükkaya role: CONTACT phone: 05422931357 email: burcukucukkaya1992@gmail.com lat: 41.67719 lon: 26.55597 hasResults: False

 nctId: NCT06348316 id: TÜTF-GOBAEK 2023/45 briefTitle: Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies overallStatus: RECRUITING date: 2023-09-30 date: 2024-04-02 date: 2024-07-30 date: 2024-04-04 date: 2024-04-04 name: Trakya University class: OTHER briefSummary: Aim: In this prospective, randomized controlled study, it was aimed to examine the effects of early half-swaddle and kangaroo care practices in term babies on maternal sleep quality and postpartum depression.

Design: The prospective, randomized controlled study conditions: Mothers conditions: Postpartum Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 136 type: ESTIMATED name: Half swaddle name: Kangaroo care measure: Mother sleep quality evaluated using the Pittsburgh Sleep Quality Index (PSQI) measure: Postpartum depression evaluated using the Edinburgh Postnatal Depression Scale (EPDS) sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Trakya University status: RECRUITING city: Edirne zip: 22030 country: Turkey name: Burcu Küçükkaya role: CONTACT phone: 05422931357 email: burcukucukkaya1992@gmail.com lat: 41.67719 lon: 26.55597 hasResults: False

 nctId: NCT06348303 id: PMMD-01 briefTitle: Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-04-04 date: 2024-04-26 name: Primus Pharmaceuticals class: INDUSTRY name: ClinOhio Research Services, LLC briefSummary: Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each participant will be enrolled to two (2), single dose, study treatment arms in a crossover design. The treatments will occur consecutively with seven (7) days separating days of dosing. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Single mask of participants. Participants will be prevented from knowing product dose. whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Metaxalone m640 mg oral tablet name: Metaxalone 800 mg oral tablet measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test). measure: Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path measure: Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale measure: Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes measure: The number of product related adverse events experienced by participants from Visit 2 through Visit 4 sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: ClinOhio Research Institute status: RECRUITING city: Columbus state: Ohio zip: 43213 country: United States name: J Sanders role: CONTACT phone: 614-683-4900 lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06348290 id: JY-JM1899-105 briefTitle: Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-31 date: 2024-09-15 date: 2024-04-04 date: 2024-04-04 name: Jemincare class: INDUSTRY briefSummary: This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 72 type: ESTIMATED name: JMKX001899 name: Itraconazole name: Midazolam name: Rifampin name: dextromethorphan name: Rosuvastatin name: digoxin measure: maximum concentrations (Cmax ) for plasma measure: area under the curve from time 0 to infinity(AUC0-inf) for plasma measure: area under the curve from time 0 to the last time point (AUC0-t) for plasma sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06348277 id: 121119 briefTitle: Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students overallStatus: COMPLETED date: 2018-01-02 date: 2020-04-07 date: 2020-06-17 date: 2024-04-04 date: 2024-04-04 name: Lawrence University class: OTHER briefSummary: The investigators examined whether brief, app-based interventions were helpful in alleviating mental health symptoms during the transition to college. In particular, the investigators were interested in whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone. conditions: Depression, Anxiety conditions: Self-Injurious Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 130 type: ACTUAL name: Mindfulness plus mood monitoring name: Mood monitoring measure: Depressive Symptoms measure: Anxiety Symptoms measure: Urges to Self-injure measure: Rumination measure: Worry measure: Depressive Symptoms measure: Depressive Symptoms measure: Anxiety Symptoms measure: Anxiety Symptoms measure: Urges to self-injure measure: Urges to self-injure measure: Rumination measure: Rumination measure: Worry measure: Worry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lawrence University city: Appleton state: Wisconsin zip: 54911 country: United States lat: 44.26193 lon: -88.41538 hasResults: False

 nctId: NCT06348264 id: SDC-1 briefTitle: Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma overallStatus: RECRUITING date: 2024-03-30 date: 2029-03-30 date: 2031-03-30 date: 2024-04-04 date: 2024-04-04 name: Peking University First Hospital class: OTHER name: Jiangsu Hengrui Pharmaceutical Co., Ltd. name: Beijing Biote Pharmaceutical Co.,Ltd briefSummary: The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC).

The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years. conditions: Salivary Gland Neoplasm Duct studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Rezvilutamide name: Leuprolide Acetate measure: 3-year disease-free survival (DFS) measure: 3-year overall survival (OS) measure: 3-year disease-specific survival (DSS) measure: 3-year distant-metastatic free survival (DMFS) measure: Adverse events measure: 5-year disease-free survival (DFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Xueying Ren, MD role: CONTACT phone: +86 10 83572408 email: xy_ren1031@126.com lat: 39.9075 lon: 116.39723 facility: Peking University School and Hospital of Stomatology status: RECRUITING city: Beijing state: Beijing country: China name: Xiaofeng Shan, MD role: CONTACT phone: +86 10 82195390 email: kqsxf@263.net lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06348251 id: STU00219612 briefTitle: FoodSteps for Binge Eating & Food Insecurity overallStatus: RECRUITING date: 2024-03-26 date: 2024-11-30 date: 2024-11-30 date: 2024-04-04 date: 2024-04-04 name: Northwestern University class: OTHER briefSummary: The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity. conditions: Binge Eating conditions: Type 2 Diabetes conditions: Food Insecurity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: FoodSteps measure: Recruitment and retention rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University Feinberg School of Medicine status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Andrea K Graham, PhD role: CONTACT phone: 312-503-5266 email: andrea.graham@northwestern.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06348238 id: 2074997 briefTitle: Strategies to Improve Well-Being and Diabetes Management overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-28 date: 2027-02-28 date: 2024-04-04 date: 2024-04-04 name: Elizabeth Scharnetzki class: OTHER name: MaineHealth Institute for Research briefSummary: This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are:

* Will self-affirmation reduce feelings of stigmatization?
* Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors.
* Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it.

After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 150 type: ESTIMATED name: Self-Affirmation measure: Social Identity Threat Concerns (SITC) Scale measure: Two-Factor Weight Bias Internalization Scale measure: Diabetes Stigma Assessment Scale measure: The Revised Diabetes Self-Management Questionnaire measure: Confidence in Diabetes Self-Care Scale measure: Blood glucose measure: Hemoglobin A1C measure: Patient-reported age measure: Patient Gender measure: Patient Race measure: Patient ethnicity measure: Patient's highest level of education completed measure: Household income measure: Zip code measure: Years since diagnosis measure: Diabetes Management Plan measure: Physical activity measure: Continuous glucose monitor use measure: Height measure: Weight measure: History of weight-based victimization (moderator/covariate) measure: Problem Areas in Diabetes Questionnaire (moderator/covariate) measure: Generalized Anxiety Disorder 7-item (moderator/covariate) measure: Patient Health Questionnaire (PHQ-9) (moderator/covariate) measure: Stigma Consciousness Questionnaire (moderator/covariate) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research city: Westbrook state: Maine zip: 04092 country: United States name: Elizabeth Scharnetzki role: CONTACT phone: 805-340-9716 email: elizabeth.scharnetzki@mainehealth.org lat: 43.67703 lon: -70.37116 hasResults: False

 nctId: NCT06348225 id: FY24-10 briefTitle: Post-exercise Hot Water Immersion to Improve Overnight Blood Pressure acronym: ExHT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: Providence College class: OTHER briefSummary: The goal of this clinical trial is to test whether putting your legs in a hot bath after exercise improves blood pressure in people with higher blood pressure.

. The main questions it aims to answer are:

* Whether exercise alone, hot water leg bath alone, or both treatments together cause blood pressure to be lower during sleep.
* If there are any changes in heart rhythm or blood vessel health after exercise, hot water leg bath, or the two treatments together that relate to changes in blood pressure.

Participants will complete four different trials:

* 30 minutes of walking with a 45-minute lukewarm leg bath after
* 30 minutes of walking with a 45-minute hot leg bath after
* 45 minutes of a hot leg bath with no exercise
* A day with no exercise or leg bath Researchers will look at their heart rhythm, blood vessels, and blood pressure after each of these trials to see if there are differences, and if exercise and heat together can improve heart health more than exercise or heat alone. conditions: Elevated Blood Pressure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A repeated-measures design will be used with all participants completing the three acute interventions (exercise, heat, or exercise + heat) as well as a control day. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: It is not possible to mask the participant to treatments (exercise/no exercise, water temperature, etc) or the PI who is monitoring them during treatment. However, all data (hourly blood pressure, heart rate variability, and flow-mediated dilation) will be analyzed by an individual blinded to the trial/intervention. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Exercise or heat treatment measure: Ambulatory blood pressure measure: Heart Rate Variability measure: Flow-mediated dilation sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-28 uploadDate: 2024-03-28T10:14 filename: Prot_SAP_000.pdf size: 198276 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-28 uploadDate: 2024-03-28T10:15 filename: ICF_001.pdf size: 162356 hasResults: False

 nctId: NCT06348212 id: 2022-11-008C briefTitle: Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID acronym: COVID-19 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08 date: 2025-12 date: 2024-04-04 date: 2024-04-04 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: The goal of this clinical trial is to test whether the intervention of probiotics supplement can improve symptoms of long covid syndrome.

Participants will be given probiotics or placebo capsules for two month. Symptom questionnaires, cognitive function, eeg and fecal sample are recorded/collected before and after the supplement.

Researchers will compare the probiotic group and the placebo to see if probiotic supplement really make differences. conditions: Long COVID conditions: Brain Fog conditions: Cognitive Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Randomization were performed by the provider of probiotic and placebo. The participant will never know their group. The study Investigator and Outcome assessor will not know the groups of participants until they finish recruiting and data processing. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Lactobacillus paracasei PS23 name: microcrystalline cellulose measure: Long covid related symptoms measure: Hospital Anxiety and Depression Scale measure: The Pittsburgh sleep quality index measure: Fatigue Severity Scale measure: GI symptoms measure: Cognitive function-Digit symbol substitution test measure: Cognitive function-The Montreal Cognitive Assessment(MoCA) measure: Cognitive function-Color Trails making Test measure: Cognitive function-Cogstate Brief Battery (CBB) measure: EEG measure: Gut microbiota measure: Fecal metabolite sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06348199 id: SB27-3004 briefTitle: A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-03-12 date: 2025-09 date: 2027-03 date: 2024-04-04 date: 2024-04-19 name: Samsung Bioepis Co., Ltd. class: INDUSTRY briefSummary: The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:

• How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.

Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda. conditions: Non-small Cell Lung Cancer Stage IV studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 616 type: ESTIMATED name: SB27 name: Keytruda measure: Objective response rate (ORR) at Week 24 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SB Investigative Site status: RECRUITING city: Batumi country: Georgia lat: 41.64228 lon: 41.63392 facility: SB Investigative Site status: RECRUITING city: Tbilisi country: Georgia lat: 41.69411 lon: 44.83368 facility: SB Investigative Site status: RECRUITING city: Jaipur country: India lat: 26.91962 lon: 75.78781 facility: SB Investigative Site status: RECRUITING city: Surat country: India lat: 21.19594 lon: 72.83023 facility: SB Investigative Site status: RECRUITING city: Cluj-Napoca country: Romania lat: 46.76667 lon: 23.6 facility: SB Investigative Site status: RECRUITING city: Craiova country: Romania lat: 44.31667 lon: 23.8 facility: SB Investigative Site status: RECRUITING city: Sibiu country: Romania lat: 45.8 lon: 24.15 facility: SB Investigative Site status: RECRUITING city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06348186 id: Fascial Tissue Response briefTitle: Fascial Tissue Response To Manual Therapy: Implications In Long Covid Rehabilitation overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-01 date: 2024-07-31 date: 2024-04-04 date: 2024-04-04 name: University of the State of Santa Catarina class: OTHER name: Larissa Sinhorim briefSummary: According to the World Health Organization (WHO), as of mid-September 2022, more than 21 million Brazilians have recovered from COVID-19. However, post-infection symptoms continue to appear months after the end of the acute infection, a syndrome called long COVID. Therefore, the aim of this study is to investigate the responses of fascia-focused manual therapy in participants with long COVID. conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Guidebook name: Guidebook and Myofascial Reorganization® (RMF). measure: Functioning and disability measure: Biomechanical and tissue viscoelastic properties measure: Work capacity measure: Quality of life measure: Upper limb dysfunctions measure: Balance sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Santa Catarina State University status: RECRUITING city: Florianópolis state: Santa Catarina zip: 88.035-001 country: Brazil name: Larissa Sinhorim role: CONTACT lat: -27.59667 lon: -48.54917 hasResults: False

 nctId: NCT06348173 id: 2021-2190 briefTitle: Response and Remission to Treatment With Anti-IL5/IL5R Antagonists overallStatus: COMPLETED date: 2023-06-01 date: 2023-11-30 date: 2023-11-30 date: 2024-04-04 date: 2024-04-04 name: Université de Montréal class: OTHER name: GlaxoSmithKline briefSummary: The aim of this retrospective observational study is to compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials.

This study will be performed using the charts of the patients. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 109 type: ACTUAL name: Mepolizumab measure: Response to IL5/IL5R antagonists one year after cohort entry among subjects fulfilling and not fulfilling the original RCT inclusion criteria measure: Remission rate with IL5/IL5R antagonists one year after cohort entry in subjects fulfilling and not fulfilling the original RCT inclusion criteria sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital du Sacré-Coeur de Montréal city: Montréal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06348160 id: STUDY20230187 briefTitle: iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-04 date: 2024-04-04 name: Julia Blanchette class: OTHER name: The Leona M. and Harry B. Helmsley Charitable Trust briefSummary: This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 192 type: ESTIMATED name: iHERO Toolkit Resource measure: Change in financial stress as measured by the Personal Financial Well-Being Scale© (PFW) Scale (PFW) measure: Change in health insurance literacy as measured by The Health Insurance Literacy Measure (HILM) Measure (HILM) measure: Change in diabetes-specific quality of life as measured by The Type 1 Diabetes and Life Young Adult (T1DAL- Young Adult) for ages 18-25 or The Type 1 Diabetes and Life (T1DAL- Adult) for Ages 26-30. measure: Change in transition navigation readiness as measured by the The Readiness for Emerging Adults with Diabetes Diagnosed in Youth (READDY) Navigation Subscale measure: Change in HbA1c levels as measured by self-collect capillary HbA1c sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Children's Hospital Los Angeles city: Los Angeles state: California zip: 90027 country: United States name: Jaquelin Flores Garcia, MPH role: CONTACT name: Jennifer Raymond, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: University of Florida Diabetes Institute city: Gainesville state: Florida zip: 32610 country: United States name: Michael Haller, MD role: CONTACT name: Michael Haller, MD role: PRINCIPAL_INVESTIGATOR lat: 29.65163 lon: -82.32483 facility: University Hospitals city: Cleveland state: Ohio zip: 44106 country: United States name: Dionne Williams, PhD role: CONTACT phone: 216-238-6100 email: dionne.williams@uhhospitals.org lat: 41.4995 lon: -81.69541 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Steven Willi, MD role: CONTACT name: Steven Willi, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06348147 id: LCCC2323 briefTitle: Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-05 date: 2028-08 date: 2024-04-04 date: 2024-04-10 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.

This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing. conditions: Newly Diagnosed Multiple Myeloma conditions: Multiple Myeloma conditions: Autologous Stem Cell Transplantation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Daratumumab name: Lenalidomide name: Bortezomib name: Dexamethasone measure: The rate of achievement of bone marrow minimal residual disease (MRD) negativity measure: Progression Free Survival (PFS ) measure: Stringent complete response (sCR) measure: Overall Survival (OS) measure: Therapeutic discontinuation measure: Time to first response measure: Time to best response measure: Maximum depth of response (from PR to CR, including sCR) measure: Overall response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Lineberger Comprehensive Cancer Center city: Chapel Hill state: North Carolina zip: 27516 country: United States name: Ralph L Dessieu role: CONTACT email: ralph-lyne_dessieu@med.unc.edu name: Samuel M Rubinstein, MD, MSCI role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06348134 id: IRB23-0502 briefTitle: Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2034-07-01 date: 2036-07-01 date: 2024-04-04 date: 2024-04-04 name: University of Chicago class: OTHER briefSummary: Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery. conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast conditions: HER2-positive Breast Cancer conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: Trastuzumab emtansine name: Pertuzumab Injection name: Docetaxel name: Tamoxifen name: Letrozole name: Goserelin measure: Pathological Complete Response measure: Reported Adverse Events and clinical/medical records of participants measure: Percentage of participants who are suitable for breast-conserving surgery measure: Event-free survival duration reported among participants measure: Quality of life reported among study participants measure: Genetic and epigenetic factors associated with breast cancer in Nigeria sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago city: Chicago state: Illinois zip: 60615 country: United States name: Olufunmilayo Olufunmilayo role: CONTACT phone: 773-702-1632 email: folopade@medicine.bsd.uchicago.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06348121 id: WK2024003 briefTitle: Impact of Probiotics on Children With ADHD overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2024-08-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-26 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: To evaluate the efficacy and safety of probiotic product WecProB as food supplements for the treatment of clinical symptoms in children with ADHD, in comparison with placebo. conditions: Attention Deficit Hyperactivity Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Probiotic measure: Clinical symptoms of ADHD sex: MALE minimumAge: 6 Years maximumAge: 14 Years stdAges: CHILD hasResults: False

 nctId: NCT06348108 id: 232514 id: NCI-2024-01992 type: REGISTRY domain: NCI Clinical Trials Reporting Program briefTitle: Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-06-30 date: 2028-06-30 date: 2024-04-04 date: 2024-04-04 name: Thomas Martin, MD class: OTHER name: Bristol-Myers Squibb name: Janssen Research & Development, LLC briefSummary: This phase I trial tests the safety, side effects, and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma (RRMM) who are triple class refractory and have been exposed to B-cell maturation antibody (BCMA) targeted therapy. These patients currently have limited treatment options and poor survival. Talquetamab is approved for use by the Food and Drug Administration (FDA) to treat RRMM when given alone. Talquetamab can bring T-cells to the myeloma cell, resulting in myeloma cell death. Iberdomide is an investigational drug. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. Dexamethasone is a corticosteroid, is similar to a natural hormone produced by the adrenal glands. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain types of cancer including myeloma. Giving talquetamab in combination with iberdomide and dexamethasone may be safe, tolerable and effective in treating patients with RRMM conditions: Multiple Myeloma conditions: Refractory Multiple Myeloma conditions: Relapsed Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Talquetamab name: Iberdomide name: Dexamethasone name: Bone Marrow Biopsy measure: Proportion of participants reporting treatment-emergent adverse events (AEs) (Dose Escalation Cohorts) measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Escalation Cohorts) measure: Recommended phase 2 dose (RP2D) (Dose Escalation Cohorts) measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Expansion Cohort) measure: Objective response rate (ORR) (Dose Expansion Cohort) measure: Objective response rate (ORR) (Dose Escalation Cohorts) measure: Number of participants achieving VGPR or CR and MRD (negative (-)) response measure: Proportion of participants with treatment-related adverse events measure: Changes in scores on the European Organization for Research and Treatment of Cancer - Quality of Life questionnaire (EORTC-QLQ-C30) over time measure: Changes in scores on the EORTC QLQ- Multiple Myeloma Questionnaire (EORTC-QLQ-M20) over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Calfornia, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Kenya Gomez role: CONTACT email: Kenya.Gomez@ucsf.edu role: CONTACT phone: 877-827-3222 email: cancertrials@ucsf.edu lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06348095 id: WK2024004 briefTitle: Effect of Probiotics on Viral Pneumonia overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2024-10-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-26 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with viral pneumonia, in comparison with placebo. conditions: Viral Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 72 type: ESTIMATED name: Probiotic name: Placebo measure: Respiratory syncytial virus (RSV) viral load sex: ALL minimumAge: 6 Months maximumAge: 3 Years stdAges: CHILD hasResults: False

 nctId: NCT06348082 id: 2000036068 id: 1R18HS029812-01 type: AHRQ link: https://reporter.nih.gov/quickSearch/1R18HS029812-01 briefTitle: Project Women's Insomnia Sleep Health Equity Study (WISHES) acronym: Project WISHES overallStatus: NOT_YET_RECRUITING date: 2025-09 date: 2028-07 date: 2028-07 date: 2024-04-04 date: 2024-04-05 name: Yale University class: OTHER name: Department of Health and Human Services briefSummary: The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women. conditions: Insomnia conditions: Sleep Health conditions: Cardiometabolic Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Hybrid Type 1 effectiveness/implementation study using a pragmatic randomized controlled trial (RCT) with MBTI and a waitlist control. Participants will be randomly assigned by a computer-generated sequence to either the MBTI or waitlist control in a 1:1 ratio using permuted blocks stratified by age (2 strata: ≤50 or postmenopausal age \>51) with random block sizes of 2 or 4 to reduce predictability. primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 340 type: ESTIMATED name: Mindfulness-based therapy for insomnia (MBTI) measure: Change in Insomnia Severity measure: Change in Perceived Stress measure: Acceptability of Intervention (AIM) measure: Feasibility of Intervention (FIM) measure: Treatment Fidelity sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale School of Nursing Biobehavioral Lab city: West Haven state: Connecticut zip: 06516 country: United States lat: 41.27065 lon: -72.94705 hasResults: False

 nctId: NCT06348069 id: 2022-11-15783 briefTitle: Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe acronym: TOPAZ overallStatus: RECRUITING date: 2024-03-25 date: 2025-03-11 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: University of California, Berkeley class: OTHER name: Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe) name: University of California, San Francisco name: Liverpool School of Tropical Medicine briefSummary: Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr. Euphemia Sibanda, Reader (Associate Professor) of Global Health and Epidemiology at Liverpool School of Tropical Medicine, UK and Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe) and Dr. Sandra McCoy, Professor of Epidemiology and Biostatistics at the University of California, Berkeley. The goal of the proposed study is to optimize, refine and pilot a pharmacy-based PrEP intervention for female sex workers (FSW) in Zimbabwe. Despite efforts to reach the most impacted and vulnerable populations with PrEP, retention rates, particularly among FSW in Africa, are very low. Relatively high levels of uptake indicate that FSW are interested in PrEP and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. Pharmacy-based PrEP has the potential to address known barriers to PrEP retention among FSW such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of PrEP. conditions: Adherence, Medication conditions: HIV Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Groups (sites/clusters) are randomized to either the intervention (pharmacy-based PrEP refills plus gift card incentives) or the control (standard of care) and are followed and compared over time. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 200 type: ESTIMATED name: Pharmacy-based PrEP refill and gift voucher name: Control (Standard of care) measure: PrEP retention at 6 months measure: PrEP retention at 6 months among FSW who are 18-24 years of age measure: : PrEP retention at 6 months among participants who have remained active in sex work measure: FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies measure: HIV tests measure: HIV care referrals sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CESHHAR Zimbabwe status: RECRUITING city: Harare zip: 0000 country: Zimbabwe name: Oppah Kuguyo role: CONTACT email: oppah.kuguyo@ceshhar.co.zw lat: -17.82772 lon: 31.05337 hasResults: False

 nctId: NCT06348056 id: 2022-07-15499 briefTitle: A Comparison of the Metabolic Effects of Zinc-Amino Acid (ZnAA) Versus Zinc Gluconate overallStatus: RECRUITING date: 2024-01-22 date: 2024-08-30 date: 2024-12-31 date: 2024-04-04 date: 2024-04-08 name: University of California, Berkeley class: OTHER briefSummary: Food consumption affects zinc metabolism within the body. Lowe and colleagues demonstrated that zinc is directed out of plasma and into tissues, such as into the liver, postprandially . It is likely that zinc absorbed with a meal is directed to the liver via the portal circulation whereas that zinc taken in the fasted state is more readily directed to peripheral blood plasma. Zinc taken with food is more likely to be bound to components of the food matrix and, therefore, it is not absorbed as efficiently by Zip4 ionic zinc transporters in the upper gastrointestinal tract. Some of the zinc in the food matrix may, however, be co-absorbed with amino acids over the whole length of the small intestine . Co-absorption of zinc with amino acids may explain the greater effects of zinc taken with food on omega-6 fatty acid desaturation . The investigators propose that this effect may be maximized by providing supplemental zinc complexed with amino acids. Since the zinc amino acid complex likely mimics the absorption and retention of zinc bound to protein in food, the investigators further propose that zinc, bound to amino acids taken in the fasted state will be directed into the cellular compartments more efficiently than zinc associated with gluconate.

The primary aim in this study is to determine whether providing a zinc amino acid complex has a greater effect on indices of essential fatty acid desaturation compared with zinc gluconate when the zinc complexes are taken in the fasting state.

The investigators hypothesize that taking a zinc amino acid (Zn-AA) complex in a fasted state daily for two weeks has a greater effect on the Fatty Acid Desaturase 1 (FADS1) activity compared with zinc gluconate. Also, if the uptake of ionic zinc gluconate into cellular compartments is reduced in comparison to Zn-AA because the zinc gluconate is retained in the plasma, two weeks of a daily zinc gluconate will have a greater effect on fasting plasma zinc concentrations compared to a Zn- AA complex. conditions: Response of Fatty Acid Desaturation to Zinc Intake studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will take the first zinc supplement for two weeks, followed by a two-week washout period, and then take the second zinc supplement for two weeks. The order of whether the first supplement is the zinc amino acid complex, or zinc gluconate, will be randomized. primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: The two zinc supplements will have the same appearance, and will be in coded bottles, such that the participant, care provider, investigator, and outcomes assessor may be kept unaware of the order of the supplements for each participant until the data analysis is complete. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: 30 mg Zn Amino Acid daily for 13 days name: 30 mg Zn Gluconate daily for 13 days measure: FADS1 activity index measure: Fasted plasma zinc concentration sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of California, Berkeley status: RECRUITING city: Berkeley state: California zip: 94720 country: United States name: Yasaman Massih, MPH role: CONTACT phone: 415-279-2171 email: ynmassih@berkeley.edu lat: 37.87159 lon: -122.27275 hasResults: False

 nctId: NCT06348043 id: SU_PumpKIN id: 1UG3HL163311-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1UG3HL163311-01A1 briefTitle: Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial acronym: PumpKIN overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2028-12 date: 2029-12 date: 2024-04-04 date: 2024-04-04 name: Stanford University class: OTHER name: University of Texas name: Carelon Research name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases. conditions: Heart Failure With Reduced Ejection Fraction conditions: Pediatric HD, Stage IV conditions: LVAD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Jarvik 2015 LVAD measure: Survival to heart transplant, recovery or 180 days of support in the absence of severe stroke. measure: Freedom from symptomatic stroke measure: Incidence rate of all protocol-defined SAE's through 180 days of support definitely or probably related to the device measure: Distribution of Pediatric Stroke Outcomes Measures measure: The KOSCHI score measure: Overall survival on Jarvik 2015 support to 180 days sex: ALL minimumAge: 6 Months maximumAge: 16 Years stdAges: CHILD hasResults: False

 nctId: NCT06348030 id: 17401 briefTitle: Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-04-04 date: 2024-04-08 name: St. Joseph's Healthcare Hamilton class: OTHER briefSummary: Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels \<7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Medtronic Signia Stapler name: Vessel Sealer Extend Energy Device and SureForm Stapler measure: Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection measure: Operating Room Time measure: Length of Stay in Hospital measure: Duration of Chest Tube measure: Intraoperative Complications and Adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Joseph's Healthcare Hamilton city: Hamilton state: Ontario zip: L8N 4A6 country: Canada name: Yogita S Patel, BSc role: CONTACT phone: 905-522-1155 phoneExt: 35096 email: patelys@mcmaster.ca name: Waël C Hanna, MDCM, MBA, FRCSC role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 hasResults: False

 nctId: NCT06348017 id: Yozgat City Hospital briefTitle: Frequency of Neuropathic Pain in Patients With Plantar Fasciitis overallStatus: COMPLETED date: 2023-10-19 date: 2024-03-01 date: 2024-03-15 date: 2024-04-04 date: 2024-04-09 name: Yozgat City Hospital class: OTHER briefSummary: Study Design This prospective cross-sectional study was undertaken between November 2023 and March 2024. Written and verbal informed consent was obtained from all patients. The study protocol was approved by University Human Research Ethics Committee (AEŞH-EK 1-2023-612).

Patients While 106 patients who applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months, received foot radiography and were diagnosed with PF were included in the study as a patient group; 100 patients who did not have foot pain and had musculoskeletal pain for at least 6 months were included in the study as a control group, between November 2023 and March 2024. All the participants were aged 18 to 65 years. Patients with a history of diabetes, hypothyroidism and CKD, a history of malignancy, with vasculitis, neurological diseases that may cause neuropathic pain, lumbar discopathy, those with a previous history of fracture or surgery in the heel area, received injections or ESWT treatment due to heel pain in the last 3 months, rheumatic diseases that may affect pain such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, and severe circulatory disorders on the side with pain, were excluded from the study. The study was commenced after obtaining the approval of the local ethics committee and informed consent of the participants.

All patients' personal information (age, gender, occupation, education information), general health information (smoking and alcohol use information, known chronic disease history, body mass index), severity of heel pain and when it started were recorded. While the Foot Function Index (FFI) scale, which evaluates the functionality of the foot, was applied to the patient group; the Visual Analog Scale (VAS), which evaluates pain intensity, the Pain-DETECT scale, which evaluates neuropathic pain, and the Central Sensitization Scale (CSI), which evaluates central sensitization, were applied to the patient and control groups. The details of the implementation of the instruments are as follows: conditions: Chronic Plantar Fasciitis conditions: Control Group studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 206 type: ACTUAL measure: Pain-DETECT measure: Foot Function Index measure: Central Sensitization Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yozgat City Hospital city: Yozgat zip: 66100 country: Turkey lat: 39.82 lon: 34.80444 hasResults: False

 nctId: NCT06348004 id: 2024IIT-0125 briefTitle: The Association Between Albumin Administration and Short-term Rebleeding Risk in Cirrhosis Patients With Acute Variceal Hemorrhage and Stable Hemodynamics overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2024-04 date: 2024-04 date: 2024-04-04 date: 2024-04-04 name: Zhejiang University class: OTHER briefSummary: The impact of albumin administration in cirrhotics with acute variceal hemorrhage (AVH) is controversial. We aim to investigate the short-term rebleeding risk associated with albumin administration in a retrospective study of hospitalized cirrhotics with AVH with stable hemodynamics. This retrospective analysis includes clinical data of cirrhosis patients with acute variceal bleeding admitted to our hospital from January 2021 to October 2023. Propensity score matching will be performed to account for potential confounders associated with albumin use for outcome analysis. According to the outcome, patients will be divided into rebleeding group and non-rebleeding group. To investigate the impact of albumin infusion on the rebleeding risk in the propensity-matched cohort, patients will be divided into albumin user group and albumin non-user group. The primary outcome is the rebleeding risk within 30 days after discharge. conditions: Cirrhosis conditions: Acute Variceal Haemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: The rebleeding risk within 30 days after discharge. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06347991 id: Pro00140155 briefTitle: Alberta Chiropractic SelfBack Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: University of Alberta class: OTHER name: Chiropractic Association of Alberta briefSummary: Recurrent and persistent low back pain (LBP) is a massive problem in Canada that causes a substantial pain, disability, cost, and even premature death.

The good news is that treatments for recurrent and persistent LBP are available. Many guidelines now recommend education and exercise as the best intervention for chronic LBP. Unfortunately, education and exercise programs are not publicly funded in Canada-only Canadians with extended health benefits can access these programs.

As a result, the 50% of Canadians who do not have extended health benefits often seek care for LBP from their publicly funded physicians. Physicians, in turn, have little choice but to reach for what they have available, including opioids, x-rays and referrals to specialists. Not only are these interventions unhelpful for chronic LBP, they are often harmful, sometimes deadly, and disproportionately affect lower socio-economic status households.

A possible solution to this problem exists in a validated app (SelfBack) that provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of treatment plans to individuals is achieved by using case-based reasoning (CBR) methodology which is a branch of artificial intelligence.

This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through their chiropractors.

The results of this study will help us understand the barriers and facilitators of distributing and using the app through Alberta Chiropractors. This information will be used to apply for funding for a larger study to understand the effectiveness of the app as an intervention for persistent and recurrent LBP. conditions: Chronic Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: SelfBack measure: The percentage of patients who utilize the SelfBack app measure: The percentage of clinicians who utilize the SelfBack app sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347978 id: 24-41296 briefTitle: Personalized DBS for OCD Guided by Stereoencephalography Mapping overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-04 date: 2024-04-04 date: 2024-04-04 name: Andrew Moses Lee, MD, PhD class: OTHER briefSummary: This is a double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment. conditions: Obsessive-Compulsive Disorder conditions: OCD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 10 type: ESTIMATED name: Deep Brain Stimulation measure: Primary Feasibility Endpoint #1 - Stimulation Target That Acutely Improves OCD Symptoms measure: Primary Feasibility Endpoint #2 - Identifying an electrophysiological biomarker of OCD measure: Primary Feasibility Endpoint #3 - Acute Symptomatic Improvement measure: Primary Feasibility Endpoint #4 - Completion of Stages 1 and 2 measure: Primary Safety Endpoint - Serious Adverse Events measure: Primary Efficacy Endpoint - Treatment Response measure: Secondary Efficacy Endpoint #1 - Improvement in YBOCS scores from Baseline measure: Secondary Efficacy Endpoint #2 - Improvement in OCD Symptoms from Baseline measure: Secondary Efficacy Endpoint #3 - Improvement in Depression Symptoms from Baseline sex: ALL minimumAge: 22 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06347965 id: IIT20220541B-R1 briefTitle: Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy overallStatus: COMPLETED date: 2023-02-01 date: 2023-11-30 date: 2024-02-20 date: 2024-04-04 date: 2024-04-04 name: Xin Wang class: OTHER briefSummary: The goal of this clinical trial is to verify the effectiveness and safety of the low load blood flow restriction training program. The intervention effect, tolerance and compliance of low load blood flow restriction training and progressive resistance training on lung cancer patients complicated with sarcopenia during chemotherapy will be compared, in order to provide new ideas for improving or reversing sarcopenia.

The main questions it aims to answer are:

Can low load blood flow restriction training improve sarcopenia in chemotherapy induced lung cancer patients? Which training method is more effective and tolerable between low load blood flow restriction training and progressive resistance training?

Participants will be randomly divided into 3 groups：

1. Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.
2. Low load blood flow restriction group (LL-BFRT): The researchers will provide participants with a low load blood flow restriction training program constructed by our research group.
3. Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training. conditions: Sarcopenia conditions: Lung Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ACTUAL name: Low load blood flow restriction training name: Progressive resistance training group measure: Grip strength measure: Appendicular Skeletal Muscle Index (ASMI) measure: Step speed measure: Body mass index (BMI) measure: Quality of life for lung cancer patients measure: Exercise compliance measure: Exercise safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital, Zhejiang University School of Medicine city: HangZhou state: Zhejiang zip: 310020 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06347952 id: SE1188 briefTitle: Mapping Arterial Perforators Within the Breast During Mammoplasty acronym: Map-total overallStatus: COMPLETED date: 2022-04-27 date: 2024-01-25 date: 2024-01-29 date: 2024-04-04 date: 2024-04-04 name: Royal Marsden NHS Foundation Trust class: OTHER briefSummary: Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result.

In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery.

We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery.

A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps).

We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply.

In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ACTUAL name: Use of Acoustic and color imaging doppler during surgery for breast cancer measure: Full-thickness (complete or partial) necrosis of nipple-areolar complex sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Marsden - Surrey city: Sutton state: England zip: SM2 5PT country: United Kingdom lat: 51.35 lon: -0.2 hasResults: False

 nctId: NCT06347939 id: 2023-06638-01 briefTitle: Mediastinal EBUS Cryobiopsy Study In Sweden acronym: MECRIS overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2028-12-31 date: 2024-04-04 date: 2024-04-19 name: Region Skane class: OTHER briefSummary: This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis).

Follow up four weeks after the procedure to assess the risk for postoperative complications. conditions: Mediastinal Lymphadenopathy conditions: Lung Cancer conditions: Sarcoidosis conditions: Lymphoma conditions: Tuberculosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Mediastinal lymph nodes cryobiopsies measure: Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis. measure: Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Respiratory medicine and allergy department, Skåne University Hospital status: RECRUITING city: Lund country: Sweden name: Hamid Akbarshahi, MD, PhD role: CONTACT phone: 004646171000 email: hamid.akbarshahi@med.lu.se lat: 55.70584 lon: 13.19321 facility: Norrlands universitetssjukhus status: RECRUITING city: Umeå country: Sweden name: Annelie Behndig, MD, PhD role: CONTACT phone: 0907850000 email: annelie.behndig@umu.se lat: 63.82842 lon: 20.25972 hasResults: False

 nctId: NCT06347926 id: PROICM 2023-11 EVA briefTitle: Evaluation of the Effect of Photobiomodulation on Sexual Quality of Life in Women With Breast Cancer acronym: EVABIOSEIN overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-08 date: 2025-08 date: 2024-04-04 date: 2024-04-04 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER briefSummary: The treatment of breast cancer as well as the disease are responsible for genito-urinary symptoms that can persist over time and impair quality of life. Given the improved prognosis of breast cancer, more and more patients are confronted with specific post-cancer issues, and the care has become a major health challenge.

Sexual health is a crucial component of well-being and overall quality of life. Vaginal dryness and dyspareunia are symptoms frequently found in patients treated for breast cancer, with chemotherapy and hormone therapy as risk factors. However, the treatment of sexual disorders remains underdeveloped in France.

Vaginal dryness is part of a broader syndrome known as genitourinary syndrome of menopause (GSM), or vulvovaginal atrophy, which may combine vulvovaginal (dryness, irritation, burning), sexual (dyspareunia) and urinary (infections, pollakiuria, urgency) symptoms secondary to hypoestrogenemia, exacerbated by breast cancer treatments. Since hormonal treatments are contraindicated, the first-line treatment for GSM in patients treated for breast cancer is the application of non-hormonal trophic treatments (regular vaginal moisturizers, lubricants during intercourse). However, these treatments are often insufficient to provide effective relief. There is therefore growing interest in the development of second-line treatments for GSM : intra-vaginal hyaluronic acid injections, laser, photobiomodulation (PBM), etc. PBM using Light Emitting Diodes (LED) has been proposed as an alternative treatment for genitourinary syndrome of the menopause. The tissues are exposed to light sources in the visible spectrum, inducing non-thermal, non-cytotoxic biological effects that improve vaginal tissue trophicity. A study is planned to evaluate the use of photobiomodulation in 2nd-line treatment of GSM (after 1st-line treatment with vaginal moisturizers) and on the quality of sexual life of patients treated for breast cancer at any stage of treatment. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Treatment by photobiomodulation primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Photobiomodulation measure: Sexual satisfaction score on one dimension of the SHQ-22 questionnaire measure: Sexual quality of life scores obtained on all dimensions of the SHQ-22 questionnaire measure: Patient Global Impression of Improvement (PGI-I) score measure: Determination of the Vaginal Health Index clinical score measure: Determination of symptoms of vulvovaginal atrophy by a visual numerical scale measure: Determination of adverse events by using Common Terminology Criteria for Adverse Events (CTCAE) scale of the National Cancer Institute. measure: Number of patients taking other treatments for treating sexual troubles sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Cancer in Montpellier city: Montpellier state: Hérault zip: 34298 country: France name: Angélique Bobrie, MD role: CONTACT phone: 467618576 phoneExt: +33 email: angelique.bobrie@icm.unicancer.fr name: Angélique Bobrie, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06347913 id: Soh-Med-24-03-09MS briefTitle: Umblical Artery Systolic \Diastolic Ratio and Amniotic Fluid Index in Prediction of Fetal Outcome in Term Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2025-03 date: 2024-04-04 date: 2024-04-04 name: Sohag University class: OTHER briefSummary: Antepartum fetal surveillance is the cornerstone of management in pregnancy. \[1\] It is done primarily to reduce the incidence of adverse fetal outcomes. It minimizes morbidity by optimizing the timing of delivery. Fetus at risk of chronic hypoxia is identified and unnecessary interventions are avoided. However, fetal surveillance acts as a diagnostic modality to detect the influence of maternal, placental, and fetal factors on the fetus. The timely detection of morbid changes in the fetal status followed by adequate interventions to avoid death or disability is one of the most important objectives of prenatal care. \[2\] Tests now commonly done for antepartum fetal surveillance are nonstress test (NST), amniotic fluid index (AFI), biophysical profile, Doppler study of umbilical artery (UA), and middle cerebral artery (MCA).\[3 6\] However, AFI and UA Doppler velocimetry both form an essential part of the antenatal surveillance in the assessment of fetal well being. UA Doppler is a powerful tool that allows the obstetrician to follow a sequence of fetal hemodynamic events that happen in response to placental insufficiency. \[7\] However, several studies have reported higher sensitivities and specificities for UA Doppler ratio for prediction of fetal prognosis. \[3 6\] Amniotic fluid is the product of complex and dynamic fetal and placental physiologic processes. Disruption of the fine balance may result in overproduction or underproduction of fluid. Liquor adequacy often reflects the fetal status. Oligohydramnios is associated with increased perinatal loss. Furthermore, other studies indicate that UA velocimetry is a predictor of adverse outcomes in pregnancies complicated by oligohydramnios. \[8,9\] Thus, arterial Doppler velocimetry measurement may be useful in predicting adverse pregnancy outcomes adjunct to other antenatal surveillance tests, especially the AFI. Therefore, the present study will be done to evaluate the comparative assessment of UA ratio and AFI in predicting adverse perinatal outcomes. conditions: Umblical Artery Doppler in Term Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 213 type: ESTIMATED name: ultrasound measure: Umbilical Artery Systolic/Diastolic Ratio sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Sohag university Hospital city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06347900 id: Soh-Med-23-09-7PD briefTitle: Corneal Topographic Changes in Different Grades of OSA overallStatus: RECRUITING date: 2024-01-01 date: 2024-04-30 date: 2024-06-30 date: 2024-04-04 date: 2024-04-04 name: Sohag University class: OTHER briefSummary: Corneal topographic parameters in different degrees of obstructive sleep apnea conditions: Corneal Ectasia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Pentacam (corneal topographic changes detection), Polysymnography measure: Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values. sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Ophthalmology department, Sohag University status: RECRUITING city: Sohag zip: 82511 country: Egypt name: Elshimaa A.Mateen role: CONTACT phone: 0201282223427 email: elshimaa.moussa@yahoo.com lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06347887 id: SGI-PCR-01 briefTitle: Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection overallStatus: COMPLETED date: 2021-05-31 date: 2024-01-16 date: 2024-01-16 date: 2024-04-04 date: 2024-04-04 name: Singlera Genomics Inc. class: INDUSTRY briefSummary: The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1965 type: ACTUAL name: ColonAiQ test and Colonoscopy measure: Sensitivity for colorectal cancer with ColonAiQ test measure: Specificity for colorectal cancer with ColonAiQ test measure: PPV for colorectal cancer with ColonAiQ test measure: NPV for colorectal cancer with ColonAiQ test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Affiliated Hospital of Xuzhou Medical University city: Xuzhou state: Jiangsu zip: 221000 country: China lat: 34.18045 lon: 117.15707 facility: The First Affiliated Hospital of Shandong First Medical University city: Jinan state: Shandong zip: 250000 country: China lat: 36.66833 lon: 116.99722 facility: Shanxi Provincial People's Hospital city: Taiyuan state: Shanxi zip: 030012 country: China lat: 37.86944 lon: 112.56028 facility: Xi'an Daxing Hospital city: Xi'an state: Shanxi zip: 710000 country: China lat: 34.25833 lon: 108.92861 facility: Xi'an Gaoxin Hospital city: Xi'an state: Shanxi zip: 710000 country: China lat: 34.25833 lon: 108.92861 facility: Zhejiang provincial people's hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 facility: Fudan University Shanghai Cancer Center city: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06347874 id: ANES-2024-32820 briefTitle: Cryo Rib Fracture Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-31 date: 2026-11-30 date: 2024-04-04 date: 2024-04-04 name: University of Minnesota class: OTHER briefSummary: The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter. conditions: Rib Fractures studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized prospective controlled trial. This will be single blinded trial. The individual doing the outcome assessments will be blinded. Randomization will be 1:1. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The individual doing the outcome assessments will be blinded. whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Cryoablation name: ESP Catheter measure: Maximum pain score on POD (Post Operative Day) 7 measure: Opioid Use measure: Functional Pain Scores measure: Number of Patients using opioids at POD 30 measure: Length of hospital stay measure: Number of patients returned home by POD 30 measure: time to first ambulation measure: number of patients admitted to ICU measure: number of patients that required mechanical ventilation measure: Pulmonary Function Testing. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347861 id: C4891003 briefTitle: A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults overallStatus: RECRUITING date: 2024-04-02 date: 2024-06-16 date: 2024-07-05 date: 2024-04-04 date: 2024-04-16 name: Pfizer class: INDUSTRY name: Arvinas Estrogen Receptor, Inc. briefSummary: The purpose of the study is to look at how various tablets of a study medicine called vepdegestrant are processed in the body. This will be studied in healthy adult participants after food.

This study looks at how the medicine is changed and removed from the body after a participant takes it.

This study is seeking for participant who:

* are healthy males, and healthy females who do not have the possibility to have children.
* are 18 years of age or older.
* weigh more than 45 Kilograms (99 pounds).

The study consists of 3 treatments. Each participant will be assigned by chance to receive the 3 treatments in a certain sequence. This will be done over 3 study periods. Each treatment consists of a single amount of vepdegestrant taken by mouth in each study period. There will be a washout period between each study periods. The washout period is the time allowed for the medicine to get washed out from the body. How the medicine was processed will be calculated following each dose in each period. The total study duration is about 13 weeks. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 48 type: ESTIMATED name: single dose of vepdegestrant as tablet formulation (Treatment A) name: single dose of vepdegestrant as tablet formulation (Treatment B) name: single dose of vepdegestrant as tablet formulation (Treatment C) measure: Maximum observed concentration (Cmax) for vepdegestrant measure: Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for vepdegestrant measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Number of Participants With Clinical Laboratory Abnormalities measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs measure: Number of Participants With Electrocardiogram (ECG) Abnormalities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prism Research LLC dba Nucleus Network status: RECRUITING city: Saint Paul state: Minnesota zip: 55114 country: United States lat: 44.94441 lon: -93.09327 hasResults: False

 nctId: NCT06347848 id: IstanbulUCKA briefTitle: The Effect of Psychoeducation Focused on Reducing Internalized Stigma overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-05-01 date: 2024-09-01 date: 2024-04-04 date: 2024-04-04 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: In the fight against stigma, the focus should be on the education of individuals diagnosed with mental illness. Psychoeducation has an important place in the treatment and rehabilitation of mental health problems. Psychoeducation is necessary for early recognition of signs and symptoms of diseases, ensuring compliance with treatment, improving coping skills, as well as combating stigma, preventing internalized stigma, and counteracting social stigma. If individuals with mental disorders have adequate knowledge about the causes of stigma, they may be less prone to internalized stigma. conditions: Schizophrenia conditions: Treatment Adherence conditions: Stigma, Social studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two parallel groups randomized control study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Psychoeducation Focused on Reducing Internalized Stigma measure: Internalized Stigma of Mental Illness Scale measure: Medication Adherence Reporting Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa (IUC) city: Istanbul state: Şişli country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06347835 id: Gut-Intervention-SAR-2024 briefTitle: Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2026-01 date: 2024-04-04 date: 2024-04-22 name: Peking Union Medical College Hospital class: OTHER briefSummary: The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Currently, there is a lack of definition criteria for sarcopenia based on biomarkers. The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. Therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: symbiotic name: whey protein name: symbiotic placebo name: whey protein placebo measure: Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks measure: Change from Baseline of grip strength at 12 weeks measure: Change from Baseline of Short Physical Performance Battery score at 12 weeks measure: Change from Baseline of gait speed at 12 weeks measure: Change from Baseline of gut microbiota composition at 12 weeks measure: Change from Baseline of inflammation status at 12 weeks measure: Change from Baseline of microbiota-derived metabolites at 12 weeks sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China name: Kang Yu, MD role: CONTACT phone: +86 010-69155550 email: yuk1997@sina.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06347822 id: 23-011276 briefTitle: Increasing Access to Evidence-Based Care in Integrated Behavioral Health overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-10 date: 2024-10 date: 2024-04-04 date: 2024-04-04 name: Mayo Clinic class: OTHER briefSummary: The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future. conditions: Psychotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 34 type: ESTIMATED name: Therapy Session measure: Satisfaction with IBH therapy measure: Satisfaction with Action Plan measure: Change in readiness for change scores measure: Change in PHQ-9 scores measure: Change in GAD-7 scores measure: Change in Valuing Questionnaire (Values Progress subscale) measure: Change in Valuing Questionnaire (Values Obstruction subscale) measure: Change in CompACT scores (Valued Action) measure: Change in CompACT scores (Openness to Experience) measure: Change in CompACT scores (Behavioral Awareness) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06347809 id: 18-006343 id: NCI-2024-01225 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 18-006343 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine overallStatus: ENROLLING_BY_INVITATION date: 2018-11-07 date: 2029-02-01 date: 2029-02-01 date: 2024-04-04 date: 2024-04-19 name: Mayo Clinic class: OTHER briefSummary: This study explores the potential use of DNA markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests. conditions: Prostate Adenocarcinoma conditions: Prostate Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 300 type: ESTIMATED name: Non-Interventional Study measure: Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP) measure: Accuracy of CAP detection measure: Comparison of sample volumes sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06347796 id: 23-0160 id: 1UG3NS128397-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1UG3NS128397-01A1 briefTitle: Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study acronym: CHESS overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2029-09 date: 2029-09 date: 2024-04-04 date: 2024-04-04 name: The University of Texas Medical Branch, Galveston class: OTHER name: National Institute of Neurological Disorders and Stroke (NINDS) briefSummary: The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are:

* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?
* What is the safety of MMAE and conventional open surgery in these patients?

Participants will be asked to:

* Share their medical history and undergo physical examinations
* Have blood drawn
* Have CT scans of the head
* Answer questionnaires
* Undergo MMAE or conventional open surgery
* Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety. conditions: Chronic Subdural Hematoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 520 type: ESTIMATED name: Conventional Surgery name: Middle Meningeal Artery Embolization (MMAE) measure: Need for Rescue Surgery or Death measure: Safety of MMAE and Conventional Open Surgery sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas Medical Branch city: Galveston state: Texas zip: 77555 country: United States name: Study Manager role: CONTACT phone: 262-470-4293 email: jlspahn@utmb.edu name: Peter Kan, MD role: PRINCIPAL_INVESTIGATOR lat: 29.30135 lon: -94.7977 hasResults: False

 nctId: NCT06347783 id: STUDY00026893 briefTitle: Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-11-15 date: 2024-12-15 date: 2024-04-04 date: 2024-04-04 name: Oregon Health and Science University class: OTHER briefSummary: The purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. We are hoping to also explore the relationship between insulin pumps, sleep, and overnight blood sugar control. Your information will not be stored and used for future research.

The goal of this observational study is learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. The main questions it aims to answer are:

Do insulin pumps improve sleep, worsen sleep or have no effect at all? What is the relationship between insulin pumps, sleep, and overnight blood sugar control?

Participants will be asked to:

* Complete questionnaires regarding demographic data and diabetes history.
* Complete surveys regarding sleep quality before and after starting an insulin pump.
* Wear a FitBit during sleep for 2 weeks and fill out daily sleep diaries over a 2 week period prior to starting an insulin pump.

After 1-2 months after initiation of an insulin pump, participants will be asked again to:

* Complete surveys regarding sleep quality
* Wear a FitBit during sleep for 2 weeks
* Fill out daily sleep diaries over the same 2 week period. conditions: Type1diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Insulin pump measure: Sleep duration measure: Sleep efficiency measure: Sleep Disturbance Scale for Children measure: Promis Short Form 8a measure: Time in range sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Oregon Health and Science University city: Portland state: Oregon zip: 97239 country: United States name: Rachel L Palting, DO role: CONTACT phone: 503-494-1966 email: palting@ohsu.edu name: Ines Guttman-Bauman, MD role: CONTACT phone: 503-494-8509 email: Guttman@ohsu.edu name: Rachel L Palting, DO role: PRINCIPAL_INVESTIGATOR name: Ines Guttman-Bauman, MD role: SUB_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06347770 id: ThirdSunYat-senECII202329903 briefTitle: Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women overallStatus: RECRUITING date: 2023-11-01 date: 2025-10 date: 2025-10 date: 2024-04-04 date: 2024-04-08 name: Third Affiliated Hospital, Sun Yat-Sen University class: OTHER briefSummary: This study aims to evaluate the effect of probiotics 7 days before cesarean section (CS) on postoperative recovery and the change of gut microbiota in pregnant women. Samples were obtained from a total of 80 pregnant individuals, divided into control group and probiotics group. Anal exhaust time and first defecating time were set as the primary outcome of recovery of CS. 16S rRNA amplicon sequencing of the V4 region was analyzed to evaluate the composition of them. conditions: Microbiota conditions: Postoperative Recovery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Probiotic Blend Oral Tablet measure: analysis of postoperative recovery measure: 16S rRNA amplicon sequencing of the V4 region sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Zhe Li status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Yiwen Zhang, MD role: CONTACT phone: +86-18145701061 lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06347757 id: NorthernJiangsuhospital1 briefTitle: A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy overallStatus: COMPLETED date: 2020-01-01 date: 2023-12-31 date: 2024-03-15 date: 2024-04-04 date: 2024-04-04 name: Northern Jiangsu People's Hospital class: OTHER briefSummary: The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial. conditions: Anti-Reflux Alimentary Reconstruction conditions: Laparoscopic Proximal Gastrectomy conditions: Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ACTUAL name: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy measure: Incidence of reflux esophagitis measure: Incidence of anastomotic leakage measure: Incidence of anastomotic stenosis measure: Operative time measure: Intra-operative blood loss measure: Overall survival, and disease-free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiajie Zhou city: Yangzhou country: China lat: 32.39722 lon: 119.43583 hasResults: False

 nctId: NCT06347744 id: RADX-P-2401 briefTitle: Radicle Rest 24: A Study of Health and Wellness Products on Sleep and Related Health Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-09 date: 2024-12 date: 2024-04-04 date: 2024-04-08 name: Radicle Science class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sleep and related health outcomes. conditions: Sleep conditions: Sleep Disturbance conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be stratified based on gender at birth then randomized to one of the study arms. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Participants will be stratified based on gender at birth then randomized to one of the study arms whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 1200 type: ESTIMATED name: Radicle Rest Placebo Control Form 1 name: Radicle Rest Active Study Product 1.1 Usage name: Radicle Rest Placebo Control Form 2 name: Radicle Rest Active Study Product 2.1 Usage measure: Change in sleep measure: Change in feelings of anxiety measure: Change in fatigue measure: Change in mood (emotional distress-depression) measure: Minimal clinically important difference (MCID) in sleep measure: Minimal clinically important difference (MCID) in feelings of anxiety measure: Minimal clinically important difference (MCID) in fatigue measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression) sex: ALL minimumAge: 21 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radicle Science, Inc city: Del Mar state: California zip: 92014 country: United States lat: 32.95949 lon: -117.26531 hasResults: False

 nctId: NCT06347731 id: VAR-2024-01 briefTitle: Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan) overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-03 date: 2025-03 date: 2024-04-04 date: 2024-04-17 name: Varian, a Siemens Healthineers Company class: INDUSTRY briefSummary: This study is a clinical trial of prospective, single-center, single-arm objective performance criteria. This trial will be conducted with a total of 47 participants enrolled. All participants will be treated with radiation therapy using the medical device of Varian ProBeam360° Proton Therapy System (ProBeam360°), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration. conditions: Tumor, Solid studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: prospective, open-label, non-randomized, single-arm objective performance criteria primaryPurpose: TREATMENT masking: NONE count: 47 type: ESTIMATED name: Proton Radiation Therapy measure: Effectiveness measure: tumor disease control rate reaches the objective performance criteria (80%) measure: Safety measure: Incidence of CTCAE grade 3 toxic reaction is acceptable (lower than 5%) measure: Safety measure: Incidence of CTCAE grade 4 and 5 toxic reaction is acceptable (0%) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347718 id: CASTLE id: 2022-001366-35 type: EUDRACT_NUMBER id: DRKS00032279 type: REGISTRY domain: Deutsches Register Klinischer Studien (DRKS) briefTitle: CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease acronym: CASTLE overallStatus: RECRUITING date: 2023-07-17 date: 2026-05-31 date: 2026-05-31 date: 2024-04-04 date: 2024-04-04 name: University of Erlangen-Nürnberg Medical School class: OTHER briefSummary: The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells. conditions: Systemic Lupus Erythematosus conditions: Systemic Sclerosis conditions: Dermatomyositis conditions: Polymyositis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Phase 1:

Evaluating the safety of CAR-T-Cells in systemic autoimmune diseases with 8 patients

Phase 2:

Evaluating the efficiency of CAR-T-Cells in systemic autoimmune diseases with 16 patients primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: anti-CD19 CAR T cell therapy measure: To assess the safety of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc and DM/PM). measure: Clinical efficacy SSc measure: Clinical efficacy SLE measure: Clinical efficacy DM measure: Cellular response measure: Serological response measure: Success of IMP process measure: Physicians Global Assessment to measure quality of life measure: Patient's Global Assessment to measure quality of life measure: Health Assessment Questionnaire measure: Functional Assessment of Chronic Illness Therapy measure: SLE-specific disease activity over time per subject measure: SSc-specific disease activity over time per subject measure: DM/PM-specific disease activity over time per subject measure: SLE-specific disease activity over time per subject measure: DM/PM-specific disease activity over time per subject sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Erlangen status: RECRUITING city: Erlangen state: Bavaria zip: 91054 country: Germany name: Georg Schett, Prof. Dr. role: CONTACT name: Daniela Bohr, Dr. role: CONTACT lat: 49.59099 lon: 11.00783 hasResults: False

 nctId: NCT06347705 id: 23-252 briefTitle: A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer overallStatus: RECRUITING date: 2024-03-28 date: 2029-03-28 date: 2029-03-28 date: 2024-04-04 date: 2024-04-05 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 99 type: ESTIMATED name: 2141-V11 Antibody measure: Number of participants with a complete response or minimal residual disease. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited protocol activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All protocol activites) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites) status: RECRUITING city: Rockville Centre state: New York zip: 11553 country: United States name: Matthew Dallos, MD role: CONTACT phone: 646-888-4716 lat: 40.65871 lon: -73.64124 hasResults: False

 nctId: NCT06347692 id: SCBR-240/2024 briefTitle: Effect of Antigravity Treadmill in Knee Osteoarthritis (AGTreadmill) acronym: AGTreadmill overallStatus: NOT_YET_RECRUITING date: 2024-04-07 date: 2024-04-20 date: 2025-04-20 date: 2024-04-04 date: 2024-04-04 name: Prince Sattam Bin Abdulaziz University class: OTHER briefSummary: To date, the anti-gravity treadmill, as a representative method of lower body positive pressure treadmills, has been rarely reported for knee osteoarthritis rehabilitation.

Purpose: This study aims to evaluate the effect of antigravity treadmill training on pain, gait characteristics, and function in patients with knee osteoarthritis. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study included 40 patients with knee osteoarthritis who were randomly assigned to one of two groups: the antigravity treadmill group (n=20) or the control group (n=20). For 12 weeks, the antigravity treadmill group received training on the Alter G treadmill (75% weight-bearing, 30 minutes per session, three times per week) combined with traditional physical therapy. During the same period, the control group received only traditional physical therapy. The Visual Analogue Scale, Walkway System, and the Western Ontario and McMaster Universities Arthritis Index were used to assess pain, spatiotemporal gait parameters, and patient function, respectively. All outcome measures were obtained pretreatment, post-treatment primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients were randomly assigned to either the antigravity treadmill group (n = 20) or the control group (n = 20 ) using an online randomization website (www.randomization.com). The control group received a conventional physical therapy program. The therapists responsible for measuring and assessing the outcomes remained blinded to the group assignments. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: antigravity treadmill name: physical therapy exercise program measure: Assessment of patient pain measure: Evaluation of gait parameters (step length) measure: Evaluation of gait parameters (step time) measure: Evaluation of gait parameters (velocity) measure: Evaluation of patient function sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347679 id: WCHSIRB-CT-2024-160 briefTitle: Effects of Aromatherapy on Anxiety and Pain During Dental Treatments in Adults: a Randomized Controlled Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-04-04 date: 2024-04-04 name: Sichuan University class: OTHER briefSummary: Dental anxiety is a common problem in dental care. The aim of this protocol is to evaluate the effect of orange and tea essential oil for the control of anxiety and pain in adults during dental treatments. conditions: Dental Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Aroma diffuser with single-note sweet orange essential oil name: Aroma diffuser with single-note tea tree essential oil name: Aroma diffuser with water measure: Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS) measure: Pain scale - Visual Analog Scale (VAS) measure: Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S) measure: Vital sign 1 - systolic blood pressure (SBP) measure: Vital sign 2 - diastolic blood pressure (DBP) measure: Vital sign 3 - heart rate (HR） measure: Vital sign 4 - oxygen saturation (SpO2） sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06347666 id: 23082905 briefTitle: Coaching in Early Development Project overallStatus: RECRUITING date: 2024-01-12 date: 2025-02 date: 2025-07 date: 2024-04-04 date: 2024-04-04 name: Rush University Medical Center class: OTHER briefSummary: Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. The purpose of this project is to evaluate an evidence-based model of caregiver coaching for CEH that screen positive for developmental delay. We will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff. conditions: Developmental Delay studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One group will receive the caregiver coaching intervention. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Caregiver coaching measure: Parenting Sense of Competence Scale measure: Parenting Stress Scale measure: Mullen Scales of Early Learning measure: Maternal Behavior Responsivity Scale sex: ALL minimumAge: 12 Months maximumAge: 6 Years stdAges: CHILD facility: Rush University Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Lauren Little role: CONTACT phone: 312-942-1759 email: lauren_little@rush.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06347653 id: 2023KT127 briefTitle: Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL) overallStatus: RECRUITING date: 2023-11-28 date: 2027-01-31 date: 2030-01-31 date: 2024-04-04 date: 2024-04-04 name: Peking University class: OTHER briefSummary: This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients. conditions: Nodal T-follicular Helper Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: linperlisib combined with CHOP regimen measure: progression-free survival measure: ORR measure: CR rate measure: Success rate of stem cell collection measure: overall survival (OS) measure: time to next anti-lymphoma treatment measure: adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bejing Cancer Hospital status: RECRUITING city: Beijing state: Beijing country: China name: PING WEI LIU, master role: CONTACT phone: 0086-13522796323 lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06347640 id: KingAbdullahUH2 briefTitle: Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth Using Platelet-rich Fibrin overallStatus: RECRUITING date: 2023-04-01 date: 2025-12-01 date: 2027-12-01 date: 2024-04-04 date: 2024-04-04 name: King Abdullah University Hospital class: OTHER name: Jordan University of Science and Technology briefSummary: Regenerative endodontic procedures are intended to replace damaged tooth structures, including dentine and root structures, in addition to cells of the pulp-dentine complex. This treatment modality have been tested on immature necrotic teeth because they are anticipated to have a greater chance of pulp tissue regeneration.

However, it has been recently suggested for treating fully formed mature necrotic permanent teeth with closed apices since the conventional root canal treatment yielded many drawbacks.

A number of studies have evaluated the regeneration outcomes of using blood clot as a scaffold. However, there are limited studies in the literature on using other scaffolds such as platelet-rich fibrin (PRF).

This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth. Fifty patients with necrotic mature teeth with periapical lesions will be invited to participate in this study. Teeth will be treated using calcium hydroxide as intracanal medicament then using PRF (n=25) and blood clot (n=25) as scaffold. All teeth will be sealed coronally using NeoMTA Plus™. Treated teeth will be assessed clinically and radiographically using 2D periapical radiographs. The reported clinical and radiographic outcomes will be compared using SPSS. conditions: Pulp Revascularization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: induced bleeding name: plasma rich fibrin measure: Complete healing measure: regain the pulp sensibility sex: ALL minimumAge: 12 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Jordan University of Science and Technology status: RECRUITING city: Irbid zip: POBOX 3030 country: Jordan name: Lama A Awawdeh role: CONTACT phone: 0795412954 email: lawawdeh@hotmail.com lat: 32.55556 lon: 35.85 hasResults: False

 nctId: NCT06347627 id: UW23139 briefTitle: Communicating Human Papillomavirus Vaccine With Japanese Parents and Caregivers With Daughters Aged 12-18 overallStatus: ENROLLING_BY_INVITATION date: 2023-12-22 date: 2024-12 date: 2024-12 date: 2024-04-04 date: 2024-04-04 name: The University of Hong Kong class: OTHER name: London School of Hygiene and Tropical Medicine name: Nagasaki University briefSummary: This study aims to comprehensively assess confidence in and acceptance of human papillomavirus (HPV) vaccines among Japanese parents and caregivers with daughters aged 12-18 and their decision-making process. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1600 type: ESTIMATED name: Group 1 (I x S x S x F) name: Group 2 (O x S x S x F) name: Group 3 (I x E x S x F) name: Group 4 (O x E x S x F) name: Group 5 (I x S x S x M) name: Group 6 (O x S x S x M) name: Group 7 (I x E x S x M) name: Group 8 (O x E x S x M) name: Group 9 (I x S x D x F) name: Group 10 (O x S x D x F) name: Group 11 (I x E x D x F) name: Group 12 (O x E x D x F) name: Group 13 (I x S x D x M) name: Group 14 (O x S x D x M) name: Group 15 (I x E x D x M) name: Group 16 (O x E x D x M) measure: Willingness to receive HPV vaccines for daughters measure: Confidence in HPV vaccine safety sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London School of Hygiene and Tropical Medicine city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06347614 id: 2021-FXY-042 briefTitle: Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study acronym: Two-step RP overallStatus: ACTIVE_NOT_RECRUITING date: 2021-09-01 date: 2024-12-01 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Sun Yat-sen University class: OTHER briefSummary: The goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. The main questions it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising? conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: Two-step Radical Prostatectomy measure: Biochemical Recurrence-free Survival measure: Surgical time measure: Estimated blood loss measure: Hospital stay measure: Continence ContinenceContinence Continence Continence Continence Continence Continence Continence Continence measure: Lower urinary tract symptoms measure: Erectile function measure: Positive surgical margin rate measure: Complication sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06347601 id: 2024-03-011AC briefTitle: Survey on Sexual and Gender in the Healthcare in Taiwan overallStatus: RECRUITING date: 2024-03-13 date: 2025-02-01 date: 2025-02-20 date: 2024-04-04 date: 2024-04-29 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: This study addresses the pervasive issue of sexual harassment within Taiwanese society, particularly within the medical field, where comprehensive research is lacking. The research objective is to explore patterns of sexual harassment and gender discrimination experiences among physicians and medical students in Taiwan, while also investigating potential associations with professional burnout and mental health. Employing a convergent mixed-methods design, the study combines quantitative surveys and qualitative in-depth interviews. While lacking a control group and utilizing non-blinding methods without random assignment, the study aims to recruit 1000 participants aged 18 or older, considering both valid responses and potential dropouts. Additionally, interviews will be conducted with 30 individuals who have experienced sexual harassment or are interested in gender issues. The research methods will assess sexual harassment experiences, professional burnout, and depressive symptoms as primary outcomes or indicators. conditions: Sexual Harassment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: Without Intervention measure: Center for Epidemiologic Studies Depression Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: Jheng-Min Yu, M.D. role: CONTACT phone: 0933238592 email: TaipeiDU2017@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06347588 id: OBI&ICI briefTitle: Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-12 date: 2024-04-04 date: 2024-04-05 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER briefSummary: The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study. conditions: Occult Hepatitis B Infection in Cancer Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA measure: To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV measure: Evaluation of the incidence of reactivation in patients during immunotherapy measure: Evaluation of the association between HBV-specific T-cell response and HBV reactivation measure: Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor characteristics (histology and stage) and type and line of treatment (immunotherapy, combined treatment with chemotherapy + immunotherapy). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs San Matteo Pavia city: Pavia state: PV zip: 27100 country: Italy name: Alessandra Ferrari role: CONTACT phone: 0382.503689 email: alessandra.ferrari@smatteo.pv.it name: ANGIOLETTA LASAGNA role: PRINCIPAL_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06347575 id: APHP230522 briefTitle: Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function on Spinal Cord Injured Patients acronym: CAVERSTIM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2025-11 date: 2024-04-04 date: 2024-04-04 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Comphya SA briefSummary: The main objective of the study is to assess the safety and tolerability of cavernous nerve electrical stimulation in patients with spinal cord injured (SCI) by assessing and measuring complications.

As the secondary objectives, despite the limited cohort size, this long-term study aims to obtain preliminary data on efficacy of cavernous nerve stimulation to improve erectile function for sexual intercourse, as well as to assess patient's satisfaction using:

* Objective assessment of the erectile response upon CaverSTIM activation with the RigiScan device.
* Subjective assessment of the erectile function with validated questionnaires:

  1. A 6-item self-report instrument assessing male erectile function (Erectile Function domain of the International Index of Erectile Function, IIEF-EF);
  2. A log-diary five item questionnaire completed after each sexual attempt (Sexual Encounter Profile, SEP);
  3. A self-reporting measure that scores erection hardness on a 4-point scale (Erection Hardness Score, EHS);
  4. The Global Assessment Question (GAQ).

In addition, the study aims to refine the method of implantation (step-by-step delineation of all technical approaches for device implantation, including duration of surgical procedure, blood loss, methods to access the periprostatic region, tissue dissection, device placement and fixation) prior to planning for larger scale clinical investigation. conditions: Spinal Cord Injuries conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Implantation of the caverStim device measure: Safety evaluation measure: Pain assessement measure: Complications related to implantation surgery measure: Evaluation of IIEF-EF measure: Evaluation of EHS measure: Evaluation of SEP measure: Evaluation of GAQ sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of neurology-urology-andrology, Raymond Poincaré hospital - APHP city: Garches zip: 92380 country: France lat: 48.84226 lon: 2.18232 facility: Department of Urology, La pitié Salpêtrière Hospital - APHP city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06347562 id: 934 briefTitle: Optical Genome Mapping for the Diagnosis of Neurodevelopmental Disorders overallStatus: RECRUITING date: 2022-06-15 date: 2025-06-14 date: 2025-06-14 date: 2024-04-04 date: 2024-04-04 name: IRCCS Eugenio Medea class: OTHER briefSummary: to evaluate the ability of the Optical genome Mapping (OGM) approach to detect simple and complex constitutional chromosomal aberrations of clinical relevance, which had previously been identified with standard diagnostic approaches (karyotyping, FISH, CNV-microarray) in the context of neurodevelopmental disorders (NDDs) with/wo congenital anomalies (CA) conditions: Neurodevelopmental Disorder (Diagnosis) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 58 type: ESTIMATED name: Optical Genome Mapping measure: Diagnostic concordance rate sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Scientific Institute E. Medea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Clara Bonaglia, PhD role: CONTACT phone: 031877913 phoneExt: +39 email: clara.bonaglia@lanostrafamiglia.it lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06347549 id: HE-SF2024/09 briefTitle: The Impact of Diaphragmatic Breathing Instructions and Inspiratory Pressures on Diaphragm Contraction in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2026-04-15 date: 2024-04-04 date: 2024-04-04 name: Hong Kong Metropolitan University class: OTHER briefSummary: This is a cross-sectional obsessional study.

This study aims (1) to investigate the relationship between sternocleidomastoid muscle recruitment and diaphragm thickness fraction during increasing inspiratory resistance in healthy adults; (2) to compare diaphragmatic and sternocleidomastoid muscle recruitment patterns with and without a standard diaphragmatic breathing instruction with increasing inspiratory resistance in healthy adults.

Participants will be asked to breathe through a pressure threshold inspiratory loading device under different inspiratory resistances with and without a standard diaphragmatic breathing instruction. sternocleidomastoid muscle activity will be measured with surface electromyography, and diaphragm thickness will be assessed with ultrasonography. conditions: Diaphragm studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 36 type: ESTIMATED name: Various intensities of inspiratory muscle training measure: Diaphragmatic thickening fraction measure: Muscle activation of the sternocleidomastoid muscle measure: Perceived Exertion Borg scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-25 uploadDate: 2024-03-28T00:38 filename: Prot_SAP_000.pdf size: 185477 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-25 uploadDate: 2024-03-28T00:39 filename: ICF_001.pdf size: 204027 hasResults: False

 nctId: NCT06347536 id: IRAS331831 id: NIHR156698 type: OTHER_GRANT domain: NIHR HTA briefTitle: Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease acronym: RAPID overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-12-31 date: 2027-12-31 date: 2024-04-04 date: 2024-04-19 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER name: King's College London name: University College, London name: Imperial College London name: University of Cambridge name: University of Southampton name: University of Nottingham name: University of Leicester name: Frimley Health NHS Foundation Trust name: Newcastle University name: University of Bristol name: Asthma and Lung UK briefSummary: Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality.

Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed.

A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum. conditions: COPD conditions: COPD Exacerbation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1400 type: ESTIMATED name: Supported rescue pack measure: Time to first all-cause readmission within 90 days of discharge measure: Time to and frequency of COPD-related readmissions at 30 and 90 days measure: Days alive and out of hospital at day 90 measure: Time to and frequency of all COPD exacerbations at days 30 and 90 measure: Cumulative systemic oral corticosteroids use over 90 days measure: Cumulative systemic antibiotic use over 90 days measure: Health care contacts at baseline, days 90 and 180, and 1 year measure: All cause readmission at 30 days measure: All cause-, cardiovascular- and COPD- related mortality at day 90 and over 12 months measure: EQ-5D-5L Health questionnaire (quality of life) at days 90 and 180, and 1 year measure: Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at days 90 and 180 and 1 year measure: Qualitative interviews to examine and describe usual care measure: Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm measure: Serious adverse events measure: Antimicrobial resistance measure: Quality of life COPD assessment Test (CAT) score at days 90, 180 and 1 year sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Birminham NHS Foundation Trust city: Birmingham country: United Kingdom lat: 52.48142 lon: -1.89983 facility: Blackpool Teaching Hospitals city: Blackpool country: United Kingdom lat: 53.81667 lon: -3.05 facility: Bradford Teaching Hospitals NHS Foundation Trust city: Bradford country: United Kingdom lat: 53.79391 lon: -1.75206 facility: University Hospitals Sussex NHS Foundation Trust city: Brighton country: United Kingdom lat: 50.82838 lon: -0.13947 facility: North Bristol University Trust city: Bristol country: United Kingdom lat: 51.45523 lon: -2.59665 facility: County Durham and Darlington NHS Foundation Trust city: Durham country: United Kingdom lat: 54.77676 lon: -1.57566 facility: East Suffolk and North Essex Foundation Trust city: Ipswich country: United Kingdom lat: 52.05917 lon: 1.15545 facility: University Hospitals of Morecambe Bay NHS Foundation Trust city: Lancaster country: United Kingdom lat: 54.04649 lon: -2.79988 facility: University Hospitals of Leicester NHS Trust city: Leicester country: United Kingdom lat: 52.6386 lon: -1.13169 facility: Cardiff and Vale University Health Board city: Llandough country: United Kingdom lat: 51.44556 lon: -3.44722 facility: Guy's and St Thomas' NHS Foundation Trust city: London country: United Kingdom name: Mona Bafadhel, Professor role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust city: London country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Royal Free London NHS Foundation Trust city: London country: United Kingdom name: John Hurst, Professor role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Maidstone and Tunbridge Wells NHS Trust city: Maidstone country: United Kingdom lat: 51.26667 lon: 0.51667 facility: South Tees NHS Foundation Trust city: Middlesbrough country: United Kingdom lat: 54.57623 lon: -1.23483 facility: Milton Keynes University Hospital NHS Foundation Trust city: Milton Keynes country: United Kingdom lat: 52.04172 lon: -0.75583 facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust city: Newcastle Upon Tyne country: United Kingdom lat: 54.97328 lon: -1.61396 facility: Northumbria Healthcare NHS Foundation Trust city: North Shields country: United Kingdom lat: 55.01646 lon: -1.44925 facility: Nottingham University Hospitals Trust city: Nottingham country: United Kingdom lat: 52.9536 lon: -1.15047 facility: Oxford University Hospitals NHS Foundation Trust city: Oxford country: United Kingdom lat: 51.75222 lon: -1.25596 facility: Salisbury NHS Foundation Trust city: Salisbury country: United Kingdom lat: 51.06931 lon: -1.79569 facility: University Hospital Southampton NHS Foundation Trust city: Shirley country: United Kingdom lat: 52.41074 lon: -1.81952 facility: Frimley Health NHS Foundation Trust city: Slough country: United Kingdom lat: 51.50949 lon: -0.59541 facility: South Tyneside and Sunderland NHS Trust city: South Shields country: United Kingdom lat: 54.99859 lon: -1.4323 facility: Stockport NHS Foundation Trust city: Stockport country: United Kingdom lat: 53.40979 lon: -2.15761 facility: North Tees and Hartlepool NHS Foundation Trust city: Stockton-on-Tees country: United Kingdom lat: 54.56848 lon: -1.3187 facility: Sherwood Forest Hospitals NHS Foundation Trust city: Sutton In Ashfield country: United Kingdom lat: 53.12542 lon: -1.26135 facility: Somerset Foundation Trust city: Taunton country: United Kingdom lat: 51.01494 lon: -3.10293 facility: Somerset Foundation Trust city: Yeovil country: United Kingdom lat: 50.94159 lon: -2.63211 hasResults: False

 nctId: NCT06347523 id: FirstShantou briefTitle: VR-Based Preoperative Rehabilitation Program for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction overallStatus: RECRUITING date: 2024-04-02 date: 2024-10-01 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: First Affiliated Hospital of Shantou University Medical College class: OTHER briefSummary: Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. They will be randomly divided into two groups: an experimental group and a control group. conditions: Anterior Cruciate Ligament (ACL) Reconstruction conditions: Preoperative Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: The VR-based preoperative rehabilitation program; name: standard nursing care, measure: knee joint range of motion measure: Lysholm knee function score measure: SAS self-rating anxiety scale scale measure: SDS self-rating depression scale scale measure: Visual Analog Scale pain score measure: Barthel Index for basic activities of daily living measure: time to first ambulation post-surgery measure: postoperative complications measure: nursing satisfaction sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: "The First Affiliated Hospital of Shantou University Medical College status: RECRUITING city: Shantou state: Guangdong zip: 515000 country: China name: Zeshan Chen role: CONTACT phone: +8613592896271 lat: 23.36814 lon: 116.71479 hasResults: False

 nctId: NCT06347510 id: E-25403353-050.99-174660 briefTitle: The Level of sST2 in Pediatric Heart Failure overallStatus: COMPLETED date: 2021-08-16 date: 2024-02-16 date: 2024-02-16 date: 2024-04-04 date: 2024-04-04 name: Eskisehir Osmangazi University class: OTHER briefSummary: Introduction: Suppression of tumorigenicity 2 (ST2) is a receptor member belongs to the Interleukin-1 (IL-1) family. The ligand and soluble versions are its two isoforms. The interleukin-33-ST2 ligand complexs development provides protection against heart fibrosis and hypertrophy. Investigations on heart failure in adults has demonstrated that it does not change by age, body mass index (BMI), creatinine, hemoglobin, and albumin levels, in contrast to NT pro brain natriuretric peptit. In adult heart failure patients, it has been demonstrated to be an independent predictor of mortality and cardiovascular events. The most recent guideline recommends using it as class 2b in the diagnosis of adult heart failure. Studies on ST2 in children are rare. The purpose of this study is to assess the prognostic value of ST2 for cardiovascular events in young individuals suffering from heart failure.

Method: The study included pediatric patients (0-18 years old) with congenital heart disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment. Height, weight, gender, saturation, heart failure classification (Ross or New York heart Assosiation), medications taken, the electrocardiogram, echocardiography, Pro BNP, and sST2 values of the patients, as well as any hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery during follow-up Data on arrhythmia and death were gathered during a 1-year follow-up. The SPSS software application was used to carry out the statistical analysis. conditions: Congenital Heart Disease conditions: Congestive Heart Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 59 type: ACTUAL name: Suppression of tumorigenicity 2 (ST2) measure: Soluble suppression of tumorigenicity levels with or without major cardiovascular event measure: Pro BNP levels measure: Major cardiovascular event ( such as hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery) sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Eskisehir Osmangazi University city: Eskisehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False

 nctId: NCT06347497 id: 000001230988 briefTitle: Zonisamide Versus Topiramate in Migraine overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-02 date: 2025-05-01 date: 2024-04-04 date: 2024-04-24 name: Kafrelsheikh University class: OTHER briefSummary: Investigators aim to compare the effect of zonisamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency conditions: Migraine studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We will assess The number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either zonisamide and acetaminophen or topiramate and acetaminophen from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included zonisamide and acetaminophen, and Drug B included topiramate and acetaminophen. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Zonisamide 50 MG name: Topiramate 50 MG measure: The change in migraine days per 28 days measure: The total number of migraine days after three months of treatment measure: The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency. measure: HIT-6 score absolute reduction in each group after three months of treatment measure: The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months. sex: ALL minimumAge: 10 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: mohamed_gomaa@med.kfs.edu.eg lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06347484 id: IRB00411716 briefTitle: Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT) acronym: CONNECT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-10 date: 2024-04-04 date: 2024-04-04 name: Johns Hopkins University class: OTHER name: Morgan State University name: American Heart Association briefSummary: The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning community that provides tailored education on cardiovascular (CV) health and research participation; connects community members to CV-related research; and disseminates CV-related study findings. The overreaching goal of CONNECT is to improve participation of underrepresented communities in CV research, including as women, Black adults, and Latino adults, through increasing participants' clinical trial awareness, trust in biomedical research, and willingness to participate in clinical trials. CONNECT will use digital and community-engaged approaches to identify and recruit 1000 adults with cardiovascular disease or a cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will receive tailored educational information on CV health and research participation via text message. Participants will also have the opportunity to be matched to ongoing CV research studies based on basic demographic information and areas of interest. The educational information will be sent to participants for 12 months. The investigators hypothesize that CONNECT will increase participants' clinical trial awareness, trust, and willingness to participate in clinical trials and that the proportion of Black and Latin adults and women enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for recruitment. conditions: Cardiovascular Diseases conditions: Hypertension conditions: Diabetes Type 2 conditions: Stroke conditions: Recruitment conditions: Overweight and Obesity conditions: Hyperlipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 1000 type: ESTIMATED name: Formal Toned Educational Messages name: Understanding Toned Educational Messages name: Casual Toned Educational Messages measure: Participant accrual measure: Participant accrual in partnering cardiovascular research studies measure: Trust in Biomedical Research using the Perceptions of Research Trustworthiness Scale (PoRT) measure: Clinical trials awareness and knowledge will be assessed using items adapted from the Health Information National Trends Survey (HINTS) measure: Willingness to participate in research will be measured by asking participants one related question sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347471 id: SBS-2023-477 briefTitle: The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy acronym: SPARTAN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-04 date: 2024-04-04 date: 2024-04-04 name: Infectious Diseases Research Collaboration, Uganda class: OTHER name: London School of Hygiene and Tropical Medicine name: Radboud University Medical Center briefSummary: A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and are treated with conventional artemisinin-combination therapies (ACT) as part of standard clinical care. From this population, we will select P. falciparum gametocyte carriers.

Before, during and after ACT treatment, the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy, molecular methods, parasite culture and mosquito feeding assays. Parasite clearance will be determined in the first days (d0-3) after treatment.

The study population will consist of passively recruited patients with uncomplicated P. falciparum malaria who are microscopy positive for gametocytes. Participants will be treated with conventional therapies for uncomplicated malaria without randomization: artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA-PPQ). All doses are supervised. Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment.

Gametocyte carriage and gametocyte commitment/production will be determined for resistant and wild type infections before, during and after treatment. In addition, venous blood will be collected at three timepoints to assess transmission to mosquitoes before (d0), during (d2) and after treatment (d7). The total duration of participation will be 7 days, the primary endpoint will be the reduction in mosquito infection rates at d2 (artemether-lumefantrine) or d7 (dihydroartemisinin-piperaquine) compared to pre-treatment. conditions: Falciparum; Malaria studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Artemether-lumefantrine name: Dihydroartemisinin-Piperaquine measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline. measure: Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline measure: Mean oocyst intensity (in all/all infected mosquitoes) measure: Male and female gametocyte sex ratio (proportion male) measure: Gametocyte circulation time measure: Gametocyte area under the curve measure: Asexual parasite prevalence measure: Asexual parasite density measure: Total parasite prevalence measure: Total parasite density measure: The density of ΔPfK13 vs wild type genotypes measure: The density of ΔPfK13 vs wild type genotypes in oocysts and sporozoites in mosquitoes that become infected before and after initiation of treatment sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Ambrosoli Memorial Hospital city: Kalongo state: Agago District country: Uganda name: Maurice Akao, MBChB role: CONTACT facility: Patongo Health Facility IV city: Patongo state: Agago District country: Uganda name: MD role: CONTACT lat: 2.74472 lon: 33.32417 hasResults: False

 nctId: NCT06347458 id: BG-CA-23-001 briefTitle: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-08 date: 2024-04-04 date: 2024-04-04 name: Guangzhou Bio-gene Technology Co., Ltd class: INDUSTRY briefSummary: This is a single-arm, single-dose dose-escalation and dose-expansion study. conditions: Leukemia conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: BG1805 measure: 1.Dose Limited Toxicity Rate measure: 2.Incidence of Treatment-Emergent Adverse Events measure: 3.Concentration of CAR-T cells after Infusion (PK) measure: 4.overall response rate, ORR measure: 5.Concentration of Cytokine after Infusion (PD) sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06347445 id: GSM012024 briefTitle: Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus-2 (TEMD-2 Study) acronym: TEMD-2 overallStatus: COMPLETED date: 2022-10-01 date: 2023-01-30 date: 2023-01-30 date: 2024-04-04 date: 2024-04-04 name: Gulhane School of Medicine class: OTHER briefSummary: This study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey. conditions: Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 5707 type: ACTUAL name: There is no intervention. measure: Glycemia control status of Turkish adult patients with diabetes mellitus measure: Blood pressure control status of Turkish adult patients with diabetes mellitus measure: Lipid control status of Turkish adult patients with diabetes mellitus. measure: Weight control status of Turkish adult patients with diabetes mellitus. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gulhane School of Medicine Department of Endocrinology and Metabolism city: Ankara zip: 06010 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06347432 id: 24-119-H briefTitle: Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-03 date: 2027-03 date: 2024-04-04 date: 2024-04-04 name: Grand Valley State University class: OTHER briefSummary: For children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Power wheelchair skills training using the IndieTrainer system measure: Change in understanding how to use a power wheelchair measure: Change in power wheelchair skill performance measure: Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance measure: Change in children's perceptions of changes in their performance of power wheelchair skill performance sex: ALL minimumAge: 5 Years maximumAge: 17 Years stdAges: CHILD facility: Grand Valley State University city: Grand Rapids state: Michigan zip: 49503 country: United States lat: 42.96336 lon: -85.66809 hasResults: False

 nctId: NCT06347419 id: Iayas8 briefTitle: Body Awareness and Spinal Stability in Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-06-30 date: 2024-07-30 date: 2024-04-04 date: 2024-04-04 name: Gazi University class: OTHER briefSummary: Thirty volunteer patients diagnosed with scoliosis by a specialist physician at Gazi University Hospital Orthopedics and Traumatology Department and subsequently referred to Gazi University Physiotherapy and Rehabilitation Department for exercise training will be included in the study. The lumbar Pressure Measurement Test with Stabilizer and Rotation Stability Tests will be utilized to evaluate the spinal stability of the patients. Body awareness will be assessed using the Body Awareness Survey, comprising 18 questions. All assessments will be conducted at the Orthopedic Rehabilitation Clinic within the relevant department.

The results obtained from this study will elucidate the relationship between body awareness and spinal stability in individuals with scoliosis. conditions: Scoliosis Idiopathic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Physiotherapy evaluation measure: Spinal stability measure: Rotary Stability measure: Body Awareness sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University Hospital city: Ankara zip: 06500 country: Turkey name: İnci H Ayas role: CONTACT phone: 0 312 216 26 21 email: inciayass@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06347406 id: FSKesihatan briefTitle: Effects of Combined Physiotherapy Management and Education overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-04 date: 2024-04-04 name: Fakulti Sains Kesihatan class: OTHER briefSummary: This observational study aims to determine the effects of combined physiotherapy programs and education in patellofemoral pain syndrome. The main questions it aims to answer are:

* Are there any effects of combined physiotherapy program among individuals with PFPS on:

  i) Pain ii) Muscle functions (strength, muscle bulk, flexibility) iii) Knee muscle functional performance (anteromedial lunge, step-down, bilateral squat, and balance and reach) iv) Kinesiophobia v) Quality of life Participants will be
* Measure for the anthropometrics data including body weight, height, and BMI.
* Answer the Numerical Pain Rating scale
* Abswe Malay version of KOOS-PF and TAMPA scale.
* Once they finished with the questionnaire, the participants will be stationed into station 1 (HDD), station 2 (Realtime Ultrasound) and station 3 (Dartfish Motion Analysis) Treatment they will receive
* Blood flow restrictions cuff with physiotherapy exercises
* Patient education Researcher will compare Blood flow exercises combined with physiotherapy exercises and education (Group A) with Physiotherapy exercises (Group B) to see if there is an effect on i) Pain ii) Muscle Functions (strength, muscle bulk, flexibility iii) Functional performance (anteromedial lunge, step-down, bilateral squat, balance, and reach) iv) Kinesiophobia v) Quality of life conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 128 type: ESTIMATED name: Blood flow restriction combined with physiotherapy and education measure: Numerical Pain Rating measure: The Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) measure: Tampa Scale measure: Hand held dynamometer (HDD) measure: Knee Muscle performance Test with Dartfish software measure: Real time ultrasounds sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Fakulti Sains Kesihatan status: RECRUITING city: Shah Alam state: Selangor Darul Ehsan zip: 42300 country: Malaysia name: Zarina Zahari role: CONTACT phone: 0132094170 email: zarinazahari@uitm.edu.my name: Nurul Atiqah Mohamed Mosbi role: CONTACT phone: 603-3258 4300 email: atiqahmosbi@uitm.edu.my lat: 3.08507 lon: 101.53281 hasResults: False

 nctId: NCT06347393 id: 6425 briefTitle: Transgender and Gender Diverse Individuals Screening for Breast Cancer acronym: GENESIS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-31 date: 2026-03-31 date: 2024-04-04 date: 2024-04-24 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER name: Istituto Europeo di Oncologia name: Luigi Sacco University Hospital name: Fatebenefratelli Hospital name: Ospedale Policlinico San Martino name: Università degli studi di Messina, Messina name: IRCCS Azienda Ospedaliero-Universitaria di Bologna name: Arcispedale Santa Maria Nuova-IRCCS name: Federico II University name: Azienda Ospedaliero-Universitaria Careggi briefSummary: The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer in transgender and gender-diverse population. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 1600 type: ESTIMATED name: Mammography and Breast Ultrasound measure: Incidence of Breast Cancer measure: The adherence rate to the screening sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347380 id: CIP011 briefTitle: Usability Study of the FemPulse System overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-30 date: 2024-08-30 date: 2024-04-04 date: 2024-04-04 name: FemPulse Corporation class: INDUSTRY briefSummary: The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable. conditions: Overactive Bladder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: FemPulse System measure: Patient Satisfaction sex: FEMALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347367 id: EU-FTR-GK-01 briefTitle: Short-term Effect of Exercise and Self-manual Approaches to Bloating - Distention overallStatus: RECRUITING date: 2023-01-01 date: 2024-04-17 date: 2024-04-19 date: 2024-04-04 date: 2024-04-04 name: Ege University class: OTHER briefSummary: Abdominal bloating and distension (ABD) are the most commonly gastrointestinal symptoms reported by patients with various functional gut disorders such as functional dyspepsia, irritable bowel syndrome and it is frequently associated with constipation. The pathophysiology of ABD is complex, often multifactorial and poorly understood. The reseach was hypothesised that short-term self-manual approaches and exercise for core muscles would have a positive effect on the symptoms of ABD. conditions: Gastrointestinal System Disease conditions: Functional Bloating conditions: Distension; Bowel conditions: Gastrointestinal Motility Disorder conditions: Pelvic Floor Dyssynergia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned to Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) and Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Triple (Participant, Investigator and Outcomes Assessor) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) name: Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles) measure: Abdominal bloating and distention (ABD) Perception of sensations measure: Superficial Electromyography (EMG) measure: Gastrointestinal Symptom Rating Scale (GSRS) measure: High-resolution anorectal manometry (HRAM) measure: Balloon Expulsion Test (BET) measure: Colon Transit Time (CTT) measure: Ultrasonography (USG) measure: Digital dynamometer sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University Faculty of Medicine, Department of Gastroenterology status: RECRUITING city: İzmir state: Bornova zip: 35100 country: Turkey name: Gülruh KARABAĞLI role: CONTACT phone: +90 5326612245 email: gulruhazad@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06347354 id: CRO-2024-15 briefTitle: Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Breast Cancer and Metastatic Lymph Nodes acronym: FLUO overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-08 date: 2025-08 date: 2024-04-04 date: 2024-04-04 name: Centro di Riferimento Oncologico - Aviano class: OTHER briefSummary: In the case of a pre-operative diagnosis of ductal carcinoma in situ (DCIS), sentinel lymph node biopsy is generally not indicated whereas it is considered standard clinical practice for patients with clinical stage I-II infiltrating breast cancer who have clinically negative axillary lymph nodes or clinically suspicious lymph nodes with negative needle aspiration findings. It is not uncommon that, in patients with ductal carcinoma in situ at preoperative diagnosis, there may be an upgrade on definitive histological examination due to the identification of foci of infiltration (about one-fifth of cases), requiring axillary lymph node biopsy in a second surgery. Prospective studies have shown that the sentinel lymph node identification rate after recent breast-conserving surgery is suboptimal. With regard to the false negative rate (FNR), several studies demonstrated that it could be associated with different techniques used for lymph node identification. Lymph node biopsy by Indocyanine green (ICG) is capable of identifying the sentinel lymph node, however, there are no data in literature on the permanence of ICG in the lymph node system. The knowledge of this data would allow the application of this method, already considered safe for the identification of the sentinel lymph node at the time of breast surgery, also in those situations in which the sentinel lymph node biopsy is postponed due to the upgrade of definitive histological diagnosis from carcinoma in situ to infiltrating/micro-infiltrating carcinoma.The main objective of this trial is to evaluate the permanence of fluorescence at the level of axillary lymph nodes 3 weeks after subcutaneous injection in patients who are candidates to radical axillary surgery. Marking the sentinel lymph node before breast surgery in cases of DCIS with risk factors could reduce the false negative rate, allowing to increase the accuracy of the procedure in identifying the lymph node potentially involved by metastatic infiltration. In addition, the identification of the sentinel lymph node in patients who are candidates to radical axillary surgery, could increase the sensitivity of the surgery in staging axillary disease and could make the lymph node exeresis more targeted, reducing the morbidity of the surgery resulting in a better outcome for the patient. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Indocyanine green measure: Permanence of fluorescence at the level of axillary lymph nodes at 2-3 weeks after subcutaneous injection of Indocyanine Green (2.5 mg), in patients who will undergo radical axillary surgery measure: Identification of the total number of fluorescent lymph nodes measure: Differences in the qualitative assessment (intensity) of fluorescence between the removed lymph nodes: lymph nodes will be divided into group A "intense fluorescence" and group B "mild fluorescence" measure: Association between histological positivity for metastases in sentinel and non-sentinel lymph nodes measure: Association between the patient's demographic/clinical variables and the presence or absence of fluorescent lymph nodes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS city: Aviano state: Pordenone zip: 33081 country: Italy name: Stefano Fracon, MD role: CONTACT phone: 0434659317 email: stefano.fracon@cro.it name: Samuele Massarut, MD role: CONTACT email: smassarut@cro.it name: Stefano Fracon, MD role: PRINCIPAL_INVESTIGATOR lat: 46.07056 lon: 12.59472 hasResults: False

 nctId: NCT06347341 id: 2019-A02014-53 briefTitle: GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity acronym: GLUTN overallStatus: TERMINATED date: 2021-10-27 date: 2023-03-24 date: 2023-03-24 date: 2024-04-04 date: 2024-04-04 name: University Hospital, Clermont-Ferrand class: OTHER name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement name: UCA (UFR de Médecine et UFR Pharmacie) briefSummary: For 25 years, non-celiac gluten sensitivity (NCGS) has been the subject of very prolific and confusing scientific literature. This clinical entity is defined by the appearance of digestive and extradigestive symptoms in the hours/days following the consumption of foods containing gluten, in the absence of celiac disease (CD) and wheat allergy (WA). The physiopathological mechanisms, neither allergic or autoimmune, remain poorly defined and no The main objective of the study was to demonstrate the role of gluten in triggering digestive symptoms and extradigestive products from the NCGS. The secondary objectives were to identify the pathophysiological mechanisms and diagnostic marker(s).usable diagnostic marker in the clinic has not yet been identified. conditions: The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective, crossover, randomized, double-blind clinical study comparing a gluten-containing diet to a gluten-free diet. primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ACTUAL name: Clinical study comparing a gluten-containing diet to a gluten-free diet measure: The main objective of the study is to confirm the role of gluten in triggering the digestive and extradigestive symptoms of NCGS. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Estaing city: Clermont-Ferrand zip: 63100 country: France lat: 45.77966 lon: 3.08628 hasResults: False

 nctId: NCT06347328 id: 23-AOI-01 briefTitle: The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain acronym: InCHO overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-01 date: 2027-03 date: 2024-04-04 date: 2024-04-05 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Lumbar facet joints have been implicated in chronic low back pain in over 45% of patients with isolated chronic common low back pain.

Low back pain is the most common form of spinal pain, more chronic and severe than cancer pain. The annual prevalence of chronic low back pain ranges from 15% to 45% (one-off prevalence, 30%; lifetime prevalence, 54-80%). Because of this extremely high incidence, doctors from a wide range of specialities perform interventional techniques in a variety of settings.

Facet joints have long been recognised as a source of back pain. In 1911, Goldthwait first recognised their role as a potential source of back pain. In 1933, Ghormley introduced the term "facet syndrome", defining lumbosacral pain with or without radicular pain. Badgley later suggested that facet joints could be a primary source of pain independently of spinal nerve compression. They demonstrated the role of posterior facet joints (PFJs) in a large number of patients with low back pain whose symptoms were not caused by a herniated disc. The underlying physiological concept of the PJF was introduced by Hirsch et al in 1963. They demonstrated that injecting a hypertonic saline solution into the region of the facet joints caused pain.

The management of chronic low back pain due to zygapophyseal involvement (lumbar facet joints) consists primarily of conservative treatment. This is based on analgesics, anti-inflammatory drugs, physiotherapy and weight loss, where appropriate. Other non-surgical options may be proposed, including glucocorticoid injections into the facet joints. Glucocorticoid injections, which act by reducing inflammation, are commonly used in routine care to treat spinal pain. This pain may be due to a variety of pathologies, including discogenic or facet-related, or mixed, ligamentous or muscular, linked to a regional or global disorder of spinal statics. They are commonly used as a standard treatment for chronic spinal pain.

Traditionally, in routine clinical practice, if there is significant paravertebral contracture and the clinical signs point to posterior joint involvement, a glucocorticoid injection is given in the doctor's surgery at the time of consultation, using anatomical landmarks to guide needle placement. However, few studies have demonstrated the efficacy of anatomical marking for infiltration of posterior joints, notably Cohen et al. Sui's systematic review of the use of this technique.

With the advent of new imaging modalities such as ultrasound, more and more practitioners are turning to image-guided injections. To date, only the fluoroscopy-guided technique is considered reliable for facet joint infiltration.

In order to improve the clinical efficacy of the various interventional therapeutic solutions, some authors have supported the use of ultrasound guidance. Several studies have been published comparing ultrasound-guided infiltration and infiltration using anatomical location in the shoulder region, the iliopsoas and in epicondilitis. While ultrasound guidance in areas such as the iliopsoas or the shoulder seems useful, it has not yet been proven that guidance is advantageous in spinal areas, such as the facet joints.

To our knowledge, no randomised, methodologically sound study has yet been carried out to compare the benefit of ultrasound-guided infiltration versus infiltration with anatomical location.

The aim of our study is to show that ultrasound-guided zygoapophyseal infiltration is superior to anatomically-guided infiltration in terms of pain assessment. conditions: Chronic Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 102 type: ESTIMATED name: echo-guided infiltration name: non-echo-guided infiltration measure: Change of pain progression measure: measure function state by EIFEL questionnaire measure: measure function state by ODI questionnaire measure: pain evaluation by VAS scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de NICE city: Nice state: CHU De Nice zip: 06000 country: France name: STEPHANIE FERRERO, MD role: CONTACT phone: +33492035477 email: ferrero.s@chu-nice.fr name: CHRISTIAN ROUX, Pr role: CONTACT email: roux.c2@chu-nice.fr name: STEPHANIE FERRERO, MD role: PRINCIPAL_INVESTIGATOR name: CHRISTIAN ROUX, Pr role: SUB_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Ch Cannes city: Cannes country: France name: JOHANNA AZYLAY, MD role: CONTACT email: J.AZULAY@ch-cannes.fr lat: 43.55135 lon: 7.01275 hasResults: False

 nctId: NCT06347315 id: 2302.CLI briefTitle: Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI) overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-12-15 date: 2027-12-15 date: 2024-04-04 date: 2024-04-29 name: Société des Produits Nestlé (SPN) class: INDUSTRY briefSummary: Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI) conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel and pivotal primaryPurpose: OTHER masking: TRIPLE maskingDescription: Randomized whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 380 type: ESTIMATED name: BrainXpert name: Placebo measure: Preclinical Alzheimer's Cognitive Composite (PACC) score measure: Preclinical Alzheimer's Cognitive Composite (PACC) (components effects) measure: Montreal Cognitive Assessment (MoCA) score measure: Preclinical Alzheimer's Cognitive Composite (PACC) accelerated decline measure: Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory IIb Delayed Recall Score accelerated decline measure: Mini-Mental State Examination (MMSE) score accelerated decline measure: Emergent Adverse Events (Safety and tolerability) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347302 id: EID 2023 briefTitle: Study of Vitreoretinal Molecular Changes During Rhegmatogenous Retinal Detachment acronym: LIPIDRET overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-04-04 date: 2024-04-04 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Retinal detachment is a condition with an estimated incidence of between 9.5 and 18.2 cases per 100,000 individuals.

It is an ophthalmological emergency that threatens visual acuity and requires surgery. However, despite satisfactory post-operative anatomical results, vitreoretinal proliferation and photoreceptor death can still have a negative impact on visual prognosis. These complications are still not fully understood.

A previous study carried out by the Eye, Nutrition and Cell Signalling team at the CSGA, comparing mouse models of retinal detachment with healthy control retinas, revealed an increase in pro-inflammatory cytokines and a change in retinal lipid abundance in detached retinas.

However, these results have yet to be confirmed in humans. Our main hypothesis is that the vitreous content of omega-3 PUFAs and proteins is altered during the onset of retinal detachment, since it reflects both intraocular inflammation and photoreceptor apoptosis.

We therefore wish to demonstrate that the protein and PUFA contents of the vitreous humour are different between eyes with retinal detachment and eyes not affected by retinal detachment after macular surgery (epiretinal membrane or macular hole). We would like to show that the vitreous PUFA content is lower in the macular surgery group due to the absence of photoreceptor apoptosis and the absence of dehiscence causing communication between the subretinal space (photoreceptors whose membranes are very rich in PUFAs) and the vitreous space. We also hope to identify changes in the protein composition of vitreous fluid in patients with retinal detachment, with overexpression of proteins involved in inflammation pathways.

In addition, we hypothesise that retinal omega-3 PUFA content is a factor influencing retino-vitreal proliferation and functional and anatomical recovery from retinal detachment. To this end, we will study the correlation between retinal PUFA-3 content and the clinical presentation and postoperative course of retinal detachment.

Finally, with the aim of identifying a serum marker for the prognostic evaluation of retinal detachment, we will use as a candidate a biomarker of retinal omega-3 PUFA content that we have developed in an Age-Related Macular Degeneration (AMD) model. We will analyse the correlation between this biomarker and levels of omega-3 PUFAs measured directly in the retina.

To do this, we will analyse intraoperative samples of vitreous humour, sub-retinal fluid and retinal fluid from patients undergoing vitrectomy for retinal detachment in the Ophthalmology Department of the Dijon University Hospital. A group of control patients will consist of patients operated on by vitrectomy for macular surgery (epiretinal membrane or macular hole) for whom a vitreous humour sample will also be taken.

Clinical information on the characteristics of the retinal detachment will be collected. During the consultation, the patient will be questioned about any history of dyslipidaemia and any current treatment, including the use of lipid-enriched food supplements. Post-operative follow-up with prospective collection of clinical and paraclinical data on anatomical and functional evolution will be carried out up to 6 months after the occurrence of retinal detachment.

A blood sample will be taken to establish a lipid profile in all patients. We will thus gain a better understanding of the changes in lipid and protein content in the vitreous humour, sub-retinal fluid and retina, and the demonstration of a link between the initial presentation and the postoperative anatomical and functional evolution of retinal detachment. This will provide a better understanding of the lipid-dependent mechanisms linked to inflammation and photoreceptor degeneration during retinal detachment, and will ultimately make it possible to develop new therapeutic strategies to improve visual prognosis. conditions: Rhegmatogenous Retinal Detachments studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 160 type: ESTIMATED name: Blood sampling name: vitreous sampling name: Sub-retinal fluid sampling name: Retinal tissue sampling measure: Molecular content of fatty acids and proteins in the vitreous humour of eyes operated on for retinal detachment and eyes operated on for macular surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Dijon Bourgogne city: Dijon zip: 21000 country: France name: Petra EID role: CONTACT phone: 0380295173 phoneExt: +33 email: petra.eid@chu-dijon.fr lat: 47.31667 lon: 5.01667 hasResults: False

 nctId: NCT06347289 id: CHSD_0024_REA briefTitle: Refusal of Organ Donation: a Study of Psychological, Anthropological and Cultural Factors overallStatus: COMPLETED date: 2022-01-01 date: 2023-04-30 date: 2024-03-29 date: 2024-04-04 date: 2024-04-04 name: Centre Hospitalier de Saint-Denis class: OTHER name: Agence de La Biomédecine briefSummary: The Hospital of Saint Denis (HSD) has been involved for several years in the dynamics of organ donation. In spite of the evolution of the practices of coordination of the collection of samples, the rate of refusal of organ donation is increasing in our hospital, contrary to the rest of France.

Based on hypotheses derived from psychological and anthropological perspectives, this survey will provide first-hand information on the personal, family and cultural issues related to organ donation. It will be a question of identifying and locating individual and collective representations concerning death, its definition, and the associated symbols and rites. Based on the collection of these representations, we will be able to propose hypotheses of a psychological, social and anthropological nature on resistance to organ donation. conditions: Psychology conditions: Anthropology conditions: Refusal, Organ Donation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ACTUAL measure: Demographic information measure: Demographic information measure: Demographic information measure: Demographic information sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hopitalier de Saint-Denis city: Saint-Denis state: Seine Saint Denis zip: 93200 country: France lat: 48.93326 lon: 2.36666 hasResults: False

 nctId: NCT06347276 id: 2023-RW320-08 briefTitle: Cerebral Microembolization Associated With PFO Closure overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: China National Center for Cardiovascular Diseases class: OTHER_GOV briefSummary: This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO. conditions: Thrombosis Cardiac studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: PFO occluder; ASD occluder measure: De novo cerebral microembolization sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chaowu Yan status: RECRUITING city: Beijing state: Beijing zip: 100037 country: China name: Chaowu Yan, PhD and MD role: CONTACT phone: +861088398408 email: chaowuyan@163.com name: Chaowu Yan, PhD and MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06347263 id: PER 332 briefTitle: Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-04-30 date: 2024-04-04 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: The goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis. conditions: Isolated Intrabony Periodontal Defects in Patients With Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Blinding of the operator and patient is not applicable.

- Outcome assessor (primary and secondary outcomes) \& biostatistician will be blinded whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Entire papilla preservation technique measure: Clinical attachment level (CAL) gain change from baseline to 12 months measure: Linear bone fill change from baseline to 12 months sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of dentistry, Cairo University status: RECRUITING city: Cairo zip: 3753450 country: Egypt name: Nesma M Shemias, Ass Lecturer role: CONTACT email: nesma.shemais@dentistry.cu.edu.eg name: Manal M Hosny, Professor role: CONTACT email: manal.hosny@dentistry.cu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06347250 id: SGB-Bulbar Palsy briefTitle: A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia overallStatus: COMPLETED date: 2022-01-01 date: 2023-05-02 date: 2023-05-31 date: 2024-04-04 date: 2024-04-04 name: Babujinaya Cela class: OTHER_GOV briefSummary: This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function. conditions: Bulbar Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ACTUAL name: Nerve Block name: Lidocaine Hydrochloride name: routine therapy name: placebo block measure: The Functional Oral Intake Scale measure: Yale Pharyngeal Residue Severity Rating Scale measure: penetration-aspiration scale measure: Video fluoroscopic swallowing study measure: The Swallowing Quality of Life Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ZhenD No.1 Hos. city: Zhenzhou country: China lat: 32.28034 lon: 119.16999 hasResults: False

 nctId: NCT06347237 id: NL84429.078.23 briefTitle: PsA Digital Phenotyping and Inflammation Drivers Study acronym: PDPID overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2025-12 date: 2024-04-04 date: 2024-04-04 name: Jolanda Luime class: OTHER name: University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences name: Aristotle University of Thessaloniki - Hipokrateion Hospital Thessaloniki name: Portuguese Society of Rheumatology - The Rheumatic Diseases Portuguese Registry (Reuma.pt) briefSummary: The goal of this observational study is to develop and internally validate a machine learning model for detecting flare using a digital biomarker and a machine learning model for predicting flare, in patients with psoriatic arthritis. The main questions it aims to answer are:

* In patients with psoriatic arthritis, is a digital biomarker capable of detecting a flare as compared to clinical defined flare by the rheumatologist?
* In patients with psoriatic arthritis, what factors trigger a psoriatic arthritis flare ?

Participants will be requested to:

* Install app on their phone
* Use a smartwatch
* Complete questionnaires
* Collect biological material conditions: Psoriatic Arthritis conditions: Flare Up, Symptom conditions: Psoriatic Arthritis Aggravated studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Absence of flare in patients measure: Minimal disease Activity (MDA) measure: Psoriatic Arthritis Disease Activity Score (PASDAS) measure: Disease Activity Psoriatic Arthritis (DAPSA) measure: Psoriatic Arthritis Impact of Disease (PsAID) measure: Morning stiffness measure: Keystroke dynamics measure: Screen time measure: Accelerometer data measure: Gyroscope sensor data measure: Steps count measure: Physical activity intensity and categories measure: Motion measure: Distance measure: Pulse Ox measure: Respiration measure: Body battery measure: Stress (digital) measure: Heart rate measure: Beat-to-beat intervals measure: Sleeping time measure: Sleeping type measure: Hand and feet photos measure: Hand and body movements videos measure: Medical history measure: Joint count measure: Enthesitis measure: Body surface area measure: Weight measure: Height measure: Abdominal circumference measure: ClASsification criteria for Psoriatic ARthritis (CASPAR) score measure: Demographics measure: VAS Pain measure: HAQ questionnaire measure: VAS patient global measure: PSAID questionnaire measure: SF-36 questionnaire measure: EQ5d questionnaire measure: Work Productivity and Activity Impairment (WPAI) questionnaire measure: Health care questionnaire measure: Patient Health Questionnaire (PHQ9) questionnaire measure: Perceived Stress Scale (PSS) measure: Global Rating of Change (GRoC) Scale measure: Life events questionnaire measure: Digital literacy questionnaire measure: Inflammatory blood marker measure: Genetic variants measure: Gut microbiome measure: Stress (cortisol levels) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347224 id: BCFC-BCS-VIRTUAL2024 briefTitle: Both Column Fixation Corridor in Pelvic Surgery overallStatus: COMPLETED date: 2023-10-01 date: 2024-02-01 date: 2024-03-01 date: 2024-04-04 date: 2024-04-04 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: The concepts of the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. This study aims to evaluate the feasibility and potential advantages of this novel screw fixation technique, thereby filling the existing gap in knowledge and establishing standards for its application. conditions: Acetabular Fractures studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 400 type: ACTUAL name: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models. measure: Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06347211 id: Attikon Hospital briefTitle: "Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management overallStatus: RECRUITING date: 2024-01-10 date: 2026-01-10 date: 2026-01-10 date: 2024-04-04 date: 2024-04-05 name: Attikon Hospital class: OTHER briefSummary: The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension. conditions: Hypotension During Surgery conditions: Prevention of Hypotension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithm measure: TWA hypotension (measured with Acumen IQ sensor) measure: Incidence of hypotension measure: Time spent in hypotension measure: Treatment choice (drugs/fluids) measure: Diagnostic guidance protocol deviations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Attikon Hospital status: RECRUITING city: Athens zip: 12462 country: Greece name: Orestis Milionis role: CONTACT phone: +306948333359 email: Orestismilionis@gmail.com name: Orestis Milionis role: PRINCIPAL_INVESTIGATOR name: Tatiana Sidiropoulou role: PRINCIPAL_INVESTIGATOR lat: 37.97945 lon: 23.71622 hasResults: False

 nctId: NCT06347198 id: 20230807-02 briefTitle: Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer overallStatus: RECRUITING date: 2024-04-10 date: 2024-12-01 date: 2025-05-01 date: 2024-04-04 date: 2024-04-04 name: Wuhan Union Hospital, China class: OTHER name: Huazhong University of Science and Technology briefSummary: This is a single-center exploratory clinical study to explore the efficacy and safety of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Fruquintinib name: Sintilimab name: Inulin measure: Intestinal microbiota diversity, abundance and taxonomic information measure: adverse events measure: Objective remission rate (ORR) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Disease control rate (DCR) measure: Duration of remission (DOR) measure: Concentration of various serum metabolites measure: Concentration of various plasma Cytokine Changes measure: Frequency of peripheral blood lymphocyte measure: Correlation between dietary fiber intake and progression-free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Min Jin status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Min Jin role: CONTACT phone: 18807108606 email: minjin86@126.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06347185 id: EORTC-2236-HNCG-QLG briefTitle: Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study acronym: SupCare overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-04 date: 2028-12 date: 2024-04-04 date: 2024-04-04 name: European Organisation for Research and Treatment of Cancer - EORTC class: NETWORK briefSummary: This is a late phase II, prospective, multicenter randomized study, to assess the value of early palliative care integrated with the standard oncologic care in patients with Recurrent Metastatic (RM) Head and Neck Cancer (HNC) proposed to first line palliative systemic treatment.

The study randomizes patients in a 1:1 fashion to standard oncologic care, in which the palliative care is requested as needed (reactive approach) or to early palliative care integrated with the standard oncologic care (proactive approach).

Standard of Care: the oncologist will be the main referral of the patient, deciding the therapeutic approach, the assessments requested, in terms of type of exams and timing and the need of possible further support from other expertise. The oncologist will base the choices also upon the results of the Liverpool Head and Neck Patient Concern Inventory (PCI-H\&N) and the patient's preferences. At the end of the first oncological visit, the physician will be asked to predict the survival of the patient.

Integrated approach: Besides the Oncology visit, patient will have the palliative care expert visit and follow up. The oncologist will define the therapeutic approach and the assessments requested, in terms of type of exams and timing. The palliative care clinician and the oncologist will judge the burden of symptoms and together they will propose the suggested interventions to relief the symptoms, with a particular attention to a validated instrument (the PCI-H\&N) and patient priority questionnaire's results.

Stratification Factors

* Institution
* Performance Status (PS) (0 vs 1-2)
* Presence of any caregiver at home
* Type of treatment (Immunotherapy alone vs any other combination)

Study duration: the total study duration is estimated at 36 months, with a total accrual time estimated to be 24 months from first patient in (FPI) and with an additional follow-up period of 12 months.

End of study occurs when all patients have completed their end of study visit and the study is mature for all analyses defined in the protocol and the database has been cleaned and frozen for these analyses. conditions: Head and Neck Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 160 type: ESTIMATED name: Early palliative care, integrated with the standard oncologic care (proactive approach) name: Palliative care requested as needed, integrated with the standard oncologic care (reactive approach) measure: Change from baseline in emotional functioning and pain scores according to Item List (IL) 250 questionnaire at 15 weeks. measure: Change from baseline in emotional functioning and pain scores according to Item List 250 (IL250) questionnaire at 6 weeks, 24 weeks and 52 weeks. measure: Change from baseline in the selected Health Related Quality of Life (HRQoL) scales from the Item List 250 (IL250) questionnaire at 6 weeks, 15 weeks, 24 weeks and 52 weeks measure: Number of unplanned visits to emergency room or specialist visits measure: Hospitalization due to treatment toxicities or tumour signs/symptoms, as evaluated by number of admissions and duration measure: Identification of the rate of patients starting a new systemic treatment in the last three months of life measure: Rate of patients receiving systemic treatment in the last month of life measure: Rate of patients with a tracheostomy performed in the last 3 months of life measure: Rate of patients with gastrostomy performed in the last 3 months of life measure: Caregiver/family members' satisfaction (FAMcare questionnaire) at 15 weeks measure: Overall Survival (OS) measure: Prediction error of survival (defined as the difference between actual survival (AS) of patients and clinician prediction of survival (CPS)) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347172 id: 2024p000278 id: U54AG063546 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG063546 briefTitle: Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-11-15 date: 2025-01-15 date: 2024-04-04 date: 2024-04-04 name: Brigham and Women's Hospital class: OTHER name: Brown University name: National Institute on Aging (NIA) briefSummary: The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified. conditions: Alzheimer Disease conditions: Mild Cognitive Impairment conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 360 type: ESTIMATED name: Nudge Intervention measure: Composite of the percentage of eligible PCPs or their PLWD/care partners who view or click on information measure: Number of nudges that fire as intended: Fidelity measure: Discontinuation or prescribed reduction in medication sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347159 id: EDG-7500-102 briefTitle: A Study of EDG-7500 in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (CIRRUS-HCM) overallStatus: RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-04 date: 2024-04-04 name: Edgewise Therapeutics, Inc. class: INDUSTRY briefSummary: This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 either as a single or multiple dose in adult patients with obstructive hypertrophic cardiomyopathy. conditions: Hypertrophic Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: EDG-7500 name: EDG-7500 measure: Incidence of treatment-emergent adverse events measure: Change from baseline in left ventricular outflow tract (LVOT) gradient measure: Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine) status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Edgewise Therapeutics, Inc. role: CONTACT lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06347146 id: R01HD112323 type: NIH link: https://reporter.nih.gov/quickSearch/R01HD112323 id: R01HD112323 type: NIH link: https://reporter.nih.gov/quickSearch/R01HD112323 briefTitle: Bridges2Scale: Testing Implementation Strategies overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-03-31 date: 2028-07-31 date: 2024-04-04 date: 2024-04-04 name: Washington University School of Medicine class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The goal of this clinical trial is to compare two multifaceted strategies (standard vs enhanced) for scaling Bridges in a two-arm Hybrid III effectiveness-implementation cluster randomized controlled trial (RCT) in adolescent and youths affected by AIDS \[AYaAIDS\] (ages 13-17 years) from 48 schools in the Greater Masaka region of Uganda. The main aims of the clinical trial are: Aim 1. Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. The investigators will assess fidelity to Bridges (primary implementation outcome) and sustainment of Bridges (exploratory implementation outcome).

Aim 2. Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4. Compare the cost and cost-effectiveness of the two implementation strategies. Using an activity-based ingredients approach, the investigators will examine how much each strategy costs to achieve a unit of effect. conditions: HIV/AIDS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 1440 type: ESTIMATED name: Financial Literacy Training (FLT) workshops name: Mentorship name: Income Generation Activity (IGA) name: Youth Development Accounts (YDA) measure: Intervention Fidelity measure: HIV prevalence measure: Sexual risk-taking behavior measure: Economic stability measure: School attainment measure: Depressive Symptoms measure: Proportion of adolescents living with HIV who are virally suppressed measure: Proportion of HIV negative adolescents who use PrEP measure: Hopelessness measure: Self-Esteem measure: Self-concept sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06347133 id: AROAPOC3-3009 id: 2023-509302-30 type: EUDRACT_NUMBER briefTitle: Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia acronym: MUIR-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2026-10 date: 2024-04-04 date: 2024-04-04 name: Arrowhead Pharmaceuticals class: INDUSTRY briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety. conditions: Hypertriglyceridemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1328 type: ESTIMATED name: Plozasiran Injection name: Placebo measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo measure: Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment measure: Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo measure: Change from Baseline in C-peptide During the Treatment Period Compared to Placebo measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo measure: Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo measure: Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347120 id: PI2024_843_0011 briefTitle: Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction acronym: BOWNTI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03 date: 2027-04 date: 2024-04-04 date: 2024-04-18 name: Centre Hospitalier Universitaire, Amiens class: OTHER name: Centre Hospitalier de Beauvais name: CHU de Rouen - Accueil name: Hospital Avicenne name: Centre Hospitalier Universitaire Dijon name: University Hospital, Limoges name: Saint Antoine University Hospital name: Centre Hospitalier Universitaire de Besancon name: Hôpital Cochin name: University Hospital, Toulouse name: CH Abbeville name: University Hospital, Angers briefSummary: Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a tremendous health care expenses.

The working group on ASBO of the World Society of Emergency Surgery suggested two distinct approaches for the management of acute ASBO: non-operative management (NOM) which concerning around 85% of patients and operative management (OM) :

* OM: if there is clinical signs of strangulation, peritonitis, bowel ischemia, or if IV CT Scan shows sign of ischemia, strangulation, peritonitis, or if the occlusion persists for more than 72 hours;
* NOM in all other cases, including nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h.

NGT is an old concept first describe for treatment of ASBO based on several studies made on the dog where he proved efficacy of NGT by aspirating gas in the stomach favorising venous decompression and survival of patients. Since, NGT became one of the pillars of NOM.

However NGT is quite bad tolerated by patients (ranked the most painful hospital procedure), some of them refuse it, others put off after the beginning of the treatment and one of the most frequent complications of NGT is pneumonia, which is quite surprising when the first argument for its insertion is to avoid inhalation pneumonia.

Four specific retrospectives studies showed that absence of NGT is possible in 20 to 80% of included patients and was associated with a decrease: in transit recovery time; in complications rate (including rates of pneumonia); in length of stay (LOS); without an increased risk of surgery or resection. 20-87% (a total of 922 patients) were managed successfully conservatively without NGT with a reduction LOS of 2-6 days compared with NGT. But none of this series focused on the patient relief as an endpoint. A retrospective critical analysis of our own management (January - December 2019, n=96) found that: only 17% of patients had a NGT during the IV CTscan, the presence of the NGT did not influence neither gastric volume nor the rate of full stomach, and gastric volume did not influence patient management.

To summarize, the investigators therefore know that the insertion of a NGT is painful, does not relieve all patients, and has an unquantified therapeutic effect on the evolution of ASBO. That is why it is pertinent, in 2023, to question the useless of NGT in the treatment of ASBO, in selected patients. This study would be the first randomized controlled trial to focus on the absence of NGT for the NOM of patients with ASBO. The results of this study could lead to a change in the surgical practice. The absence of NGT in ASBO management appears to be an innovative practice, in rupture with the current practice. This is a part of the simplification of patients'care suffering from ASBO. conditions: Small Bowel Obstruction Adhesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 504 type: ESTIMATED name: nasogastric tube name: NOM without NGT insertion measure: Decrease of complication rate in patient without NGT group compared to control group measure: aspiration pneumonia rate in both patient groups sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amiens Universitary Hospital city: Amiens country: France name: jean marc Regimbeau, Pr role: CONTACT phone: +33 3 22 08 89 05 email: regimbeau.jean-marc@chu-amiens.fr name: charles sabbagh, Pr role: SUB_INVESTIGATOR name: Aiham Ghazali, Pr role: SUB_INVESTIGATOR name: Thierry Yzet, Pr role: SUB_INVESTIGATOR name: François Mauvais, MD role: PRINCIPAL_INVESTIGATOR name: Lilian Schwarz, MD role: PRINCIPAL_INVESTIGATOR name: Christophe Tresallet, MD role: PRINCIPAL_INVESTIGATOR name: Pablo Ortega deballon, MD role: PRINCIPAL_INVESTIGATOR name: Muriel Mathonnet, MD role: PRINCIPAL_INVESTIGATOR name: Jérémie Lefevre, MD role: PRINCIPAL_INVESTIGATOR name: Zaher Lakkis, MD role: PRINCIPAL_INVESTIGATOR name: David Fuks, MD role: PRINCIPAL_INVESTIGATOR name: Fabrice Muscari, MD role: PRINCIPAL_INVESTIGATOR name: Corina Iederan, MD role: PRINCIPAL_INVESTIGATOR name: Aurelien Venara, MD role: PRINCIPAL_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False

 nctId: NCT06347107 id: S67215 briefTitle: Robotic Subretinal tPA Injection Study acronym: RoTIS overallStatus: RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-04 date: 2024-04-04 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: DORC Dutch Ophthalmic Research Center International BV briefSummary: In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following:

* The robotic stabilizer (prototype - FAMHP approval received)
* 41G subretinal needle (CE marked - used within label)
* Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes.

As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review. conditions: Subretinal Hemorrhage conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Investigator-initiated, academic, mono-center, prospective, interventional case study primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Robotic subretinal tPA injection measure: Percentage of patients with succesful subretinal insertion of the robot-held 41G needle measure: Percentage of patients with stable subretinal position of the needle for at least 3 minutes. measure: Device-related adverse events measure: Functional outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Peter Stalmans, MD PhD role: CONTACT email: peter.stalmans@uzleuven.be name: Ivo De Clerck, MD role: CONTACT email: ivo.declerck@uzleuven.be name: Ivo De Clerck, MD role: SUB_INVESTIGATOR name: Peter Stalmans, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06347094 id: 610/2023/SPER/UNIPR briefTitle: Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols acronym: PRE-CARE-DIET overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2025-12-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: University of Parma class: OTHER name: Azienda Ospedaliero-Universitaria di Parma name: University of Milan name: Foundation for Liver Research name: National Research Council, Spain briefSummary: This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response. This study presents an observational part, for targeted recruitment and volunteers characterization, and an experimental part for the dietary and deep phenotyping. conditions: Individual Variability in (Poly)Phenol Metabolism conditions: Cardiometabolic Health conditions: Personalized Dietary Intervention conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Metabotypes will also be masked to participants and investigators, while the dietary treatment will not. whoMasked: OUTCOMES_ASSESSOR count: 330 type: ESTIMATED name: Personalized Dietary Plan name: Oral (Poly)phenol Challenge Test (OPCT) name: General Dietary Advice measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation-Older Persons measure: Anthropometric measurements: weight, height and body mass index measure: Anthropometric measurements: waist and hip circumferences detection measure: Body composition: bioelectrical impedance analysis measure: Blood pressure measure: Heart rate measure: Biomarkers of cardiometabolic health: hematochemical and urine analysis measure: Biomarkers of cardiometabolic health: alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase measure: Biomarkers of cardiometabolic health: homocysteine measure: Biomarkers of cardiometabolic health: insulin measure: Biomarkers of cardiometabolic health: glycated hemoglobin and glycated albumin measure: Biomarkers of cardiometabolic health: quantitative insulin-sensitivity check index measure: Biomarkers of cardiometabolic health: homeostasis model assessment beta-cell function measure: Biomarkers of cardiometabolic health: homeostasis model assessment of insulin resistance measure: Inflammatory status measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 10-years measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 30-years measure: Risk prediction scores: Hard Coronary Heart Disease - 10-years risk measure: Risk prediction scores: First Coronary Heart Disease - 2-years risk measure: Risk prediction scores: Framingham Heart Study for Diabetes measure: Risk prediction scores: Framingham Heart Study for Hypertension measure: Risk prediction scores: Framingham Heart Study for Stroke measure: Risk prediction scores: Framingham Heart Study for Fatty Liver Disease measure: Risk prediction scores: Atherosclerotic Cardiovascular Disease measure: Risk prediction scores: QRESEARCH risk estimator version 3 measure: Risk prediction scores: QDiabetes Score measure: Risk prediction scores: Finnish Diabetes Risk Score measure: Risk prediction scores: Cuore Project - Calculating the individual risk score measure: Evaluation of adherence to healthy and sustainable dietary models: the Healthy Eating Index measure: Evaluation of adherence to healthy and sustainable dietary models: Italian Mediterranean Index measure: Evaluation of adherence to healthy and sustainable dietary models: Greek Mediterranean Index measure: Evaluation of adherence to healthy and sustainable dietary models: DASH Index measure: Evaluation of adherence to Mediterranean diet measure: Nutritional and energy assessment: LARN measure: Nutritional and energy assessment: EPIC measure: Dietary intake assessment of plant bioactive compounds and dietary components related to gut microbiome measure: Lifestyle factors assessment: general information measure: Lifestyle factors assessment: sleep quality (PSQI) measure: Lifestyle factors assessment: sleep quality (ESS) measure: Lifestyle factors assessment: sleep quality (ISI) measure: Lifestyle factors assessment: physical activity (IPAQ) measure: Lifestyle factors assessment: state of health (BDI) measure: Lifestyle factors assessment: state of health (SF-36) measure: (Poly)phenol metabolites and changes in the prevalence of aggregate phenolic metabotypes measure: Other plant bioactive metabolites measure: Food/gut/host-derived metabolites measure: Biomarkers of food intake and of healthy dietary patterns measure: Untargeted metabolomics measure: Genetic differences measure: Gut microbiota composition measure: Oral microbiota composition measure: Biomarkers of adipose tissue function measure: Biomarkers of food intake regulation sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Parma - Plesso Biotecnologico Integrato city: Parma state: PR zip: 43125 country: Italy name: Pedro M Mena Parreño, PhD role: CONTACT phone: +39 0521 903970 email: pedromiguel.menaparreno@unipr.it name: Joana M Santos Rebelo, MSc role: CONTACT phone: +39 0521902043 email: joanamaria.santosrebelo@unipr.it name: Pedro M Mena Parreño, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.79935 lon: 10.32618 facility: Azienda Ospedaliero-Universitaria di Parma city: Parma state: PR zip: 43126 country: Italy name: Riccardo Bonadonna, MD role: CONTACT phone: +39 0521 033307 email: riccardo.bonadonna@unipr.it lat: 44.79935 lon: 10.32618 hasResults: False

 nctId: NCT06347081 id: P.T.REC/012/00449 briefTitle: Effect of Nd-YAG Laser on Hypertrophic Scar acronym: Nd-YAG overallStatus: COMPLETED date: 2022-05-01 date: 2024-02-28 date: 2024-02-28 date: 2024-04-04 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.

T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures. conditions: Hypertrophic Scar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: one treatment one control group primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Nd- YAG laser at 532nm wavelength measure: hypertrophic scar maturation measure: hypertrophic scar volume sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Physical Therapy city: Cairo zip: 12613 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06347068 id: LCCC2128-ATL briefTitle: Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2028-05 date: 2024-04-04 date: 2024-04-23 name: UNC Lineberger Comprehensive Cancer Center class: OTHER name: Bellicum Pharmaceuticals briefSummary: This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC). conditions: Breast Cancer conditions: Relapse conditions: Resistant Cancer conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: iC9-CAR.B7-H3 T Cell Therapy name: cyclophosphamide name: fludarabine measure: Toxicity: NCI-CTCAE measure: Toxicity: Cytokine Release Syndrome (CRS) measure: Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) measure: The recommended phase 2 dose (RP2D) NCI-CTCAE v5. measure: The recommended phase 2 dose (RP2D) CRS Grading measure: The recommended phase 2 dose (RP2D) measure: Objective response rate measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Duration of Response (DOR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Catherine Cheng role: CONTACT phone: 919-445-4208 email: catherine_cheng@med.unc.edu name: E. Claire Dees, MD, MSc role: SUB_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06347055 id: 403690 briefTitle: NeuroControl of Nicotine Dependence overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2030-03-25 date: 2030-04-30 date: 2024-04-04 date: 2024-04-08 name: University of Missouri-Columbia class: OTHER briefSummary: The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours. conditions: Nicotine Dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Repetitive Transcranial Magnetic Stimulation (rTMS) measure: Acute effects of cTBS on cognitive control measure: Exploratory: Acute effects of cTBS on fMRI brain response measure: Safety and Tolerability sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06347042 id: 012/004897 briefTitle: Effect of Qigong on Sleep Quality in Fibromyalgia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-06 date: 2024-04-04 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: This study aims to determine any significant efficacy of qigong exercise on sleep quality and heart rate variability in patients with fibromyalgia. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: qigong exercise + routine medical treatment +Anti-inflammatory diet name: routine medical treatment +Anti-inflammatory diet only measure: Sleep quality measure: Heart Rate variability measure: Quality of Life o measure the quality of life of patients with problems found fibromyalgia. measure: pain self-administered questionnaire measure: Fatigue :prevalence and severity of fatigue measure: Depression and Anxiety assess Depression and Anxiety sex: FEMALE minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Physical therapy Cairo University city: Cairo state: Giza country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06347029 id: Endothelial dysfunction briefTitle: Evaluation of Endothelial Dysfunction Using the "Flow Mediated Dilation" Test in a Population of Chronic Renal Failure Patients at Different Stages, and Evaluation of the Role of Antiphospholipid Antibodies overallStatus: RECRUITING date: 2023-10-17 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Brugmann University Hospital class: OTHER briefSummary: The vascular endothelium is an organ in its own right, playing, among other things, a primordial role in the control of vascular tone. This vascular tone is ensured by pro-dilator mediators (nitric oxide (NO), prostacyclins (PGI2)), or vasoconstrictors (endothelin, thromboxane A2 or PGH2).Uremic toxin accumulation in chronic kidney disease (CKD) is a well-known factor in endothelial dysfunction, often associated with higher cardiovascular risk. This association is also present for terminal chronic kidney disease characterized by the need to resort to an extra-renal purification technique (in-center hemodialysis (HD), daily home hemodialysis (HDQ), peritoneal dialysis) or to resort to renal transplantation.

For HD to be effective, it is essential that the blood flow rate passing through the dialyzer is greater than 300ml/min. This imperative requires that any hemodialysis patient have specific vascular access (dialysis catheter or arteriovenous fistula (AVF)) to ensure these flow rates. The vascular access of choice is the arteriovenous fistula , because it is associated with a lower risk of infection and lower morbidity and mortality. Making an arteriovenous fistula consists of surgically creating an anastomosis between a vein and an artery.

Complications of arteriovenous fistula are common. Arteriovenous fistula maturation may be delayed (maturation delay) or even absent. Drainage veins and/or anastomoses can also be the site of stenosis or thrombosis. The pathophysiology of these complications is complex and multifactorial. Among the risk factors for these complications (delay or absence of maturation, stenosis thrombosis), the positivity of antiphospholipid antibodies (aPL) can be cited, as well as endothelial dysfunction.

Antiphospholipid syndrome (APS) is an autoimmune disease causing a thrombotic phenotype. This is an acquired thrombophilia. In the general population, the prevalence of antiphospholipid antibodies is around 0.5%; this prevalence is far from rare in hemodialysis, since it represents up to 37% in dialysis patients. In a retrospective study carried out at Brugmann University Hospital in 2023 , on 115 patients with AVF and in whom aPL dosages were available, the prevalence of persistent positivity (2 positive dosages spaced more than 12 weeks apart) was 21%.

Interestingly, a third of the cohort presented an antibody profile that did not allow them to be classified according to the classification criteria in force. This group corresponds to patients with a single positive dosage, either not recontrolled or recontrolled negative. This group was called Fluctuating. This fluctuating group was associated with arteriovenous fistula complications in a 2019 study.

Endothelial dysfunction is also implicated in the pathophysiology of APS. In clinical practice, the "flow mediated dilation" (FMD) test makes it possible to assess endothelial dysfunction in vivo. It involves the phenomenon of post-occlusive hyperemia which is mainly linked to NO and endothelium-dependent vasodilation. In the brachial artery, NO is the sole mediator of FMD. Endothelial dysfunction according to FMD has been described in populations with advanced chronic kidney disease, as well as patients with cardiovascular diseases. Hemodialysis patients with delayed/absence of arteriovenous fistula maturation have more pathological FMDs compared to dialysis patients without fistula problems. However, the additive role of aPL in this different population has not been studied in terms of endothelial dysfunction by FMD.

The objective of this study is to evaluate the weight of antiphospholipid biology on endothelial dysfunction in hemodialysis patients, using the FMD test.

1. Compare endothelial dysfunction by FMD according to the stage of chronic kidney disease and in comparison to a control group without chronic kidney disease.
2. Characterize the FMD pre or post dialysis and according to the duration of the long (for example between Thursday and Sunday) vs. short (between Tuesday and Thursday) inter-dialytic period.
3. Evaluate the relationship between endothelial dysfunction according to FMD, aPL positivity and arteriovenous fistula complications in hemodialysis patients.
4. Evaluate the risk factors associated with endothelial dysfunction according to FMD, and in particular evaluate the impact of antiphospholipid antibodies.
5. Evaluate the correlation between endothelial dysfunction according to FMD and other markers of endothelial dysfunction (urinary NO and metabolites of urinary NO, PGI2, endothelin, PGH2). conditions: Chronic Renal Failure studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: Urine sampling name: Blood sampling name: Flow mediated dilatation test measure: Nitric oxide (NO) plasma level measure: Endothelin 1 (ET-1) plasma level measure: E-Selectine plasma level measure: P-Selectine plasma level measure: Intercellular Adhesion Molecule 1 (ICAM-1) plasma level measure: Interleukin 6 (IL-6) plasma level measure: Nitric oxide (NO) urine concentration measure: Endothelin 1 (ET-1) urine concentration measure: Tumour Necrosis Factor alpha (TNF alpha) urine concentration measure: Interleukin 6 (IL-6) urine concentration measure: Flow mediated dilatation test result (%) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brugmann University Hospital status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Maxime Taghavi, MD PhD role: CONTACT email: Maxime.TAGHAVI@chu-brugmann.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06347016 id: AROAPOC3-3004 id: 2023-509301-80 type: EUDRACT_NUMBER briefTitle: Study of Plozasiran in Adults With Severe Hypertriglyceridemia acronym: SHASTA-4 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2026-10 date: 2024-04-04 date: 2024-04-16 name: Arrowhead Pharmaceuticals class: INDUSTRY briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol. conditions: Severe Hypertriglyceridemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Plozasiran Injection name: Placebo measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo measure: Proportion of Subjects Who Achieve Fasting TG Levels of < 500 mg/dL (<5.65 mmol/L) at Month 10 and Month 12 measure: Adjudicated Abdominal Clinical Event Rate (Including Emergency Room Visits or Hospitalizations for Abdominal Pain Attributed to Hypertriglyceridemia and Events of Documented Pancreatitis) During the Treatment Period Compared to Placebo at Month 12 measure: Proportion of Subjects Who Achieve Fasting TG Levels of <150mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo measure: Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment measure: Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment measure: Change from Baseline in Hemoglobin A1c (HbA1c) and Other Glycemic Control Parameters During the Treatment Period Compared to Placebo measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo measure: Change from Baseline in C-Peptide During the Treatment Period Compared to Placebo measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo measure: Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo measure: Initiation of New Medication for Hyperglycemia among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12 measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06347003 id: AROAPOC3-3003 id: 2023-509300-14 type: EUDRACT_NUMBER briefTitle: Phase 3 Study of Plozasiran in Adults With Severe Hypertriglyceridemia acronym: SHASTA-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2026-10 date: 2024-04-04 date: 2024-04-04 name: Arrowhead Pharmaceuticals class: INDUSTRY briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol. conditions: Severe Hypertriglyceridemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 405 type: ESTIMATED name: Plozasiran Injection name: Placebo measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo measure: Proportion of Participants Who Achieve Fasting TG Levels of <500 mg/dL (<5.65 mmol/L) at Month 10 and Month 12 Compared to Placebo measure: Adjudicated Abdominal Clinical Event Rate (Including Emergency Room Visits or Hospitalizations for Abdominal Pain Attributed to Hypertriglyceridemia and Events of Documented Pancreatitis) During the Treatment Period Compared to Placebo at Month 12 measure: Proportion of Participants Who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment measure: Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment measure: Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo measure: Change from Baseline in C-peptide During the Treatment Period Compared to Placebo measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo measure: Incidence Rates of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo measure: Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346990 id: Faculty 2023-2024-2-2 briefTitle: The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-14 date: 2025-05-15 date: 2024-04-04 date: 2024-04-05 name: Applied Science Private University class: OTHER briefSummary: This study is planned to check the effect of holy Quran recital on the development of delirium after conronary artery bypass graft surgery (CABG). Different studies have been done before about the effects of non-pharmacological intervention on delirium after CABG, howvere, none was designed specifically to check the effect of Holy Qoyran on this outcome. conditions: Coronary Artery Disease conditions: Coronary Artery Bypass Graft Surgery conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups in this study. The intervention group and the control group. For the control group, patients are receiving routine care . For the intervention group, after patients were (1) extubated, (2) hemodynamically stable, and (3) negatively rated on primary CAM-ICU, they receive holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each. We choose these times based on the nurses' recommendations about the minimal interruptions from physician rounds and family visits. The selection of Surah Al-Rahman was based on the widespread belief that it is among the most melodic and calming passages in the Quran, especially when recited by the well-known reciter Qari AbdulBasit. 1,5,40 The listening was done using one-use headphones on an iPad. The intervention was discontinued if the participant developed delirium primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Taking into consideration that this was a RCT, blinding the participants was not possible. However, data collectors and data analyzer were blinded. Directly after the intervention, each day at 3pm and 9 pm, the participants were evaluated for development of delirium by the Research assistant how do not know in which group was the participant allocated, and if the result was positive the intervention was discontinued. whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: Holy Quran Recital measure: Delirium measure: Length of stay-ICU measure: Length of stay-hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346977 id: DTO-20231214 briefTitle: Diagnosis of Leptomeningeal Metastasis and the Monitoring of Intrathecal Chemotherapy Efficacy in NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Wuhan Union Hospital, China class: OTHER briefSummary: Non-small cell lung cancer (NSCLC), occupying a disquieting position as the second most prevalent and deadliest neoplasm worldwide, afflicts an estimated 30% of its patients with intracranial metastatic spread. Among these, leptomeningeal metastasis (LM) is an exceptionally surreptitious and perilous manifestation, often evading timely and accurate diagnosis. The clinical landscape is further complicated by the presence of patients who, due to various reasons, are unable to undergo lumbar puncture, a procedure crucial for the investigation of LM. Moreover, even when cerebrospinal fluid (CSF) analysis via conventional cytological and immunohistochemical methods is attempted, a definitive diagnosis of LM may remain elusive in a subset of cases.

Intrathecal chemotherapy, particularly via the administration of pemetrexed, which has demonstrated both notable efficacy and an acceptable safety profile when delivered directly into the cerebrospinal space, constitutes a cornerstone of treatment for NSCLC-LM. Despite its importance, the lack of robust, validated biomarkers to gauge the therapeutic response to such interventions represents a significant knowledge gap. This deficit is compounded by the inherent challenges associated with CSF samples, including their limited availability and the suboptimal sensitivity and high resource demands of current ctDNA assessment techniques.

To address these pressing diagnostic and monitoring needs in NSCLC-LM management, the investigator proposes a forward-looking, non-interventional clinical study harnessing the power of cutting-edge proteomic technologies. These platforms, characterized by their high throughput, exquisite sensitivity, and minimal sample volume requirements, offer a promising avenue for elucidating the intricacies of chemotherapy response in intrathecal therapy. The study aims to provide valuable insights into improving diagnostic accuracy for LM in NSCLC patients and to establish a more rigorous framework for assessing treatment efficacy in individuals undergoing intrathecal chemotherapy, ultimately contributing to enhanced patient care and personalized therapeutic strategies. conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Pemetrexed measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union hospital city: Wuhan state: Hubei zip: 430000 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06346964 id: 2024-341 briefTitle: Self-Care Management in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-22 date: 2025-06-30 date: 2024-04-04 date: 2024-04-04 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: Self-management of chronic diseases requires the ability to manage the symptoms, treatment, and lifestyle changes inherent in living with a chronic disease. Rational drug use by older adults is of particular importance. Mobile applications are being developed to facilitate the compliance of older adults with chronic diseases with medication treatment and to increase their disease self-management skills. The research was planned to strengthen participation in social life through rational drug use and disease self-care management in older adults with chronic diseases. The research will be conducted in a parallel group randomized controlled manner. In the research, a mobile application will be developed for the use of older adults. Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention. conditions: Disease Self Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ESTIMATED name: mobile application measure: Participation in social life (Social Inclusion Scale) measure: Participation in social life (Social Inclusion Scale) measure: Participation in social life (Social Inclusion Scale) sex: ALL minimumAge: 60 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Yıldırım Beyazıt University city: Ankara state: Çubuk/Turkey zip: 06760 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06346951 id: LPan briefTitle: Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS) acronym: IFS overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-09-30 date: 2024-09-30 date: 2024-04-04 date: 2024-04-04 name: Sichuan Provincial People's Hospital class: OTHER briefSummary: The goal of this survey is to learn about the current status of the diagnosis and treatment of invasive fungal infections among intensive care physicians in Sichuan Province (IFS). Its primary focus lies on answering the following questions: ①awareness and proficiency in diagnosis and treatment; ②the use of antifungal medications; ③the application of microbiological identification and diagnostic methods. We aim to analyze the problems and deficiencies that existed among intensive care physicians in order to provide a basis for the development of targeted training and intervention measures. conditions: Invasive Fungal Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: The survey on the hospital's diagnostic and treatment standards and infrastructure for invasive fungal infections measure: The survey on the awareness of an invasive fungal infection among intensive care physicians sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346938 id: 2024WHXH001 briefTitle: The Clinical Significance of CT-based Biomarkers in the Classification and Prognosis of Bronchiectasis overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2027-03-26 date: 2027-03-26 date: 2024-04-04 date: 2024-04-04 name: Wuhan Union Hospital, China class: OTHER briefSummary: As the third major chronic airway disease in China, bronchiectasis has a wide range of patients. However, the involved sites, morphological features and airway obstruction of bronchiectasis are varied, and clinical heterogeneity is high, making prognosis and severity difficult to evaluate. CT plays an important role in the diagnosis and classification of ramadasis. Based on this, we analyzed the CT findings of patients with bronchiectasis and followed up patients with bronchiectasis to understand their disease progression and prognosis, so as to further analyze the role of CT biomarkers in the type and prognosis of bronchiectasis diseases. conditions: Bronchiectasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Frequency of acute exacerbations of bronchiectasis measure: Deterioration of lung function measure: Severity of dyspnoea measure: Degree of emphysema measure: Mucus plug score measure: Bhalla scores on CT of participants' lungs measure: Frequency of hospitalisation measure: Death sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wuhan Union Hospital city: Wuhan state: Hubei zip: 430022 country: China name: Xiaorong Wang role: CONTACT phone: 18627195231 phoneExt: +86 email: rong-100@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06346925 id: SHR8735-116 briefTitle: Study of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-04 date: 2024-04-04 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: This study was designed as a single-center, randomized, open, two-cycle, cross-over trial. It is planned to enroll 18 healthy subjects conditions: Adult Patients With Chronic Primary ITP conditions: Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Herombopag Olamine Tablets measure: Cmax measure: AUC0-t measure: AUC0-∞ measure: Tmax measure: t1/2 measure: CL/F measure: V/F measure: Incidence and severity of adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The Second Hospital of Anhui Medical Uniersity city: Hefei state: Anhui zip: 230601 country: China name: Wei Hu role: PRINCIPAL_INVESTIGATOR lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06346912 id: TXB2023022 briefTitle: CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2027-04-15 date: 2024-04-04 date: 2024-04-04 name: Zhejiang University class: OTHER name: Shanghai YaKe Biotechnology Ltd. briefSummary: Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma. conditions: Acute Lymphoblastic Leukemia,B-Cell conditions: Non-hodgkin Lymphoma,B Cell studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: CD19-BAFF Targeted CAR T-cells measure: Dose-limiting toxicity (DLT) measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Overall response rate ,ORR measure: Duration of remission ,DOR measure: Event-free survival, EFS measure: Overall survival, OS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first affiliated hospital of medical college of zhejiang university city: Hangzhou state: Zhejiang zip: 310000 country: China name: He Huang, MD role: CONTACT phone: 86-13605714822 email: hehuangyu@126.com name: Yongxian Hu, MD role: CONTACT phone: +8615957162012 email: huyongxian2000@aliyun.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06346899 id: TAK-743-4012 briefTitle: A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China overallStatus: NOT_YET_RECRUITING date: 2024-08-14 date: 2025-08-13 date: 2025-08-13 date: 2024-04-04 date: 2024-04-04 name: Takeda class: INDUSTRY briefSummary: The Chinese health authority has approved lanadelumab to prevent Hereditary Angioedema (HAE) attacks in persons of 12 years and older. It has also approved icatibant to treat acute HAE attacks in persons 2 years and older.

One of the main aims of this study is to learn about the number of HAE attacks in 1 month in Chinese persons with HAE during their treatment with lanadelumab. The other main aim is to learn how much time is needed to resolve acute HAE attacks when treated with icatibant. Other aims of this study are to learn more about side effects of lanadelumab and icatibant treatment as well as to collect additional information on the treatment with lanadelumab, such as the dose and how often it needs to be given, reasons for stopping the treatment with lanadelumab and how long it was taken until stopping. Participants will be treated by their doctors according to routine medical practice. Only data already available in the medical records of the participants will be reviewed and collected during this study. conditions: Hereditary Angioedema (HAE) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 130 type: ESTIMATED name: No intervention measure: Monthly Rate of HAE Attacks for Each Lanadelumab-treated Participant During the Lanadelumab Exposure Period measure: Median Time to Complete Attack Resolution for Icatibant Treated Participants measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Lanadelumab and Icatibant Exposure Period measure: Dosage of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period measure: Frequency Administration of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period measure: Number of Participants with Reasons of Discontinuation of Lanadelumab During the Lanadelumab Exposure Period measure: Time to Lanadelumab Discontinuation Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346886 id: 23-011703 briefTitle: HTN App for HTN Control and Cardiovascular Health Among African-Americans overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-04-04 date: 2024-04-04 name: Mayo Clinic class: OTHER name: Miami Heart Research Institute Inc. briefSummary: The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: FAITH! HTN app measure: Absolute Change in Systolic Blood Pressure (BP) measure: HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects) measure: Proportion of subjects reaching BP control measure: Change in BP as assessed by home BP cuff measurements measure: CV Health Knowledge as measured by module assessment scores measure: Hypertension (HTN) Knowledge as assessed by 11-item questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Lainey Moen role: CONTACT phone: 507-266-7062 email: Moen.Lainey@mayo.edu name: Ashton Krogman role: CONTACT phone: (507) 266-2087 email: Krogman.Ashton@mayo.edu name: LaPrincess Brewer, M.D., M.P.H. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06346873 id: 23-008090 briefTitle: Demonstrating Efficacy of JOGO for the Treatment of Tremor overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2027-09 date: 2024-04-04 date: 2024-04-04 name: Mayo Clinic class: OTHER briefSummary: This research is being done to determine the effectiveness of a new treatment, called JOGO, for patients with functional tremor (FT). JOGO is a biofeedback device that has been shown to help patients with several conditions, e.g., chronic pain, migraine, and Parkinson's disease (PD)-related tremor. JOGO provides biofeedback by using wireless adhesive stickers, called surface electromyography, to get information about muscle activity. This information is then used to modify symptoms through a series of training sessions with a physical therapist and individual practice. conditions: Functional Neurological Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: JOGO measure: Change in TETRAS scores 1 month measure: Change in TETRAS scores 2 months measure: Change in QUEST scores measure: Tremor prevalence measure: Tremor resolution 1 month measure: Tremor resolution 2 months measure: Change in BDI-II scores measure: Change in BAI scores measure: Change in Intolerance of Uncertainty Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224 country: United States lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06346860 id: 09.2024.241 briefTitle: Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-04 date: 2024-04-19 name: Marmara University class: OTHER briefSummary: Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach. conditions: Opioid Use conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 56 type: ESTIMATED name: Regional Block Comparison measure: Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device measure: Postoperative pain assessment with Numeric Rating Scale (NRS) measure: Comparison of the frequency of treatment related complications measure: Participant satisfaction sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University School of Medicine city: Istanbul country: Turkey name: Beliz Bilgili role: CONTACT phone: 05362187927 email: belizbilgili@gmail.com name: Ayse Deniz Kayir role: CONTACT phone: 05465626316 email: kayir_95@hotmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06346847 id: TAC/231001/AKM/IBS id: IBS-D PAM type: OTHER domain: The Akkermansia Company briefTitle: Study to Assess Effects of Pasteurized Akkermansia Muciniphila vs Placebo in Participants With Diarrhea-predominant IBS acronym: PAM-DIGEST overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-04 date: 2024-04-04 name: A-Mansia Biotech S.A. class: INDUSTRY name: Vedic Lifesciences Pvt. Ltd. briefSummary: The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of pasteurized Akkermansia muciniphila on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of pAkk on anxiety, low mood and stress of the participants, as well as its safety and tolerability.

The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase). conditions: Diarrhea-Predominant Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-blind, Placebo-controlled primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 380 type: ESTIMATED name: Pasteurized Akkermansia muciniphila (pAKK) name: Placebo measure: To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome. measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8 measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Generalized Anxiety Disorder (GAD)-7 score measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the GAD-7 from baseline at week 12. measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Patient Health Questionnaire (PHQ)-9 score measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the PHQ-9 from baseline at week 12. measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Perceived Stress Scale (PSS) measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Bristol Stool Form Score (BSFS) measure: To assess the impact of the Investigational Product in comparison to placebo on occurrence of normal BSFS score at the end of the study measure: To assess the impact of the Investigational Product in comparison to placebo on the quality of life as assessed by the mean change in IBS-QOL scores measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in IBS-SSS value measure: To assess the impact of the Investigational Product in comparison to placebo on compliance with the intake of the investigational product measure: To assess the impact of the Investigational Product in comparison to placebo on Safety and tolerance measure: To assess the impact of the Investigational Product in comparison to placebo on the impact of IBS on their quality of life using the IBS-Quality of Life (IBS-QoL) instrument. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: HCG Hospital city: Ahmedabad state: Gujarat zip: 380006 country: India name: Dr. Manoj Vithalani, MBBS, MD role: CONTACT phone: 9825024355 email: drmvithalani@gmail.com name: Dr. Manoj Vithalani, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 23.02579 lon: 72.58727 facility: Anand Multispeciality Hospital city: Vadodara state: Gujarat zip: 390016 country: India name: Dr. Himanshu Patel, MBBS, DNB role: CONTACT phone: 8141001672 email: dr.himanshuvpatel@gmail.com name: Dr. Himanshu Patel, MBBS, DNB role: PRINCIPAL_INVESTIGATOR lat: 22.29941 lon: 73.20812 facility: Stress Test Clinic city: Mumbai state: Maharashtra zip: 400059 country: India name: Dr. Ramesh Dargad, MBBS, MD role: CONTACT phone: 9820152828 email: rohitdargad@outlook.com name: Dr. Ramesh Dargad, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 19.07283 lon: 72.88261 facility: Criticare Asia Multispeciality Hospital & Research Centre city: Mumbai state: Maharashtra zip: 400069 country: India name: Dr. Sanjeev Khanna, MD, MNAMS role: CONTACT phone: 9820055090 email: dr.sanjeevkhanna@yahoo.com name: Dr. Sanjeev Khanna, MD, MNAMS role: PRINCIPAL_INVESTIGATOR lat: 19.07283 lon: 72.88261 facility: Surya Multispeciality Hospital city: Nashik state: Maharashtra zip: 422003 country: India name: Dr. Gaurav Bachhav, MD, DM role: CONTACT phone: 9867111119 email: drgauravbachhav@gmail.com name: Dr. Gaurav Bachhav, MD, DM role: PRINCIPAL_INVESTIGATOR lat: 19.99727 lon: 73.79096 facility: Astha Clinic city: Nashik state: Maharashtra zip: 422011 country: India name: Dr. Mohit Chaudhary, MBBS, MD role: CONTACT phone: 7744825746 email: m.chaudhary8@gmail.com name: Dr. Mohit Chaudhary, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 19.99727 lon: 73.79096 facility: Apollo Hospital city: Navi Mumbai state: Maharashtra zip: 400614 country: India name: Dr. Amey Sonavane, MBBS, DNB role: CONTACT phone: 9619879955 email: amey_max@yahoo.com name: Dr. Amey Sonavane, MBBS, DNB role: PRINCIPAL_INVESTIGATOR lat: 19.03681 lon: 73.01582 facility: Swara Hospital city: Palghar state: Maharashtra zip: 401303 country: India name: Dr. Prashant Walke, MBBS, MD role: CONTACT phone: 9860844434 email: walkedrprashant@gmail.com name: Dr. Prashant Walke, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 19.69693 lon: 72.76543 facility: Gastrohub Hospital city: Pune state: Maharashtra zip: 411027 country: India name: Dr. Mandar Doiphode, MBBS, DNB role: CONTACT phone: 9850077168 email: mandardoiphode22@gmail.com name: Dr. Mandar Doiphode, MBBS, DNB role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: Umarji Mother and Child Care Hospital city: Pune state: Maharashtra zip: 411045 country: India name: Dr. Prasad Bhatte, MD DM role: CONTACT phone: 9920039265 email: prasadbhate07@gmail.com name: Dr. Prasad Bhatte, MD DM role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: Lifeline Multispeciality Hospita city: Pune state: Maharashtra zip: 412101 country: India name: Dr. Shrikant Kote, MBBS, MD role: CONTACT phone: 7506360679 email: shri.kote86@gmail.com name: Dr. Shrikant Kote, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: Asian Institute of Medical sciences city: Thāne state: Maharashtra zip: 421203 country: India name: Dr Vineet Chaudhari, MD, DNB role: CONTACT phone: 7337422597 email: chaudhari.vineet@gmail.com name: Dr Vineet Chaudhari role: PRINCIPAL_INVESTIGATOR lat: 19.19704 lon: 72.96355 facility: Maharaja Agrasen Superspeciality Hospital city: Jaipur state: Rajasthan zip: 302039 country: India name: Dr. Prabhat K Sharma, MBBS, MD role: CONTACT phone: 9983995050 email: pksharma.clinical@gmail.com name: Dr. Prabhat K Sharma, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 26.91962 lon: 75.78781 facility: Samvedna Hospita city: Varanasi state: Uttar Pradesh zip: 221005 country: India name: Dr. Hemant K Gupta, MBBS, MD, DM role: CONTACT phone: 8573888800 email: drhemantg26@gmail.com name: Dr. Hemant K Gupta, MBBS, MD, DM role: PRINCIPAL_INVESTIGATOR lat: 25.31668 lon: 83.01041 hasResults: False

 nctId: NCT06346834 id: PRO-sIPV-4002 briefTitle: Sequential Vaccination of Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains From Different Manufacturers overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-08-31 date: 2024-12-30 date: 2024-04-04 date: 2024-04-15 name: Sinovac Biotech Co., Ltd class: INDUSTRY briefSummary: To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV. conditions: Poliomyelitis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: sIPV measure: Geometric Mean Increase (GMI) measure: Geometric Mean Titer (GMT) measure: Seropositivity rate measure: Seroconversion rate measure: Adverse reaction incidence measure: Serious adverse events incidence sex: ALL maximumAge: 12 Months stdAges: CHILD hasResults: False

 nctId: NCT06346821 id: WestChinaGBMTTFieldsV1.0 briefTitle: Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data overallStatus: RECRUITING date: 2023-07-04 date: 2024-04-01 date: 2024-05-01 date: 2024-04-04 date: 2024-04-04 name: Sichuan University class: OTHER briefSummary: The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:

* The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients.
* The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone.

Participants will:

* Receive or not receive TTFields.
* Concomitantly or adjuvantly receive TTFields. conditions: Glioblastoma Multiforme studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Optune® (Tumor Treating Fields) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: Lei Liu, PhD, MD role: CONTACT phone: +8618980606231 email: liuleihx@gmail.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06346808 id: PDAC-OV briefTitle: Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-04 date: 2024-04-04 name: Sichuan University class: OTHER briefSummary: The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Oncolytic virus Plus Anti-PD1 and Chemotherapy measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability] measure: R0 resection rate measure: ORR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan University city: Chengdu state: Sichuan zip: 610000 country: China name: Zhong Wu, MD role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06346795 id: SelcukC briefTitle: Class II Restorations With High-Filled Flowable Composites overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-01 date: 2025-06-01 date: 2024-04-04 date: 2024-04-25 name: Selcuk University class: OTHER briefSummary: In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p\<0.05). conditions: Dental Caries conditions: Class II Dental Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: High-filling flowable dental composite measure: Retention measure: Color match measure: Marginal discoloration measure: Marginal adaptation measure: Secondary caries measure: Surface texture measure: Anatomical form measure: Postoperative sensitivity sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06346782 id: IRB00370545 briefTitle: Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy (I-PCIT) in Pediatric Cancer acronym: I-PCIT overallStatus: RECRUITING date: 2024-02-19 date: 2028-08-01 date: 2028-08-01 date: 2024-04-04 date: 2024-04-04 name: Johns Hopkins All Children's Hospital class: OTHER briefSummary: This study is being done to learn whether a telehealth intervention called "Internet-Based Parent Child Interaction Therapy," or I-PCIT," can help parents improve the child's behavior if the child currently or previously went through cancer treatment.

Parents who choose to be in this study will complete a survey to help researchers figure out if the parent is eligible for the larger study. If a parent is eligible for the larger study and chooses to participate, if so, the participants will be randomly assigned to either receive the I-PCIT intervention now or to be on a waitlist and begin I-PCIT in 5-6 months. The whole study consists of completing I-PCIT sessions with a clinician and completing 3-4 follow-up surveys after the initial screener survey. conditions: Pediatric Cancer conditions: Oncology conditions: Disruptive Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pilot feasibility trial. We are using a 2:1 (intervention: waitlist control) randomized controlled design. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 300 type: ESTIMATED name: Internet-Based Parent-Child Interaction Therapy measure: I-PCIT Feasibility as assessed by intervention completion measure: I-PCIT Acceptability as assessed by the Treatment Evaluation Inventory Short form sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins All Children's Hospital status: RECRUITING city: Saint Petersburg state: Florida zip: 33701 country: United States name: Melissa Faith, Ph.D. role: CONTACT phone: 727-295-8477 email: mfaith1@jhmi.edu lat: 27.77086 lon: -82.67927 hasResults: False

 nctId: NCT06346769 id: SelcukB briefTitle: Composite Restorations Performed by Placing Polyethylene Fiber overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-10-15 date: 2025-04-15 date: 2024-04-04 date: 2024-04-04 name: Selcuk University class: OTHER briefSummary: This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was used for the significance of the difference between time-dependent changes within each group (p\<0.05). conditions: Endodontically Treated Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 68 type: ACTUAL name: Polyethylene Fiber measure: Retention measure: Color match measure: Marginal Discoloration measure: Marginal adaptation measure: Secondary caries measure: Surface texture measure: Anatomical form sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department city: Konya country: Turkey lat: 37.87135 lon: 32.48464 facility: Selcuk University, Faculty of Dentistry city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06346756 id: SelcukA briefTitle: Clinical Evaluation of Class II Restorations overallStatus: COMPLETED date: 2023-01-01 date: 2023-07-01 date: 2023-07-15 date: 2024-04-04 date: 2024-04-04 name: Selcuk University class: OTHER briefSummary: This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.

The study included 62 patients and 147 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. GCI only in premolar teeth; GCA, TP, and FU have been used to restore premolar and molar teeth. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p\<0.05). conditions: Dental Caries conditions: Dental Caries Class II studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 62 type: ACTUAL name: Treatment of dental caries. measure: Retention measure: color match measure: marginal adaptation measure: marginal discoloration measure: surface texture measure: anatomical form measure: secondary caries measure: postoperative sensitivity sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Selcuk University, Faculty of Dentistry city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06346743 id: IRB/2023/1119/SIMS briefTitle: Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Neonatal Jaundice. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-08 date: 2024-04-04 date: 2024-04-04 name: Muhammad Zark class: OTHER_GOV briefSummary: Neonatal jaundice has significant importance in neonatal morbidity and mortality world-wide. Though phototherapy has a relentless use in neonatal jaundice, its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents. This study is conducted to observe the reduction of serum bilirubin level in neonates treated with Fenofibrate as an adjuvant to phototherapy in treatment of exaggerated physiological hyperbilirubinemia. After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted and later on, the data will be analyzed in the SPSS 26. Quantitative variables like age will be presented as mean ± SD. Qualitative variables like gender will be presented as percentage and frequency. Comparison of two groups intervention group and non-intervention group, apply independent sample t-test. P value \< 0.05 will be taken as significant. Limitation of the proposed study includes limited sample size, study population limited to only one hospital and no follow-up in plan. If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns, it will be beneficial to minimize the risk of the complications, rapid regression of hyperbilirubinemia \& shortening the length of hospital stay. conditions: Physiological Neonatal Jaundice conditions: Physiological Hyperbilirubinaemia studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare the effects of Fenofibrate adjuvant to phototherapy with conventional phototherapy for exaggerated neonatal hyperbilirubinemia in the form of bilirubin reduction, duration of phototherapy, hospital stay \& observation of side-effects.

After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted. primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: Fenofibrate name: Phototherapy measure: number of days needed for serum bilirubin to decrease below phototherapy range measure: Hospital length of Stay sex: ALL minimumAge: 24 Hours maximumAge: 14 Days stdAges: CHILD facility: Services Institute of Medical Sciences city: Lahore state: Punjab zip: 54000 country: Pakistan name: Noman Abdullah role: CONTACT phone: +923124100143 email: info@sims.edu.pk name: Muhammad Zark, MBBS role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06346730 id: 142-18 briefTitle: The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI) acronym: (IUI) overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-30 date: 2024-09-30 date: 2024-04-04 date: 2024-04-09 name: Suleyman Demirel University class: OTHER briefSummary: This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. Virtual reality glasses will be applied to the intervention group. conditions: Virtual Reality conditions: Anxiety conditions: Patient Satisfaction conditions: Intrauterine Insemination (IUI) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The sample will divide into intervention and control groups primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 90 type: ESTIMATED name: Virtual reality glasses to intervention group measure: State Trait Anxiety Inventory (STAI) measure: Patient's Perception of Nursing Care Scale sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06346717 id: SINOPU-elif 2 briefTitle: Mobile Application Based Care for Total Knee Prosthesis Patients acronym: KneeMobilApp overallStatus: RECRUITING date: 2024-03-27 date: 2025-03-30 date: 2025-03-30 date: 2024-04-04 date: 2024-04-04 name: Sinop University class: OTHER briefSummary: Total knee prosthesis (TKP); It is a surgical treatment used in the management of functional limitations and severe pain occurring on the degenerated joint surface as a result of rheumatoid arthritis, osteoarthritis, posttraumatic arthritis and other nonspecific arthritis. Nursing care is of great importance in the success of TKP surgery. Reducing pain, preventing complications, increasing self-care ability, and improving the quality of life by improving postoperative knee functions are the main goals of postoperative nursing care. In order to achieve these goals, patients and their relatives need to receive training on home care in the post-operative period before discharge. With the increasing use of mobile technologies in daily life and the increasing adoption of e-health, the opportunity for people to improve their self-management skills through e-health is increasing. Mobile Health (m-Health) provides convenience in many areas such as educating the public, warning about potential diseases and disease risks, and communicating with messages, notifications and video when necessary. It also affects the way nursing services are delivered and provides great benefits in the delivery of nursing services. For all these reasons, it was aimed to examine the effect of mobile application-supported care given to patients with total knee prosthesis on functional status and self-care ability. conditions: Knee Prosthesis conditions: Mobile Application studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: "Knee Prosthesis-M" mobile application service measure: Knee Injury and Osteoarthritis Outcome Score = KOOS measure: Exercise of Self-Care Agency=ESCA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elif ALTINKAYNAK SARAL status: RECRUITING city: Merkez state: Osmaniye Köyü zip: 5700 country: Turkey name: ELİF ALTINKAYNAK SARAL, PhD role: CONTACT phone: 05436071986 email: ealtinkynk@hotmail.com name: Sonay GÖKTAŞ, PhD role: CONTACT phone: 05324567776 email: sonay.goktas@sbu.edu.tr hasResults: False

 nctId: NCT06346704 id: PR5030-66 briefTitle: Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis acronym: NHS-MS-EGYPT overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2026-11-30 date: 2026-11-30 date: 2024-04-04 date: 2024-04-04 name: SYSNAV class: INDUSTRY briefSummary: The study aims to assess the validity of real-world activity monitoring by the Syde® wearable device in subjects with multiple slclerosis. The Syde® collected data will be compared to on-site conventional clinical endpoints for MS pathology (EDSS, FSS and T25FWT). Subjects with multiple sclerosis will be assessed every 6 months for 2 years. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Digital HealthTechnology measure: Longitudinal change of 95th centile of stride velocity measure: Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346691 id: MTU-EC-IM-0-235/66 briefTitle: Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-09-30 date: 2024-12-31 date: 2024-04-04 date: 2024-04-05 name: Thammasat University class: OTHER briefSummary: The goal of this clinical trial is to determine if doxofylline and procaterol are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.

The main questions it aims to answer are:

* Does doxofylline demonstrate a comparable bronchodilator effect to procaterol in COPD participants?
* What medical problems do participants experience when taking doxofylline and procaterol?" conditions: COPD studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Crossover randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Doxofylline name: Procaterol measure: Forced expiratory volume in 1 second (FEV1) measure: Forced vital capacity (FVC) measure: Forced expiratory flow at 25-75% of FVC (FEF25-75) measure: modified Medical Research Council (mMRC) score measure: COPD Assessment Test (CAT) sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346678 id: MTU-EC-IM-0-016/67 briefTitle: Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients With Chronic Obstructive Pulmonary Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-08-31 date: 2024-10-31 date: 2024-04-04 date: 2024-04-04 name: Thammasat University class: OTHER briefSummary: The goal of this observational study is to investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:

• Do Accuhaler tester, Ellipta tester, and Turbutester demonstrate comparable accuracy to the In-check DIAL for assessing inspiratory inhalation force in COPD patients? conditions: Chronic Obstructive Pulmonary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: Accuhaler tester measure: Accuracy of Accuhaler tester measure: Accuracy of Ellipta tester measure: Accuracy of Turbutester measure: Prevalence of suboptimal peak inspiratory flow rate measure: Prevalence of insufficient peak inspiratory flow rate sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346665 id: DZIF Tx-Cohort briefTitle: The Transplant Cohort of the German Center for Infection Research overallStatus: RECRUITING date: 2016-01 date: 2025-12 date: 2030-12 date: 2024-04-04 date: 2024-04-23 name: Technical University of Munich class: OTHER name: Hannover Medical School name: University Hospital Heidelberg name: Universität Tübingen name: Klinikum der Universität München name: Max von Pettenkofer-Institut München name: Nierenzentrum Heidelberg name: Helmholtz Centre for Infection Research briefSummary: Medical data and biological samples obtained from transplant patients are collected and managed across Germany with the help of the DZIF Transplant Cohort. The data and samples form the basis of scientific studies which investigate the connections between numerous factors influencing an organ's susceptibility to infection and organ function. conditions: Infections conditions: Transplant Complication conditions: Transplant Failure conditions: Immunosuppression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Realisation of studies that focus on the the medical needs of transplant patients, particularly with regard to their susceptibility to infection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Technische Universität München status: RECRUITING city: München country: Germany name: Daniela Schindle, Dr. role: CONTACT lat: 48.13743 lon: 11.57549 hasResults: False

 nctId: NCT06346652 id: REC-UOL-216-03-2024 briefTitle: Effects of Core Strengthening and PNF Pattern on Static Balance and Plantar Pressure in Chronic Stroke Patients overallStatus: RECRUITING date: 2024-03-10 date: 2024-04-22 date: 2024-04-30 date: 2024-04-04 date: 2024-04-04 name: University of Lahore class: OTHER briefSummary: Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.

This study aims to compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients. conditions: Chronic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 73 type: ESTIMATED name: Routine Physical Therapy name: Routine Physical Therapy+ PNF and Core Stregthening measure: Static Standing Balance measure: Plantar Pressure sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: The University of Lahore Teaching Hospital status: RECRUITING city: Lahore zip: 54000 country: Pakistan name: Safa Saleem, MSPTN role: CONTACT phone: 03354028864 email: safah.saleem@gmail.com name: Sameed Liaqat, MPhil role: CONTACT phone: 03249004200 email: samiliaqat3@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06346639 id: LithuananianSportsU-17 briefTitle: Effect of a 16-day Hot and Cold Acclimation on Adaptive Responses and Health-related Indicators overallStatus: RECRUITING date: 2024-04-04 date: 2029-04-04 date: 2029-04-04 date: 2024-04-04 date: 2024-04-15 name: Lithuanian Sports University class: OTHER briefSummary: There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE maskingDescription: The researchers who will analyze the saliva and venous blood samples will be blinded. count: 31 type: ESTIMATED name: 16-day hot and cold acclimation measure: Change in body mass and body composition (kg) measure: Change in skinfold thickness (mm) measure: Change in body mass index (kg/m^2) measure: Change in body surface area (m^2) measure: Change in substrate oxidation measure: Change in substrate oxidation (g/day) measure: Change in ventilation (l/min) measure: Change in breathing frequency (t/min) measure: Change in resting energy expenditure (kcal/day) measure: Change in metabolic heat production (W) measure: Change in heart rate (bpm) measure: Change in blood pressure (mmHg) measure: Change in mean arterial pressure (mmHg) measure: Change in heart rate variability (ms) measure: Change in heart rate variability (time domain) (ms) measure: Change in heart rate variability (time domain) (Ln) measure: Change in heart rate variability (frequency domain) (ms^2) measure: Change in heart rate variability (frequency domain) (Ln) measure: Change in stroke volume (ml) measure: Change in stroke volume index (ml/m^2) measure: Change in cardiac output index (l/min//m^2) measure: Change in cardiac output index (l/min) measure: Change in contractility index measure: Change in ventricular ejection time (ms) measure: Change in ventricular ejection fraction (percent) measure: Change in end diastolic volume (ml) measure: Change in systemic vascular resistance (dyn.s/cm5.m^2) measure: Change in cardiac work index (kg.m/m^2) measure: Change in early diastolic filling ratio (percent) measure: Change in testosterone concentration (µg/dl) measure: Change in female sex hormones concentration (pg/mL) measure: Change in salivary cortisol concentration (µg/dl) measure: Change in cytokines concentrations (pg/ml) measure: Change in complete blood count (10^9/L) measure: Change in complete blood count (percent) measure: Change in lipid profile (mmol/l) measure: Change in catecholamines concentration (ng/ml) measure: Change in insulin concentration (μIU/ml) measure: Change in glucose tolerance (mmol/l) measure: Change in anxiety and depression (points) measure: Change in plasma metabolites of the kynurenine pathway (μm) measure: Change in body temperature (°C) measure: Change in physiological strain index measure: Change in cold strain index measure: Change in root mean square (RMS) amplitude (mV) measure: Change in pain sensations measure: Change in thermal sensations (points) measure: Change in shivering/sweating (points) measure: Change in thermal comfort (points) measure: Height (m) measure: Change in physical activity (in h) measure: Change in sleep (in h) measure: Change in oxygen saturation (percent) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Lithuanian Sports University status: RECRUITING city: Kaunas zip: LT-44221 country: Lithuania name: Diana Reklaitienė, PhD role: CONTACT lat: 54.90272 lon: 23.90961 hasResults: False

 nctId: NCT06346626 id: 2WIN-S2024 briefTitle: To Evaluate the Consistency and Repeatability of Portable Automatic Optometry 2-WINS for Cycloplegic Optometry in Adolescents and Children overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-04 date: 2024-04-04 name: He Eye Hospital class: OTHER briefSummary: Myopia, also known as short-sightedness or near-sightedness, is a prevalent condition that typically emerges during childhood and early adulthood. It occurs when the eye elongates excessively, causing images of distant objects to focus in front of the retina, leading to blurred distance vision. The number of people with myopia is increasing every year, reaching half of the world's population by 2050. The global potential productivity loss due to uncorrected refractive errors was $244 billion in 2015. Due to the strong association between high myopia and pathological changes in the choroid, retina, and sclera, leading to irreversible vision loss, and the fact that correcting the refractive error does not halt the progression of pathology, the prevention of myopia, especially high myopia, has emerged as a crucial international public health concern. In ocular examinations of children under noncycloplegic conditions, the influence of accommodation cannot be disregarded.

Cycloplegic refraction is widely regarded as the gold standard in epidemiological assessment of refractive errors in pediatric populations. Moreover, due to children's decreased cooperation and unreliable responses, subjective refraction tests are less valued, and objective tests under cycloplegia are preferred. The portable vision screener 2WIN-S is a binocular tool that detects various ocular abnormalities and measures the refraction of both eyes. Along with measuring phorias/tropias in prismatic diopters and objective refraction in the range of -15D to +15D, 2WIN-S also captures additional features.

This study employed the cycloplegic condition to measurements using 2WIN-S, ARK-1 and subjective testing, we wanted to test the reliability and accuracy of 2WIN-S. conditions: Optometry studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: The optometric result (2WIN-S) measure: The optometric result(ARK-1) measure: The optometric result(subjective refraction) measure: The optometric result sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06346613 id: B2024-076R briefTitle: Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU overallStatus: RECRUITING date: 2024-03-07 date: 2025-01-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Most ICU patients experience sleep and circadian disruption (SCD), which causes a profound negative impact on patients, such as prolonged mechanical ventilation, glucose intolerance, and the occurrence of delirium. In order to better promote the alignment of circadian rhythm in ICU patients, this project will explore the prevalence of SCD and a series of influencing factors contributing to SCD in ICU patients, to help construct targeted intervention programs in the future. conditions: Sleep Deprivation conditions: Circadian Rhythm Disorders conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 56 type: ESTIMATED measure: Rhythmicity of melatonin levels. measure: Overnight sleep duration measure: Wake after sleep onset(WASO) measure: Overnight Rapid Eye Movement (REM) proportion measure: Overnight non-rapid eye movement stage 1 (NREM1) proportion measure: Overnight non-rapid eye movement stage 2 (NREM2) proportion measure: Overnight non-rapid eye movement stage 3 (NREM3) proportion measure: Sleep period time ratio (sleep continuity) measure: Subject sleep quality measure: Activity counts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road status: RECRUITING city: Shanghai zip: 20032 country: China name: Shining Cai, MSc role: CONTACT phone: 86-021-64041990 phoneExt: 2724 email: cai.shining@zs-hospital.sh.cn name: Yuxia Zhang, PhD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06346600 id: SKG0106-LF briefTitle: A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD overallStatus: RECRUITING date: 2024-04-02 date: 2031-03 date: 2031-03 date: 2024-04-04 date: 2024-04-04 name: Skyline Therapeutics class: INDUSTRY briefSummary: This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection. conditions: Neovascular (Wet) Age-related Macular Degeneration studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 83 type: ESTIMATED name: SKG0106 measure: Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) measure: Mean change in best corrected visual acuity (BCVA) at each visit from baseline measure: Mean change in macular central subfield thickness (CST) at each visit from baseline measure: Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ophthalmic Consultants of Boston status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: Retina Consultants of Texas status: NOT_YET_RECRUITING city: Katy state: Texas zip: 77494 country: United States lat: 29.78579 lon: -95.8244 facility: Wagner Macula & Retina Center status: NOT_YET_RECRUITING city: Norfolk state: Virginia zip: 23502 country: United States lat: 36.84681 lon: -76.28522 facility: The Second Hospital Of Anhui Medical University status: NOT_YET_RECRUITING city: Hefei state: Anhui country: China lat: 31.86389 lon: 117.28083 facility: Zhejiang Provincial People's Hospital status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 facility: Eye Hospital, WMU (Zhejiang Eye Hospital) status: NOT_YET_RECRUITING city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 facility: Beijing Hospital status: NOT_YET_RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: EYE & ENT Hospital of Fudan University status: RECRUITING city: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine status: NOT_YET_RECRUITING city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06346587 id: VRU751-C001 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-04 date: 2024-04-23 name: [Redacted] hasResults: False

 nctId: NCT06346574 id: STUDY-0004282 briefTitle: HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial) acronym: HEART overallStatus: RECRUITING date: 2023-12-14 date: 2024-11 date: 2024-12 date: 2024-04-04 date: 2024-04-04 name: Tufts University class: OTHER name: United States Department of Agriculture (USDA) name: National Head Start Association briefSummary: With funding from the United States Department of Agriculture (USDA), the Tufts University's Friedman School of Nutrition Science and Policy will be implementing a new, health and wellbeing program for Head Start educators at ABCD Head Start Centers in the greater Boston area.

The purpose of this study is to evaluate the combined impact of a health and wellness program and behavior change guides. The evaluation will focus on ABCD Head Start educators as the study population. Tufts University's Friedman School of Nutrition Science and Policy is responsible for implementing and evaluating this new intervention through surveys and analysis of administrative (health and wellness App) data.

A paper and pencil survey will be used to gather information on dietary, physical activity, and sleep behaviors. The surveys will also include a module on satisfaction with the health and wellness App and Guides. Survey data will be combined with the administrative data about App utilization. conditions: Dietary Habits conditions: Physical Inactivity conditions: Sleep Hygiene studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Study participants will be educators at Head Start centers where either the intervention is offered at the onset of the study (intervention group) or after six months (comparison condition). primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Experimental measure: Use of health and wellness App measure: Engagement with Guide measure: Nutrition behaviors measure: Physical activity behaviors measure: Sleep habits measure: BMI measure: Cholesterol measure: Triglycerides measure: Blood pressure measure: Blood glucose sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts University status: RECRUITING city: Boston state: Massachusetts zip: 02111 country: United States name: Katrina Sarson, MS, MEd role: CONTACT phone: 617-636-3737 email: katrina.sarson@tufts.edu name: Sujata Dixit-Joshi, MPH, PhD role: CONTACT phone: 617-636-3737 email: sujata.dixit_joshi@tufts.edu name: Christina Economos, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06346561 id: Soh-Med-24-02-10MS briefTitle: The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study overallStatus: RECRUITING date: 2024-03-30 date: 2024-08-30 date: 2024-08-30 date: 2024-04-04 date: 2024-04-04 name: Sohag University class: OTHER briefSummary: The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge.

The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. In this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery.

Hence, there is no enough studies about controlled hypotension in DCR we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during DCR surgery. conditions: Nasolacrimal Duct Obstruction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Dexmedetomidine name: Labetalol measure: Assess non invasive blood pressure during DCR surgery To compare between the effect of dexmedetomidine and labetalol in providing controlled hypotension. measure: Effectiveness of dexamedetomidine for prolongation of postoperative analgesia. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Sohag University hospitals status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, Professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06346548 id: VF-ES-DIG briefTitle: Study on the Chromatic Perception of Digital Systems in Aesthetic Field overallStatus: NOT_YET_RECRUITING date: 2024-09-27 date: 2025-06-15 date: 2025-06-15 date: 2024-04-04 date: 2024-04-04 name: Paolone Gaetano class: OTHER briefSummary: The study under consideration aims to evaluate differences in chromatic perception among three distinct color acquisition methodologies. Specifically, recruited patients will undergo testing with three different color detection systems, including two intraoral photography methodologies and one digital intra oral scanning. All procedures conducted are part of normal clinical practice. conditions: Color Detection of Upper Central Incisors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 78 type: ESTIMATED name: oral photography measure: Comparison of chromatic values of the upper central incisors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele city: Milano zip: 20132 country: Italy name: Federico Vannini role: CONTACT phone: +393450764177 email: f.vannini@studenti.unisr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06346535 id: 2022-05703-01 briefTitle: PrimeCog: Primary Care Cognitive Testing acronym: PrimeCog overallStatus: RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2029-04-01 date: 2024-04-04 date: 2024-04-23 name: Region Östergötland class: OTHER briefSummary: The PrimeCog study aims to describe the symptomatology and pathophysiology of stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) compared to healthy controls (HC). The participants will be recruited at primary care centers, and samples of blood, saliva, and hair will be collected. Digital questionnaires covering psychosocial variables and screening instruments for the detection of depression, anxiety, etc., along with a digital cognitive test battery, will be performed at home. Subsequently, an MRI of the brain will be performed, and analysis of biomarkers for stress, inflammation, and neurodegeneration will be conducted. These procedures will be repeated after twelve and twenty-four months. The study will investigate differences in the biomarkers, neuroimaging findings, and cognitive abilities between patients with SED, MDD, and controls over time. Associations between the symptom severity of MDD/SED and psychosocial variables, cognition, MRI, and the biomarkers will also be examined. The aim is to provide new diagnostic tools for differentiation between MDD and SED and guide individualized treatment based on underlying pathophysiology and cognitive function. All necessary competences for conducting this extensive study are represented within the research group. The PrimeCog study is unique in its comprehensive design, addressing knowledge gaps, and directly comparing these diagnoses over time in primary care, where patients are typically treated. conditions: Mental Health Issue conditions: Cognitive Symptom conditions: Primary Health Care studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Cognitive Testing measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding memory measure: Cognitive Test Results regarding memory measure: Cognitive Test Results regarding executive function measure: Cognitive Test Results regarding executive function measure: Cognitive Test Results regarding executive function measure: Cognitive Test Results regarding language measure: Cognitive Test Results regarding language measure: Cognitive Test Results regarding visuospatial capacity measure: MRI features, measured by morphological and quantitative MR sequences of the brain measure: Biochemical Profile in blood regarding inflammation, stress and neurodegeneration measure: Biochemical Profile in saliva regarding inflammation and stress measure: Biochemical Profile in hair regarding exposure to stress sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Region Ostergotland, primary care centrum status: RECRUITING city: Linköping state: Ostergotland country: Sweden name: Hanna Israelsson Larsen, PhD role: CONTACT phone: 0738317008 email: hanna.israelsson.larsen@regionostergotland.se name: Anna Segernas, PhD role: CONTACT phone: +46733641430 email: anna.segernas@liu.se name: Hanna Israelsson Larsen, PhD role: PRINCIPAL_INVESTIGATOR name: Anna Segernäs, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.41086 lon: 15.62157 hasResults: False

 nctId: NCT06346522 id: FMASU R37/2024 briefTitle: Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU overallStatus: RECRUITING date: 2024-02-24 date: 2024-07 date: 2024-08 date: 2024-04-04 date: 2024-04-04 name: Ain Shams University class: OTHER briefSummary: Catheter-related bladder discomfort (CRBD) is a frequent complaint after urinary bladder catheterization which is commonly done in the perioperative period. CRBD shows similar symptoms to overactive bladder (OAB); so, drugs used for the management of OAB could influence symptoms of CRBD. Trospium chloride and gabapentin are effective in managing patient with OAB even the resistant cases. We will evaluate and compare the efficacy of both oral trospium and gabapentin on prevention of CRBD in the postoperative period in the ICU in in patients undergoing spinal surgery and requiring intraoperative catheterization of the urinary bladder. conditions: Catheter-related Bladder Discomfort (CRBD) studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, randomized, comparative, clinical trial study primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Gabapentin (Gaptin ®) 400mg oral capsule once name: Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule measure: The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake measure: Total fentanyl requirements in micrograms (µg) measure: Numerical Pain Rating Scale (NPRS) (0-10) measure: Side effects of the study drugs measure: Ramsay sedation score sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Ain Shams University-Faculty of Medicine status: RECRUITING city: Cairo country: Egypt name: Ahmed M Mohamed, MD role: CONTACT phone: 002 01121318459 email: drahmed.mostafa.mohamed@med.asu.edu.eg name: Wessam Z Selima, MD role: CONTACT phone: 002 01001958858 email: w.z.selima@med.asu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06346509 id: PORT-77-101 briefTitle: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-12-23 date: 2024-12-23 date: 2024-04-04 date: 2024-04-04 name: Portal Therapeutics, Inc. class: INDUSTRY briefSummary: A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants. conditions: Healthy Adult Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 108 type: ESTIMATED name: PORT-77 name: Placebo measure: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I) measure: Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II) measure: Plasma concentration of a single-dose of PORT-77 (Part I) measure: Plasma concentration of the steady-state of PORT-77 (Part II) measure: Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I) measure: Evaluate effects of single doses of PORT-77 on ECG parameters (Part I) measure: Evaluate effects of single doses of PORT-77 on ECG parameters (Part II) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion city: Tempe state: Arizona zip: 85283 country: United States role: CONTACT email: mara.baier@celerion.com name: Mara Baier, DO role: PRINCIPAL_INVESTIGATOR lat: 33.41477 lon: -111.90931 hasResults: False

 nctId: NCT06346496 id: H23133 briefTitle: Young People Aged 18-25 With Depression or Anxiety Mood Participate in an LLM-based Digital Dialogue Intervention Study overallStatus: COMPLETED date: 2023-11-20 date: 2023-12-18 date: 2024-01-15 date: 2024-04-04 date: 2024-04-09 name: Institute of Psychology, Chinese Academy of Sciences class: OTHER briefSummary: This study is a 28-day randomized controlled trial (RCT). Residents were randomly assigned to an intervention group or a waiting group according to the order in which they were successfully contacted by the staff, and each user was asked to engage in a total of 28 days of dialog intervention with the Douyin companion bot and complete three psychological questionnaires (on Days 1, 14, and 28); however, the intervention group began to receive the dialog intervention after completing the first questionnaire, and the waiting group began to receive the dialog intervention after completing the third questionnaire. During the first four weeks, the waiting group was treated as a blank control. The two groups of subjects completed the three questionnaires at exactly the same point in time. Each user's depression, anxiety, and positive and negative emotions were measured using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Scale (GAD-7) and the Positive and Negative Affect Schedule (PANAS), respectively. conditions: LLM-based AI Dialogue Bot conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 657 type: ACTUAL name: Douyin Xinqing AI dialog bot name: Douyin Xinqing AI dialog bot for delayed intervention measure: Depression measure: Anxiety measure: Positive and negative moods sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Institute of Psychology, Chinese Academy of Sciences city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06346483 id: STU00218929 briefTitle: Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off overallStatus: RECRUITING date: 2023-06-09 date: 2024-06-09 date: 2025-06-09 date: 2024-04-04 date: 2024-04-04 name: Northwestern University class: OTHER name: Ohio State University briefSummary: The purpose of this study is to compare Moses 2.0 pulse modulation technology and the standard high powered Holmium Laser lithotripsy and how it will affect time in the operating room, time using the laser, laser energy, and stone free rates.

Currently Moses 2.0 laser technology is FDA approved and currently used in practice since 2021. No study to this date has compared Moses 2.0 without pulse modulation laser technology to Moses 2.0 with pulse modulation laser technology.

The study will be including kidney and ureteral stones (a kidney stone located in the tube between the kidney and the bladder) that are 6mm and greater, but less than 20 mm in size undergoing ureteroscopic treatment. High powered lasers are used for "dusting". Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine. conditions: Kidney Stone conditions: Ureteral Stone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Dusting measure: Operative time measure: Stone Free Rate measure: Lasing time measure: Total laser energy (kJ) measure: Detection of postoperative strictures sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern Medicine status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Alyssa McDonald role: CONTACT lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06346470 id: 3430-12 briefTitle: The Effect of Web-Based Breast Self-Examination Education overallStatus: RECRUITING date: 2024-02-19 date: 2024-05-31 date: 2024-05-31 date: 2024-04-04 date: 2024-04-04 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Breast cancer is the most common type of cancer among women. Reasons such as diagnosing breast cancer at an early stage increases the chances of treatment and survival, and the fact that the masses are largely noticed by the individual themselves, point to the importance of breast self-examination (BSE) . BSE skill is among the nursing skills. When the literature was examined, it was seen that the web-based education method was frequently used for cognitive skills during nursing education, but its use was limited for psychomotor skills training. It was determined that in BSE training, in addition to traditional education, methods such as concept maps and peer-supported education were used, but web-based education methods were not used. It is thought that the study will contribute to the literature in these aspects. conditions: Education conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ESTIMATED name: Web-based breast self examination education measure: Skill and Knowledge of BSE measure: Attitude of Web-Based Education measure: Self-Directed Learning Skills sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florence Nightingale Faculty of Nursing status: RECRUITING city: Istanbul state: Şişli zip: 34381 country: Turkey name: Olga İncesu, PhD role: CONTACT phone: 05334942989 email: olga.incesu@iuc.edu.tr name: Olga İncesu, PhD role: PRINCIPAL_INVESTIGATOR name: Öykü Kara, Msc role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06346457 id: IRTG_P08 briefTitle: Breast Cancer & Antiestrogenic Therapy & Brain overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2026-04-01 date: 2024-04-04 date: 2024-04-04 name: International Research Training Group 2804 class: OTHER name: German Research Foundation name: University Hospital Tuebingen name: Uppsala University briefSummary: The study aims to investigate the effect of anti-estrogenic therapy in breast cancer patients on neural reward processing, psychosexual health, and quality of life, in reproductive vs. menopausal women. The investigators are directly comparing four groups 1) premenopausal women diagnosed with breast cancer receiving anti-estrogenic therapy, 2) postmenopausal women diagnosed with breast cancer with and without previous hormonal replacement therapy, receiving anti-estrogenic therapy, 3) premenopausal healthy women, and 4) postmenopausal healthy women. Furthermore, via assessment and integration of various data including subjective/self-report data via questionnaires and a standardized interview, physiological/endocrine (via blood sample), psychological and neural data (including anatomical scans, Diffusion tensor imaging (DTI), resting state, and a reward processing paradigm), this project will shed light on the connection between the brain, anti-estrogenic therapy, and psychosexual health. conditions: Breast Cancer Female conditions: Healthy Female conditions: Menopause conditions: Anti-estrogenic Therapy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 180 type: ESTIMATED name: Tamoxifen name: Letrozole name: Letrozole + GnRH measure: Correlations between antiestrogen hormone therapy and brain function & structure measure: Correlations between antiestrogen hormone therapy and reward processing in both behavioral and neural aspects measure: Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Reward Processing Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Correlation between antiestrogen hormone therapy and psychosexual health measure: Correlation between antiestrogen hormone therapy and quality of life measure: Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Correlation between antiestrogen hormone therapy and cognitive changes measure: Quality of Life Disparities: Contrasting Breast Cancer Patients with Healthy Controls sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Tuebingen; Department of Psychiatry & Psychotherapy Tuebingen city: Tuebingen state: BW zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06346444 id: 2.780.113 briefTitle: Biomarkers in Rett Syndrome acronym: BIRS overallStatus: RECRUITING date: 2020-08-03 date: 2024-02-20 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: IRCCS Fondazione Stella Maris class: OTHER name: Meyer Children's Hospital IRCCS name: Azienda USL Toscana Nord Ovest name: University of Dublin, Trinity College briefSummary: Rett syndrome (RTT) is an X-linked genetic disorder that causes severe neurological development disorder. In its classic form, it seems to affect almost exclusively females with an incidence of up to one in 10,000 females. Patients affected by Rett Syndrome can present a wide range of symptoms, in different combinations and of varying intensity, such as slowed growth of head circumference, abnormalities in walking and balance, loss of functional use of the hands often replaced by repetitive and stereotyped hand movements like "hand washing", loss of communicative-relational skills including expressive language, epilepsy, breathing abnormalities, and osteo-muscular alterations. In light of the growing potential of clinical therapies, identification and early diagnosis are considered essential. Many disease modification strategies have been achieved through translational research studies and clinical trials that have allowed the recognition of the most effective therapeutic and clinical interventions to date.

This study arises from the need to advance in the understanding of the pathogenesis of RTT through a multicentric collaboration in order to (a) identify early biomarkers of RTT (b) delve into the alterations of interconnectivity, crucial for understanding the loss of motor functions and language through systematic collection of anamnestic, genetic, and clinical-instrumental data. The aim is to provide a valuable contribution to the study of the clinical phenotype of Rett and the identification of early interventions. conditions: Rett Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Diagnostic test and behavioral measure: Age at diagnosis measure: Mutation in MECP2 measure: Neuroscope alterations measure: Electroencephalogram (EEG) alterations measure: Brain magnetic resonance imaging (MRI) alteration measure: Bone densitometry alterations measure: Thoracic radiographic alterations measure: Lumbosacral spine radiographic alterations measure: Clinical Global Impression (CGI) scale measure: The Rett Syndrome Behavioural Questionnaire (RSBQ) measure: Alterations of neurovisual functions measure: Possibility of applying alternative forms of communication to verbal communication sex: FEMALE minimumAge: 0 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Trinity College Institute of Neuroscience, Lloyd Building, D2 status: RECRUITING city: Dublin country: Ireland name: Daniela Tropea role: CONTACT email: daniela.tropea@tcd.ie lat: 53.33306 lon: -6.24889 facility: Ospedale Versilia Centro di Riferimento status: RECRUITING city: Lido Di Camaiore state: Lucca zip: 55049 country: Italy name: Ilaria Gemo role: CONTACT email: ilaria.gemo@uslnordovest.toscana.it lat: 43.90012 lon: 10.2269 facility: IRCCS Fondazione Stella Maris status: RECRUITING city: Calambrone state: Pisa zip: 56128 country: Italy name: Roberta Battini role: CONTACT phone: 050886282 email: rbattini@fsm.unipi.it lat: 43.58333 lon: 10.3 facility: AOU Meyer status: RECRUITING city: Firenze zip: 50139 country: Italy name: Viola Doccini role: CONTACT email: viola.doccini@meyer.it lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06346431 id: 20240301 briefTitle: Efficacy of Digital Problem Solving Application in Reduction of Anxiety, Depression and Substance Use Disorder Symptoms acronym: Efficacy overallStatus: NOT_YET_RECRUITING date: 2026-03 date: 2026-11 date: 2026-12 date: 2024-04-04 date: 2024-04-04 name: 7 Generation Games class: INDUSTRY briefSummary: The focus of this study is the impact of usage of a mobile application to support problem-solving therapy on symptoms of anxiety, depression and substance use. conditions: Anxiety conditions: Depressive Symptoms conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: DSPT - Digital Support for Problem-solving Therapy measure: Generalized Anxiety Disorder Scale-7 measure: Center for Epidemiological Studies Depression Scale measure: Drug Abuse Screening Test measure: Michigan Alcohol Screening Test sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06346418 id: PNRR-MR1-2022-12376622 briefTitle: Maternal Genes and Epimutations: Beckwith-Wiedemann Syndrome & Reproductive Risks overallStatus: RECRUITING date: 2023-05-19 date: 2025-01 date: 2025-05 date: 2024-04-04 date: 2024-04-04 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: Istituto Auxologico Italiano name: Università degli Studi della Campania Luigi Vanvitelli name: Federico II University briefSummary: Pathogenic variants in subcortical maternal complex (SCMC) have been identified not only in mothers of Beckwith-Wiedemann syndrome (BWS) babies but also in women with reproductive disturbances such as failed pregnancy attempts and recurrent pregnancy loss. Based on the higher incidence of BWS in children born from Assisted Reproductive Technology (ART), this project aims to investigate incidence and molecular mechanism of pathogenic variants of SCMC in women with reproductive disorders. Study objectives will be (i) assess the incidence of these variants as a cause of differences in reproductive outcomes in the infertile female population and mothers of children with BWS; (ii) identify methylation changes in women with reproductive problems including those with offspring affected by BWS; (iii) determine the molecular causes underlying female infertility and imprinting disorder associated with damaging SCMC gene variants by employing a mouse model. conditions: Beckwith-Wiedemann Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 208 type: ESTIMATED name: WES analysis name: whole-genome methylation analysis measure: MEG Incidence measure: Compare DNA methylation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Edgardo Somigliana, PhD role: CONTACT phone: +390255034303 email: edgardo.somigliana@policlinico.mi.it lat: 45.46427 lon: 9.18951 facility: Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20145 country: Italy name: Silvia Russo, Phd role: CONTACT phone: +393493237520 email: s.russo@auxologico.it lat: 45.46427 lon: 9.18951 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-12-20 uploadDate: 2024-03-28T05:11 filename: Prot_SAP_000.pdf size: 817568 hasResults: False

 nctId: NCT06346405 id: 10 briefTitle: Central Serous Chorioretinopathy and Micropulse Laser Treatment acronym: LEVEO overallStatus: RECRUITING date: 2023-05-31 date: 2025-05-31 date: 2025-05-31 date: 2024-04-04 date: 2024-04-04 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: To evaluate choroidal and choriocapillaris changes in patients with central serous chorioretinopathy, undergone sub threshold micropulse laser treatment, following any improvement with conservative therapy with Acetazolamide and/or Eplerenone conditions: Central Serous Chorioretinopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: Subthreshold Micropulse Laser Treatment measure: Vessel density changes measure: Choroidal thickness measure: Choroidal thickness and vessel density measure: Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern measure: Metamorphopsia measure: Metamorphopsia and BCVA measure: Ellipsoid Zone Integrity measure: Improvement in retinal function measure: Quality of life (QoL) measure: Ellipsoid zone and BCVA sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Agostino Gemelli, IRCCS status: RECRUITING city: Roma state: R zip: 00168 country: Italy name: Maria Cristina Savastano, MD, PhD role: CONTACT phone: (+39)063015 email: mariacristinasavastano@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06346392 id: D9802C00001 briefTitle: AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 overallStatus: RECRUITING date: 2024-03-04 date: 2026-04-10 date: 2026-10-09 date: 2024-04-04 date: 2024-04-04 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2. conditions: Gastric Cancer conditions: Gastroesophageal Junction Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized in a 1:1:1 ratio to one of the following intervention arms until the dose selection decision is made:

Arm 1: AZD0901 arm 1 IV, Q3W Arm 2: AZD0901 arm 2 IV, Q3W Arm 3: Participants in the Investigator's choice arm, including regionally accepted chemotherapies or targeted therapies 2L: Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W 2L: Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only) 2L: Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only) 3L+: Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W 3L+: TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China) 3L+: Apatinib 500-850 mg, orally once daily, Q4W (China only) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is an open-label study; however, it will be conducted 'sponsor-blind' and the specific treatment to be taken by a participant will be assigned using an IRT/RTSM. To maintain the integrity of the study, sponsor access to treatment records will be restricted, and, in particular, under no circumstances will the sponsor undertake any efficacy analysis by treatment arm during the study. A Study Integrity Plan will be generated in which nominated individuals who will be granted access to any treatment-revealing data will be pre-specified, with their reason for requiring access detailed. whoMasked: OUTCOMES_ASSESSOR count: 589 type: ESTIMATED name: AZD0901 name: AZD0901 name: Ramucirumab+ paclitaxel name: Paclitaxel name: Docetaxel name: Irinotecan name: TAS-102 name: Apatinib measure: Progression Free Survival (PFS) in all randomized participants measure: Overall Survival (OS) for 3L+ participants measure: OS in all randomized participants measure: PFS for 3L+ participants measure: Objective Response Rate (ORR) in all randomized participants measure: ORR for 3L+ participants measure: Duration of Response (DoR) in all randomized participants measure: Serum concentrations of AZD0901, total antibody and MMAE measure: Status of ADA to AZD0901 measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Changes from baseline in vital signs, clinical laboratory results, and ECGs measure: PK parameters (such as peak concentration, as data allow) of AZD0901, total antibody and MMAE measure: PK parameters (such as trough concentration, as data allow) of AZD0901, total antibody and MMAE measure: Prevalence and incidence of ADA to AZD0901 measure: Titer of ADA to AZD0901 sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 facility: Research Site status: WITHDRAWN city: Santa Rosa state: California zip: 95403 country: United States lat: 38.44047 lon: -122.71443 facility: Research Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: Research Site status: NOT_YET_RECRUITING city: Marietta state: Georgia zip: 30060 country: United States lat: 33.9526 lon: -84.54993 facility: Research Site status: WITHDRAWN city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 facility: Research Site status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64111 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: WITHDRAWN city: Saint Louis state: Missouri zip: 63110 country: United States lat: 38.62727 lon: -90.19789 facility: Research Site status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63128 country: United States lat: 38.62727 lon: -90.19789 facility: Research Site status: NOT_YET_RECRUITING city: Mineola state: New York zip: 11501 country: United States lat: 40.74927 lon: -73.64068 facility: Research Site status: NOT_YET_RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Research Site status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 facility: Research Site status: NOT_YET_RECRUITING city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Research Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19111 country: United States lat: 39.95233 lon: -75.16379 facility: Research Site status: NOT_YET_RECRUITING city: Charlottesville state: Virginia zip: 22908 country: United States lat: 38.02931 lon: -78.47668 facility: Research Site status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2N 4N2 country: Canada lat: 51.05011 lon: -114.08529 facility: Research Site status: NOT_YET_RECRUITING city: Barrie state: Ontario zip: L4M 6M2 country: Canada lat: 44.40011 lon: -79.66634 facility: Research Site status: NOT_YET_RECRUITING city: London state: Ontario zip: N6C 2R5 country: Canada lat: 42.98339 lon: -81.23304 facility: Research Site status: NOT_YET_RECRUITING city: Ottawa state: Ontario zip: K1H 8L6 country: Canada lat: 45.41117 lon: -75.69812 facility: Research Site status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M5G 2M9 country: Canada lat: 43.70011 lon: -79.4163 facility: Research Site status: NOT_YET_RECRUITING city: Beijing zip: 100210 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Changsha zip: 410013 country: China lat: 28.19874 lon: 112.97087 facility: Research Site status: RECRUITING city: Chengdu zip: 610000 country: China lat: 30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Chengdu zip: 610042 country: China lat: 30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Fuzhou City zip: 350001 country: China facility: Research Site status: NOT_YET_RECRUITING city: Fuzhou zip: 350014 country: China lat: 26.06139 lon: 119.30611 facility: Research Site status: RECRUITING city: Guangzhou zip: 510060 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510120 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510655 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: RECRUITING city: Guangzhou zip: 510700 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Hangzhou zip: 310020 country: China lat: 30.29365 lon: 120.16142 facility: Research Site status: NOT_YET_RECRUITING city: Hangzhou zip: 310022 country: China lat: 30.29365 lon: 120.16142 facility: Research Site status: NOT_YET_RECRUITING city: Harbin zip: 150049 country: China lat: 45.75 lon: 126.65 facility: Research Site status: NOT_YET_RECRUITING city: Hefei zip: 230601 country: China lat: 31.86389 lon: 117.28083 facility: Research Site status: NOT_YET_RECRUITING city: Jinan zip: 250117 country: China lat: 36.66833 lon: 116.99722 facility: Research Site status: NOT_YET_RECRUITING city: Jining zip: 272029 country: China lat: 35.405 lon: 116.58139 facility: Research Site status: NOT_YET_RECRUITING city: Lanzhou zip: 730000 country: China lat: 36.05701 lon: 103.83987 facility: Research Site status: NOT_YET_RECRUITING city: Lishui zip: 323000 country: China lat: 28.46042 lon: 119.91029 facility: Research Site status: NOT_YET_RECRUITING city: Luoyang zip: 471003 country: China lat: 34.68361 lon: 112.45361 facility: Research Site status: NOT_YET_RECRUITING city: Nanjing zip: 210008 country: China lat: 32.06167 lon: 118.77778 facility: Research Site status: NOT_YET_RECRUITING city: Nanjing zip: 210009 country: China lat: 32.06167 lon: 118.77778 facility: Research Site status: NOT_YET_RECRUITING city: Qingdao zip: 266003 country: China lat: 36.06488 lon: 120.38042 facility: Research Site status: NOT_YET_RECRUITING city: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 facility: Research Site status: NOT_YET_RECRUITING city: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 facility: Research Site status: NOT_YET_RECRUITING city: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 facility: Research Site status: NOT_YET_RECRUITING city: Shenyang zip: 110042 country: China lat: 41.79222 lon: 123.43278 facility: Research Site status: NOT_YET_RECRUITING city: Shijiazhuang zip: 050011 country: China lat: 38.04139 lon: 114.47861 facility: Research Site status: NOT_YET_RECRUITING city: Suzhou zip: 215004 country: China lat: 31.30408 lon: 120.59538 facility: Research Site status: NOT_YET_RECRUITING city: Tianjin zip: 300060 country: China lat: 39.14222 lon: 117.17667 facility: Research Site status: NOT_YET_RECRUITING city: Urumqi zip: 830000 country: China lat: 43.80096 lon: 87.60046 facility: Research Site status: NOT_YET_RECRUITING city: Wuhan zip: 430000 country: China lat: 30.58333 lon: 114.26667 facility: Research Site status: NOT_YET_RECRUITING city: Wuhan zip: 430030 country: China lat: 30.58333 lon: 114.26667 facility: Research Site status: NOT_YET_RECRUITING city: Xi'an zip: 710061 country: China lat: 34.25833 lon: 108.92861 facility: Research Site status: NOT_YET_RECRUITING city: Yinchuan zip: 750004 country: China lat: 38.46806 lon: 106.27306 facility: Research Site status: NOT_YET_RECRUITING city: Zhengzhou zip: 450003 country: China lat: 34.75778 lon: 113.64861 facility: Research Site status: NOT_YET_RECRUITING city: Besançon Cedex zip: 25030 country: France lat: 47.24878 lon: 6.01815 facility: Research Site status: NOT_YET_RECRUITING city: Brest zip: 29200 country: France lat: 48.3903 lon: -4.48628 facility: Research Site status: NOT_YET_RECRUITING city: Lille zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: Research Site status: NOT_YET_RECRUITING city: Lyon zip: 69008 country: France lat: 45.74848 lon: 4.84669 facility: Research Site status: NOT_YET_RECRUITING city: Nantes zip: 44000 country: France lat: 47.21725 lon: -1.55336 facility: Research Site status: NOT_YET_RECRUITING city: PARIS Cedex 12 zip: 75571 country: France lat: 48.85341 lon: 2.3488 facility: Research Site status: NOT_YET_RECRUITING city: Poitiers zip: 86021 country: France lat: 46.58333 lon: 0.33333 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 10249 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 13353 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Dresden zip: 1067 country: Germany lat: 51.05089 lon: 13.73832 facility: Research Site status: NOT_YET_RECRUITING city: Essen zip: 45130 country: Germany lat: 51.45657 lon: 7.01228 facility: Research Site status: NOT_YET_RECRUITING city: Frankfurt zip: 60488 country: Germany lat: 50.11552 lon: 8.68417 facility: Research Site status: NOT_YET_RECRUITING city: Göttingen zip: 37075 country: Germany lat: 51.53443 lon: 9.93228 facility: Research Site status: NOT_YET_RECRUITING city: Hamburg zip: 20251 country: Germany lat: 53.57532 lon: 10.01534 facility: Research Site status: NOT_YET_RECRUITING city: Heidelberg zip: 69120 country: Germany lat: 49.40768 lon: 8.69079 facility: Research Site status: NOT_YET_RECRUITING city: Heilbronn zip: 74078 country: Germany lat: 49.13995 lon: 9.22054 facility: Research Site status: NOT_YET_RECRUITING city: Leipzig zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 facility: Research Site status: NOT_YET_RECRUITING city: Mainz zip: 55131 country: Germany lat: 49.98419 lon: 8.2791 facility: Research Site status: NOT_YET_RECRUITING city: Marburg zip: 35043 country: Germany lat: 50.80904 lon: 8.77069 facility: Research Site status: NOT_YET_RECRUITING city: Moers zip: 47441 country: Germany lat: 51.45342 lon: 6.6326 facility: Research Site status: NOT_YET_RECRUITING city: München zip: 81377 country: Germany lat: 48.13743 lon: 11.57549 facility: Research Site status: NOT_YET_RECRUITING city: Hong Kong zip: 150001 country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site status: NOT_YET_RECRUITING city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site status: NOT_YET_RECRUITING city: Florence zip: 50134 country: Italy lat: 43.77925 lon: 11.24626 facility: Research Site status: NOT_YET_RECRUITING city: Milano zip: 20162 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site status: NOT_YET_RECRUITING city: Milan zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site status: NOT_YET_RECRUITING city: Modena zip: 41124 country: Italy lat: 44.64783 lon: 10.92539 facility: Research Site status: NOT_YET_RECRUITING city: Napoli zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 facility: Research Site status: NOT_YET_RECRUITING city: Padova zip: 35128 country: Italy lat: 45.40797 lon: 11.88586 facility: Research Site status: NOT_YET_RECRUITING city: Pisa zip: 56100 country: Italy lat: 43.70853 lon: 10.4036 facility: Research Site status: NOT_YET_RECRUITING city: Vicenza zip: 36100 country: Italy lat: 45.54672 lon: 11.5475 facility: Research Site status: NOT_YET_RECRUITING city: Kashiwa zip: 227-8577 country: Japan lat: 35.86224 lon: 139.97732 facility: Research Site status: NOT_YET_RECRUITING city: Tokyo zip: 104-0045 country: Japan lat: 35.6895 lon: 139.69171 facility: Research Site status: NOT_YET_RECRUITING city: Gdańsk zip: 80-219 country: Poland lat: 54.35205 lon: 18.64637 facility: Research Site status: NOT_YET_RECRUITING city: Katowice zip: 40-514 country: Poland lat: 50.25841 lon: 19.02754 facility: Research Site status: NOT_YET_RECRUITING city: Kraków zip: 31-501 country: Poland lat: 50.06143 lon: 19.93658 facility: Research Site status: NOT_YET_RECRUITING city: Lublin zip: 20-081 country: Poland lat: 51.25 lon: 22.56667 facility: Research Site status: NOT_YET_RECRUITING city: Szczecin zip: 71-730 country: Poland lat: 53.42894 lon: 14.55302 facility: Research Site status: NOT_YET_RECRUITING city: Tomaszów Mazowiecki zip: 97-200 country: Poland lat: 51.53131 lon: 20.00855 facility: Research Site status: NOT_YET_RECRUITING city: Warszawa zip: 02-034 country: Poland lat: 52.22977 lon: 21.01178 facility: Research Site status: NOT_YET_RECRUITING city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site status: NOT_YET_RECRUITING city: Barcelona zip: 8035 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site status: NOT_YET_RECRUITING city: Madrid zip: 28034 country: Spain lat: 40.4165 lon: -3.70256 facility: Research Site status: NOT_YET_RECRUITING city: Madrid zip: 28041 country: Spain lat: 40.4165 lon: -3.70256 facility: Research Site status: NOT_YET_RECRUITING city: Orense zip: 32005 country: Spain lat: 42.33669 lon: -7.86407 facility: Research Site status: NOT_YET_RECRUITING city: Santander zip: 39008 country: Spain lat: 43.46472 lon: -3.80444 facility: Research Site status: NOT_YET_RECRUITING city: Sevilla country: Spain lat: 37.38283 lon: -5.97317 facility: Research Site status: NOT_YET_RECRUITING city: Bern zip: 3010 country: Switzerland lat: 46.94809 lon: 7.44744 facility: Research Site status: NOT_YET_RECRUITING city: Genève 14 zip: 1205 country: Switzerland lat: 46.20222 lon: 6.14569 facility: Research Site status: NOT_YET_RECRUITING city: Lausanne zip: 1011 country: Switzerland lat: 46.516 lon: 6.63282 facility: Research Site status: NOT_YET_RECRUITING city: Zürich zip: 8032 country: Switzerland lat: 47.36667 lon: 8.54999 facility: Research Site status: NOT_YET_RECRUITING city: Kaohsiung zip: 00807 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site status: RECRUITING city: Tainan country: Taiwan lat: 22.99083 lon: 120.21333 facility: Research Site status: RECRUITING city: Taipei zip: 112 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Taoyuan zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 facility: Research Site status: NOT_YET_RECRUITING city: Cambridge zip: CB2 0QQ country: United Kingdom lat: 52.2 lon: 0.11667 facility: Research Site status: NOT_YET_RECRUITING city: London zip: EC1A 7BE country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SW3 6JJ country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Manchester zip: M20 4BX country: United Kingdom lat: 53.48095 lon: -2.23743 facility: Research Site status: NOT_YET_RECRUITING city: Oxford zip: OX3 7LE country: United Kingdom lat: 51.75222 lon: -1.25596 facility: Research Site status: NOT_YET_RECRUITING city: Taunton zip: TA1 5DA country: United Kingdom lat: 51.01494 lon: -3.10293 facility: Research Site status: NOT_YET_RECRUITING city: Hanoi zip: 100000 country: Vietnam lat: 21.0245 lon: 105.84117 facility: Research Site status: NOT_YET_RECRUITING city: Ho Chi Minh city zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site status: NOT_YET_RECRUITING city: Vinh zip: 460000 country: Vietnam lat: 18.67337 lon: 105.69232 hasResults: False

 nctId: NCT06346379 id: 2023-K086-01 briefTitle: The Effect of Baduanjin on Physical Fitness and Bone Density in Maintenance Hemodialysis Patients overallStatus: RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2025-10-01 date: 2024-04-04 date: 2024-04-19 name: Affiliated Hospital of Nantong University class: OTHER briefSummary: The aim of this study is to examine the effect of 12-month Baduanjin exercise on physical fitness and bone density in maintenance hemodialysis (MHD) patients. 50 MHD patients aged 18-75 will included in this study and randomly divided into two groups (intervention group and control group). The intervention group will be led by a professional person and underwent Baduanjin exercise three times a week before hemodialysis. The control group maintained routine treatment and daily activities. conditions: Rehabilitation conditions: Physical Fitness conditions: Bone Density conditions: Hemodialysis Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Baduanjin exercise measure: Muscle strength measurement measure: Five-times Sit-to-Stand Test (FTSST) measure: Timed "up and go" test (TUGT) measure: The sitting forward flexion test measure: The Standing on one-leg with eyes closed test (SOLECT) measure: Bone mineral density test measure: Changes in the Short Form-36(SF-36) measure: Changes in the Hospital Anxiety and Depression Scale （HADS） measure: European Quality of Life Five Dimension（EQ-5D-5L) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Nantong University status: RECRUITING city: Nantong state: Jiangsu zip: 226000 country: China name: Li Yuan role: CONTACT phone: 0086-051381168416 email: yuanlint@163.com name: Yuan Zhang role: CONTACT phone: 0086-051381168411 email: 49260183@qq.com lat: 32.03028 lon: 120.87472 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-07-10 uploadDate: 2024-03-18T04:22 filename: Prot_SAP_000.pdf size: 179776 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-07-10 uploadDate: 2024-03-28T03:53 filename: ICF_001.pdf size: 247762 hasResults: False

 nctId: NCT06346366 id: NL.82557.018.22 briefTitle: Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy acronym: PANORAMA overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-25 date: 2024-04-01 date: 2024-04-01 date: 2024-04-04 date: 2024-04-04 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy, making more patients operable. After total pancreatectomy, all patients develop insulin dependent diabetes mellitus (IDDM). Glucose control in these patients is challenging due to the complete absence of both pancreatic insulin and glucagon secretion, and most patients report decreased quality of life due to fear of hypoglycemic events and the need for continuous glucose monitoring.

The CE marked bihormonal artificial pancreas (BIHAP) provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm. In a recent pilot study (APPEL5+, NL.8871) the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy. This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment (78.30%, \[IQR 71.05%-82.61%\] vs. 57.38% \[IQR 52.38%-81.35%\], p=0.03).

Now, larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy, with sufficient attention for long-term glycemic control (HbA1c) and patient-reported outcomes.

The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial. Patients will be randomized to start with the BIHAP (after a training period) or current diabetes care (i.e. insulin pen or pump). Hereafter, all patients will cross over. conditions: Pancreatic Neoplasms conditions: Type 3c Diabetes conditions: Total Pancreatectomy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients are randomized to a 3-month treatment period with the bihormonal artificial pancreas (BIHAP) (preceded by a training period) or a 3-month treatment with their current diabetes care. Hereafter, all patients will cross over. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Bihormonal artificial pancreas (BIHAP) / closed loop measure: Time in range measure: Efficacy of open and closed loop system measure: Efficacy of open and closed loop system measure: Efficacy of open and closed loop system measure: Efficacy of open and closed loop system measure: Efficacy of open and closed loop system measure: Adverse events and device issues associated with closed loop system with BIHAP measure: Patient reported outcomes on quality of life - WHO-5 measure: Patient reported outcomes on quality of life - EQ-5D-5L measure: Patient reported outcomes on quality of life - DTSQc andDTSQs measure: Patient reported outcomes on quality of life - PAID-20 measure: Patient reported outcomes on quality of life - HFS-II measure: Patient reported outcomes on quality of life - PSQI measure: Patient reported outcomes on quality of life - INSPIRE measure: Patient reported outcomes on quality of life - Hypoglycaemia unawareness measure: Patient reported outcomes on quality of life - benefits and disadvantages of BIHAP treatment measure: Other treatment endpoints - daily insulin and glucagon use measure: Other treatment endpoints - activity of BIHAP algorithm measure: Other treatment endpoints - daily insulin use measure: Other treatment endpoints - treatment related actions measure: Other treatment endpoints - demographics measure: Other treatment endpoints - demographics measure: Other treatment endpoints - concomitant medication sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC city: Amsterdam zip: 1081 HV country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06346353 id: Chess Cognition SUD briefTitle: Substance Consumption, Personality, and Cognitive Functioning of Chess Players overallStatus: RECRUITING date: 2024-01-31 date: 2024-05-31 date: 2024-05-31 date: 2024-04-04 date: 2024-04-04 name: Central Institute of Mental Health, Mannheim class: OTHER briefSummary: The aim of this project is to find out if there is a difference in addictive behavior, personality traits, and cognitive abilities between chess players and non-chess players. conditions: Addiction conditions: Alcohol conditions: Nicotine conditions: Drugs conditions: Personality conditions: Depression conditions: Anxiety studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 910 type: ESTIMATED measure: Substance Craving measure: Alcohol Use measure: Automatic Alcohol Craving measure: Severity of Nicotine Dependence measure: Automatic Cigarette Craving measure: Smoking Consequences measure: Drug Abuse measure: Personality measure: Depression measure: Anxiety measure: self-efficacy measure: coping with stress measure: Inhibition capacity measure: Working Memory capacity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit status: RECRUITING city: Mannheim country: Germany name: Sabine Vollstädt-Klein role: CONTACT lat: 49.4891 lon: 8.46694 hasResults: False

 nctId: NCT06346340 id: 936 briefTitle: A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-11 date: 2024-09 date: 2024-09 date: 2024-04-04 date: 2024-04-04 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Miebo measure: Mean difference between absolute deviations from predicted refractive error in the study eye. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 105 city: Laguna Hills state: California zip: 92655 country: United States lat: 33.61252 lon: -117.71283 facility: Site 102 city: Petaluma state: California zip: 92954 country: United States lat: 38.23242 lon: -122.63665 facility: Site 103 city: Largo state: Florida zip: 33770 country: United States lat: 27.90979 lon: -82.78842 facility: Site 104 city: Saint Louis state: Missouri zip: 63131 country: United States lat: 38.62727 lon: -90.19789 facility: Site 101 city: Somersworth state: New Hampshire zip: 03878 country: United States lat: 43.26175 lon: -70.86534 hasResults: False

 nctId: NCT06346327 id: Absent End-Diastolic Flow briefTitle: Clinical Significance Of Intermittently Absent End-Diastolic Flow Of The Fetal Umbilical Artery On Perinatal And Neonatal Outcomes Dr. Zeynep Kayaoğlu Yıldırım Dr. Alperen İnce Dr Gökhan Bayanmelek Dr Gökhan Bolluk overallStatus: COMPLETED date: 2020-06-01 date: 2023-08-31 date: 2023-10-30 date: 2024-04-04 date: 2024-04-04 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Objective: This study aimed to estimate the risk of adverse perinatal outcomes among pregnant patients with intermittently absent (iAEDF) and persistently absent end-diastolic umbilical artery flow (pAEDF). The fetal risks associated with persistently absent end-diastolic flow have been described. However, the risks associated with intermittent absent end-diastolic flow are not well-known.

Study design: We performed a retrospective cohort study of patients diagnosed with the iAEDF or pAEDF at our institution from 2020 to 2023. Fetuses were classified under two categories: iAEDF group and pAEDF group.Neonatal outcomes, demographic information, pregnancy outcomes and pregnancy complications were compared between patients with iAEDF and those with pAEDF. conditions: Absent End-Diastolic Flow Of The Fetal Umbilical Artery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 137 type: ACTUAL measure: neonatal outcomes measure: latency from the time of absent endiastolic flow diagnosis to delivery measure: pregnancy complications (Number of Pregnancies complicated with IUMF, ablatio placenta, fetal distress, Intrauterine growth restriction and amniotic fluid abnormalities). sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: İstanbul Başakşehir Çam ve Sakura City Hospital city: Istanbul state: Türkiye zip: 34480 country: Turkey lat: 41.01384 lon: 28.94966 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-08 uploadDate: 2024-04-02T18:47 filename: Prot_SAP_000.pdf size: 410898 hasResults: False

 nctId: NCT06346314 id: 12241976 briefTitle: Is There an Immediate Effect on Pectoralis Minor Length After Performing a Prone Scapular Retraction Exercise overallStatus: COMPLETED date: 2021-07-15 date: 2022-01-10 date: 2022-01-10 date: 2024-04-04 date: 2024-04-04 name: Andrews University class: OTHER briefSummary: The goal of this clinical trial is to test normal participants.

The main question it aims to answer is:

• Do the participant's pectoralis minor muscles change length immediately after performing an exercise that recruits the scapular retractor muscles? Participants will have their pectoralis minor muscle measured, then perform an exercise recruiting the scapular retractor muscles, and then have their pectoralis muscle measured again. conditions: Pectoralis Minor Length studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: Scapular retraction exercise measure: Pectoralis Minor Length sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: North Idaho Physical Therapy city: Hayden state: Idaho zip: 83835 country: United States lat: 47.76602 lon: -116.78658 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-30 uploadDate: 2023-11-30T13:36 filename: Prot_SAP_000.pdf size: 341703 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2021-04-19 uploadDate: 2024-03-12T17:52 filename: ICF_001.pdf size: 286800 hasResults: False

 nctId: NCT06346301 id: NL83374.018.23 briefTitle: Imagery Rescripting as a Stand-alone Treatment for OCD and BDD. overallStatus: RECRUITING date: 2023-04-21 date: 2026-01 date: 2027-01 date: 2024-04-04 date: 2024-04-04 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: The goal of this multiple baseline case series study is to test the effect of imagery rescripting (ImRs) in Obsessive Compulsive Disorder (OCD) and Body Dysmorphic Disorder (BDD).

Primary objective :The course of schema or core beliefs and change in OCD and BDD. To investigate the effectiveness of imagery rescripting on factors presumed to underlie the disorder, according to schema theory, and on OCD and BDD symptoms.

Secondary objective: The change in OCD and BDD symptoms (full questionnaire), schemata and modes, core emotions, mood, affect and obtrusiveness of intrusion.

Other objectives are research into the working mechanisms of imagery rescripting by collecting qualitative data from patients and their practitioner in a qualitative interview.

For this study, a multiple-baseline single-case experimental design (SCED) is used testing different outcome variables in 18 OCD patients and 18 BDD patients. After a variable baseline period of 3-8 weeks participants will start twice weekly with imagery rescripting for 12 sessions, followed by a 6 week follow up.

Participants will rate schema- or core beliefs and OCD or BDD severity on a visual analogue scale. In addition participants will rate core emotions, affect and obtrusiveness of the intrusion. Secondary we will asses four times questionnaires about OCD of BDD symptoms, depression and schemas en modes. After treatment participants will be interviewed about their experiences. conditions: Obsessive-Compulsive Disorder conditions: Body Dysmorphic Disorders conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Multiple baseline case series design: Patients wil be randomized to different lengths of baseline period and the effectiveness of the treatment is tested by comparing means and slopes of daily reported schema- or core beliefs and OCD and BDD severity, primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Imagery rescripting measure: Schema of core beliefs measure: Obsessive Compulsive (OCD) and Body Dysmorphic (BDD)symptoms measure: Core Emotions, affect strength, obtrusiveness of intrusion. measure: Yale Brown Obsessive Compulsive Scale (Y-BOCS(-BDD)) measure: Hamilton Depression Rating Scale (HDRS) measure: Young Schema Questionnaire (YSQ) and Schema Mode Inventory (SMI) measure: Qualitative interview sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Psychiatry, AMC status: RECRUITING city: Amsterdam-Zuidoost state: Noord-Holland zip: 1105 AZ country: Netherlands name: Tibor van Verseveld role: CONTACT phone: +31619624228 email: t.r.vanverseveld@amsterdamumc.nl lat: 52.3075 lon: 4.97222 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2023-06-23 uploadDate: 2024-02-27T15:21 filename: Prot_SAP_ICF_000.pdf size: 672806 hasResults: False

 nctId: NCT06346288 id: M24-144 briefTitle: A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-01-20 date: 2025-05-27 date: 2024-04-04 date: 2024-04-24 name: AbbVie class: INDUSTRY briefSummary: Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD

Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States.

Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months.

Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects. conditions: Inflammatory Bowel Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study will only include lactating women who are receiving treatment with risankizumab for IBD in accordance with their treating physician, although this study is non-interventional regarding treatment with risankizumab, it is considered interventional due to the collection of breast milk from the lactating mothers. primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Breast Milk Sampling name: Risankizumab measure: To determine the concentration of risankizumab in breastmilk sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346275 id: 3rdZhejiangCMU-11 briefTitle: Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-04 date: 2025-04 date: 2024-04-04 date: 2024-04-04 name: The Third Affiliated hospital of Zhejiang Chinese Medical University class: OTHER briefSummary: Background: Alzheimer's disease (AD) is characterized by cognitive impairment and behavioral impairment, and increasing attention is paid in the gait of AD patients. The aim of this randomized controlled trial (RCT) is to explore the effect of acupuncture on the cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices.

Methods: In this RCT, a total of 108 AD patients will be randomly assigned into acupuncture group or control group for 8 weeks. The primary outcome will be Three-dimensional gait analysis and cerebral hemodynamics using functional near-infrared spectroscopy (fNIRS). Secondary outcomes include Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Barthel Index (BI).

Discussion: This trial is expected to explore the effect of acupuncture on cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices for AD patients. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Acupuncture measure: Three-dimensional gait analysis measure: Cerebral hemodynamics measure: Mini-Mental State Examination measure: Montreal Cognitive Assessment measure: Barthel Index sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346262 id: STUDY20230921 briefTitle: Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care overallStatus: RECRUITING date: 2024-03-05 date: 2026-01-01 date: 2026-01-01 date: 2024-04-04 date: 2024-04-04 name: Martha Sajatovic class: OTHER briefSummary: This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings.

Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures. conditions: Epilepsy studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 43 type: ESTIMATED name: SMART RM name: Valtoco Nasal Product measure: Change in number of seizures as measured by patient report. measure: Change in quality of life as measure by QOLIE-31 measure: Change in functional status as measure by Short-Form Health Survey (SF-36) measure: Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9) measure: Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES) measure: Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS) measure: Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS) measure: Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS) measure: Change in number of emergency room visit as measure by patient report measure: Change in number of hospitalizations as measure by patient report measure: Change in number of non study outpatient services utilization as measure by patient report sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Medical Center status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Kari M Zimmermann, MA role: CONTACT phone: 216-368-8775 email: kmz24@case.edu lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06346249 id: 49/2024 briefTitle: Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain. overallStatus: RECRUITING date: 2024-03-04 date: 2024-05 date: 2024-05 date: 2024-04-04 date: 2024-04-04 name: Universidad de Extremadura class: OTHER briefSummary: The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Electrical Stimulation Therapy name: Manual Therapy name: Exercise Therapeutic measure: Changes in Pain measure: Changes Pressure Pain measure: Changes in Disability measure: Changes in Range of Motion measure: General Health. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: María de los Ángeles Cardero Durán status: RECRUITING city: Badajoz zip: 06006 country: Spain name: María de los Ángeles Cardero Durán, Doctor role: CONTACT email: mcarderod@unex.es lat: 38.87789 lon: -6.97061 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-27 uploadDate: 2024-04-01T16:35 filename: ICF_000.pdf size: 253582 hasResults: False

 nctId: NCT06346236 id: 69HCL21_0843 id: 401 type: OTHER domain: AGORA HCL briefTitle: Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity. acronym: NEO-TYR overallStatus: COMPLETED date: 2020-03-01 date: 2021-07-01 date: 2022-09-01 date: 2024-04-03 date: 2024-04-03 name: Hospices Civils de Lyon class: OTHER briefSummary: Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.

In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 \< 12 pmol/L and a level of TSH \< 15 mUI/L before 15 days of life or \< 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis. conditions: Transient Hypothyroxinemia of Prematurity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 373 type: ACTUAL name: L-thyroxine at a dose of 7.5 µg/kg/d for THOP name: THOP without treatment name: NoTHOP measure: Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation. sex: ALL maximumAge: 2 Weeks stdAges: CHILD facility: HFME city: Bron zip: 69300 country: France lat: 45.73333 lon: 4.91667 facility: CHU Grenoble city: Grenoble zip: 38100 country: France lat: 45.16667 lon: 5.71667 facility: CHU Saint EtienneHopital city: Saint-Étienne zip: 42000 country: France lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06346223 id: HSEARS20230928006 briefTitle: Mindfulness-Based Intervention for Family Caregivers overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-03 date: 2024-04-04 name: The Hong Kong Polytechnic University class: OTHER name: Health and Medical Research Fund briefSummary: The aim of this study is to investigate the efficiency of a single-session mindfulness-based intervention for reducing stress and promoting psychological health in family caregivers of people with dementia. The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices, psychoeducation and group sharing activities in the single-session mindfulness intervention. A self-practice tool kit with the teaching materials (e.g., recording of guided mindfulness activities) will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit.

Participants will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). Both groups will complete the same assessments at the same time-points. conditions: Caregiving Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A single-blinded, parallel-group, randomized-controlled trial (RCT) design. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 160 type: ESTIMATED name: Mindfulness and psychoeducation name: Psychoeducation measure: Perceived Caregiving Stress in the Family Caregiver measure: Depressive Symptoms in the Family Caregiver measure: Positive Aspect of Caregiving in the Family Caregiver measure: Dyadic Relationship Between the Family Caregiver and the Care Recipient measure: Trait Mindfulness in the Family Caregiver measure: Neuropsychiatric Syndromes in the Care Recipient measure: Feasibility of Eligibility and Enrollment measure: Feasibility of Attendance Rate measure: Feasibility of Adherence to Self-Practice measure: Feasibility of Retention Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346210 id: UNT: U1111-1288-2037 briefTitle: Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients overallStatus: COMPLETED date: 2024-04-02 date: 2024-04-02 date: 2024-04-02 date: 2024-04-03 date: 2024-04-10 name: Uppsala University class: OTHER name: Healthcare Region Dalarna briefSummary: Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 4000 type: ACTUAL name: Tracheostomy measure: Ventilator free days alive measure: 60 day mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Uppsala University city: Uppsala country: Sweden lat: 59.85882 lon: 17.63889 hasResults: False

 nctId: NCT06346197 id: ET23-185 briefTitle: Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas acronym: CIME overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2028-05-15 date: 2028-05-15 date: 2024-04-03 date: 2024-04-03 name: Centre Leon Berard class: OTHER name: Agenus Inc. briefSummary: CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm). conditions: Gastric Cancer conditions: MSI-H conditions: Metastatic Cancer conditions: Advanced Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 124 type: ESTIMATED name: Balstilimab name: Botensilimab name: Folfox Protocol name: XELOX name: Nivolumab measure: Survival of patients measure: Progression free survival measure: Objective response rate measure: Duration of response measure: Adverse Event description as assessed by CTCAE V5.0 measure: EORTC QLQ C30 measure: Gene expression and genomic profile description measure: Gene expression and genomic profile description measure: Number of tumor samples with modification of tumor microenvironment under study treatments measure: Value of Tumor mutational Burden (Mutation/ Megabase) on tumor and blood (circulating tumor DNA) during treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Léon Bérard city: Lyon country: France name: Clélia COUTZAC, MD role: CONTACT email: clelia.coutzac@lyon.unicancer.fr lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06346184 id: HM-EMMA-101 briefTitle: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-06-08 date: 2024-06-08 date: 2024-04-03 date: 2024-04-12 name: Hanmi Pharmaceutical Company Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fasting condition in healthy volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: HCP2303 name: RLD2302 name: RLD2102 measure: AUCt measure: Cmax measure: AUCinf measure: Tmax measure: t1/2 measure: CL/F measure: Vd/F sex: ALL minimumAge: 19 Years maximumAge: 54 Years stdAges: ADULT facility: Jeonbuk University Hospital city: Jeonju state: Jeollabuk-do country: Korea, Republic of name: Jin A Lee, Researcher role: CONTACT phone: 063-259-3550 name: Min-gul Kim, MD role: PRINCIPAL_INVESTIGATOR lat: 35.82194 lon: 127.14889 hasResults: False

 nctId: NCT06346171 id: 408/06.03.2024 briefTitle: VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain acronym: VRIPanx-COL overallStatus: NOT_YET_RECRUITING date: 2024-04-28 date: 2024-08-30 date: 2024-11-30 date: 2024-04-03 date: 2024-04-05 name: Grigore T. Popa University of Medicine and Pharmacy class: OTHER briefSummary: Colonoscopy is an invaluable tool for the diagnosis and management of colon diseases, especially colorectal cancer (CRC) - the third most common cancer worldwide. Its unmatched ability to detect CRC and premalignant growths makes it the gold standard; however, it is not without its challenges. Patients often experience pre-procedure anxiety and discomfort primarily related to anticipated pain, which negatively impacts both the procedure and its outcomes.

Colonoscopy procedural anxiety not only exacerbates the experience of pain, but also may compromise the quality of bowel preparation, augment procedure and recovery room times, and increase the use of sedation, particularly among females, who report greater pre-procedural anxiety, and perceive the procedure to be more painful and harder to endure. This underscores the importance of interventions aimed at mitigating anxiety to improve patient experience and adherence to colonoscopy procedures.

The profound positive corelation between anxiety and pain impact on outcomes of colonoscopy warrants an investigation of comprehensive patient care strategies. A growing body of evidence indicates that non-pharmacologic interventions, such as music therapy and immersive virtual reality (iVR), may effectively reduce anxiety, pain, and enhance overall patient satisfaction.

Understanding barriers to colonoscopy compliance, such as fear of cancer diagnosis, the perception of invasiveness, and feelings of embarrassment is paramount to enhancing CRC screening uptake, therefore lowering mortality. conditions: Procedural Anxiety conditions: Procedural Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The VRIPanx-COL study is an RCT investigating the efficacy of VR-facilitated integrative psychotherapy compared to VR distraction only and NSE-Col. Variance minimisation and propensity score matching are used to ensure that the groups are balanced and to supplement the internal validity of evaluating the efficacy of the intervention. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: To ensure credible outcomes, robust blinding for participants, care providers, and outcome assessors is vital to minimize bias. Participants will be briefed generally about participating in VR distraction research, with no details on psychotherapy inclusion. Gastroenterologists and outcome assessors remain blinded to intervention types, using standard tools for unbiased outcome evaluation. The principal investigator, aware of the intervention nature, conducts psychotherapy sessions or engages in simple discussion for control arm VR exposure. Another gastroenterologist oversees randomization to maintain blinding. Standardized VR distractions and pre-programmed randomization ensure unbiased participant allocation, reinforcing study validity through meticulous concealment and blinding protocols. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Virtual Reality Integrative Psychotherapy name: Virtual Reality Distraction measure: Reduction in Procedure-Related Anxiety measure: Pain perception measure: Feasibility and Acceptability of VRIP-Col Interventions measure: Qualitative Feedback on VRIP-Col Interventions measure: Trait anxiety measure: Quality of Life impact VRIP-Col sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Medicine and Pharmacy Grigore T Popa city: Iaşi state: Iasi zip: 700115 country: Romania lat: 47.16667 lon: 27.6 hasResults: False

 nctId: NCT06346158 id: 2024-3615 briefTitle: Prediction of Propofol Effect-Site Concentration Associated With Deep Anesthesia acronym: PRESCOD-AI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-03 date: 2024-04-03 name: Ciusss de L'Est de l'Île de Montréal class: OTHER name: CIUSSS du Nord de l'Ile de Montréal briefSummary: The goal of this observational study is to explore the variability of the concentration at the effect site (Ce) of propofol to reach deep anesthesia (DA) during induction of general anesthesia in adults.

The investigators hypothesized that there is a great variability in this Ce that could be precisely explained by

* Electroencephalographic (EEG) features available prior to induction of anesthesia
* Cognitive performance
* Patients characteristics Participants will undergo preoperative cognitive testing and awake EEG. Then, induction of general anesthesia will be performed using continuous infusion of propofol. The Ce at which Deep anesthesia is observed will be recorded. conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Cognitive testing name: electroencephalogram name: High density electroencephalogram name: General anesthesia measure: Concentration at the effect-site propofol associated with deep anesthesia (CeDA) measure: Coefficient of determination between statistical, spectral, entropic features extracted from the electroencephalogram and the Concentration at the effect-site propofol associated with deep anesthesia measure: Coefficient of determination between multivariable model and the Concentration at the effect-site propofol associated with deep anesthesia measure: Mean absolute error between predicted Concentration at the effect-site propofol associated with deep anesthesia by the machine-learning model and observed Concentration at the effect-site propofol associated with deep anesthesia. measure: Concentration at the effect-site propofol associated with loss of consciousness (CeLOC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346145 id: MIMS study id: 2023-00453 type: OTHER_GRANT domain: Swdeish research council briefTitle: Impact of Bariatric Surgery on Heart Disease Compared to Standard Care acronym: MIMS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2030-05-01 date: 2024-04-03 date: 2024-04-03 name: Danderyd Hospital class: OTHER name: Karolinska Institutet name: The 21 healthcare regions in Sweden briefSummary: Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS. conditions: Obesity, Morbid conditions: Bariatric Surgery Candidate conditions: Heart Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: Bariatric surgery name: Standard care measure: MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis. measure: Total event rate measure: All-cause mortality measure: Cardiovascular death measure: Remission of type 2 diabetes (T2D) and hypertension measure: Myocardial infarction measure: Stroke measure: Myocardial revascularization (not related to MI) measure: hospital admission because of heart failure as a primary ICD diagnosis. measure: hospital admission because of atrial fibrillation as a primary ICD diagnosis. measure: Safety, i.e., no excess of severe complications (Clavien-Dindo ≥3b (a complication requiring intervention under general anesthesia or resulting in organ failure or death)) and long-term morbidity. measure: Body weight change measure: Change in quality of life measure: All-cause hospitalizations measure: Change in quality of life sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346132 id: 2024-00043 CE 4516 briefTitle: Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: Schlotterbeck Hervé class: OTHER briefSummary: The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia. conditions: Virtual Reality conditions: Medical Device conditions: Local Anesthesia conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Virtual reality application measure: Global pain intensity experienced during the procedure. measure: Need for supplementary sedation and/or analgesia during the procedure. measure: Global anxiety intensity experienced during the procedure. measure: Patient's comfort during the procedure assessed by the surgeon and cardiologist. measure: Incidence of motion sickness during the virtual reality experience. measure: Patient's perceived procedure duration. measure: Maximal systolic arterial blood pressure. measure: Incidence of hypotensive or hypoxic events during procedure. measure: Total dose of local anaesthetic used during the procedure. measure: Change in anesthetic strategy during procedure. measure: Interruption of virtual reality experience during the procedure. measure: Intra- and post-procedure complications. measure: Overall patient's comfort and satisfaction experienced during the procedure. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto CardioCentro city: Lugano state: Ticino zip: 6900 country: Switzerland name: Herve Schlotterbeck, MD role: CONTACT phone: +41918115189 email: herve.schlotterbeck@eoc.ch lat: 46.01008 lon: 8.96004 hasResults: False

 nctId: NCT06346119 id: PI-2023-01 briefTitle: Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital acronym: ETDR overallStatus: RECRUITING date: 2023-02-27 date: 2024-01-05 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: Centre Hospitalier de Niort class: OTHER briefSummary: This is a randomized prospective study. This objective is the impact of "relaxing touch" on the use of chemical restraint for patients in intensive care from the lifting of sedation until extubation. conditions: Reaction Anxiety conditions: Difficult or Failed Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be conducted in two parallel groups. At the inclusion, each patient will be assigned to one of two groups by randomization; one group will receive the "touch" and the second group will not receive it will be the control arm. primaryPurpose: OTHER masking: SINGLE maskingDescription: It's a person external to the care service and to the randomization process will collect the possible prescription of a chemical restraint or the evolution of this chemical restraint by the resuscitator, in order to maintain the blind. whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day measure: chemical restraint measure: self-extubations measure: patient discomfort measure: respiratory rate measure: Ratio chemical restraint use measure: cardiac frequency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Niort status: RECRUITING city: Niort zip: 79000 country: France lat: 46.32313 lon: -0.45877 hasResults: False

 nctId: NCT06346106 id: 23-0075 briefTitle: The Diagnostic Experience of Male Rett Syndrome overallStatus: RECRUITING date: 2023-05-24 date: 2024-04-30 date: 2024-04-30 date: 2024-04-03 date: 2024-04-03 name: Children's Hospital Colorado class: OTHER name: University of Colorado, Denver name: Vanderbilt University School of Medicine name: University of Alabama at Birmingham name: University of Pennsylvania name: International Rett Syndrome Foundation name: Rocky Mountain Rett Association briefSummary: The Diagnostic Experience of Male Rett Syndrome collects information on the lived experiences of parents or caregivers to boys with Rett Syndrome. Key information examined includes the process of getting a male Rett syndrome diagnosis, your son's systems of care, and your priorities for his health needs.

Enrolled participants will complete an online survey with questions about having a son with Rett Syndrome. The Diagnostic Experience of Male Rett Syndrome study is available to parents or caregivers to boys (alive or passed) with Rett Syndrome. Compensation is not provided. conditions: Rett Syndrome conditions: RTT studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED name: Male Rett measure: Diagnostic experiences measure: Attainment of developmental milestones and any regressions measure: QI-disability measure: Parent priorities for care and counseling measure: Parenting experience measure: Information regarding child's death, if applicable measure: Family demographics measure: Systems of supports measure: Healthcare preferences sex: MALE minimumAge: 0 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Anschutz Medical Campus status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Natalia Klamut role: CONTACT phone: 720-277-9095 email: malerettstudy@cuanschutz.edu name: Timothy Benke, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Talia Thompson, PhD role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06346093 id: CHEC2024-089 briefTitle: Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-12-31 date: 2026-12-31 date: 2024-04-03 date: 2024-04-03 name: Xiangyu Kong class: OTHER briefSummary: This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD-L1 therapy in the advanced gastric cancer. conditions: Advanced Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: Fecal Microbiota Transplantation Capsules name: Placebo measure: Objective response rate (ORR) measure: Rate of Disease Control measure: Progression-free Survival (PFS) measure: Overall Survival (OS) measure: Incidence of Adverse Events Related to Treatment measure: Change in the intestinal microbiome community measure: Quality of life based on the questionnaire measure: Quality of life based on the questionnaire measure: Change in the immunity measure: Marker of nutritional status measure: Marker of nutritional status measure: Marker of nutritional status measure: Body Weight measure: Appetite measure: Marker of nutritional status measure: Marker of nutritional status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai Hospital city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06346080 id: s68670 briefTitle: Molecular Analysis for Gastro-Esophageal Cancer: Multicenter Discrete Choice Experiment acronym: MAGECmultiDiCE overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-01 date: 2026-08-01 date: 2024-04-03 date: 2024-04-03 name: KU Leuven class: OTHER briefSummary: The goal of this survey is to investigate the participants' preference for a specific screening/diagnostic tool to detect and assess gastro-esophageal cancer.

The main question it aims to answer are:

* Which diagnostic modality is preferred by patients and the general population?
* Which features of the diagnostic test are most detrimental in the decision-making for one or the other modality?
* Are geographical differences present in regard to the preference for a diagnostic modality?

Participants will be asked to complete a survey of 20-25min, including a brief intake regarding their socio-economic status. This approach will allow us to correct for confounding factors. conditions: Esophageal Cancer conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A survey will be conducted in a single group of participants from different geographical regions and backgrounds primaryPurpose: OTHER masking: NONE count: 2200 type: ESTIMATED name: Survey measure: The rate of contribution of diagnostic features to the preference of participants measure: The percentage differences in preference of participants between geographical regions measure: Assess the rate patient-level demographics influence the importance of a test feature, expressed as an odds ratio measure: Assess the rate of trade-off demonstrated as odds ratio between cancer-related mortality reduction and costs sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346067 id: ERAS-254-02 briefTitle: A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-04 date: 2028-12 date: 2024-04-03 date: 2024-04-29 name: Erasca, Inc. class: INDUSTRY briefSummary: Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2.

Stage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy). conditions: Advanced or Metastatic NRAS-mutant Melanoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 470 type: ESTIMATED name: Naporafenib name: Dacarbazine name: Temozolomide name: Trametinib measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 2: To compare PFS and OS for patients who are randomized to receive the combination of naporafenib + trametinib to that of patients who receive physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy) measure: Adverse Events measure: Duration of Response (DOR) measure: Time to Response (TTR) measure: Disease Control Rate (DCR) measure: Overall Response Rate (ORR) measure: Plasma concentration (Cmax):Stage 1 only measure: Area under the curve (AUC):Stage 1 only measure: Quality of Life: To assess disease and treatment-related QOL in patients with NRASm melanoma. measure: Duration of Response (DOR) for CNS disease in participants measure: Overall Response Rate (ORR) for CNS disease in participants measure: Disease Control Rate (DCR) for CNS disease in participants sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SCRI Oncology Partners (formerly Tennessee Oncology) city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06346054 id: s68669 briefTitle: Molecular Assessment for Gastro-Esophageal Cancer acronym: MAGEC overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2029-07-01 date: 2029-07-01 date: 2024-04-03 date: 2024-04-03 name: KU Leuven class: OTHER briefSummary: The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer.

The main questions this study aims to answer:

Are oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups.

Participants will provide a breath and blood sample during their routine standard of care visits. conditions: Esophageal Cancer conditions: Gastric Cancer conditions: Barrett Esophagus studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants with gastro-esophageal cancer, participants with Barrett's esophagus and Healthy controls will be monitored in parallel to identify oncometabolic biomarkers related to cancer primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: Breath analysis name: Blood analysis measure: Identification of the concentrations of oncometabolites measure: Assessment of incidence of early-stage cancer measure: Assessment of incidence of therapy response measure: Assessment of percentage change of therapy response measure: Assessment of incidence of recurrence sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346041 id: HJG-IDOV-SAFE-LYSW briefTitle: Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2026-04-01 date: 2024-04-03 date: 2024-04-03 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD or MFD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of IDOV-SAFETM in patients with advanced solid tumors. conditions: Neoplasms studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 19 type: ESTIMATED name: Oncolytic Virus injection(IDOV-SAFETM) measure: Dose Limiting Toxicities (DLT) measure: Incidence of adverse events and severe adverse events measure: MTD/MFD measure: The Pharmacokinetics characteristics of IDOV-SAFETM((biological distribution and viral expulsion)) measure: Immunogenicity of IDOV-SAFETM measure: ORR measure: DCR measure: DOR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346028 id: 2023/086 briefTitle: Implementation of Transcranial Magnetic Stimulation for Smoking Cessation overallStatus: RECRUITING date: 2024-03-30 date: 2025-06-30 date: 2025-06-30 date: 2024-04-03 date: 2024-04-03 name: Centre for Addiction and Mental Health class: OTHER briefSummary: Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively.

The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada.

Participants will be asked to come to CAMH to:

* Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment
* Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision.

Objectives

• Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health. conditions: Smoking studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Brainsway H4 deep rTMS coil and Brainsway stimulator system measure: The primary objective of the study is to evaluate the feasibility of implementing rTMS in the Nicotine Dependence Clinic (NDC) at CAMH, in Toronto. This is determine by reach, the extent to which patients are engaging in the rTMS treatment. measure: Identify rates of adoption of rTMS in Nicotine Dependence Clinic measure: Identify contextual determinants of rTMS adoption and reach NDC through a qualitative approach. measure: Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC. measure: Explore patient-HCP communication about shared treatment decision-making for rTMS. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Addiction and Mental Health (CAMH) status: RECRUITING city: Toronto state: Ontario country: Canada name: Alexandra S, BScH role: CONTACT phone: 416-535-8501 phoneExt: 31551 email: rtms.smoking@camh.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06346015 id: HX-A-2023050 briefTitle: Gamma Entrainment Stimulation for Cognitive Dysfunction After aSAH acronym: GES-aSAH overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2025-03-31 date: 2024-04-03 date: 2024-04-03 name: Beijing Tiantan Hospital class: OTHER name: Shanghai Joyingmed Sensory Stimulation Lab briefSummary: The goal of this clinical trial is to Explore and verify whether 40Hz audio and binaural beat 40Hz audio can improve the postoperative cognitive dysfunction seen in patients with aneurysmal subarachnoid hemorrhage. This study is a single-center, prospective, randomized, controlled clinical trial. Patients with aneurysmal subarachnoid hemorrhage were selected and randomized into intervention group (audio adjuvant group) and control group (conventional treatment group). Patients in the intervention group will receive audio therapy after surgery, and patients in the control group will receive usual care. EEG, fMRI and mRS scores were evaluated after 3 months of follow-up. conditions: Subarachnoid Hemorrhage, Aneurysmal conditions: Cognitive Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The relevant neuroimaging evaluation process is blinded to the evaluator to ensure the objectivity of the evaluation results. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Gamma Entrainment Stimulation measure: Montreal Cognitive Assessment (MoCA) scores < 22 measure: mini-mental state examiniation (MMSE) < 27 measure: modified Rankin Scales (mRS) > 2 measure: electroencephalogram (EEG) indicators measure: functional Magnetic Resonance Imaging (fMRI) indicators measure: Safety indicator sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06346002 id: 2026_e_2017 briefTitle: Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children overallStatus: COMPLETED date: 2017-03-01 date: 2020-03-31 date: 2020-03-31 date: 2024-04-03 date: 2024-04-03 name: Bishop's University class: OTHER briefSummary: Background: Prevention programs for children such as mindfulness-based interventions (MBIs) are often implemented in schools to prevent psychological disorders from emerging and contribute to children' mental health.

Aim: This study used a randomized cluster design and assessed the impact of a MBI on well-being and mental health of elementary school children's.

Method: 13 elementary school classrooms were randomly allocated to the experimental condition (7 classrooms, n = 127 students) or the waitlist control condition (6 classrooms, n = 104 students). Participants in the experimental condition received a 10-week MBI. conditions: Mindfulness-based Intervention conditions: Elementary School Children conditions: Mental Health Wellness 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized cluster trial with a wait-list control primaryPurpose: PREVENTION masking: NONE count: 231 type: ACTUAL name: Mindfulness-based intervention measure: Symptoms of Mental Health Disorders measure: Basic Psychological Needs Satisfaction measure: Process Measure sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: École primaire Préville city: Saint-Lambert state: Quebec zip: J4S 1M8 country: Canada lat: 45.50008 lon: -73.51028 hasResults: False

 nctId: NCT06345989 id: 187157 briefTitle: Time and Cost-implications of Intraoral Scans vs Alginate Impressions: A Randomised Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: University of Sheffield class: OTHER name: Nottingham University Hospitals NHS Trust briefSummary: This research project investigates the time and cost implications of two common techniques in orthodontics: alginate impressions and intraoral scans. Alginate impressions (putty moulds) are a traditional technique that has been used in orthodontic practice for many years. Intraoral scans are a more modern method and are becoming more commonly used in orthodontic practice. Both alginate impressions and intraoral scans are a means of recording a copy of a patient's teeth which aids in record keeping and treatment planning.

Whilst the majority of the available literature reveals patient preference in favour of intraoral scanning, it remains common practice to use alginate impressions for orthodontic records. Considerations such as time implications, device costs, associated software expenses, and the need for clinician training pose challenges to widespread adoption of intraoral scanning. When comparing chairside time taken for intraoral scans versus alginate impressions, there are varying findings, requiring a thorough investigation.

The main question being addressed is:

- Are intraoral scans more time efficient than alginate impressions?

The secondary question being addressed is:

- Are intraoral scans more cost effective than alginate impressions?

This research protocol outlines a clinical trial, evaluating the chairside time and costs associated with intraoral scanning versus alginate impressions. The sample population will be orthodontic patients ages 9 years and above attending the orthodontic department at a district general hospital.

The outcomes of this study will provide important insights into the practicality and economic viability of intraoral scanning versus alginate impressions in orthodontic settings, thereby informing clinical practices within the United Kingdom. This research contributes to strengthening the evidence base surrounding orthodontic techniques and their implications for patient-centred care. conditions: Chairside Time and Costs Associated With Intraoral Scanning Versus Alginate Impressions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective single-centre parallel arm randomised controlled trial, with an allocation ratio of 1:1 to investigate the difference in chairside time and cost of alginate impressions vs intraoral scans. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Due to the nature of the study, blinding to intervention will not be possible for the participants or clinicians during data acquisition. All data analysis will be carried out blinded using a coded data set. whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Alginate impression name: Intraoral scan measure: Chairside time taken for alginate impressions vs intraoral scans. measure: Cost implications of alginate impressions vs intraoral scans. sex: ALL minimumAge: 9 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Queens Medical Centre, Nottingham University Hospitals NHS Trust city: Nottingham state: Nottinghamshire zip: NG7 2UH country: United Kingdom name: Hannah Hook, BDS role: CONTACT phone: 07853993215 email: hannah.hook@nuh.nhs.uk name: Andrew Flett, BDS role: CONTACT email: andrew.flett@nuh.nhs.uk lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06345976 id: RLX_2023_10 briefTitle: Functional Impairment in Albinism acronym: PLAIB overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-03 date: 2024-04-03 name: Fondation Ophtalmologique Adolphe de Rothschild class: NETWORK briefSummary: Albinism is a genetic and hereditary anomaly that affects pigmentation. This pathology is characterized by a deficit in melanin production. In humans, the clinical diagnosis of albinism is based on a number of factors, including :

* In the integumentary region: fair skin tone, with white hair, eyelashes and eyebrows.
* Ophthalmological: reduced visual acuity, photophobia, nystagmus, transilluminated blue irises, hypopigmentation of the retina at the back of the eye with fovea plana.

As treatment options begin to emerge for certain albinism-induced anomalies (including, for example, the depigmentation that causes photophobia), it is desirable to understand what these patients' complaints are, and to gather their views on the emergence of treatments targeting just one of their complaints, namely glare. conditions: Albinism, Ocular studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: questionnaire measure: To determine whether patients with albinism would be interested in a treatment that could improve their glare without improving their visual acuity. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06345963 id: HSC-MS-23-1044 briefTitle: Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2030-05-01 date: 2024-04-03 date: 2024-04-05 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity. conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: active H-coil delivered rTMS measure: brain microstructural integrity from magnetic resonance imaging (MRI) measure: Resting-state functional connectivity (rsFC) from functional MRI measure: Electrophysiological responses measured by mismatch negativity and steady-state auditory evoked potentials from electroencephalography recording (EEG) measure: Cognitive insight, depression, perception, and delusion measured from questionnaires measure: Cognitive functions measured by the MATRICS consensus cognitive battery (MCCB) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The University of Texas Health Science Center, Houston city: Houston state: Texas zip: 77054 country: United States name: Xiaoming Du, PhD role: CONTACT phone: 410-402-6036 email: Xiaoming.Du@uth.tmc.edu name: Victoria Acosta role: CONTACT phone: 713-486-2740 email: Victoria.Acosta@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06345950 id: 2022-04-003 briefTitle: Pharmacokinetics and Safety of a New Micellar Glutathione Formulation overallStatus: COMPLETED date: 2022-06-21 date: 2022-12-31 date: 2023-06-30 date: 2024-04-03 date: 2024-04-03 name: Factors Group of Nutritional Companies Inc. class: INDUSTRY name: Isura briefSummary: This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.

The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period. conditions: Bioavailability conditions: Safety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of one intervention with higher bioavailability is evaluated in an additional single-arm, 30-day trial. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 16 type: ACTUAL name: Liposomal Glutathione name: Standard Glutathione name: New Micellar Glutathione (Lipomicel) measure: AUC: the area under the concentration-time curve measure: Cmax: maximum plasma concentration measure: Tmax: the time point of maximum plasma concentration measure: Alanine aminotransferase (ALT) measure: Aspartate aminotransferase (AST) measure: Alkaline phosphatase (ALP) measure: Bilirubin measure: Serum creatinine measure: Blood urea nitrogen (BUN) measure: Glomerular filtration rate (GFR) measure: C-reactive protein (CRP) measure: White blood cell count (WBC) measure: Hemoglobin (Hb) measure: Hematocrit (Hct) measure: Platelet count measure: Fasting blood glucose measure: Total cholesterol measure: Low-density lipoprotein (LDL) cholesterol measure: High-density lipoprotein (HDL) cholesterol measure: Triglycerides sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ISURA city: Burnaby state: British Columbia zip: V2N 4S9 country: Canada lat: 49.26636 lon: -122.95263 hasResults: False

 nctId: NCT06345937 id: REB #44724 briefTitle: Multiple Risk Factor Intervention Trial (Ms. FIT) acronym: MsFIT overallStatus: RECRUITING date: 2024-04-01 date: 2027-08-01 date: 2028-08-01 date: 2024-04-03 date: 2024-04-04 name: University of Toronto class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: This study aims to produce new evidence, specific to women, on the efficacy and mechanisms of exercise and diet for cardiometabolic risk reduction in pre and postmenopausal women. Using a 3-arm randomized controlled trial (RCT) with equal recruitment and stratification by menopausal status to 6 months of: 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:

* How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women?
* What is the effect modification of adding a diet quality intervention to exercise?
* What is the effect modification by menopausal status?

The investigators hypothesize that exercise adaptations will be: 1) largest peripherally, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause. conditions: Metabolic Disturbance conditions: Sedentary Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3-arm parallel-group randomized controlled trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: It is not possible to blind participants to their assigned intervention. Care providers are not involved. The outcome assessors for any assessments involving potential for subjectivity in data collection or analysis will be blinded to group assignment. whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Behavioural Experimental: guidelines-based physical activity name: Behavioural Experimental: guidelines-based physical activity and healthy eating name: Behavioural: Stretching exercise measure: Insulin resistance measure: Hepatic insulin resistance measure: Metabolic syndrome severity measure: Framingham 10-year risk (%) measure: Cardiorespiratory fitness measure: Heart Rate Recovery measure: Exercise stroke volume & cardiac output measure: Left ventricular ejection fraction measure: Left ventricular mass measure: Arteriovenous Oxygen Difference (avO2diff) measure: Endothelial Function measure: Carotid Intima Media Thickness measure: Central & Peripheral Arterial stiffness measure: Blood Pressure measure: Resting Heart Rate & Heart Rate Variability measure: Thigh Myosteatosis measure: Knee flexion and extension (strength and endurance) measure: Thigh Muscle Volume measure: Biochemical markers of skeletal muscle protein content measure: Biochemical markers of skeletal muscle structure measure: Biochemical markers of skeletal muscle enzyme activity measure: Whole-body fat and fat-free mass measure: Visceral adipose tissue measure: Liver fat fraction measure: Body circumferences measure: Concentration of inflammation biomarkers in blood measure: Lipid panel: high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total Cholesterol, Triglycerides measure: Hemoglobin A1c measure: Dietary intake measure: Liver enzymes: alanine transaminase (ALT), aspartate aminotransferase (AST), and albumin measure: Liver fibrosis measure: Aerobic physical activity adherence measure: Resistance exercise adherence measure: Diet quality measure: Health-related quality of life measure: Menopausal symptom presence and severity measure: Psychosocial stress measure: Depression & Anxiety measure: Barriers and self-efficacy for physical activity measure: Physical activity motivation measure: Sleep quality - subjective measure: Sleep quantity and quality - device measured measure: Self-reported physical activity measure: Serum Estradiol measure: Salivary Estradiol measure: Hemoglobin measure: Free fatty acids measure: Body weight measure: Body mass index (BMI) measure: Energy Balance sex: FEMALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Toronto status: RECRUITING city: Toronto state: Ontario zip: M5S 2C9 country: Canada name: Amy A. Kirkham, PhD role: CONTACT phone: 416-946-4069 email: amy.kirkham@utoronto.ca name: Jenna B. Gillen, PhD role: CONTACT phone: 416-978-3244 email: jenna.gillen@utoronto.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06345924 id: Meraki_Palliative Care briefTitle: Music Therapy for Cancer Patients(Meraki_PC) acronym: Meraki_Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2024-07 date: 2025-07 date: 2024-04-03 date: 2024-04-15 name: University of Valencia class: OTHER briefSummary: The overall aim of the study is to analyse the impact of a music therapy-based treatment on the emotional well-being and quality of life of cancer patients in palliative care (PC). To this end, the effectiveness and efficiency of a music therapy-based treatment to improve adaptation to illness and psychological well-being in this population will be validated and implemented.

Specifically, the implementation of an individualised treatment programme for palliative care patients will be carried out. conditions: Cancer conditions: Palliative Care studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: MERAKI_PC measure: Change in Anxiety and Depression Symptomatology (T1, T2 and T4) measure: Change in Quality of Life (T1, T2 and T4) measure: Change in emotional distress (T1, T2, T3 and T4) measure: Change in Social Suport (T1 and T4) measure: Change in Resilience (T1 and T4) measure: Change in Spirituality (T1 and T4) measure: Change Knowledge of the disease (T1 and T4) measure: Barthel Index measure: Pfeiffer Short Form Mental State Questionnaire, SPMSQ measure: Charlson Comorbidity Index (CCI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Dr. Moliner status: RECRUITING city: Serra state: Valencia country: Spain name: Miguel Fombuena, PhD role: CONTACT email: fombuena_mig@gva.es name: Selene Valero-Moreno, PhD role: SUB_INVESTIGATOR name: Isabel Bellver Vercher role: SUB_INVESTIGATOR name: Ana Alegre Soler role: SUB_INVESTIGATOR name: José Jorge Botella Trellis, Dr. role: SUB_INVESTIGATOR name: Cristina Rocío Espejo Fernández, Dra. role: SUB_INVESTIGATOR name: María Carmen Badía Picazo, Dra. role: SUB_INVESTIGATOR lat: 39.68333 lon: -0.43333 hasResults: False

 nctId: NCT06345911 id: NEU-49/899 briefTitle: Do Vacutainers With Animal Characters Reduce Fear and Anxiety? overallStatus: COMPLETED date: 2021-12-01 date: 2022-02-25 date: 2022-03-30 date: 2024-04-03 date: 2024-04-03 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using vacutainers of three different animal characters. conditions: Procedural Pain conditions: Acute Pain conditions: Fear conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 180 type: ACTUAL name: Experimental group measure: Children's Fear Scale measure: Wong-Baker FACES Pain Rating Scale sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: Karaman Education and Research Hospital city: Karaman country: Turkey lat: 37.18111 lon: 33.215 hasResults: False

 nctId: NCT06345898 id: 2023-1479 briefTitle: Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS) overallStatus: RECRUITING date: 2023-11-17 date: 2026-12-30 date: 2029-12-30 date: 2024-04-03 date: 2024-04-03 name: West China Hospital class: OTHER briefSummary: This trial is to evaluate the safety and efficacy of JWK002 treatment of X-linked retinoschisis(XLRS). This study will enroll subjects aged 5-18 years old to receive a sub-retinal injection of JWK002. conditions: X Linked Retinoschisis studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 9 type: ESTIMATED name: JWK002 measure: Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events) measure: Best corrected visual acuity (BCVA) measure: Full-field electroretinogram(ff-ERG) measure: Macular structure as assessed by swept source optical coherence tomography measure: Visual field sex: MALE minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: West China Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610023 country: China name: Licong Liang role: CONTACT email: 932968425@qq.com name: Fang Lu role: CONTACT email: lufang@wchscu.cn lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06345885 id: PROPMHP002 briefTitle: Immunogenicity and Safety of One Dose of HPV Vaccine overallStatus: COMPLETED date: 2023-02-23 date: 2024-01-17 date: 2024-01-17 date: 2024-04-03 date: 2024-04-03 name: Xiamen Innovax Biotech Co., Ltd class: INDUSTRY briefSummary: This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil conditions: Human Papillomavirus Vaccines studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 200 type: ACTUAL name: HPV vaccine measure: Anti-HPV seropositivity measure: Anti-HPV Seropositivity measure: HPV Antibody Titers measure: Local and Systemic Reactions/Event sex: FEMALE minimumAge: 9 Years maximumAge: 14 Years stdAges: CHILD facility: Fujian Provincial Center for Disease Control and Prevention city: Fuzhou state: Fujian zip: 350012 country: China lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06345872 id: STUDY005883 id: 1R01DA054311 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA054311 briefTitle: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain overallStatus: RECRUITING date: 2024-04 date: 2028-01 date: 2028-07 date: 2024-04-03 date: 2024-04-18 name: University of South Florida class: OTHER name: National Institutes of Health (NIH) name: National Institute on Drug Abuse (NIDA) briefSummary: The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain. conditions: Chronic Pain conditions: Chronic Insomnia conditions: Opioid Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 165 type: ESTIMATED name: CBT-I name: Treatment as usual name: Tapered Withdrawal measure: Change in Insomnia Severity Index measure: Change in Pain Intensity - Daily Electronic Sleep Diaries measure: Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries measure: Change in Sleep Onset Latency- Daily Electronic Sleep Diaries measure: Change in Sleep Efficiency- Daily Electronic Sleep Diaries measure: Change in Fatigue - Daily Electronic Sleep Diaries measure: Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries measure: Change in Perceived Stress Scale measure: Change in Peripheral Arousal measure: Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging measure: Change in Thermal Pain Response measure: Change in Opioid Use (Quantitative) measure: Change in Opioid Use (Self-Report) measure: Change in Objective Wake After Sleep Onset (Actigraph) measure: Change in Objective Sleep Onset Latency (Actigraph) measure: Change in Objective Sleep Efficiency (Actigraph) measure: Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging measure: Short Inventory of Problems measure: Change in Pain Catastrophizing Scale measure: Change in 36-Item Short Form Survey (SF-36) measure: Change in Depression (Beck Depression Inventory-II) measure: Change in State-Trait Anxiety Inventory (STAI) measure: Medications/Substances Uses and Dosages measure: Change in Subjective Opioid Withdrawal Scale (SOWS) measure: Change in Opioid Cravings Scale measure: Change in NIH Toolbox sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Florida status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Christina S McCrae, PhD role: CONTACT phone: 813-974-1804 email: christinamccrae@usf.edu name: Jasmine L Niazi, MS role: CONTACT phone: (813) 906-0483 email: jlniazi@usf.edu lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06345859 id: UP-23-00467 id: R01MH133842 type: NIH link: https://reporter.nih.gov/quickSearch/R01MH133842 briefTitle: Regulation of Affect and Physiology in Depression acronym: RAPID overallStatus: RECRUITING date: 2024-03-22 date: 2028-04-30 date: 2029-06-30 date: 2024-04-03 date: 2024-04-03 name: University of Southern California class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 252 type: ESTIMATED name: Heart rate variability biofeedback measure: Physiological regulation success measure: Average level of heart rate variability measure: Perceived regulation success sex: ALL minimumAge: 18 Years maximumAge: 27 Years stdAges: ADULT facility: University of Southern California status: RECRUITING city: Los Angeles state: California zip: 90089 country: United States name: Umiemah Farrukh role: CONTACT phone: 213-740-4503 email: carlab@usc.edu lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06345846 id: Secondary IOL briefTitle: Stability of Secondary Intraocular Lenses With no Capsular Support overallStatus: ENROLLING_BY_INVITATION date: 2022-12-30 date: 2025-12 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Vienna Institute for Research in Ocular Surgery class: OTHER briefSummary: Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 82 type: ESTIMATED name: IFIOL name: SFIOL measure: Centration of the IOL measure: Tilt of the IOL sex: ALL minimumAge: 21 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna city: Vienna zip: 1140 country: Austria lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06345833 id: ENT-2024-32847 briefTitle: Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07-01 date: 2026-07-01 date: 2024-04-03 date: 2024-04-10 name: University of Minnesota class: OTHER briefSummary: Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.

Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\[12\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date. conditions: Hemophilia conditions: Hemorrhage conditions: Facelift Surgery studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: 1%Tranexamic acid with standard local name: 3% TXA name: 1% TXA with local plus 3% TXA-soaked pledgets measure: Blood loss measure: adverse effects of TXA rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06345820 id: Evolux briefTitle: Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses overallStatus: RECRUITING date: 2023-06-28 date: 2025-06 date: 2025-06 date: 2024-04-03 date: 2024-04-04 name: Vienna Institute for Research in Ocular Surgery class: OTHER briefSummary: Comparison of the clinical performance of two enhanced monofocal IOLs with similar design. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 35 type: ESTIMATED name: Evolux name: Tecnis Eyhance measure: Monocular intermediate visual acuity measure: Monocular distance visual acuity measure: Monocular near visual acuity sex: ALL minimumAge: 21 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna status: RECRUITING city: Vienna zip: 1140 country: Austria name: Andreas Rotter, MD role: CONTACT phone: 01 91021 phoneExt: 57564 email: office@viros.at name: Manuel Ruiss, MSc role: CONTACT phone: 01 91021 phoneExt: 57564 email: office@viros.at lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06345807 id: 2023-A02617-38 briefTitle: Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation acronym: APIC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11 date: 2026-11 date: 2024-04-03 date: 2024-04-05 name: Elsan class: OTHER briefSummary: The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient. conditions: Individualised Physical Activity Program conditions: Coronary Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: interventional study, randomized in 3 parallel groups, single center, primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 192 type: ESTIMATED name: Individuals activity programs name: activity program name: no Physical Activity program measure: 6 minutes walk test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06345794 id: 27111 id: J5C-MC-FOAG type: OTHER domain: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company briefTitle: A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2024-06-17 date: 2024-06-17 date: 2024-04-03 date: 2024-04-03 name: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company class: INDUSTRY name: Eli Lilly and Company briefSummary: The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: LY4100511 (DC-853) name: Itraconazole name: Fluconazole name: Carbamazepine measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853) measure: PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853) measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON San Antonio Clinical Research Unit city: San Antonio state: Texas zip: 78209 country: United States role: CONTACT phone: 210-283-4500 name: Chinonye Ogbonnaya-Odor role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06345781 id: 2174433-1 briefTitle: Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-05 date: 2024-04-03 date: 2024-04-03 name: Craig Hospital class: OTHER name: Neuroscience Research Australia briefSummary: The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device. conditions: Spinal Cord Injuries conditions: Neurogenic Bowel studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Abdominal Functional Electrical Stimulation measure: Bowel Management Time (BMT) measure: Bowel Management Strategy measure: Stimulation Dose measure: EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire measure: International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire measure: Visual Analog Scale (VAS) measure: Neurogenic Bladder Symptom Score (NBSS) measure: Intervention Acceptability measure: Intervention Safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Craig Hospital city: Englewood state: Colorado zip: 80113 country: United States lat: 39.64777 lon: -104.98776 hasResults: False

 nctId: NCT06345768 id: 147258369 briefTitle: The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients' Fear, Stress and Comfort. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-03 date: 2024-04-03 name: Akdeniz University class: OTHER briefSummary: Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.

Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.

In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort. conditions: Cholecystitis conditions: Stress conditions: Fear conditions: Comfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: Stress Ball measure: Fear of surgery measure: Fear of surgery measure: Comfort measure: Comfort measure: Stress measure: Stress sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06345755 id: VX23-407-001 briefTitle: A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of VX-407 in Healthy Participants overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-03 date: 2024-04-26 name: Vertex Pharmaceuticals Incorporated class: INDUSTRY briefSummary: The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants. conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 95 type: ESTIMATED name: VX-407 name: Placebo name: Midazolam measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407 measure: Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407 measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407 measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407 measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407 measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407 measure: Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON Lenexa status: RECRUITING city: Lenexa state: Kansas zip: 66219 country: United States lat: 38.95362 lon: -94.73357 hasResults: False

 nctId: NCT06345742 id: ATADEK-2023-10/396 briefTitle: The Effect of Parental Participation on Newborn Comfort During Diaper Care overallStatus: RECRUITING date: 2023-12-19 date: 2025-02-01 date: 2025-02-01 date: 2024-04-03 date: 2024-04-03 name: Acibadem University class: OTHER briefSummary: It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants.

H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.

H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants.

H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants. conditions: Preterm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 105 type: ESTIMATED name: No parental participation name: Mother participation name: Father participation measure: Level of Parental Stress measure: Change in Level of Comfort sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD facility: Acıbadem University status: RECRUITING city: İstanbul state: Ataşehir zip: 34750 country: Turkey name: Tuğba Türker, Nurse role: CONTACT email: tugba.turker@live.acibadem.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06345729 id: 1084-004 id: MK-1084-004 type: OTHER domain: Merck id: U1111-1296-8093 type: OTHER domain: UTN id: 2023-507776-42 type: REGISTRY domain: EU CT briefTitle: A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004) overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2029-02-19 date: 2031-02-18 date: 2024-04-03 date: 2024-04-09 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:

Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS). conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: MK-1084 name: Placebo name: Pembrolizumab measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Number of Participants Who Experience One or More Adverse Event (AEs) measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06345716 id: renal colic 2024 briefTitle: Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic acronym: RC overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-03-15 date: 2025-11-30 date: 2024-04-03 date: 2024-04-03 name: University of Monastir class: OTHER briefSummary: This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group. conditions: Renal Colic studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 1500 type: ESTIMATED name: paracétamol tramadol name: Paracétamol cafeine name: Placebo measure: Pain recurrence measure: Painful recurrence measure: number of patient who revist the ED for residual pain measure: Adverse effects sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06345703 id: NeuShen Therapeutics briefTitle: First-into-human Study of NS-136 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-02 date: 2024-04-03 date: 2024-04-03 name: NeuShen Therapeutics class: INDUSTRY briefSummary: The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:

* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen?
* What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen? conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The trial consists of three parts: the first part is a single ascending dose (SAD) study, the second part is a multiple ascending dose (MAD) study, and the third part is food effect (FE) study. The first two parts (SAD and MAD) will be randomized, double-blind, single or multiple ascending dose and placebo-controlled study designs. The third part (FE) will be a randomized, open-label, two-period, crossover study design. To evaluate the safety, tolerability, pharmacokinetic profile, and the effect of food on the PK profile of NS-136 in healthy subjects and to determine the maximum tolerated dose (MTD) primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Placebo name: NS-136 tablet measure: Number of Participants with Treatment-Related Adverse Events measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CMAX Clinical Research Pty Ltd city: Adelaide state: South Australia zip: 5000 country: Australia name: Study Services Director role: CONTACT phone: +61 08 7088 7900 email: cmax@cmax.com.au lat: -34.92866 lon: 138.59863 hasResults: False

 nctId: NCT06345690 id: VIA-2023-003 briefTitle: VIA Disc NP Registry 3.0 overallStatus: RECRUITING date: 2024-02-27 date: 2027-01-01 date: 2027-01-01 date: 2024-04-03 date: 2024-04-03 name: VIVEX Biologics, Inc. class: INDUSTRY name: Moxie Clinical briefSummary: Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP. conditions: Discogenic Pain conditions: Back Pain conditions: Back Pain, Low studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: VIA Disc NP measure: Numeric Pain Rating Scale (NPRS) measure: Oswestry Disability Index (ODI) measure: Patient Satisfaction measure: Pain Medication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Denver Spine & Pain Institute status: RECRUITING city: Greenwood Village state: Colorado zip: 80111 country: United States name: Josephine Steinbrecher role: CONTACT email: josephine@denverpaininstitute.com name: Scott Bainbridge, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.61721 lon: -104.95081 facility: The Orthopedic Institute status: RECRUITING city: Gainesville state: Florida zip: 32605 country: United States name: Carole Newell role: CONTACT email: cnewell@toi-health.com name: Ajay Antony, M.D. role: PRINCIPAL_INVESTIGATOR lat: 29.65163 lon: -82.32483 facility: Interventional Pain Specialists - Pain Clinic status: RECRUITING city: Opelousas state: Louisiana zip: 70570 country: United States name: Lisa Briggs role: CONTACT email: lisa@ipspain.org name: Albert Gros, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.53353 lon: -92.08151 facility: Premier Pain Solutions status: RECRUITING city: Asheville state: North Carolina zip: 28803 country: United States name: Courtney Musser role: CONTACT email: courtney@premierpainnc.com name: Javid Baksh, M.D. role: PRINCIPAL_INVESTIGATOR lat: 35.60095 lon: -82.55402 facility: Crystal Coast Pain Management status: RECRUITING city: New Bern state: North Carolina zip: 28560 country: United States name: Amy Harum role: CONTACT email: aharum@crystalcoastpm.com name: Kirk Harum, M.D. role: PRINCIPAL_INVESTIGATOR lat: 35.10849 lon: -77.04411 hasResults: False

 nctId: NCT06345677 id: ViXe-CLP-0002 briefTitle: Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects acronym: XAVIER overallStatus: COMPLETED date: 2023-06-09 date: 2024-02-01 date: 2024-02-01 date: 2024-04-03 date: 2024-04-09 name: Vensica Therapeutics Ltd. class: INDUSTRY name: Blueclinical, Ltd. briefSummary: The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder. The main question\[s\] it aims to answer are: • The rate of device and drug related serious adverse events during treatment and throughout the follow up period • Investigator, subject and technician satisfaction from treatment, and • Assess the initial efficacy of the drug-device combination compared to placebo-sham combination. Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks, during which they will visit the clinic after 2, 6 and 12 weeks. Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit. conditions: Overactive Bladder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 48 type: ACTUAL name: ViXe Xombination name: Placebo + Sham measure: Adverse Events Rate measure: Usability and ease-of-use perception by investigator, subject and technician measure: Daily Urgency Urinary Incontinence measure: Total Daily Episodes measure: Urinary Urgency measure: Voiding Leaks measure: Quality of Life Queationnsaire measure: Nocturia sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHUC city: Coimbra country: Portugal lat: 40.20564 lon: -8.41955 facility: HSOG city: Guimarães country: Portugal lat: 41.44443 lon: -8.29619 facility: CHLN city: Lisboa country: Portugal lat: 38.71667 lon: -9.13333 facility: CHUSJ city: Porto country: Portugal lat: 41.14961 lon: -8.61099 facility: Hospital Lusíadas city: Porto country: Portugal lat: 41.14961 lon: -8.61099 facility: Hospital Prelada city: Porto country: Portugal lat: 41.14961 lon: -8.61099 facility: Hospital Luz Setúbal city: Setúbal country: Portugal lat: 38.5244 lon: -8.8882 facility: CHVNG city: Vila Nova De Gaia country: Portugal lat: 41.13363 lon: -8.61742 hasResults: False

 nctId: NCT06345664 id: 548/2022BO1 briefTitle: Interdisciplinary E-health Based Follow-up of Preterm Born Children acronym: NeoUp overallStatus: RECRUITING date: 2023-03-01 date: 2024-10 date: 2024-12 date: 2024-04-03 date: 2024-04-08 name: University Hospital Tuebingen class: OTHER briefSummary: The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children. conditions: Preterm Birth studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 90 type: ESTIMATED name: Diagnostics and intervention recommendations measure: Bayley Scales of Infant and Toddler Development measure: Wechsler Intelligence Scale for Children (WISC-V) measure: Children's Sleep Habit Questionnaire (CSHQ-DE 4-10) measure: Sleep Self Report (SSR) measure: Somatics measure: Child Behavior Checklist (CBCL) measure: Youth Self Report (YSR) measure: Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB) measure: KIDSCREEN-27 (The KIDSCREEN) measure: Parent's Stress Inventory (EBI) measure: App-questions measure: Postexperimental questionnaire measure: Demographic data measure: Actigraphy measurement measure: Video of a sleeping sequence measure: Sleep cartoon for children measure: Kiddie-Sads-Present and Lifetime Version (K-SADS PL) measure: Self efficacy dealing with social situations (WIRKSOZ) measure: Group interviews sex: ALL minimumAge: 2 Years maximumAge: 10 Years stdAges: CHILD facility: University Hospital Tuebingen status: RECRUITING city: Tuebingen zip: 72076 country: Germany name: Annette Conzelmann, Prof. Dr. role: CONTACT name: Axel Franz, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Mirja Quante, Dr. role: PRINCIPAL_INVESTIGATOR name: Andrea Bevot, Dr. role: PRINCIPAL_INVESTIGATOR name: Anna Haigis role: SUB_INVESTIGATOR name: Dorothee Fütterer, Dr. role: SUB_INVESTIGATOR name: Annette Conzelmann, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Tobias Renner, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06345651 id: 2023-03, Version 7 briefTitle: Brain Oscillation-synchronized Stimulation of the Frontal Cortex in Major Depressive Disorder acronym: BOSSFRONT2 overallStatus: RECRUITING date: 2023-09-01 date: 2025-08 date: 2025-08 date: 2024-04-03 date: 2024-04-03 name: University Hospital Tuebingen class: OTHER briefSummary: Major depressive disorder (MDD) is a common severe psychiatric disease with enormous socioeconomic costs for the patient and society alike. Current pharmacological treatments are ineffective in a substantial fraction of patients and are accompanied by unwanted side effects. Using a novel non-invasive brain stimulation method to specifically target and modulate dysfunctional brain oscillations with high spatial and temporal precision this study will investigate the efficacy of EEG-triggered transcranial magnetic stimulation to alleviate de-pressive symptomatology in patients with MDD in a double-blind randomized controlled pilot clinical trial. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a single-site randomized standard TMS therapy-controlled double-blind paral-lel-group design clinical trial. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In both conditions the identical setup is used consisting of Neuronavigation, EEG and TMS. Only in the experimental condition the treatment will be EEG-informed. In the control condition the treatment will be applied indepentently of the EEG signal. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Transcranial Magnetic Stimulation measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: MADRS (Montgomery-Åsberg Depression Rating Scale) 4 weeks after intervention measure: HDRS-17 (Hamilton Depression Rating Scale-17) measure: BDI-2 (Beck Depression Inventory-2) measure: IDS-30 (Inventory of depressive symptoms-30) measure: Response Rate measure: Remission Rate sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen status: RECRUITING city: Tuebingen state: Baden-Wuerttemberg zip: 72076 country: Germany name: Anne Lieb, Dr. role: CONTACT phone: +4970712980483 email: anne.lieb@uni-tuebingen.de name: Andreas J. Fallgatter, Prof. role: PRINCIPAL_INVESTIGATOR name: Ulf Ziemann, Prof. role: PRINCIPAL_INVESTIGATOR name: Julia Becker-Sadzio, Dr. role: SUB_INVESTIGATOR name: Anne Lieb, Dr. role: PRINCIPAL_INVESTIGATOR lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06345638 id: 854343 briefTitle: Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2025-04-30 date: 2025-05-31 date: 2024-04-03 date: 2024-04-03 name: University of Pennsylvania class: OTHER briefSummary: This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD).

* The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD.
* The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC.
* The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood. conditions: Sickle Cell Disease conditions: Vaso-occlusive Crisis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: C-reactive protein level sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Penn Medicine University City city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: Pennsylvania Hospital city: Philadelphia state: Pennsylvania zip: 19107 country: United States lat: 39.95233 lon: -75.16379 facility: Hospital of the University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19143 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06345625 id: 6012 briefTitle: Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults acronym: BALANCAR overallStatus: RECRUITING date: 2024-04-15 date: 2027-01 date: 2028-01 date: 2024-04-03 date: 2024-04-16 name: Universiteit Antwerpen class: OTHER briefSummary: The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing. conditions: Aged conditions: Accidental Fall conditions: Postural Balance conditions: Gait studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Cognition name: Sensory function name: Frailty name: Biomechanical movement analysis name: Screening name: Follow up measure: Spatio-temporal parameters of gait measure: Foot placement estimator measure: Onset latency measure: Peak amplitude measure: Fixation duration measure: Gain measure: Latency measure: Fall characteristics measure: Multisensory integration measure: Digit symbol substitution test measure: Trail making test measure: Go/No Go test measure: Head Repositioning Accuracy measure: Fly test measure: Fly test measure: vHIT measure: fHIT measure: Frailty measure: Age measure: Gender measure: Medical history measure: Fall history sex: ALL minimumAge: 65 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: University of Antwerp status: RECRUITING city: Antwerp zip: 2160 country: Belgium name: Ann Hallemans, PhD role: CONTACT phone: +32 3 265 29 12 email: ann.hallemans@uantwerpen.be name: PhD role: CONTACT lat: 51.21989 lon: 4.40346 hasResults: False

 nctId: NCT06345612 id: Hypoxia-Exercise-DiabetesT1 briefTitle: Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes overallStatus: RECRUITING date: 2023-11-15 date: 2025-06 date: 2025-07 date: 2024-04-03 date: 2024-04-03 name: Silesian Centre for Heart Diseases class: OTHER briefSummary: Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: hypoxia name: normoxia name: creatine supplementation name: no creatine supplementation measure: Metabolic control of diabetes measure: Time in range measure: Time below range measure: Maximum oxygen consumption (VO2max) sex: MALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland status: RECRUITING city: Zabrze state: Silesia zip: 41-800 country: Poland name: Marta Wróbel, PhD role: CONTACT phone: 48606873060 email: mwrobel@sum.edu.pl lat: 50.32492 lon: 18.78576 hasResults: False

 nctId: NCT06345599 id: LK2023100 briefTitle: PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-01-10 date: 2027-01-10 date: 2024-04-03 date: 2024-04-03 name: Second Affiliated Hospital of Soochow University class: OTHER briefSummary: The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and efficacy of the PRaG treatment modality combined with chemotherapy neoadjuvant therapy for locally advanced pancreatic cancer. conditions: Pancreatic Ductal Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Radiotherapy name: Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab name: Chemotherapy:Albumin-bound paclitaxel、Gemcitabine measure: Adverse events measure: Serious adverse events measure: 1-year overall survival measure: Objective response rate measure: Disease control rate measure: Overall survival measure: R0 resection rate measure: Progression free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-22 uploadDate: 2024-03-26T10:41 filename: Prot_SAP_000.pdf size: 1237855 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-27 uploadDate: 2024-03-26T10:44 filename: ICF_001.pdf size: 376918 hasResults: False

 nctId: NCT06345586 id: 078066 briefTitle: Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-03 date: 2024-04-03 name: Chulalongkorn University class: OTHER briefSummary: The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery conditions: Contraception studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants received Drospirenone will be assess for cervical mucus change by modified Insler score primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: Drospirenone measure: Cervical mucus by modified Insler score measure: Estrogen and progesterone levels versus time measure: Number of Participants With Treatment-Related Adverse Events sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chulalongkorn University city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06345573 id: BASEC 2020-02922 briefTitle: Heart-brain-axis and Psychosocial Stress overallStatus: ACTIVE_NOT_RECRUITING date: 2021-10-11 date: 2023-11-20 date: 2024-11 date: 2024-04-03 date: 2024-04-08 name: University of Zurich class: OTHER briefSummary: The main study objective is to prospectively determine the influence of sex-related risk factors and psychosocial variables on neuronal stress responses and myocardial perfusion in a population of 64 female and male individuals 50-75 years of age and free of cardiovascular disease. conditions: Mental Stress conditions: Myocardial Ischemia conditions: Sex Role conditions: Gender studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ACTUAL name: Mental stress measure: Amygdala-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV) measure: Difference between the rest and stress amygdala-to-cerebellum perfusion ratios (kBq/kBq) measure: Myocardial flow reserve (MFR, no unit) measure: Amygdala-to-vmPFC ratio of glycolytic metabolic activities (SUV/SUV) measure: Difference between the rest and stress amygdala-to-vmPFC perfusion ratios (kBq/kBq) measure: Myocardial blood flow (MBF) at rest (mL/g/min) measure: Myocardial blood flow (MBF) at stress (mL/g/min) measure: Heart-rate response (HRR, no unit) measure: Salivary cortisol (mol/L) measure: Noradrenaline (mL/min) measure: Adrenaline (mL/min) measure: Dopamine (mL/min) measure: Spleen metabolic activity (SUV) measure: Bone marrow metabolic activity (SUV) measure: Aorta metabolic activity (SUV) measure: Left ventricular ejection fraction (LVEF, %) measure: C-reactive protein (CRP, mg/L) measure: Interleukin-2 (IL-2, pg/mL) measure: Interleukin-4 (IL-4, pg/mL) measure: Interleukin-6 (IL-6, pg/mL) measure: Interleukin-8 (IL-8, pg/mL) measure: Interleukin-10 (IL-10, pg/mL) measure: Tumor necrosis factor (TNF, pg/mL) measure: Matrix metalloproteinase-9 (MMP9, pg/mL) measure: Monocyte Chemoattractant Protein-1 (MCP1, pg/mL) measure: Vascular Cell Adhesion Molecule (VCAM) measure: Gender score questionnaire measure: Rate-Pressure-Product (RPP, in beats per minute x mmHg) measure: vmPFC-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV) measure: Nail cortisol value (pg/mg) measure: General Anxiety Disorder (GAD-7) Questionnaire measure: Patient Health Questionnaire (PHQ-8) measure: Shortened Maastricht Exhaustion Questionnaire measure: Type D Personality (DS14) questionnaire measure: Wagnild & Young Score resilience questionnaire measure: Perceived Stress Scale (PSS-4) questionnaire measure: Jenkins Sleep Scale (JSS-4) measure: Trier Inventory for Chronic Stress (TICS) measure: Perceived stress measure: Left ventricular stroke volume (LVSV, mL) measure: Left ventricular end-systolic volume (LVESV, mL) measure: Left ventricular end-diastolic volume (LVEDV, mL) measure: Estradiol levels (pmol/L) measure: Progesterone levels (nmol/L) measure: Sex Hormone Binding Globulin (SHBG) levels (nmol/L) measure: Total testosterone levels (nmol/L) measure: Free testosterone levels (pmol/L) sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich city: Zürich zip: 8091 country: Switzerland lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06345560 id: 077766 briefTitle: Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-03 date: 2024-04-03 name: Chulalongkorn University class: OTHER briefSummary: The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption conditions: Contraception studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre-bariatric surgery pharmacokinetics study of Drospirenone compare with post-bariatric surgery primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: Drospirenone measure: Plasma concentration versus Time of Drospirenone measure: Number of Participants With Treatment-Related Adverse Events sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chulalongkorn University city: Bangkok zip: 10330 country: Thailand name: Punyawee Utaipatanacheep role: CONTACT lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06345547 id: EDGE 003539 briefTitle: Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE) acronym: MMUSCLE overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-05-02 date: 2027-05-31 date: 2024-04-03 date: 2024-04-03 name: University Hospital, Antwerp class: OTHER briefSummary: The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\[s\] it aims to answer are:

* what is the prevalence and development of sarcopenia in cirrhosis?
* what is the role of malnutrition? Participants will

  * undergo a muscle ultrasound of the lower and upper limb muscles
  * handgrip strength will be measured
  * malnutrition screening and assessment
  * complete a questionnaire to assess quality of life conditions: Sarcopenia conditions: Cirrhosis conditions: Malnutrition studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: ultrasound measure: Prevalence of sarcopenia: muscle mass measure: Prevalence of sarcopenia: muscle strength measure: Development of sarcopenia: changes in muscle mass measure: Development of sarcopenia: changes in muscle strength measure: Development of sarcopenia: changes in muscle quality measure: Decompensation events: MELD score • MELD evolution measure: Decompensation events: mortality • MELD evolution measure: Decompensation events: transplantation • MELD evolution measure: Malnutrition measure: Quality of life in cirrhosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Antwerp city: Edegem state: Antwerpen zip: 2650 country: Belgium name: Karolien Dams, MD role: CONTACT phone: +3238213635 phoneExt: 5175 email: karolien.dams@uza.be name: Jolien Derdeyn, MD role: CONTACT phone: +328213807 phoneExt: 3807 email: jolien.derdeyn@uza.be name: Jolien Derdeyn, MD role: SUB_INVESTIGATOR name: Thomas Vanwolleghem, MD, Phd role: SUB_INVESTIGATOR name: Philippe Jorens, MD, PhD role: SUB_INVESTIGATOR name: Stany Perkisas, MD, PhD role: SUB_INVESTIGATOR name: Karolien Dams, MD role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 hasResults: False

 nctId: NCT06345534 id: ONZ-2023-0255 briefTitle: FAST-FORWARD vs HAI5 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2033-12-31 date: 2033-12-31 date: 2024-04-03 date: 2024-04-03 name: University Hospital, Ghent class: OTHER briefSummary: Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions. conditions: Cancer, Breast studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients participating in the study will be randomized 1:1 between the FAST-FORWARD schedule and the HAI5 schedule. The first group is treated according to the FAST-FORWARD schedule, consisting of 5 radiation sessions on 5 consecutive working days (e.g. Monday to Friday). 2 rest days are allowed in the schedule, so that the treatment lasts a maximum of 7 days. The second group is treated according to the HAI5 schedule, developed by the radiotherapy department of Ghent University Hospital. In this schedule, at least 1 day of rest is scheduled between each treatment session, so the treatment is administered over 10-14 days. primaryPurpose: TREATMENT masking: NONE maskingDescription: Both healthcare provider and patient know the treatment count: 740 type: ESTIMATED name: Questionnaire measure: Early side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitary Hospital city: Ghent zip: 9000 country: Belgium name: Liv Veldeman, MD, PhD role: CONTACT phone: 09 332 30 15 email: liv.veldeman@uzgent.be name: Emma Van Damme, MD role: CONTACT phone: 09 332 19 53 email: emma.vandamme@uzgent.be lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06345521 id: 2022-1-4032-3 briefTitle: The Follow-up System of Pediatric Heart Failure and the Establishment of End-stage Heart Failure Registry overallStatus: RECRUITING date: 2022-01-01 date: 2024-06-22 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: China National Center for Cardiovascular Diseases class: OTHER_GOV name: Peking University First Hospital name: Beijing Children's Hospital briefSummary: Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure conditions: Heart Failure conditions: Congenital conditions: End-stage Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: the recurrence rate of heart failure measure: NT-proBNP level measure: Incidence rate of drug adverse reactions measure: Readmission rate for heart failure sex: ALL maximumAge: 14 Years stdAges: CHILD facility: Fuwai hospital status: RECRUITING city: Beijing country: China name: Shoujun Li, MD role: CONTACT phone: +86 13501071589 email: drlishoujunfw@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06345508 id: 2024-12161 briefTitle: Early Detection of Liver Cancer by QUS acronym: QUS in HCC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-06 date: 2029-12 date: 2024-04-03 date: 2024-04-12 name: Centre hospitalier de l'Université de Montréal (CHUM) class: OTHER name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal name: Canadian Institutes of Health Research (CIHR) briefSummary: Worldwide, liver cancers are the third most common cause of cancer mortality. Even when liver cancer is suspected by blood tests, imaging is required to determine the location, size, and extent of disease. Medical societies therefore recommend surveillance with ultrasound every 6 months in at-risk patients. However, a key challenge to improving the survival is that ultrasound may miss half of early-stage liver cancers, thus diagnosis must rely on additional tests such as computed tomography (CT), magnetic resonance imaging (MRI), or biopsy. Hence, there is a clear need to improve the ability to detect liver cancers, especially with ultrasound. The investigator's team proposes novel ultrasound approaches to detect cancer nodules invisible on conventional ultrasound based on differences in mechanical and structural properties between liver and tumor. Improving detection is critical because liver cancer can be cured only if detected at an early stage, as shown by improvements in survival rates in patients enrolled in surveillance programs. The investigator's multi-disciplinary, national, and international team includes experts in clinical fields (hepatology, oncology, radiology, pathology), basic sciences (engineering, medical physics, machine learning, biostatistics), and patient partnership. The investirgator will apply the methodology of patient partner recruitment and collaborate with the Centre of Excellence on Partnership with Patients and the Public to select potential new collaborators. This will permit this project to be informed at every stage by patient and family perspectives, ensuring that the results of this project will be more robust, impactful, and aligned with the priorities, needs and experiences of those who live with liver cancer. The investigator submits a research proposal focused on advanced imaging techniques because imaging constitutes a foundation for surveillance, diagnosis, staging, treatment selection and assessment of treatment response in patients with liver cancer. conditions: Hepatocellular Carcinoma conditions: Liver Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 328 type: ESTIMATED name: Quantitative Ultrasound name: B-mode Ultrasound name: Magnetic Resonance Imaging name: Liver Biopsy measure: Compare the sensitivity of QUS + B-mode US vs B-mode US alone for lesion detection, using MRI as the reference standard for detection measure: Compare the specificity of QUS + B-mode US vs B-mode US alone for diagnosis of HCC, using MRI or biopsy as the composite reference standard for classification measure: Determine the lesion-to-liver contrast of investigational QUS techniques for detection of HCC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de l'Université de Montréal (CHUM) city: Montréal state: Quebec zip: H2X 0A9 country: Canada name: An Tang, MD, MSc role: CONTACT phone: 514-890-8000 phoneExt: 36400 email: an.tang@umontreal.ca name: Casey Bourdeau Caporuscio, MSc role: CONTACT phone: 514-890-8000 phoneExt: 14756 email: casey.bourdeau-caporuscio.chum@ssss.gouv.qc.ca name: An Tang, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06345495 id: 2023-0899 id: NCI-2024-02814 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2027-01-01 date: 2029-01-01 date: 2024-04-03 date: 2024-04-03 name: M.D. Anderson Cancer Center class: OTHER name: Incyte Corporation briefSummary: To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed. conditions: Splenomegaly conditions: Myelofibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ruxolitinib name: Allogeneic Stem Cell Transplantation name: Levetiracetam name: Eltrombopag name: Busulfan name: Romiplostim name: Fludarabine phosphate name: Cyclophosphamide name: Mesna name: Tacrolimus measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06345482 id: MHB039A-A-101 briefTitle: A Study of MHB039A for Advanced Solid Tumor overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2029-06-01 date: 2024-04-03 date: 2024-04-03 name: Minghui Pharmaceutical (Hangzhou) Ltd class: INDUSTRY briefSummary: Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 196 type: ESTIMATED name: MHB039A measure: Incidence of participants with adverse events (AE) measure: Number of participants with dose-limiting toxicity (DLT) measure: Maximum Plasma Concentration (Cmax) of MHB039A measure: The area under the plasma concentration-time curve (AUC) of MHB039A measure: To detectable anti-drug antibodies with treated subjects measure: Objective response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai zip: 200030 country: China name: Shun Lu, MD role: CONTACT phone: 13601813062 email: shun_lu@hotmail.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06345469 id: O-PBM2 briefTitle: Cost Analysis of Therapies for Severe Anemia overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-05-01 date: 2024-04-03 date: 2024-04-03 name: Helios Klinik Gotha/Ohrdruf class: OTHER name: Marisa Eichner briefSummary: The goal of this observational study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). PBM means that the body of the participant is stimulated to produce new blood by itself rather than receiving it from a blood donor, and to reduce blood losses.

The main question the study aims to answer is: Do participants treated with transfusions incur the same treatment costs than participants treated with PBM? And how much costs are this in relation to the lives saved by the therapy of severe anemia? conditions: Severe Anemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 640 type: ESTIMATED name: Patient blood management (PBM) name: Allogeneic transfusion measure: cost-effectiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06345456 id: izmirkatip briefTitle: The Value of End-tidal Capnography in Gastrointestinal Bleeding overallStatus: COMPLETED date: 2020-06-01 date: 2021-01-01 date: 2021-01-01 date: 2024-04-03 date: 2024-04-08 name: Izmir Katip Celebi University class: OTHER briefSummary: Gastrointestinal bleeding is a condition that frequently presents to emergency departments and can be fatal if diagnosis and treatment are delayed. The working mechanism of end tidal capnography is simply to detect the respiratory carbon dioxide level.

In our study, the investigators aimed to determine the severity of gastrointestinal bleeding by using the Glaskow Blachford Score and AIMS65 score in cases presenting with gastrointestinal bleeding, to determine the end tidal carbon dioxide value by capnography in these cases and to determine its effectiveness in evaluating mortality and morbidity in gastrointestinal bleeding. conditions: Gastro Intestinal Bleeding studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 103 type: ACTUAL name: End-tidal capnography measure: The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Katip Çelebi Üniversitesi city: İzmir country: Turkey lat: 38.41273 lon: 27.13838 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2020-06-01 uploadDate: 2024-04-01T04:48 filename: SAP_000.pdf size: 281538 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2020-06-01 uploadDate: 2024-04-01T04:35 filename: ICF_001.pdf size: 418132 hasResults: False

 nctId: NCT06345443 id: 23-005288 briefTitle: NRM on Vascular Perfusion in Heathy Adults acronym: NRM overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-12-31 date: 2026-05-31 date: 2024-04-03 date: 2024-04-03 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to better understand the effects of nicotinamide riboside supplement in overall cardiovascular health in healthy adults. conditions: Vascular Stiffness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The pharmacy will be responsible for randomization and dispensing appropriate randomized intervention. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Nicotinamide Riboside Malate name: Placebo measure: Reduction of Endothelial stiffness sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Snigdha Panda, BS role: CONTACT phone: 507-538-5827 email: GIMRESEARCHSTUDIES@mayo.edu name: Jennifer Soderlind role: CONTACT phone: 507-284-4799 email: GIMRESEARCHSTUDIES@mayo.edu lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06345430 id: 2023-14 briefTitle: Wearable Technological Device Applied to Patients With Chronic Pain overallStatus: COMPLETED date: 2023-11-18 date: 2024-01-15 date: 2024-01-30 date: 2024-04-03 date: 2024-04-03 name: Hacettepe University class: OTHER briefSummary: Within the scope of this research, a single session of Wearable Technological Device (Exopulse Molli-Suit) will be applied to patients with chronic back and neck pain. The results will be evaluated acutely, after 24 hours, after 1 week and after 1 month. conditions: Neck Pain conditions: Low Back Pain conditions: Chronic Pain conditions: Musculoskeletal Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Exopulse Molli-Suit (Wearable Technological Device) measure: Pain Severity measure: Sleep Qaulity measure: Disability Level measure: Repetitive Reach Test measure: Body Composition Analysis measure: Lifting object overhead test measure: Sustained Overhead Work Test measure: back performance test sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin Özel Aslıyüce city: Yeni̇mahalle state: Ankara zip: 06100 country: Turkey hasResults: False

 nctId: NCT06345417 id: O-PBM1 briefTitle: Outcomes of Patient Blood Management in Severely Anemic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-03 date: 2024-04-03 name: Helios Klinik Gotha/Ohrdruf class: OTHER name: Helios Klinikum Erfurt briefSummary: The goal of this observational cohort study is to compare patients with very low red blood counts who receive different therapy. Its main question\[s\] it aims to answer are:

* Which group of patients dies more frequent: Patients who receive patient blood management only, patients who receive patient blood management and transfusions or patients who receive only transfusions?
* Among these groups: which group of patients has more complications during hospital stay? Patients will either receive patient blood management, which is the management of anemia, bleeding and coagulation problems, will receive transfusions, that is, blood from other people, or a mix of both. conditions: Severe Anemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20000 type: ESTIMATED name: Patient Blood Management (PBM) name: Allogeneic transfusion measure: Number of dead participants at the end of hospitalization (inhospital mortality) measure: Number of participants with surgical wound complications measure: Number of participants with a documented acute myocardial infarction measure: Number of participants suffering renal injury measure: Number of days spent in hospital (Length of stay in hospital) measure: Number of participants readmitted to the studied hospital measure: Number of participants with a documented transfusion reaction measure: Number of participants receiving an allogeneic transfusion measure: Number of participants treated in an intensive care ward measure: Number of participants with documented respiratory complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Helios Klinikum city: Erfurt state: Thuringia country: Germany name: Achim Spenner role: CONTACT phone: +49-361-7810 email: Achim.Spenner@helios-gesundheit.de lat: 50.9787 lon: 11.03283 facility: Helios Klinikum city: Gotha state: Thuringia zip: 99867 country: Germany name: Petra See role: CONTACT phone: +49-3621-220 0 email: petra.seeber@helios-gesundheit.de name: Kai D role: CONTACT phone: +49-3621-220 phoneExt: 5058 email: Kai-uwe.doebel@helios-gesundheit.de lat: 50.94823 lon: 10.70193 hasResults: False

 nctId: NCT06345404 id: CPI-818-003 briefTitle: Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-03 date: 2024-04-10 name: Corvus Pharmaceuticals, Inc. class: INDUSTRY briefSummary: Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Sequential Dose Escalation primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Blinded Placebo-Controlled whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Soquelitinib name: Placebo measure: Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms measure: To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI) measure: To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Corvus Clinical Trials Information status: RECRUITING city: Burlingame state: California zip: 94010 country: United States name: Liza Tom role: CONTACT phone: 650-900-4514 email: ltom@corvuspharma.com name: Gabriel Luciano role: CONTACT phone: 6509004548 email: gluciano@corvuspharma.com lat: 37.5841 lon: -122.36608 hasResults: False

 nctId: NCT06345391 id: PANACEA_CO-CREATION_2024 briefTitle: Co-creation of Pain Science Education for Children Living Beyond Cancer acronym: PANACEA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-03 date: 2024-04-03 name: Vrije Universiteit Brussel class: OTHER name: Universitair Ziekenhuis Brussel name: University Ghent name: University Hospital, Ghent name: University of Calgary briefSummary: A pain science education (PSE) intervention for children (8-12y) living beyond cancer (CBC) will be developed through a co-creational approach with CBC, their parents and pediatric oncology clinicians. The study will be guided by the Intervention Mapping Protocol. conditions: Children Living Beyond Cancer (i.e. Child Cancer Survivor) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 24 type: ESTIMATED name: Co-creation name: Concept Mapping measure: Satisfaction with the co-created intervention measure: Understandability of the co-created intervention measure: Empowerment with regard to the co-created intervention measure: Ownership of the intervention development sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Vrije Universiteit Brussel city: Jette state: Brussels zip: 1090 country: Belgium name: Emma Rheel, PhD role: CONTACT phone: +32496908353 email: emma.rheel@vub.be name: Kelly Ickmans, PhD role: CONTACT phone: +32498483347 email: kelly.ickmans@vub.be name: Sophie Pleysier, MSc role: SUB_INVESTIGATOR lat: 50.87309 lon: 4.33419 hasResults: False

 nctId: NCT06345378 id: IRFMN_PapaGio briefTitle: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (ASST Papa Giovanni XXIII) overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-25 date: 2024-12 date: 2027-12 date: 2024-04-03 date: 2024-04-04 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients. conditions: Quality of Care conditions: Evaluation conditions: Emergency Departments conditions: Appropriateness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1200 type: ESTIMATED measure: Algorithm creation measure: Algorithm validation measure: Algorithm application measure: Appropriateness estimation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST Papa Giovanni XXIII city: Bergamo state: BG zip: 24127 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False

 nctId: NCT06345365 id: 09 briefTitle: MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) overallStatus: RECRUITING date: 2024-01-18 date: 2026-12-31 date: 2028-12-31 date: 2024-04-03 date: 2024-04-10 name: Zhongnan Hospital class: OTHER name: Ruijin Hospital name: Shanxi Province Cancer Hospital name: The First Affiliated Hospital of Zhengzhou University name: Jingzhou Central Hospital name: Yichang Central People's Hospital name: Taihe Hospital name: The Central Hospital of Xiaogan name: Xianning Central Hospital name: The First People's Hospital of Jingzhou briefSummary: Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine). conditions: Acute Myeloid Leukaemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: mitoxantrone liposome, Ara-Cytarabine and azacitidine name: Daunorubicin,Ara-Cytarabine, azacitidine measure: Complete remission rate measure: Incidence of adverse events measure: Compound CR rate measure: Objective remission rate measure: No remission rate measure: Event-free survival measure: Disease-free survival measure: Overall survival measure: Mortality rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450052 country: China lat: 34.75778 lon: 113.64861 facility: The Central Hospital of Huanggang status: NOT_YET_RECRUITING city: Huanggang state: Hubei zip: 438000 country: China lat: 23.67704 lon: 116.99961 facility: The First People's Hospital of Jingzhou status: NOT_YET_RECRUITING city: Jingzhou state: Hubei zip: 434000 country: China lat: 30.35028 lon: 112.19028 facility: Jingzhou Central Hospital status: NOT_YET_RECRUITING city: Jingzhou state: Hubei zip: 434020 country: China lat: 30.35028 lon: 112.19028 facility: Shiyan Taihe Hospital status: NOT_YET_RECRUITING city: Shiyan state: Hubei zip: 442000 country: China lat: 32.6475 lon: 110.77806 facility: Zhongnan Hospital of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430071 country: China name: Zhou Fuling, director role: CONTACT phone: +86-02767813137 email: zhoufuling@163.com lat: 30.58333 lon: 114.26667 facility: Xianning Central Hospital status: NOT_YET_RECRUITING city: Xianning state: Hubei zip: 437100 country: China lat: 29.84347 lon: 114.32201 facility: The Central Hospital of Xiaogan status: NOT_YET_RECRUITING city: Xiaogan state: Hubei zip: 432100 country: China lat: 30.92689 lon: 113.92221 facility: Yichang Central Hospital status: NOT_YET_RECRUITING city: Yichang state: Hubei zip: 443003 country: China lat: 30.71444 lon: 111.28472 facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine status: NOT_YET_RECRUITING city: Wuxi state: Jiangsu zip: 214028 country: China lat: 31.56887 lon: 120.28857 facility: Shanxi Cancer Hospital status: NOT_YET_RECRUITING city: Taiyuan state: Shanxi zip: 030009 country: China lat: 37.86944 lon: 112.56028 hasResults: False

 nctId: NCT06345352 id: IRFMN_7520_PoliMI briefTitle: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico) overallStatus: ACTIVE_NOT_RECRUITING date: 2020-09-15 date: 2024-12 date: 2027-12 date: 2024-04-03 date: 2024-04-04 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients. conditions: Quality of Care conditions: Evaluation conditions: Emergency Department conditions: Appropriateness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1200 type: ESTIMATED measure: Algorithm creation measure: Algorithm validation measure: Algorithm application measure: Appropriateness estimation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano city: Milano state: MI zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06345339 id: M21-341 briefTitle: A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants overallStatus: RECRUITING date: 2024-04-26 date: 2028-06-03 date: 2028-06-03 date: 2024-04-03 date: 2024-04-29 name: AbbVie class: INDUSTRY briefSummary: This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy. conditions: Hypothyroidism studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 2800 type: ESTIMATED name: Armour Thyroid name: Levothyroxine measure: Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response measure: Number of Participants with Adverse Events (AEs) measure: Percentage of Participants who Achieve TSH Response measure: Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid measure: Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diagnamics Inc. /ID# 262680 status: RECRUITING city: Encinitas state: California zip: 92024 country: United States lat: 33.03699 lon: -117.29198 facility: NorCal Medical Research /ID# 256512 status: RECRUITING city: Greenbrae state: California zip: 94904 country: United States lat: 37.94854 lon: -122.5247 facility: West Orange Endocrinology /ID# 256139 status: RECRUITING city: Ocoee state: Florida zip: 34761-4547 country: United States lat: 28.56917 lon: -81.54396 facility: Endocrine Research Solutions /ID# 256784 status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States name: Site Coordinator role: CONTACT phone: 678-878-4750 lat: 34.02316 lon: -84.36159 facility: West Broadway Clinic /ID# 256756 status: RECRUITING city: Council Bluffs state: Iowa zip: 51501-3822 country: United States lat: 41.26194 lon: -95.86083 facility: L-MARC Research Center /ID# 255733 status: RECRUITING city: Louisville state: Kentucky zip: 40213-1014 country: United States lat: 38.25424 lon: -85.75941 facility: Physician's East Endocrinology /ID# 256491 status: RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751 status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States lat: 40.79895 lon: -81.37845 facility: Lynn Institute of Norman /ID# 256785 status: RECRUITING city: Norman state: Oklahoma zip: 73072 country: United States lat: 35.22257 lon: -97.43948 facility: Lynn Institute of Oklahoma City /ID# 263141 status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States lat: 35.46756 lon: -97.51643 facility: Texas Diabetes and Endocrinology - Central Austin /ID# 255728 status: RECRUITING city: Austin state: Texas zip: 78731 country: United States name: Site Coordinator role: CONTACT phone: 512-334-3505 lat: 30.26715 lon: -97.74306 facility: Texas Diabetes and Endocrinology - South Austin /ID# 255723 status: RECRUITING city: Austin state: Texas zip: 78749 country: United States lat: 30.26715 lon: -97.74306 facility: North TX Endocrine Center /ID# 255737 status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: Diabetes and Thyroid Center of Ft. Worth /ID# 256781 status: RECRUITING city: Fort Worth state: Texas zip: 76132 country: United States lat: 32.72541 lon: -97.32085 facility: Juno Research /ID# 259238 status: RECRUITING city: Houston state: Texas zip: 77040-5059 country: United States lat: 29.76328 lon: -95.36327 facility: Consano Clinical Research, LLC /ID# 256138 status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States name: Site Coordinator role: CONTACT phone: 210.291.3797 lat: 29.58495 lon: -98.55252 facility: Texas Valley Clinical Research /ID# 261476 status: RECRUITING city: Weslaco state: Texas zip: 78596 country: United States lat: 26.15952 lon: -97.99084 hasResults: False

 nctId: NCT06345326 id: E1-22-3155 briefTitle: Greater Occipital Nerve Block Versus Pulse Radiofrequency in Migraine acronym: GON-B/PRF overallStatus: RECRUITING date: 2023-01-15 date: 2024-03-30 date: 2024-04-30 date: 2024-04-03 date: 2024-04-03 name: Adiyaman University Research Hospital class: OTHER name: Ankara City Hospital Bilkent briefSummary: The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF) conditions: Migraine studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective observational primaryPurpose: TREATMENT masking: NONE count: 68 type: ESTIMATED name: Greater occipital nerve block measure: NRS measure: Complications measure: the frequency of headhache sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital Bilkent status: RECRUITING city: Ankara zip: 06680 country: Turkey name: Sukriye Dadali, MD role: CONTACT phone: +905333316636 email: sukriyedadali@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06345313 id: CIRCADIAN RHYTHM briefTitle: EFFECT OF CIRCADIAN RHYTHM ON INFLAMMATORY PARAMETERS IN UNILATERAL INGUINAL HERNIORRAHIES overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-15 date: 2024-10-15 date: 2024-04-03 date: 2024-04-03 name: Ankara City Hospital Bilkent class: OTHER briefSummary: To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). The main question it aims to answer is; Is the inflammation response higher in participants who undergo surgery later in the day? Serum inflammatory parameters will be measured in both groups at the preoperative 1st hour and the postoperative 24th hour. conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Day Group name: Night Group measure: Change of IL6 (interleukin) (ng/ml) measure: Quality of recovery from anesthesia according to difference in circadian rhythm measure: Change of NLR ( Neutrophil/ Lymphocyte Ratio ) measure: Change of PLR ( Platelet / Lymphocyte Ratio ) measure: Change of SII (Systemic immune-inflammation index ) measure: Change of CRP (C Reactive Protein) (mg/dl) measure: Change of Fibrinogen (mg) measure: Change of Sedimentation (mm/hour) measure: Change of Procalcitonin (µg/l) measure: Change of Ferritin (ml/ng) measure: Postoperative pain scores according to the difference in circadian rhythm sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent City Hospital city: Ankara state: Cankaya zip: 06800 country: Turkey name: Burcu Dikmen Demiryorgan role: CONTACT phone: +905067611029 email: burcudikmen325@gmail.com name: Fatma Kavak Akelma role: CONTACT phone: +905327079113 email: fatmakavak@yahoo.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06345300 id: NCC4309 briefTitle: NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study overallStatus: RECRUITING date: 2024-03-10 date: 2024-12-12 date: 2025-12-24 date: 2024-04-03 date: 2024-04-03 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER name: Jiangsu HengRui Medicine Co., Ltd. briefSummary: The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer conditions: Borderline Resectable Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab name: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate measure: R0 resection rate measure: Event free survival (EFS) measure: Overall survival (OS) measure: Objective Response Rate(ORR) measure: Disease Control Rate（DCR） measure: Safety and tolerability by incidence, severity and outcome of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijin country: China name: Yongkun Sun role: CONTACT phone: 13141276041 email: hsunyk@126.com hasResults: False

 nctId: NCT06345287 id: 24/018-4298 briefTitle: Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-03 date: 2024-04-03 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients. conditions: Head and Neck Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 133 type: ESTIMATED name: radical radiotherapy (60Gy) name: radical radiotherapy (66Gy) name: radical radiotherapy (70Gy) name: anti-PD-1 or PD-L1 antibody measure: Progression-free survival measure: Overall survival measure: Deep partial response measure: Local-Regional failure survival measure: Toxicity Adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC status: RECRUITING city: Beijing country: China name: Jingbo Wang, Doctor role: CONTACT phone: 15811166516 email: wangjingbo303@yahoo.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06345274 id: SP0077172 id: K23DA050729 type: NIH link: https://reporter.nih.gov/quickSearch/K23DA050729 briefTitle: MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs) acronym: MBC2OTP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-02 date: 2024-04-03 date: 2024-04-22 name: Northwestern University class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 40 type: ESTIMATED name: Measurement Based Care Training and Monthly Consultation measure: Patient treatment attendance (effectiveness outcome) measure: Patient treatment attendance (effectiveness outcome) measure: Treatment provider measurement based care exposure (implementation outcome) measure: Patient opioid abstinence (effectiveness outcome) measure: Treatment provider measurement based care fidelity (implementation outcome) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Family Guidance Centers, Inc. city: Aurora state: Illinois zip: 60505 country: United States lat: 41.76058 lon: -88.32007 facility: Northwestern University Feinberg School of Medicine city: Chicago state: Illinois zip: 60611 country: United States name: Kelli Scott, PhD role: CONTACT lat: 41.85003 lon: -87.65005 facility: Family Guidance Centers, Inc. city: Chicago state: Illinois zip: 60654 country: United States name: Kelli Scott, PhD role: CONTACT lat: 41.85003 lon: -87.65005 facility: Family Guidance Centers, Inc. city: Des Plaines state: Illinois zip: 60016 country: United States lat: 42.03336 lon: -87.8834 facility: Family Guidance Centers, Inc. city: Joliet state: Illinois zip: 60435 country: United States lat: 41.52519 lon: -88.0834 hasResults: False

 nctId: NCT06345261 id: 2024-872 briefTitle: Diphenhydramine in Catheter Related Bladder Discomfort overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-03 date: 2024-04-03 name: Cairo University class: OTHER briefSummary: Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action . conditions: Catheter Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: DiphenhydrAMINE 50 Mg/mL Injectable Solution name: Saline measure: incidence of catheter related bladder discomfort postoperative measure: visual analog scale (VAS) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo university city: Cairo zip: 11562 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06345248 id: 2024-854 briefTitle: Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-03 date: 2024-04-03 name: Cairo University class: OTHER briefSummary: The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control conditions: Transversus Abdominis Plane studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: US-TAP name: LAPTAP measure: morphine needed measure: first analgesic request time measure: patients' satisfaction measure: opioid-associated side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo university city: Cairo zip: 11562 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06345235 id: ID DEC-2023/07/X/NZ5/00141 briefTitle: New Biomarkers and Plasma Prothrombotic Potential in Cardiac Transthyretin Amyloidosis overallStatus: RECRUITING date: 2023-07-11 date: 2024-07-11 date: 2024-07-11 date: 2024-04-03 date: 2024-04-19 name: John Paul II Hospital, Krakow class: OTHER briefSummary: The development of cardiac amyloidosis is caused by the deposition of misfolded, insoluble proteins in the extracellular matrix of tissues. An important element of the clinical picture of the disease is the increased risk of thromboembolic complications, independent of the occurrence of atrial fibrillation, and the presence of intracardiac thrombi. The pathomechanism may be related to an increase in filling pressure or amyloid infiltration leading to myocardial damage and endothelial dysfunction, which may activate the prothrombotic inflammatory cascade, resulting in increased thrombogenic potential. Currently, there is limited published data on the potential role of new heart failure biomarkers in the assessment of ATTR cardiomyopathy, particularly in the assessment of asymptomatic carriers of pathogenic TTR variants. Moreover, there are few literature reports on the direct assessment of the coagulation system in this group of patients, and the pathomechanism of the increased thromboembolic risk is unexplored.

Purpose of the study: To assess the diagnostic value of biomarkers related to heart failure (growth differentiation factor-15 (GDF15), soluble suppression of tumorigenicity-2 (ST2), galectin-3), amyloidosis ( TTR, tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9, matrix metalloproteinase-9), neurofilament light chain (NfL)) and the generation potential thrombin as a marker of the prothrombotic state in the course of ATTR.

Methods: This prospective, single-center study will include consecutive patients diagnosed with ATTR cardiomyopathy (GROUP 1, n=30), asymptomatic carriers of pathogenic TTR variants (GROUP 2, n=30), and a matched control group of healthy volunteers (GROUP 3 , n=20). Material for research was collected and secured from all study participants. After giving informed consent, all patients will be tested using the ELISA method from peripheral blood (enzyme-linked immunosorbent assay) GDF15, ST2, TTR, TIMP-1, MMP-9, galectin-3, NfL. The values of these biomarkers will be compared in subgroups and correlated with clinical data, laboratory test results, echocardiography including analysis of left ventricular global strain (GLS), and scintigraphy. Additionally, the prothrombotic potential of plasma will be tested in both groups of patients using the calibrated automatic thrombogram (CAT) method, in accordance with the protocol previously used in the laboratory Expected results: The project will provide information on the value of biomarkers in the assessment of ATTR cardiomyopathy, especially in the assessment of asymptomatic carriers of pathogenic TTR variants, which may translate into the creation of a diagnostic algorithm for early identification of the development of the disease. Moreover, it will allow us to determine whether patients with cardiac ATTR are characterized by a prothrombotic state, which has not yet been described in the literature and may have potential clinical implications. conditions: Transthyretin Amyloidosis studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: blood test measure: Biomarkers measure: Thrombin as a marker measure: Biomarkers measure: Biomarkers measure: Biomarkers measure: Biomarkers measure: Biomarkers measure: Biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: John Paul II Hospital status: RECRUITING city: Kraków zip: 31-202 country: Poland name: Katarzyna Holcman, MD role: CONTACT phone: 608214249 phoneExt: 48 email: katarzyna.holcman@gmail.com name: Katarzyna Holcman, MD role: PRINCIPAL_INVESTIGATOR lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06345222 id: GETAT 23/05 briefTitle: Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain overallStatus: COMPLETED date: 2023-05-01 date: 2023-07-31 date: 2023-07-31 date: 2024-04-03 date: 2024-04-04 name: Bursa Yüksek İhtisas Education and Research Hospital class: OTHER_GOV briefSummary: 92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month. conditions: The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Case control study primaryPurpose: TREATMENT masking: NONE count: 65 type: ACTUAL name: Prolotherapy measure: change in knee pain with prolotherapy application measure: change in quality of life sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bursa Yuksek Ihtisas Training and Research Hospital city: Bursa state: Türkiye zip: 16310 country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False

 nctId: NCT06345209 id: BM-D19 briefTitle: Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: BrosMed Medical Co., Ltd class: INDUSTRY name: Chinese Academy of Medical Sciences, Fuwai Hospital briefSummary: To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 236 type: ESTIMATED name: Sirolimus-coated Coronary Balloon Dilatation Catheter name: Drug-coated Coronary Balloon Dilatation Catheter measure: Late luminal loss (LLL) measure: Device success rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06345196 id: BozokUni briefTitle: Motivational Interviewing Applied to Individuals With Diabetes overallStatus: RECRUITING date: 2024-04-15 date: 2024-05-15 date: 2024-10-15 date: 2024-04-03 date: 2024-04-03 name: Bozok University class: OTHER briefSummary: This study will be conducted using a randomized controlled trial design to evaluate the effect of online individual motivational interviewing on well-being, stress and difficulties in individuals with diabetes. The study will be conducted between March 2024 and March 2025 with individuals with Type 2 Diabetes who are followed up in Yozgat Bozok University Health Practice and Research Center Internal Medicine Polyclinic. The motivational interview group will receive a motivational interview once a week, lasting a maximum of 40 minutes, consisting of a total of four sessions. Chi-square (X2), t-test, repeated measures analysis of variance, Pearson correlation coefficient, partial eta-square and linear regression analysis will be used to evaluate the data. conditions: Motivational Interviewing conditions: Stress conditions: Well-Being, Psychological conditions: Diabetes Mellitus conditions: Type2diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: motivational interview measure: Change in coping with stress measure: State of Well-Being Change measure: Changing Strength and Difficulties in Diabetes sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Akdağmadeni School of Health status: RECRUITING city: Yozgat country: Turkey name: Betül Bal role: CONTACT phone: 0 (354) 314 14 15 email: betul.bal@yobu.edu.tr lat: 39.82 lon: 34.80444 facility: Bozok University status: RECRUITING city: Yozgat country: Turkey name: Betül Bal role: CONTACT phone: 0 (354) 314 14 15 email: betul.bal@yobu.edu.tr lat: 39.82 lon: 34.80444 hasResults: False

 nctId: NCT06345183 id: CA209-1275 briefTitle: Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients overallStatus: RECRUITING date: 2024-02-19 date: 2024-04-01 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy conditions: Advanced Renal Cell Carcinoma (aRCC) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 350 type: ESTIMATED name: Nivolumab + Ipilimumab combination therapy name: Pembrolizumab + Lenvatinib combination therapy measure: Participant year of birth measure: Participant sex at birth measure: Participant primary payer measure: Participant race measure: Participant ethnicity measure: Participant U.S. state of residence measure: Participant initial Renal Cell Carcinoma (RCC) diagnoses measure: American Joint Committee on Cancer (AJCC) TNM stage measure: Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis measure: Participant renal cell carcinoma (RCC) histology results measure: Participant tumor grade measure: Participant biomarker or genetic testing method measure: Participant molecular and/or genetic mutations reported measure: Participant site of metastatic disease measure: Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) measure: Participant Karnofsky score (KPS) measure: Participant comorbidities and/or chronic conditions measure: Participant blood test results measure: Participant Memorial Sloan Kettering Cancer Center (MSKCC) score measure: Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score measure: Participant smoking status measure: Participant COVID-19 status measure: Participant surgical history measure: Participant radiation treatment history measure: Participant treatment regimen received measure: Participant treatment initiation and discontinuation dates measure: Participant rationale for discontinuation of treatment measure: Participant radiation therapy prescribed measure: Participant total number of radiotherapy cycles measure: Participant initial dose and frequency/schedule of index therapy measure: Participant index treatment dose modifications measure: Participant rationale for dose modifications of index therapy measure: Participant date of dose modifications of index therapy measure: Participant last dose and frequency/schedule of index therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardinal Health status: RECRUITING city: Dublin state: Ohio zip: 43017 country: United States lat: 40.09923 lon: -83.11408 hasResults: False

 nctId: NCT06345170 id: buhucgun05 briefTitle: Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIR/Floortime™ Therapy Program in Children With Developmental Risk overallStatus: RECRUITING date: 2023-01-03 date: 2024-04-10 date: 2024-04-10 date: 2024-04-03 date: 2024-04-03 name: Biruni University class: OTHER briefSummary: The term "developmental risk" is used as a general term for developmental delays observed in infancy and early childhood. Developmental delay refers to the delay in children reaching developmental milestones compared to their peers. The DIR/Floortime™ therapy program is an approach that uses play as a therapeutic tool, emphasising the importance of interaction involving affect and excitement in a child's development. DIR/Floortime™ therapy program aims to support the child's development with a family-centred perspective by evaluating the child and the family together. DIR/Floortime™ therapy program is known to contribute to the functional and emotional development of children and the development of parenting skills of caregivers. The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) is a parent-reported developmental screening test that aims to identify 'delays' in the social communication area skills of infants and children. The SCASI training program is a training program for children and parents developed on the basis of this screening test, which includes targeted activities to support the development process according to the child's developmental level. To the best of our knowledge, there is no study investigating the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. The aim of the study is to examine the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. A total of 34 children with developmental risk between the ages of 1 and 3 will included in the study. Participants will randomly divided into two groups: control group (n=17) in which the DIR/Floortime™ therapy program will be applied and intervention group (n=17) in which the SCASI training program will be applied in addition to the DIR/Floortime™ therapy program. The DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks, and the SCASI training program will be applied by the parents at home, 2 days a week, for an average of 30 minutes a day, for 12 weeks. Demographic and clinic informations, SCASI test, Age and Stages Questionnarie (ASQ), Age and Stages Questionnaires: Social-Emotional (ASQ-SE) and Brief Infant and Toddler Social Emotional Assessment (BITSEA) will be used as outcome measures in the study. conditions: Children With Developmental Risk studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: The DIR/Floortime™ Therapy Program name: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program measure: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) measure: Age and Stages Questionnarie (ASQ) measure: Age and Stages Questionnaires: Social-Emotional (ASQ-SE) measure: Brief Infant and Toddler Social Emotional Assessment (BITSEA) sex: ALL minimumAge: 1 Year maximumAge: 3 Years stdAges: CHILD facility: Biruni University status: RECRUITING city: Istanbul zip: 34015 country: Turkey name: Hikmet Ucgun, PT, PhD role: CONTACT phone: +905321616271 email: hikmetucgun92@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06345157 id: COMB157GIT02 briefTitle: ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2026-04-30 date: 2024-04-03 date: 2024-04-03 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting. conditions: Multiple Sclerosis, Relapsing-Remitting studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Ofatumumab measure: Annualized relapse rate (ARR) measure: Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test) measure: Fatigue Severity Scale [FSS] measure: Quality of life parameters assessed by EQ-5D-3L measure: Treatment satisfaction assessed by TSQM-9 measure: Expanded Disability Status Scale (EDSS) measure: Variation of NfL in plasma measure: Adverse Events (AEs) measure: Discontinuation rates due to AE and/or other reasons sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06345144 id: 202307211RINC briefTitle: Learning Experience of Undergraduate Nursing Students in Pediatric Oncology Ward overallStatus: RECRUITING date: 2023-08-22 date: 2024-03-29 date: 2024-03-29 date: 2024-04-03 date: 2024-04-03 name: National Taiwan University Hospital class: OTHER briefSummary: Clinical practices are crucial experiences for nursing students as they prepare themselves for future nursing work. Despite some research having been studied among Taiwanese nursing students in the past, there has been limited research into the experiences within pediatric oncology wards, where diseases are complex and frequently involve life-and-death issues. Therefore, the purpose of this study is to explore the experiences of undergraduate nursing students in pediatric oncology wards. conditions: Pediatric Cancer studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 15 type: ESTIMATED measure: Explore the experiences of undergraduate nursing students practicing in pediatric oncology wards. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wei-En Li status: RECRUITING city: New Taipei City country: Taiwan name: Wei-En Li role: CONTACT lat: 25.01111 lon: 121.44583 hasResults: False

 nctId: NCT06345131 id: KY20230829-06 briefTitle: Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery Puncture Catheterization overallStatus: RECRUITING date: 2023-07-01 date: 2024-08 date: 2024-09 date: 2024-04-03 date: 2024-04-03 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: By observing the anatomical relationship and influencing factors of the radial artery through ultrasound, the optimal puncture location is selected, and puncture catheterization is guided to reduce the number of punctures, reduce complications, and improve safety and accuracy. conditions: Surgical Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Non invasive blood pressure monitoring measure: Measure the transverse diameter of the radial artery at each anatomical point sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: Liu Han, MD role: CONTACT phone: 18951670163 email: han_cold.student@sina.com lat: 32.06167 lon: 118.77778 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-07-22 uploadDate: 2024-02-14T20:25 filename: Prot_ICF_000.pdf size: 166411 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-07-22 uploadDate: 2024-03-05T21:35 filename: SAP_001.pdf size: 300501 hasResults: False

 nctId: NCT06345118 id: FallpreventT2DMelderly briefTitle: Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus acronym: FallT2DMOLD overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: National Geriatric Hospital class: OTHER_GOV briefSummary: .This randomized controlled clinical trial aims to evaluate the effects of fall prevention in older adults with type 2 diabetes mellitus. The main questions it aims to answer are:

* Describe the current situation of falls, the risk of falls, and some related factors in elderly type 2 diabetic patients
* Evaluate the results of fall prevention and related factors in the study population.

Participants will be randomly divided into control and intervention groups. The intervention group will be trained to follow the Otago Training Program as the primary fall prevention method. On the other hand, the control group will receive the standard care following the treatment guidelines for type 2 diabetes mellitus and other comorbidities.

At the end of the intervention, the study will mainly compare the rate of fall incidents after 6 months of intervention as well as other physical performance tests. conditions: Diabetes Mellitus, Type 2 conditions: Fall conditions: Elderly Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Otago exercise program measure: Physical performance 1 - Timed Up and Go (TUG) measure: Physical performance 2 -Berg Balance Scale (BBS) measure: Activities of Daily Living (ADLs) measure: Health-related Quality of Life measure: Functional Reach Test (FRT) measure: Instrumental Activities of Daily Living (IADLs) sex: ALL minimumAge: 60 Years maximumAge: 60 Years stdAges: ADULT facility: National Geriatric Hospital status: RECRUITING city: Hanoi zip: 100000 country: Vietnam name: Huyen TT Vu, PhD role: CONTACT phone: +84913531579 email: vuthanhhuyen11@yahoo.com lat: 21.0245 lon: 105.84117 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-11 uploadDate: 2024-03-13T14:07 filename: ICF_000.pdf size: 320767 hasResults: False

 nctId: NCT06345105 id: AIeffectiveV4 briefTitle: Real Time Effective Withdrawal Time and Adenoma Detection Rate overallStatus: RECRUITING date: 2024-04-01 date: 2024-11-30 date: 2025-01-31 date: 2024-04-03 date: 2024-04-16 name: The University of Hong Kong class: OTHER briefSummary: The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' baseline adenoma detection rate (ADR). The association between the AI derived EWT with ADR during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI conditions: Colon Polyp conditions: Colon Adenoma conditions: Artificial Intelligence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 198 type: ESTIMATED name: Endoscreener QC measure: Adenoma detection rates of the endoscopists measure: Adenoma detection rate measure: Polyp detection rate sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Mary Hospital, the University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Thomas Ka Luen Lui role: CONTACT phone: +852 97360997 email: tkllui@hku.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06345092 id: Omfs.3-3-3 briefTitle: Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain overallStatus: COMPLETED date: 2022-09-01 date: 2023-03-01 date: 2023-09-01 date: 2024-04-03 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement conditions: TMJ Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 40 type: ACTUAL name: Vitamin C name: Injectable platelet rich fibrin measure: Pain management measure: disc position using MRI measure: maximum mouth opening measure: lateral excursion sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry cairo university city: Cairo zip: +2 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06345079 id: AG0219NET briefTitle: Cessation of Somatostatin Analogues After PRRT in Mid-Gut Neuroendocrine Tumours acronym: STOPNET overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-09 date: 2028-06 date: 2024-04-03 date: 2024-04-03 name: Australasian Gastro-Intestinal Trials Group class: NETWORK name: Canadian Cancer Trials Group briefSummary: Neuroendocrine tumours (NETs) are slow growing cancers, which commonly present as metastatic incurable disease. Some neuroendocrine tumours, termed functional NETs, overproduce hormones which result in a variety of symptoms. However, approximately 75% of NETs are considered non-functional meaning that they do not result in hormone overproduction. The main treatment for both functional and non-functional NETs is somatostatin analogues (SSA, a type of inhibitory hormone). These drugs slow tumour growth and reduce hormone production. Over time, the majority of patients will experience tumour growth despite treatment with SSA therapy. When this occurs, the addition of Peptide Receptor Radionuclide Therapy (PRRT, a type of targeted radiotherapy) in combination with ongoing SSA therapy is given. However, it is not known if continuing SSA therapy after commencement of PRRT is beneficial or not.

The aim of this study is to estimate the outcomes of patients with grade 1 and 2 well differentiated mid and hind-gut neuroendocrine tumours who have progressed on SSA therapy and receive subsequent PRRT with or without concurrent SSA. conditions: Neuroendocrine Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Cessation of somatostatin analogues name: Continuation of somatostatin analogues measure: 20-month progression free survival rate after PRRT measure: Assess the barriers which would impede the feasibility of a subsequent phase 3 trial measure: Measure Quality of life using the European Organisation For Research And Treatment Of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) scales measure: Measure Quality of life using the EORTC QLQ-GINET21 scales measure: Cost-effectiveness of SSA therapy cessation measure: Psycho-oncological impacts of SSA therapy cessation: Decision Regret measure: Psycho-oncological impacts of SSA therapy cessation: Fear of Cancer Progression measure: Psycho-oncological impacts of SSA therapy cessation: Decisional Conflict measure: Time to commencement of subsequent therapy measure: Overall survival measure: Rates of SSA being recommenced over time measure: Exploratory analyses sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Brisbane Women's Hospital city: Brisbane state: Queensland zip: 4006 country: Australia name: Matthew Burge role: CONTACT phone: (07) 3636 8111 email: Matthew.Burge@health.qld.gov.au name: Matthew Burge role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False

 nctId: NCT06345066 id: 18834 id: J3R-MC-YDAC type: OTHER domain: Eli Lilly And Company briefTitle: A Study of LY3841136 in Overweight and Obese Participants overallStatus: RECRUITING date: 2024-04-03 date: 2025-03 date: 2025-03 date: 2024-04-03 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks. conditions: Obesity conditions: Overweight studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Tirzepatide name: LY3841136 name: Placebo measure: Number of Participants With One or More Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration measure: Percent Change from Baseline in Body Weight measure: Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136 measure: Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fortrea CRU, Inc. status: RECRUITING city: Daytona Beach state: Florida zip: 32117 country: United States name: Hugh Coleman role: PRINCIPAL_INVESTIGATOR lat: 29.21081 lon: -81.02283 facility: Fortrea CRU, Inc. status: RECRUITING city: Dallas state: Texas zip: 75247 country: United States name: Archie Bowie role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Fortrea CRU, Inc. status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States name: Nicholas Siebers role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06345053 id: 203428 briefTitle: Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder overallStatus: RECRUITING date: 2021-05-01 date: 2024-10-01 date: 2025-10-01 date: 2024-04-03 date: 2024-04-03 name: Norwegian University of Science and Technology class: OTHER name: Møre og Romsdal Hospital Trust name: Oslo University Hospital briefSummary: There are high rates of co-occurring posttraumatic stress disorder (PTSD) among patients receiving treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, but adults in SUD treatment are often not assessed for PTSD nor offered PTSD-based interventions. One of the reasons for reluctance in offering trauma focused treatment is increased risk of drop out. PTSD and related emotion dysregulation are related to elevated psychological burden, higher dropout rates and increased risk of relapse. this is a feasibility study, where the plan is to integrate a combination of Dialectical Behaviour Therapy for Substance Use Disorder (DBT-SUD skills) a therapy targeting difficulties in emotion regulation and Narrative Exposure Therapy (NET) a trauma focused therapy, for patients with co-occurring PTSD symptoms into standard SUD treatment . The plan is to assess its potential benefits by assessing whether adding this combination to standard SUD treatment is relevant, feasible, acceptable, and safe. Treatment outcomes are 1) Prevalence of PTSD, suicidal behaviour, and self-harm, as well as the severity of difficulties in emotion regulation and emotional avoidance among patients (N approx. = 100) in inpatient treatment for SUD. 2) Change post-treatment and at 3 and 12 months follow up, from baseline in PTSD symptom severity, depressive symptoms, emotion regulation, emotion avoidance, and experience of shame. 3) Rates of dropout and relapse compared to previous rates.

This project can increase knowledge about psychological mechanisms in co-occurring PTSD and SUD and improve the quality of treatment for this vulnerable patient population. conditions: Post Traumatic Stress Disorder conditions: Substance Use Disorders conditions: Emotion Regulation conditions: Suicide conditions: Self-harm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a repeated measures follow-up feasibility study without control group. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Narrative Exposure Therapy measure: The intervention is relevant - prevalence of PTSD /SUP PTSD. measure: The intervention is relevant - prevalence of traumatic experiences. measure: The intervention is relevant - The severitiy of difficulties in emotion regulation. measure: The intervention is feasible, accepted and safe - The dropout rate from treatment. measure: The intervention is safe - Suicide behaviour while in treatment. measure: The intervention is safe - Self-harm behaviour while in treatment. measure: The intervention is accepted - participation in DBT-SUD skills sessions. measure: The intervention is feasible and accepted - Objective experience of treatment. measure: The potential benefits of the intervention - Change in PTSD symptoms from base line to 3-and 12 month follow up. measure: The potential benefits of the intervention - Change in Difficulties in emotion regulation from baseline to 3- to 12- month follow up. measure: The potential benefits of the intervention - Relapse to alcohol abuse at 3- and 12-months follow up. measure: The potential benefits of the intervention - Relapse to substance abuse at 3- and 12-month follow up. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Molde Treatment Center, Møre and Romsdal Hospital Trust status: RECRUITING city: Molde state: Møre And Romsdal zip: 6410 country: Norway name: Edvard Breivik role: CONTACT phone: +4793032613 email: edvard.breivik@helse-mr.no name: Johanna Vigfusdottir role: CONTACT phone: +4746746154 email: johannavigfusd@gmail.com lat: 62.73752 lon: 7.15912 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-15 uploadDate: 2024-03-18T06:41 filename: Prot_SAP_000.pdf size: 766255 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-25 uploadDate: 2024-03-25T10:01 filename: ICF_001.pdf size: 621574 hasResults: False

 nctId: NCT06345040 id: H-22067692 briefTitle: The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders overallStatus: RECRUITING date: 2024-02-26 date: 2025-12 date: 2026-06 date: 2024-04-03 date: 2024-04-03 name: Mental Health Services in the Capital Region, Denmark class: OTHER briefSummary: The Dialogue Study is a randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. The aim of the trial is to investigate the effect of a new virtual reality based psychotherapy for eating disorders. A total of 96 participants with a diagnosis of anorexia nervosa or bulimia nervosa will be allocated to either Virtual-reality therapy plus treatment as usual or treatment as usual. All participants will be assessed at baseline and 12- and 24 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles. conditions: Eating Disorders conditions: Anorexia Nervosa conditions: Bulimia Nervosa studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Virtual-reality intervention name: TAU - specialized treatment measure: Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire measure: Level of depressive symptoms post treatment measure: Motivation for change post treatment measure: Level of identification with the eating disorder and level of embodiment post treatment measure: Experience of the eating disorder voice post treatment measure: Beliefs about the power and benevolence of the eating disorder voice post treatment - engagement scale measure: Total score of eating disorder voice characteristics post treatment measure: Level of quality of life post treatment measure: Perceived difference in power between eating disorder voice and eating disorder patient post treatment measure: Level of acceptance of and action in relation to the eating disorder voice post treatment measure: Level of self-compassion post treatment measure: Level of body dissatisfaction post treatment measure: Level of perceived self-efficacy post treatment measure: Ability to regulate emotion post treatment measure: Level of executive functioning post treatment measure: Participant satisfaction measure: Presence of childhood traumas measure: Level of simulator sickness measure: Level of dysfunctional cognitive beliefs post treatment measure: Positive and negative aspects of eating disorders as perceived by the participant post treatment measure: Personal recovery post treatment measure: Presence of comorbidity measure: Cost effectiveness of the intervention measure: Level of cognitive (in)flexibility post treatment measure: Monitoring and reporting of adverse and unwanted events measure: Level of immersion in virtual reality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen Research Center for Mental Health - CORE status: RECRUITING city: Hellerup state: Copenhagen zip: 2900 country: Denmark name: Nina K Hansen, MSc (Psych.) role: CONTACT phone: 21699487 phoneExt: +45 email: nina.kappel.hansen@regionh.dk name: Louise B Glenthøj, DMSc, PhD role: CONTACT phone: 21452889 phoneExt: +45 email: louise.birkedal.glenthoej@regionh.dk name: Louise B Glenthøj, DMSc, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.73204 lon: 12.57093 hasResults: False

 nctId: NCT06345027 id: H-53163 CASEY briefTitle: CHIMERIC ANTIGEN RECEPTOR TREATMENT TARGETING CD70 (SEVENTY) acronym: CASEY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-05-01 date: 2042-04-01 date: 2024-04-03 date: 2024-04-03 name: Baylor College of Medicine class: OTHER briefSummary: This study is for patients that have lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease and the patients condition has come back or has not gone away after treatment, including the best treatment we know for these diseases.

Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV). This virus causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma. This suggests that the EBV plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction.

T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in blood and affect the tumor. We have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses (meaning the cancer could no longer be detected).

We think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study we will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. We know that T cells need substances called cytokines (substances such as proteins released by specific cells of the immune system) to survive and that the cells may not get enough cytokines after the cells are infused into the body. We have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.

The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on the cancer. conditions: Leukemia, Myeloid, Acute conditions: Leukemia, B-cell conditions: Leukemia, T-Cell conditions: Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Treatment Arm A measure: Dose limiting toxicity (DLT) rate measure: Overall Response Rate sex: ALL maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Texas Children's Hospital city: Houston state: Texas zip: 77030 country: United States name: Bilal Omer, MD role: CONTACT phone: 832-826-0860 email: baomer@texaschildrens.org lat: 29.76328 lon: -95.36327 facility: The Methodist Hospital city: Houston state: Texas zip: 77030 country: United States name: Bilal Omer, MD role: CONTACT phone: 832-826-0860 email: baomer@texaschildrens.org lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06345014 id: 23CP40803 briefTitle: The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome overallStatus: RECRUITING date: 2023-12-20 date: 2025-12-30 date: 2026-03-30 date: 2024-04-03 date: 2024-04-04 name: AJU Pharm Co., Ltd. class: INDUSTRY name: OM Pharma SA briefSummary: This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome conditions: Chronic Prostatitis conditions: Chronic Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 \[Uro-Vaxom® Capsule\]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks.

In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26. The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Background treatment - Xatral® XL Tab. 10 mg (alfuzosin hydrochloride): With the treatment of the investigational product, it will be administered for the first 13 weeks (Administration of the placebo will be continued to maintain the treatment compliance and blinding for the rest 13 weeks).

After week 13, Background treatment will be blinded for subject only until end of treatment period(Week 26). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 332 type: ESTIMATED name: OM-89 [Uro-Vaxom® Capsule] name: OM-89 Placebo [Uro-Vaxom® Capsule Placebo] measure: NIH-CPSI total score measure: NIH-CPSI domain score measure: Subject and Investigator's Global Assessment sex: MALE minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: AJU Pharm Co., Ltd. status: RECRUITING city: Seoul country: Korea, Republic of name: JUNGMIN LEE role: CONTACT phone: +82-02-2630-0700 email: ajuf13001@ajupharm.co.kr lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06345001 id: 22261 briefTitle: A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-08-12 date: 2024-08-30 date: 2024-04-03 date: 2024-04-29 name: Bayer class: INDUSTRY briefSummary: Researchers are studying a new potential treatment for liver cancer.

To do this, researchers have developed a protein, called a monoclonal antibody, which can find and attach itself to another protein present on the surface of liver cancer cells. This can help the new treatment to specifically target cancer cells in the liver.

In this study, researchers want to understand the distribution and processing of this monoclonal antibody in people with liver cancer.

Researchers will use the following two forms of monoclonal antibody as study interventions during this study:

* BAY3630942: This is the monoclonal antibody attached to a tracer. A tracer emits radiation that can help researchers track the monoclonal antibody in the body using imaging tests like PET/CT (positron emission tomography / computed tomography). All participants will receive a fixed dose of BAY3630942 during the study.
* BAY3547922: This is the monoclonal antibody without the tracer. Participants may receive different amounts of BAY3547922 during the study.

In this study, participants will not derive therapeutic benefit from receiving BAY3630942 or BAY3547922. However, this study may help researchers develop a new treatment for people with liver cancer and find a dose to be tested in future studies.

The main purpose of this first-in-human study is to check how BAY3630942 distributes among different organs in the body and how much of the radiation it emits is absorbed by the organs based on the total dose of BAY3630942 and BAY3547922 given. For this, the researchers will:

* measure the amount of BAY3630942 radiation found in different organs over time.
* measure the amount of BAY3630942 radiation absorbed by different organs.
* use the above information to estimate the amount of radiation that would be absorbed by the same organs from the new potential treatment.

Researchers will also monitor the number and severity of medical problems participants have after receiving BAY3630942 and BAY3547922. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study interventions.

The study participants will first receive BAY3547922 as an infusion into a vein followed by BAY3630942 as an injection into the same vein. Both interventions will be administered only once, on the same day.

Each participant will be in the study for around 44 days with up to 7 visits to the study clinic which includes:

* a visit up to 14 days before the start of the study to confirm if the participant can take part in the study.
* up to 5 visits during the imaging intervention period. During this period, participants:

  * will receive the study interventions and have blood tests on the first visit,
  * will have imaging and blood tests on the next 3 visits. The tests scheduled for the second visit may be performed during the first visit.
  * may have blood tests on the last visit.
* a follow-up visit to check their health after 30 days of receiving the study interventions.

During the study, the doctors and their study team will:

* check participants' health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)
* track and study BAY3630942 using PET/CT imaging tests

As the study interventions are not yet treatments for liver cancer, access to BAY3630942 and BAY3547922 after the end of the study will not be required. conditions: Hepatocellular Carcinoma (HCC) studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 17 type: ESTIMATED name: BAY3630942 name: BAY3547922 measure: Radioactivity concentration (SUVmean, %ID/g) of BAY3630942 in normal organs (including but not limited to kidney, spleen, liver, and bone marrow) as a function of time using 3 post-administration PET/CT scans measure: Zirconium-89 absorbed doses (mGy/MBq) in normal organs measure: Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated measure: Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922 measure: Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood) measure: AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood) measure: Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time) measure: AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HonorHealth city: Scottsdale state: Arizona zip: 85258 country: United States lat: 33.50921 lon: -111.89903 facility: University of Southern California Keck School of Medicine city: Los Angeles state: California zip: 90089 country: United States lat: 34.05223 lon: -118.24368 facility: Biogenix Molecular, LLC city: Miami state: Florida zip: 33165 country: United States lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06344988 id: 2023/41-10 briefTitle: Physical and Functional Effects of Online Exercise Program on Musicians Playing Stringed Instruments overallStatus: RECRUITING date: 2024-01-22 date: 2024-06 date: 2025-01 date: 2024-04-03 date: 2024-04-03 name: Bandırma Onyedi Eylül University class: OTHER briefSummary: Musculoskeletal problems related to instrument playing or performance are frequently seen in musicians. Different interventions such as strength training, endurance training and yoga have been used in the management of these problems. The first specific exercise program for professional orchestra musicians was developed by Chan et al. However, it has been stated that it is difficult to encourage musicians' participation in exercise due to their constantly changing work schedules, and at this point, the use of digital media such as DVDs, USBs, and educational exercise videos may have a potential role.

On the other hand, it has been stated that smart wearable devices with mobile applications (such as smart watches, smart band) as digital health interventions are an interesting, interactive and efficient psychological strategy to promote physical activity and can be used as an intervention to promote a healthy lifestyle. Based on the literature, in our study, the exercise program developed by Chan et al., will be done online via "Google Meet" and symptoms can be evaluated with objective evaluation methods. Unlike other studies using digital media, exercises will be performed synchronously and feedback will be given to the musicians simultaneously, as in face-to-face exercises. In addition, all participants will be given a smart band, they will be encouraged to use it until the end of the study, and the change in their physical activity levels will be evaluated. conditions: Musculoskeletal Diseases or Conditions conditions: Musculoskeletal Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: The exercise program name: Online education presentation name: Smart band measure: Musculoskeletal problems measure: Muscle oxygenation measure: Pressure pain threshold measure: Reaction time measure: Grip strength measure: Upper extremity function measure: Physical activity level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bursa Regional State Symphony Orchestra status: RECRUITING city: Bursa zip: 16000 country: Turkey name: Umut Çanakçı, Musician role: CONTACT phone: +90 (224) 225 59 70 name: Sule Kecelioglu, MSc role: PRINCIPAL_INVESTIGATOR name: Selnur Narin Aral, Assoc. Prof. role: SUB_INVESTIGATOR lat: 40.19559 lon: 29.06013 facility: Bursa Uludağ University Faculty of Education Fine Arts Education Department, Department of Music Education status: RECRUITING city: Bursa zip: 16285 country: Turkey name: Gülnihal Gül, Assoc. Prof. role: CONTACT phone: +90 (224) 294 09 42 name: Sule Kecelioglu, MSc role: PRINCIPAL_INVESTIGATOR name: Selnur Narin Aral, Assoc. Prof. role: SUB_INVESTIGATOR lat: 40.19559 lon: 29.06013 facility: Bursa Uludağ University State Conservatory status: RECRUITING city: Bursa zip: 16285 country: Turkey name: Görkem Çalgan, Prof. Dr. role: CONTACT phone: +90 (224) 294 27 00 name: Sule Kecelioglu, MSc role: PRINCIPAL_INVESTIGATOR name: Selnur Narin Aral, Assoc. Prof. role: SUB_INVESTIGATOR lat: 40.19559 lon: 29.06013 facility: Ege University State Conservatory of Turkish Music status: RECRUITING city: İzmir zip: 35100 country: Turkey name: Nurdan Gürtunca, Assoc. Prof. role: CONTACT phone: +90 (232) 311 29 44 name: Sule Kecelioglu, MSc role: PRINCIPAL_INVESTIGATOR name: Selnur Narin Aral, Assoc. Prof. role: SUB_INVESTIGATOR lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06344975 id: Starna Therapeutics briefTitle: A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine STR-V003 in Healthy Adults acronym: STR-V003 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-05 date: 2024-04-03 date: 2024-04-03 name: Starna Therapeutics class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: STR-V003/Placebo measure: Immediate unsolicited AEs for 30 minutes post-vaccination measure: Solicited injection site (local) and systemic reactions for 7 days postvaccination. measure: Unsolicited AEs for 28 days postvaccination measure: Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06344962 id: QYFYKYLL930611921 briefTitle: Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection overallStatus: RECRUITING date: 2023-02-28 date: 2024-12 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: The Affiliated Hospital of Qingdao University class: OTHER briefSummary: Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem. conditions: Suture, Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Absorbable Suture name: Non-absorbable Suture measure: Incidence rate of anastomotic complications measure: Time of bronchial anastomosis measure: Number of stitches measure: 5-year survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Affiliated Hospital of Qingdao University status: RECRUITING city: Qingdao state: Shandong zip: 266000 country: China name: Zhe Wu, PhD role: CONTACT phone: +86 17863934867 email: 17863934867@163.com lat: 36.06488 lon: 120.38042 hasResults: False

 nctId: NCT06344949 id: B2024-074 briefTitle: Ciprofol Versus Propofol for Tracheal Intubation in ICU overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2026-12-31 date: 2024-04-03 date: 2024-04-03 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The physiological reserves of critically ill patients are relatively low, and the risk of complications related to tracheal intubation in the ICU is higher than in the operating room. ICU tracheal intubation complications account for approximately 40% -45% of patients, including severe hypotension (10% -43%), severe hypoxemia (9% -25%), and cardiac arrest (2% -3%).Ciprofol is a novel 2,6-disubstituted phenol derivative that targeting γ-aminobutyric acid type A (GABAA)-receptor. There are four indications of ciprofol that have been approved by NMPA in recent two years: sedation and anesthesia in non-tracheal intubation procedure/operation, induction and maintenance of general anesthesia, sedation during intensive care, sedation and maintenance in gynecological outpatient surgery. The aim of this study is to compare the effects of propofol and propofol on the circulatory system during tracheal intubation in ICU patients, in order to provide a safer induction sedation regimen for emergency tracheal intubation in critically ill patients. conditions: Emergency Tracheal Intubation in Critically Ill Patients studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Ciprofol name: Propofol measure: cardiovascular collapse within 30minutes from the start of the intubation procedure measure: Success rate of sedation measure: Successful intubation on the first attempt measure: Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes) measure: The incidence of cardiac arrest within 30 minutes after tracheal intubation measure: The incidence of bradycardia within 30 minutes after tracheal intubation measure: The incidence of hypoxemia within 30 minutes after tracheal intubation measure: new requirement or increase of vasopressors measure: new requirement or increase of antiarrhythmic drugs sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06344936 id: HRS-1780-103 briefTitle: Drug-drug Interaction Study of HRS-1780 Tablets in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-03 date: 2024-04-03 name: Shandong Suncadia Medicine Co., Ltd. class: INDUSTRY briefSummary: The study was designed to evaluate the pharmacokinetic effects of itraconazole and rifampicin on HRS-1780 after oral administration of HRS-1780 tablets in healthy subjects conditions: Chronic Kidney Disease(CKD) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules measure: Assess the Cmax of HRS-1780 in plasma. measure: Assess the Tmax of HRS-1780 in plasma. measure: Assess the t1/2 of HRS-1780 in plasma. measure: Assess the AUC0-t of HRS-1780 in plasma. measure: Assess the AUC0-inf of HRS-1780 in plasma. measure: Assess the incidence and severity of adverse events in healthy subjects after administration of HRS-1780 tablets. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Beijing Hospital city: Beijing state: Beijing zip: 100730 country: China name: Xin Wang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06344923 id: KYLL briefTitle: Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-31 date: 2025-09-01 date: 2024-04-03 date: 2024-04-03 name: Qilu Hospital of Shandong University class: OTHER briefSummary: In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated. conditions: Ileostomy - Stoma conditions: Rectal Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing name: Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing measure: postoperative complications related to ileostomy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06344910 id: 20230416-C1_v2 briefTitle: PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC acronym: PROMPT-HF-AUMC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER name: AstraZeneca name: Yale University briefSummary: This is a prospective cohort study, where we aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands. conditions: Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 900 type: ESTIMATED name: Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies measure: Use of guideline-directed medical therapy (GDMT) measure: All-cause mortality measure: Hospitalisation for Heart Failure measure: other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) measure: renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06344897 id: mac1 briefTitle: The Effect of Kinesio Taping in Pediatric Surgery overallStatus: COMPLETED date: 2024-02-25 date: 2024-03-21 date: 2024-04-01 date: 2024-04-03 date: 2024-04-03 name: KTO Karatay University class: OTHER name: Nigde Omer Halisdemir University name: University of Health Sciences Konya Health Application and Research Center briefSummary: This study was planned to determine the effect of kinesio taping (KT) applied to the abdominal area after surgery on pain and gas output in children aged 6-12 years who had open appendicitis surgery. conditions: Appendicitis conditions: Surgery conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The effect of kinesio taping on pain in children aged 6-12 years who had open appendicitis surgery. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The research is in a parallel group, single-blind randomized controlled experimental design.

Simple randomization will be applied to children who have had open appendicitis surgery and meet the inclusion criteria, without any stratification in the study.

In order to determine which group the 68 children who meet the sample selection criteria in the study group will be included in, numbers from 1 to 68 will be randomly distributed to 2 groups through a computer program (https://www.randomizer.org/) without number repetition. 34 patients will be assigned to the experimental group and 34 patients to the control group. Since the person who will actively apply the taping in the study is the researcher, only the children will be blinded, therefore a single blind design will be applied. whoMasked: PARTICIPANT count: 68 type: ACTUAL name: Kinesio taping measure: Kinesio tape applying affects pain in children aged 6-12 years who have appendicitis surgery. measure: Kinesio tape applying affects fear in children aged 6-12 years who have appendicitis surgery. measure: Kinesio taping affects gas output time in children aged 6-12 years who have appendicitis surgery sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: University of Health Sciences Konya Health Application and Research Center city: Konya state: Karatay zip: 42020 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06344884 id: 23-2619 briefTitle: Early Patient Removal of Urinary Catheters After Urogynecologic Surgery acronym: CARES2 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-07 date: 2025-07 date: 2024-04-03 date: 2024-04-03 name: University of North Carolina, Chapel Hill class: OTHER briefSummary: Management of postoperative urinary retention often requires the use of indwelling catheters. In a previous study, the investigators determined that patient removal of catheters at home is non-inferior to standard office removal on postoperative day three or four (POD3-4). The purpose of this study is to determine whether patient removal of catheters at home on postoperative day one (POD1) is noninferior to removal on POD 3-4. conditions: Urinary Retention Postoperative conditions: Postoperative Urinary Tract Infection conditions: Catheter Site Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 128 type: ESTIMATED name: Early catheter removal measure: Number of patients with ongoing urinary retention (noninferiority) measure: Number of patient contacts for voiding dysfunction by Type measure: Total patient contacts for voiding dysfunction Combined measure: Number of patients treated for postoperative UTI. measure: Number of patients with ongoing urinary retention measure: Patient Satisfaction Survey Score-Pain measure: Patient Satisfaction Survey Score-Ease of Use measure: Patient Satisfaction Survey Score-Satisfaction measure: Patient Satisfaction Survey Score-Likelihood to Use Again sex: FEMALE minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Health Rex city: Raleigh state: North Carolina zip: 27607 country: United States name: Lauren Tholemeier, MD role: CONTACT phone: 984-974-0496 email: lauren_tholemeier@med.unc.edu lat: 35.7721 lon: -78.63861 hasResults: False

 nctId: NCT06344871 id: 002 briefTitle: Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF overallStatus: RECRUITING date: 2024-03-13 date: 2024-11-30 date: 2024-11-30 date: 2024-04-03 date: 2024-04-05 name: Positrigo AG class: INDUSTRY name: University of Zurich name: University of Leipzig briefSummary: The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.

The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype. conditions: Brain Diseases studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: NeuroLF name: Conventional PET scan measure: PET Image of the Brain measure: Ease of Placement (Usability) measure: Usage of accessories for patient placement (Usability) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Leipzig status: RECRUITING city: Leipzig country: Germany name: Henryk Barthel, Prof.Dr. role: CONTACT phone: +49 341 97 18082 email: Henryk.Barthel@medizin.uni-leipzig.de name: Henryk Barthel, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 51.33962 lon: 12.37129 facility: University Hospital Zurich status: NOT_YET_RECRUITING city: Zürich country: Switzerland name: Martin Hüllner, Prof. Dr. role: CONTACT phone: +41 44 255 25 80 email: martin.huellner@usz.ch name: Martin Hüllner, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06344858 id: 124/2021 briefTitle: Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI acronym: Keta-ANI overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-08-31 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: Pontificia Universidad Catolica de Chile class: OTHER briefSummary: Ketamine, an intravenous anesthetic, and analgesic agent has experienced a resurgence in its clinical application, particularly in subanesthetic doses. The aim of this observational study is to characterize the changes in the Nociception Analgesia Index (ANI) associated with the administration of an intravenous ketamine bolus using a Pharmacokinetic-Pharmacodynamic (PKPD) modeling approach. The pharmacokinetic parameters of the Domino model will be used to predict ketamine plasma concentrations after the bolus dose. An Emax model and a link model assuming a first order rate constant (ke0) will be used to fit the data. Modeling analysis will use the program NONMEM. It is expected to recruit a total of 20 patients between 40 and 80 years, ASA I, II or III, programmed for elective surgery with general anesthesia. ANI values will be recorded every 6 seconds for 5 minutes from the bolus dose. conditions: Analgesia conditions: Ketamine conditions: Pharmacokinetic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Ketamine measure: To measure ANI values after ketamine bolus dose administration. measure: To determine the time maximum predicted concentrations in each patient measure: To determine the time to maximum effect of a bolus dose of ketamine measure: To predict ketamine plasma concentrations values after ketamine bolus measure: To calculate the difference between the time of maximum ANI effect measure: Patient weight sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pontificia Universidad Catolica de Chile city: Santiago state: Metropolitana zip: 450881 country: Chile lat: -33.45694 lon: -70.64827 hasResults: False

 nctId: NCT06344845 id: PUMCH-NM-PBB3 briefTitle: Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases overallStatus: RECRUITING date: 2022-11-01 date: 2024-11 date: 2025-11 date: 2024-04-03 date: 2024-04-03 name: Peking Union Medical College Hospital class: OTHER briefSummary: In terms of the diagnostic technology of brain neurodegenerative diseases, the injection of positron tracers into the human body, so that it can combine with the corresponding protein, and show its distribution through PET imaging is a mature technology in the industry. At present, several research groups around the world are working on the development and clinical efficacy evaluation of their respective tau imaging agent compounds.This clinical research project intends to display the abnormal changes of tau protein in living brain through \[18F\]PM-PBB3 PET imaging, which is a second-generation tracer further optimized on the basis of \[11C\]PBB3, and has the advantages of closer binding to tau protein entanglement and less non-specific binding than similar imaging agents. Better image quality and a wider range of clinical applications. conditions: Neurodegenerative Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 80 type: ESTIMATED name: 18F-PBB3 PET/CT scan measure: Diagnostic Performance measure: Clinical Stage sex: ALL minimumAge: 49 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Chenhao Jia, M.D. role: CONTACT phone: 18548703382 email: jiachenhao24@163.com name: Ruixue Cui, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06344832 id: K5098 briefTitle: SSTR PET/CT for Preoperative N Stage Evaluation in GEP-NETs overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-03-01 date: 2030-03-01 date: 2024-04-03 date: 2024-04-03 name: Peking Union Medical College Hospital class: OTHER briefSummary: The research aims to prospectively include patients with GEP-NENs, undergo preoperative imaging assessment (including PET/CT and contrast-enhanced CT), and accurately delineate lymph node regions. Through postoperative pathological reports, the diagnostic performance of lymph node metastasis (LNM) in GEP-NENs is evaluated. Factors influencing the diagnostic accuracy of SSTR-PET/CT and contrast-enhanced CT are also investigated. conditions: Gastro-entero-pancreatic Neuroendocrine Tumor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: lymph node metastasis status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06344819 id: 24-062 briefTitle: An Acupuncture Study for People At High Risk for Sepsis overallStatus: RECRUITING date: 2024-03-20 date: 2028-03-20 date: 2028-03-20 date: 2024-04-03 date: 2024-04-03 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture. conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 78 type: ESTIMATED name: Acupuncture name: Sham Acupuncture measure: Number of participants recruited compared to the number of participants who complete study treatment. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Cancer Center status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Gary Deng, MD, PhD role: CONTACT phone: 646-608-8556 lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06344806 id: oyunlastirmabeslenme briefTitle: The Effect of Gamification on Breastfeeding Self-Efficacy and Infant Nutrition Attitudes of Pregnant Women acronym: gamification overallStatus: COMPLETED date: 2023-02-01 date: 2023-03-30 date: 2023-05-30 date: 2024-04-03 date: 2024-04-03 name: Lokman Hekim Üniversitesi class: OTHER_GOV briefSummary: Objective: This study was conducted to determine the effect of breastfeeding education given through gamification on breastfeeding self-efficacy and infant feeding attitudes of pregnant women.

Method: This study is a randomized controlled pretest-posttest parallel group experimental study, and 28 women included in the experimental group and 28 women in the control group. In the study, "Sociodemographic Information Form", "Breastfeeding Self-Efficacy Scale Short Form-Antenatal Form (BSES-SF), ", "Infant Nutrition Attitude Scale (IOWA)" Form was used. The data analyzed in SPSS program.

Breastfeeding education content integrated into the game program designed with the gamification technique. A training program was applied to the women in the experimental group in the last trimester. Women in the control group received the standard breastfeeding training in the hospital. Measurement tools was applied to all participants before and after the training.

Conclusion and Suggestions: In this planned study, it was aimed to teach women about breastfeeding in a digital environment in a fun way. In this study, it is found that breastfeeding education given through gamification have a positive effect on breastfeeding self-efficacy and infant feeding attitudes of pregnant women. conditions: Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Gamified Breastfeeding Education measure: breastfeeding self-efficacy measure: infant feeding attitudes sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Lokman Hekim University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06344793 id: YOUNGBC-30 briefTitle: Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer overallStatus: RECRUITING date: 2023-05-20 date: 2024-10-01 date: 2024-11-01 date: 2024-04-03 date: 2024-04-03 name: Fudan University class: OTHER briefSummary: A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED measure: PFS measure: OS sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Biyun Wang role: CONTACT phone: 18017312387 email: pro_wangbiyun@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06344780 id: YOUNGBC-28 briefTitle: Abemaciclib, Palbociclib or Dalpiciclib Combined With Endocrine Therapy as First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer overallStatus: RECRUITING date: 2023-05-20 date: 2024-10-01 date: 2024-11-01 date: 2024-04-03 date: 2024-04-03 name: Fudan University class: OTHER briefSummary: A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or metastatic Breast Cancer. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED measure: PFS measure: OS sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Biyun Wang role: CONTACT phone: 18017312387 email: pro_wangbiyun@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06344767 id: YOUNGBC-27 briefTitle: Positive ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-negative Primary Tumor overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-05-05 date: 2024-05-05 date: 2024-04-03 date: 2024-04-03 name: Fudan University class: OTHER briefSummary: To investigate the treatment pattern and efficacy of patients with negative primary ER lesion but positive ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT). conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 19 type: ACTUAL measure: Progression free survival (PFS) measure: Adverse events sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China,Shanghai city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06344754 id: gamifiedfamilyplanning briefTitle: Gamification in Family Planning Education: Impact on University Students overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-02-15 date: 2024-04-15 date: 2024-04-03 date: 2024-04-03 name: Lokman Hekim Üniversitesi class: OTHER_GOV briefSummary: More than 3 billion of the worlds population are young people under the age of 25. According to WHO data, one million girls under the age of 15 give birth each year, mostly in low- and middle-income countries, and 3 million adolescent girls between the ages of 15 and 19 are exposed to unsafe abortions. Failure to meet the family planning needs of young people in a timely, adequate and appropriate manner can have significant public health impacts. According to World Health Statistics, the global birth rate for girls between 15 and 19 years of age is 49 out of 1000, and early pregnancy and childbirth can lead to serious health and social problems. In addition, this age group does not have sufficient information about pregnancy and its complications, and their access to and utilization of health services is low. Inadequacies in the education of adolescents on sexual issues and sociocultural differences further increase the sexual and reproductive health risks of young people in the university period. Information and services that will enable individuals to understand their sexuality and help them protect themselves from sexual risks should be provided specifically for that age. Therefore, it is important for young people to know family planning methods. In this study, it was aimed to examine the effect of family planning education to be given with gamification method, which is different from the classical method in the literature, on the knowledge and attitudes of university students. conditions: Gamification conditions: Reproductive Health conditions: Family Planning conditions: Students studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: pre-test and post-test interventional study primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: the person doing the statistical analysis will be blinded count: 40 type: ESTIMATED name: Gamified education measure: Knowledge and attitude towards family planning sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Lokman Hekim University city: Ankara zip: 06300 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06344741 id: sdilek6 briefTitle: Consequences of Admission to the Delivery Room in the Early and Late Phases overallStatus: RECRUITING date: 2023-11-13 date: 2024-04-30 date: 2024-05-31 date: 2024-04-03 date: 2024-04-03 name: Kocaeli University class: OTHER briefSummary: This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G\*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses. conditions: Fear of Childbirth conditions: Neonatal conditions: Pain conditions: Maternal Distress (During Labor) conditions: Satisfaction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Accepted in latent phase name: Accepted in active phase measure: Neonatal pain and stress measure: Birth satisfaction measure: Maternal Anxiety measure: Fear of Birth sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Kocaeli University status: RECRUITING city: Kocaeli zip: 41380 country: Turkey name: Sena Dilek Aksoy, Ph.D. role: CONTACT phone: +902623034739 email: sena.dilek@kocaeli.edu.tr name: Cemile Gokce role: SUB_INVESTIGATOR lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06344728 id: INS1007-110 briefTitle: A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants acronym: INS1007 overallStatus: RECRUITING date: 2024-04-30 date: 2024-05-21 date: 2024-05-21 date: 2024-04-03 date: 2024-04-09 name: Insmed Incorporated class: INDUSTRY briefSummary: The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Brensocatib Oral Solution name: Brensocatib Oral Tablet measure: Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma measure: Number of Participants who Experienced at Least one Adverse Event (AE) measure: Concentration of Brensocatib in Plasma sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USA001 status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06344715 id: SL-T10-001_P1 briefTitle: Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC. overallStatus: RECRUITING date: 2022-10-17 date: 2024-10-31 date: 2024-10-31 date: 2024-04-03 date: 2024-04-03 name: SL VAXiGEN class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC). conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC) studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 78 type: ESTIMATED name: SL-T10 name: GX-I7 name: Pembrolizumab measure: Number of participants with treatment-emergent adverse events (TEAEs) measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 measure: PSA response rate measure: PSA progression free survival measure: Radiographic progression free survival measure: Change of induced T-cell responses for SL-T10 vaccine sex: MALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06344702 id: 2024PHB065-001 briefTitle: The Effect of CPAP on Maternal and Infant Outcomes in Pregnant Women With OSAS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-05-01 date: 2024-04-03 date: 2024-04-23 name: Peking University People's Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn about the impact of CPAP on the maternal and infant outcomes of women with obstructive sleep apnea syndrome. The main questions aim to answer are:

\[question 1\]Explore the impact of different CPAP treatment times on the maternal and infant outcomes of pregnant women with combined OSAS; \[question 2\]Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women.

The CPAP treatment group received standardized CPAP treatment and routine prenatal care, while the non CPAP treatment group and non OSAS group only received routine prenatal care. conditions: Maternal Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 108 type: ESTIMATED name: CPAP measure: Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women. sex: FEMALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06344689 id: SH9H-2023-T477 briefTitle: Surgical Correction of Cicatricial Ectropion overallStatus: COMPLETED date: 2023-12-12 date: 2024-02-28 date: 2024-03-27 date: 2024-04-03 date: 2024-04-03 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: The main purpose of this study is to verify and compare the treatment effects of scarred ectropion surgery, perform statistical descriptions, compare patients undergoing tarsal strip and skin flap procedures with those undergoing simple skin flap treatment, and compare their pre- and post-operative Ectropion Grading Scale (EGS) and subjective and objective symptom changes.

Secondary Objective: To observe the incidence and resolution of complications after lower eyelid ectropion surgery. Compare postoperative effects among patients of different ages undergoing the same surgery. conditions: Patients With Cicatricial Ectropion conditions: Over 18-year-old conditions: With Complete Clinical Record studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 26 type: ACTUAL name: Surgical treatment measure: Ectropion Grading Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai ninth people's hospital city: Shanghai zip: 200011 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06344676 id: FSIE2024Robot id: 6773 type: OTHER domain: CERec UAB briefTitle: Study of the Impact of a Social Robot on Unwanted Loneliness in Elderly People Living in Nursing Homes acronym: WITHPEPPER overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-30 date: 2024-09-30 date: 2024-04-03 date: 2024-04-03 name: Sara Domenech class: OTHER briefSummary: The goal of this clinical trial is to assess the usefulness of social robots reducing unwanted loneliness in persons over 65 living in nursing homes. The main questions it aims to answer are:

* Can social robots reduce unwanted loneliness?
* Can social robots improve quality of live and well-being? The selected centers are organized in several classes of living units. Living units are independent physical spaces with their own common facilities for the persons living in (usually around 15). Living units of the same class gather persons with similar characteristics.

To compare the added value of the robots half of the living units will be allocated to a control group, and the other half to the intervention group.

The persons in living units allocated to the control group will receive the same attentions and care which were receiving before the enrollment in the study, whereas the persons allocated to the intervention group will add a social robot to their usual therapies and activities. Namely participants will do three weekly individual cognitive stimulation sessions of 10 minutes each one, two weekly group mobility sessions of 30 minutes, one monthly conversational group about customs and traditions of 60 minutes, one 10 minutes videoconference per month with their relatives. Furthermore, participants will be able to interact freely with the robot to obtain information about the center (for instance, what is for dinner) and its activities.

The intervention will last 8 weeks. To assess the effectivity, the investigators will assess both groups, before the intervention, at the end of the intervention and 4 weeks after finishing the intervention. conditions: Elderly People conditions: Nursing Home Residents conditions: Loneliness conditions: Quality of Life conditions: Wellbeing conditions: Social Interaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 162 type: ESTIMATED name: Cognitive name: Mobility name: Social name: Relational name: Usual Care measure: Loneliness measure: Well-being measure: Quality of life, irrespective of the disease measure: Satisfaction with life measure: Depressive symptoms measure: Social Support measure: Communication sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06344663 id: KSIU-SBF-ES-02 briefTitle: Motivational Interviewing Inadequate Milk and Cortisol overallStatus: RECRUITING date: 2024-03-25 date: 2024-03-25 date: 2024-12-25 date: 2024-04-03 date: 2024-04-03 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: Motivational interviewing is a technique used in many fields. No study has been found in national and international databases investigating the effect of motivational interviewing on the perception of insufficient milk, breastfeeding motivation and cortisol level. The study aimed to evaluate the effect of motivational interviews on the perception of insufficient milk, breastfeeding motivation and cortisol level. conditions: Motivation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 130 type: ESTIMATED name: motivational interview measure: Insufficient Milk Perception Scale (ANN) measure: Breastfeeding Motivation Scale (EMS) measure: Visual Analog Scale (VAS) sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Eda Sever status: RECRUITING city: Kahramanmaraş state: Onikişubat zip: 46370 country: Turkey name: eda sever role: CONTACT phone: +90 531 232 10 96 email: edaseverr@icloud.com lat: 37.5847 lon: 36.92641 hasResults: False

 nctId: NCT06344650 id: RF-2021-12373584 briefTitle: Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study overallStatus: RECRUITING date: 2023-09-28 date: 2024-07 date: 2024-07 date: 2024-04-03 date: 2024-04-03 name: IRCCS San Raffaele class: OTHER name: Fondazione Policlinico Universitario Campus Bio-Medico name: Istituto Auxologico Italiano briefSummary: Prospective observational clinical, molecular, translational and basic study aimed at identifying the main determinants and predictive factors of risk of bone damage in acromegaly patients conditions: Acromegaly conditions: Bone Fracture studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Blood sample measure: Identify the rate of morphometric vertebral fractures in acromegalic patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Andrea Giustina status: RECRUITING city: Milan zip: 20132 country: Italy name: Gabriela Felipe role: CONTACT phone: 0226435062 email: felipe.gabriela@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06344637 id: 2566/081 I briefTitle: Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-14 date: 2024-05-30 date: 2024-07-30 date: 2024-04-03 date: 2024-04-03 name: UdonThani Hospital class: OTHER_GOV briefSummary: This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration conditions: Pain, Procedural conditions: Lidocaine conditions: Obstetric Surgical Procedures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 216 type: ACTUAL name: 10 % lidocaine spray without adrenaline name: Placebo measure: pain score during manual vauum aspiration measure: pain score after manual vauum aspiration sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: UdonThani Hospital city: Udon Thani state: UdonThani zip: 41000 country: Thailand lat: 17.41567 lon: 102.78589 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-30 uploadDate: 2024-03-20T05:36 filename: Prot_SAP_000.pdf size: 178265 hasResults: False

 nctId: NCT06344624 id: Mersin_U briefTitle: The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-06-02 date: 2025-02-01 date: 2024-04-03 date: 2024-04-03 name: Mersin University class: OTHER briefSummary: The presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. This study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled trial with a pretest-posttest design primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Using the block randomization technique, the sampled students will be split into two groups: the CBT group and the laughter group. Six will be the block size. Excel will be used to create blocks (allocation concealment) and random numbers will be generated by an assistant researcher who does not attend therapy sessions. The purpose of the program is to support mental health and evaluate its effectiveness; students will not be informed about which group they are in (participant blinding).

Research data will be coded as A and B and entered into the computer database by someone other than the researchers conducting the therapy sessions, and statistical analysis will be performed using this coding (statistician blinding). whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: CBT group name: Laughter group measure: The change in mental symptoms will be assessed using the Brief Symptom Inventory. measure: Psychological resilience will be assessed using the Psychological Resilience Scale. measure: Negative self-evaluations and thought patterns will be assessed using the Automatic Thoughts Scale. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Turkey, Mersin University city: Mersin zip: 33180 country: Turkey name: EMİNE ÖNCÜ, Assoc.Prof. role: CONTACT email: eeoncu@gmail.com name: Zeliha Yaman, Doctorate role: SUB_INVESTIGATOR name: Filiz Değirmenci, Doctorate role: SUB_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06344611 id: ILBS-DCLD-01 briefTitle: Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria overallStatus: NOT_YET_RECRUITING date: 2024-04-07 date: 2026-03-31 date: 2026-03-31 date: 2024-04-03 date: 2024-04-03 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive and/or chronic liver injury due to toxic, infectious, metabolic and genetic pathogenic factors. Traditionally, the natural history of cirrhosis has often been considered a one-way street, with a definite and irreversible progression from a compensated to a decompensated disease stage. But recent data has shown that if the underlying etiology can be successfully treated, cirrhosis can regress and recompensation of liver disease can occur. Hence, in this study we want to evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria. We would also evaluate the predictive factors of recompensation in pediatric decompensated chronic liver disase (DCLD) subjects and would explore systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis. conditions: Decompensated Cirrhosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Other measure: To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria measure: To evaluate the predictive factors of recompensation in pediatric DCLD subjects measure: To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in in pediatric subjects with decompensated cirrhosis. measure: To assess incidence of re-decompensation in patients with recompensation. sex: ALL minimumAge: 3 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Institute of Liver and Biliary Sciences city: New Delhi state: Delhi zip: 110070 country: India name: Dr Anmol Anmol, MD role: CONTACT phone: 01146300000 email: dranmol1991@gmail.com lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06344598 id: 0123РК00314 id: AP19680262 type: OTHER domain: Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan briefTitle: Identification and Assessment of Risk Factors for the Development of Osteoporosis in Adults and Children Living in the Abay Region of the Republic of Kazakhstan Using the Method of Dual-energy X-ray Absorptiometry and Clinical and Epidemiological Research overallStatus: RECRUITING date: 2023-09-01 date: 2025-11-15 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: Semey State Medical University class: OTHER name: Ministry of Science and Higher Education of the Republic of Kazakhstan briefSummary: A survey of people to identify risk factors for osteoporosis, which include age, gender, lifestyle, diet, physical activity, the presence or absence of somatic pathology. Diagnosis of osteoporosis by dual-energy X-ray absorptiometry. Conducting a correlation analysis of the relationship of the data obtained. conditions: Improving the Early Diagnosis of Osteoporosis in Adults and Children Living in the Abay Region of Kazakhstan studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED measure: Risk factors for the development of osteoporosis will be identified and quantified in the formed study groups of adults measure: to determine the diagnostic value of the risk factors for the development of osteoporosis obtained during the examination measure: to assess the state of BMD in adults using X-ray absorptiometry (DXA) measure: To carry out a correlation analysis of the relationship between the obtained data in adults of the Abay region of of the Republic of Kazakhstan sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Semey Medical University status: RECRUITING city: Semey zip: 071400 country: Kazakhstan name: Madina MD Madiyeva, PhD role: CONTACT phone: +77085244745 email: madina.madiyeva@smu.edu.kz name: Gulzhan MD Bersimbekova role: CONTACT phone: +77023728412 email: gulzhan.bersimbekova@smu.edu.kz lat: 50.42675 lon: 80.26669 hasResults: False

 nctId: NCT06344585 id: DROPOUT briefTitle: Drop-out of Infertile Couples: a Large Single Center Experience Over 10 Years acronym: dropout overallStatus: COMPLETED date: 2012-01-01 date: 2021-12-31 date: 2023-07-31 date: 2024-04-03 date: 2024-04-24 name: Istituto Clinico Humanitas class: OTHER briefSummary: Conducted at a single-center, this prospective-retrospective study focused on all couples who initiated their journey at the Fertility Center of Humanitas Research Hospital, Rozzano (Milan), Italy.

The prospective study focused on the couples whose first consultation occurred in 2021. A tailored questionnaire was administered via telephone by staff members to gather insights into the personal reasons for treatment discontinuation among non-returning patients.

Conversely, the retrospective study included all infertile couples initiating treatment between January 2012 and December 2021 at the Fertility Center. Data encompassing personal history and demographic details were extracted from the internal database of Humanitas Fertility Center to assess the factors involved in a treatment discontinuation. conditions: Infertility studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 24773 type: ACTUAL name: Drop out patients who had their first access in 2021 were additionally asked to answer to a phone -call questionnaire to assess their motivation of discontinuation measure: Dropout rate measure: Reasons for dropout collected by a phone call questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 46 Years stdAges: ADULT facility: Istituto Clinico Humanitas city: Rozzano state: Milano zip: 20089 country: Italy lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06344572 id: SAT001-KP-002 briefTitle: Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia overallStatus: RECRUITING date: 2023-09-27 date: 2025-08-31 date: 2025-09-30 date: 2024-04-03 date: 2024-04-16 name: S-Alpha Therapeutics, Inc. class: INDUSTRY briefSummary: The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients. conditions: Myopia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: SAT-001 name: Single vision spectacles measure: Change in Cycloplegic Spherical Equivalent Refractive Error measure: Change in Cycloplegic Spherical Equivalent Refractive Error measure: Change in Axial Length measure: Change in cycloplegic Spherical Equivalent Refractive Error relative to baseline depending on the myopia severity(mild myopia, moderate myopia) measure: Change in axial length relative to baseline depending on the myopia severity(mild myopia, moderate myopia) sex: ALL minimumAge: 5 Years maximumAge: 8 Years stdAges: CHILD facility: Gachon University Gil Hospital status: RECRUITING city: Incheon country: Korea, Republic of lat: 37.45646 lon: 126.70515 hasResults: False

 nctId: NCT06344559 id: 2023001006 briefTitle: Brain Criticality, Oculomotor Control, and Cognitive Effort overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-06-01 date: 2024-04-03 date: 2024-04-03 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: The project examines electroencephalography, MRI, and behavioral measures indexing flexibility (critical state dynamics) in the brain when healthy young adults do demanding cognitive tasks, and in response to transcranial magnetic stimulation. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study will involve three sessions of within-subject, crossover, double-blind transcranial magnetic stimulation with either 1) active intermittent theta burst stimulation, 2) active continuous theta burst stimulation or 3) sham intermittent or continuous theta burst stimulation. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Participants numbers will be assigned three blinded codes which are linked with either sham, active continuous, or active intermittent theta burst stimulation in the stimulator protocol. The investigator will enter the code to initiate the corresponding stimulator protocol, but will not know which protocol is active.

Half of participants will be assigned a sham code corresponding to sham continuous theta burst stimulation and half will be assigned a sham code corresponding to sham intermittent theta burst stimulation. So, for any given session, either continuous or intermittent theta burst stimulation will be used, but it will be unclear whether the stimulation is active or sham. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: transcranial magnetic stimulation measure: Critical dynamics - immediate effects of cTBS versus sham stimulation measure: Functional E/I balance - immediate effects of cTBS versus sham stimulation measure: Avalanche branching ratio - immediate effects of cTBS versus sham stimulation measure: Critical dynamics - immediate effects of iTBS versus sham stimulation measure: Functional E/I balance - immediate effects of iTBS versus sham stimulation measure: Avalanche branching ratio - immediate effects of iTBS versus sham stimulation measure: Memory-guided saccade accuracy - effects of cTBS versus sham stimulation measure: Memory-guided saccade accuracy - effects of iTBS versus sham stimulation measure: Anti-saccade accuracy - effects of cTBS versus sham stimulation measure: Anti-saccade accuracy - effects of iTBS versus sham stimulation measure: Subjective effort discounting - cTBS versus sham stimulation measure: Subjective effort discounting - iTBS versus sham stimulation measure: Subjective effort rating - cTBS versus sham stimulation measure: Subjective effort rating - iTBS versus sham stimulation sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-17 uploadDate: 2024-03-27T17:23 filename: Prot_000.pdf size: 1099938 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-07-30 uploadDate: 2024-03-27T17:01 filename: ICF_001.pdf size: 711815 hasResults: False

 nctId: NCT06344546 id: K 2023-10247 briefTitle: Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-06 date: 2024-04-03 date: 2024-04-03 name: Karolinska University Hospital class: OTHER briefSummary: The overall aim of the study is to improve understanding of refeeding syndrome (RFS) in patients admitted to the intensive care unit (ICU) using metabolomics. Patients are included as part of a prospective multicenter observational study on phosphate disorders in the ICU. Blood samples are collected day 1-7 of ICU stay. Samples from patients who develop refeeding hypophosphatemia and matched controls without hypophosphatemia are analysed for metabolomics and proteomics. Untargeted analyses will be performed to identify the affected metabolic pathways. The investigators will also perform AUROC analyses to identify potential biomarkers for early detection of RFS. conditions: Critical Illness conditions: Refeeding Syndrome conditions: Hypophosphatemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Metabolomics measure: Metabolomics measure: Metabolomics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Královské Vinohrady city: Prague country: Czechia lat: 50.08804 lon: 14.42076 facility: University Hospital Policlinico of Foggia city: Foggia country: Italy lat: 41.45845 lon: 15.55188 facility: Karolinska University Hospital city: Huddinge state: Stockholm zip: 14186 country: Sweden name: Martin Sundström Rehal, MD PhD role: CONTACT phone: +46-8-12381507 email: martin.sundstrom@gmail.com name: Olav Rooyackers, PhD role: CONTACT email: olav.rooyackers@ki.se lat: 59.23705 lon: 17.98192 facility: Karolinska Universitetssjukhuset Solna city: Stockholm country: Sweden name: Jonas Blixt, MD PhD role: CONTACT email: jonas.blixt@regionstockholm.se lat: 59.33258 lon: 18.0649 facility: Södersjukhuset city: Stockholm country: Sweden name: Rebecka Rubenson Wahlin, MD PhD role: CONTACT email: rebecka.rubenson-wahlin@regionstockholm.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06344533 id: JMKX003142iv-101 briefTitle: Study of JMKX003142 Injection in Chinese Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-01-31 date: 2025-05-30 date: 2024-04-03 date: 2024-04-03 name: Jemincare class: INDUSTRY name: Zhejiang Hangyu Pharmaceutical Co., Ltd briefSummary: To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects conditions: Healthy Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: JMKX003142 Injection name: Placebo measure: Number of the Adverse Events that are related to the single dose treatment measure: Number of the Adverse Events that are related to the multiple dose treatment sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100191 country: China name: Haiyan Li role: CONTACT name: Haiyan Li, MD role: PRINCIPAL_INVESTIGATOR name: Dongyang Liu, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06344520 id: IsiU briefTitle: Pectoralis Minor Shorthening and Swimming Performance overallStatus: COMPLETED date: 2022-12-29 date: 2023-08-30 date: 2023-10-30 date: 2024-04-03 date: 2024-04-03 name: Istinye University class: OTHER briefSummary: Swimming is one of the sports branches that includes many factors such as aerobic and anaerobic endurance, strength, flexibility, speed, quickness, rhythm, coordination as well as sportive performance and technical skills.

Athletes must have a high level of fitness, strength, coordination, agility, speed and motor control to perform at an elite level with minimal injury risk.

Repetitive upper extremity movements imposed by freestyle swimming may lead to changes in muscle length and tension by paving the way for postural misalignment in adolescent swimmers.

As can be seen in the studies, young swimmers who are preparing for the competition have postural disorders and injuries related to use, such as decreased posture, shoulder joint range of motion and subacromial distance.

Pectoralis minor stretching exercise to be performed in swimmers is aimed to improve swimming performance and prevent possible postural disorders by contributing to the increase of maximal shoulder muscle strength as well as correcting the incorrectly developed posture in children. conditions: The Study Will Not be Based on Any Disease conditions: Ability to Swim 100m Independent Freestyle conditions: Be Between the Ages of 9-16 conditions: Continuing Running as Part of a Sports Club studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: three groups as intervention, exercises group non- exercises group and scham primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 91 type: ACTUAL name: pektoralis minor shortnes name: Group in which the Pectoralis Minor stretching exercise was performed in a sham manner name: The group in which Pectoralis Minor stretching exercise was not applied measure: Speed Tests measure: Apley test measure: Round Shoulder measure: Anthropometric Measurement: measure: Posture analysis: (ANNEX2) measure: Anthropometric Measurement 2 measure: Y Balance Test measure: Eurofit Test Battery measure: Eurofit Test Battery 2 measure: Eurofit Test Battery 3 sex: ALL minimumAge: 9 Years maximumAge: 16 Years stdAges: CHILD facility: Galatasaray Ergün Gürsoy Olympic Swimming Pool city: Üsküdar state: Nuhkuyusu zip: 34662 country: Turkey lat: 41.02252 lon: 29.02369 hasResults: False

 nctId: NCT06344507 id: TAILOR-EUS briefTitle: Iconographic Registry of Pancreatobiliary Endoscopy Procedures acronym: TAILOR-EUS overallStatus: RECRUITING date: 2022-03-28 date: 2027-12-31 date: 2027-12-31 date: 2024-04-03 date: 2024-04-03 name: IRCCS San Raffaele class: OTHER briefSummary: The aim of the TAILOR-EUS study (Iconographic Registry of Bilio-Pancreatic Endoscopic Ultrasound Procedures) is to establish a clinical registry comprising images and videos generated during endoscopic procedures conducted for the investigation of pancreatic diseases (PD). The study will compile historical, pathological, and imaging data from approximately 12,000 patients (2,000 retrospectively and 10,000 prospectively) who underwent endoscopic ultrasound procedures for inflammatory pancreatic conditions (e.g., acute, recurrent, chronic pancreatitis), autoimmune bilio-pancreatic diseases (e.g., autoimmune pancreatitis), neoplastic bilio-pancreatic conditions, and screenings for individuals at high risk of developing such diseases at the Bilio-Pancreatic Endoscopy and Endoscopic Ultrasound Unit of the IRCCS San Raffaele Hospital between 2000 and 2027.

Participants have undergone or will undergo the standard diagnostic pathway appropriate for their conditions as part of routine clinical practice. All instrumental examinations and endoscopic ultrasound procedures are integral to the standard diagnostic and therapeutic approach for pancreatic diseases. conditions: Pancreas Neoplasm conditions: Cancer of Pancreas conditions: Pancreatitis conditions: Neuroendocrine Tumors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 12000 type: ESTIMATED measure: Registry for images and videos sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Hospital status: RECRUITING city: Milan zip: 20132 country: Italy name: Matteo Tacelli, MD role: CONTACT email: tacelli.matteo@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06344494 id: INTELICE-CTP-2401 briefTitle: Cardiac Interventional ICE Imaging Trial acronym: INTELICE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-03 date: 2024-04-04 name: ICE Intelligent Healthcare Co., Ltd class: INDUSTRY briefSummary: The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process. conditions: Structural Heart Diseases conditions: Atrial Septal Defect conditions: Patent Foramen Ovale conditions: Arrhythmias, Cardiac conditions: Atrial Fibrillation conditions: Supraventricular Tachycardia conditions: Valve Disease, Heart studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 130 type: ESTIMATED name: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system name: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system measure: Image quality measure: Image quality measure: Procedure success measure: Technical success measure: Procedure time measure: Device performance sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital, Capital Medical University city: Beijing state: Bejing zip: 100011 country: China name: Deyong Long, MD, PhD role: CONTACT phone: 64412431 phoneExt: 0086010 email: dragon2008@vip.sina.com name: Ribo Tang, MD, PhD role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: The First People's Hospital of Changzhou city: Changzhou state: Jiangsu zip: 213004 country: China name: Ling Yang, MD role: CONTACT phone: 68873108 phoneExt: 00860519 email: Yangling369@czfph.com name: Ling Yang, MD role: PRINCIPAL_INVESTIGATOR name: Bo Qian, MD role: SUB_INVESTIGATOR lat: 31.77359 lon: 119.95401 facility: The First Hospital Of Jilin University city: Changchun state: Jilin zip: 130021 country: China name: Shuyan Li, MD, PhD role: CONTACT phone: 88782222 phoneExt: 00860431 email: shuyanli1992@163.com name: Shuyan Li, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Hongbo Meng role: SUB_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: Shanghai General Hospital city: Shanghai state: Shanghai zip: 200081 country: China name: Songwen Chen, MD, PhD role: CONTACT phone: 18017638339 phoneExt: 0086 name: Songwen Chen, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Juan Sun role: SUB_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06344481 id: CL-00003 briefTitle: The Hyalex First-in-Human Study overallStatus: RECRUITING date: 2024-03-07 date: 2026-09 date: 2026-09 date: 2024-04-03 date: 2024-04-12 name: Hyalex Orthopaedics, Inc. class: INDUSTRY briefSummary: The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment. conditions: Cartilage Injury studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Surgical (Hyalex Cartilage Knee Implant) measure: Freedom from implant rejection and infection. measure: Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months. sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SPORTO status: RECRUITING city: Łódź zip: 09-038 country: Poland name: Klaudia Marchewa role: CONTACT email: marchewa.klaudia@gmail.com name: Marcin Domzalski, M.D. role: PRINCIPAL_INVESTIGATOR lat: 51.75 lon: 19.46667 hasResults: False

 nctId: NCT06344468 id: 531393 briefTitle: The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU overallStatus: COMPLETED date: 2023-04-12 date: 2023-06-05 date: 2024-03-04 date: 2024-04-03 date: 2024-04-03 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: The goal of this is randomized controlled study to examine the effect of early mobilization on sleep, physiological parameters, and length of stay in the intensive care unit (ICU).

The hypothesis are:

Hypothesis I: Early mobilization positively affects the sleep quality of patients.

Hypothesis II: Early mobilization positively affects the physiological parameters of patients (respiratory rate, heart rate, blood pressure, body temperature, pain).

Hypothesis III: Early mobilization shortens the length of stay of patients in the intensive care unit (ICU).

Early mobilization will begin in the experimental group after sedation is discontinued within the first 12 hours and its effects disappear. In early mobilization, in the evaluation of in-bed mobilization, physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Surgical wounds and dressing areas, if any, are protected, drains are identified, care is taken not to remove equipment such as urinary catheters or nasogastric tubes, when the patient is seated on the edge of the bed with the help of a nurse, when he/she is stood up next to the bed with the support of the nurse, when he/she is made to sit in a chair next to the bed and when he/she is in a chair. While sitting, 1st minute, 5th minute, 10th minute respiratory rate, sPO2, heart rate, blood pressure, body temperature values and pain levels will be recorded and these data will be evaluated on their own. During mobilization, if the patient develops chest pain, arrhythmia, hypertension (systolic pressure\>160 mmHg), or hypotension (systolic pressure\<90 mmHg), tachypnea, or hypoxia, a break will be taken and the physician will be consulted. The same procedures will be repeated during the mobilization of the patient in the first 24-36 hours and the necessary records will be made by the researcher.

Control Group:

After admission to the Cardiovascular Surgery ICU, the type, purpose and implementation process of the study will be explained to the patients, and a routine/standard postoperative mobilization procedure will be applied to the patients in the control group. Accordingly, patients will be mobilized in the first 24 hours after surgery, and in the evaluation of in-bed mobilization, their physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Again, arterial blood gas monitoring of the patients in the control group will be performed at maximum 4-hour intervals, and respiratory parameters will be frequently evaluated and recorded. conditions: Early Mobilization conditions: Sleep Quality conditions: Critical Care conditions: Nursing Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 82 type: ACTUAL name: Early Mobilization measure: The length of stay of patients in the intensive care unit measure: The Richards-Campbell Sleep Questionnaire (RCSQ) measure: The Glasgow Coma Scale (GCS) measure: Physiological Parameter - for the experimental group measure: Physiological Parameter - for the control group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İstanbul University-Cerrahpaşa Cerrahpaşa School of Medicine city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06344455 id: RCT Delay Discounting briefTitle: Influence of Educational Stimuli From the Pé-de-Meia Program on Delay Discounting Propensity overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-07-01 date: 2024-04-03 date: 2024-04-03 name: Federal Institute of Education, Science and Technology of the State of Mato Grosso class: OTHER briefSummary: The goal of this randomized clinical trial is to investigate how the Stay-and-Complete School Incentive Savings, part of the Pé-de-Meia Program, affects decision-making among low-income high school students, particularly their tendency towards delay discounting. This concept describes the preference for immediate gratifications over larger future rewards. The main questions it seeks to answer are:

Can exposure to the specific educational stimuli of the Pé-de-Meia Program alter students' propensity for delay discounting? How do different levels of delay discounting influence students' decision-making regarding their studies and the utilization of the program's incentives?

Participants will:

Engage in a modified version of the Iowa Gambling Task (IGT), a computerized game that simulates decision-making under uncertainty, adapted to reflect the stimuli and choices related to the Pé-de-Meia Program.

Complete questionnaires that measure their propensity for delay discounting and gather demographic and socioeconomic information.

Researchers will compare the outcomes among groups of students exposed to different types of stimuli (aligned with the program's objectives, contrasting, and a control group without modifications) to see if the specific financial and educational incentives of the Pé-de-Meia Program influence how students value immediate rewards compared to future benefits. This study is expected to contribute to the improvement of public educational policies, encouraging school retention and promoting the educational success of low-income adolescents. conditions: Delay Discounting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: School Retention and Completion Incentive Savings via Modified Iowa Gambling Task A name: Iowa Gambling Task name: School Retention and Completion Incentive Savings via Modified Iowa Gambling Task B measure: Delay Discounting 1 measure: Delay Discounting 2 measure: decision-making performance under risk and uncertainty measure: loss aversion measure: Loss Frequency-Based Decision Strategy measure: Learning sex: ALL minimumAge: 14 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06344442 id: APHP220827 briefTitle: Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial) overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2026-06-05 date: 2026-06-05 date: 2024-04-03 date: 2024-04-03 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Liver transplantation (LT) is a high-risk surgery for hemodynamic instability and haemorrhagic shock with a high-risk of acute kidney injury (AKI). Indeed, the incidence of post-transplant AKI exceeds 50% in some series with 15% of patients requiring renal replacement therapy. Acute kidney injury after LT is a predisposing factor for chronic renal failure which is independently associated with higher morbidity and mortality.

Arginine vasopressin (AVP), an essential stress hormone released in response to hypotension, binds to AVPR1a to promote vasoconstriction. Furthermore, it may have nephroprotective effects with a preferential vasoconstriction of the post-glomerular arteriole resulting in increased glomerular filtration

The hypothesis of the present work is that low-dose arginine-vasopressin supplementation reduce posttransplant AKI in liver transplantation. conditions: Acute Kidney Injury Post Liver Transplantation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, national multicentre, double-blinded, randomized ,controlled superiority trial with two parallel arms primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All the clinical teams involved intraoperatively (anaesthetists, nurse anaesthetists and surgeons) and postoperatively (doctors and nurses who will take care of the patient postoperatively) and the families will ignore the allocation of treatments for the duration of the trial,except the nurse in charge of preparing the infusions ,She will ensure respect for the blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 304 type: ESTIMATED name: Arginine vasopressin name: Norepinephrine measure: The primary objective is to compare the effect of intraoperative low-dose supplementation of AVP vs norepinephrine infusions on post-transplant Acute Kidney Injury after liver transplantation. measure: To compare into the two arms the number of packed red blood cellsand fresh frozen plasma transfused measure: To compare into the two arms the number of the Number of AKI KDIGO 1 measure: To compare into the two arms the Number of AKI KDIGO 2 measure: To compare into the Number of AKI KDIGO 3 measure: The need for renal replacement for replacement therapy (RRT) in ICU measure: The number of patients remaining on dialysis at the end of the study measure: Average intraoperative norepinephrine concentrations measure: Average intraoperative concentrations of other vasopressors and inotropes (Adrenalin, Dobutamine) measure: Number of platelets transfused intraoperatively measure: Amount of vascular filling solutions intraoperatively measure: Sequential Organ Failure Assessment (SOFA score) measure: Number of days alive outside intensive care unit measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: URC Lariboisière-Fernand Widal-saint Louis city: Paris zip: 75010 country: France name: Nabila PIZZI role: CONTACT phone: 01 40 05 49 83 phoneExt: +33 email: nabila.pizzi@aphp.fr name: Jaques DURANTEAU, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06344429 id: STL_CT_0001 briefTitle: Stellest Lenses and Low-concentration Atropine Myopia Control Among Children overallStatus: RECRUITING date: 2023-08-20 date: 2024-08-20 date: 2025-08-20 date: 2024-04-03 date: 2024-04-04 name: Essilor-Polylite Taiwan Co., Ltd. class: INDUSTRY briefSummary: The prevalence of myopia is increasing globally, especially in Asian countries. 70-80% of the young population suffers from myopia, and almost 20% have high myopia. High myopia can easily lead to blinding diseases, including retinal detachment, macular degeneration, and glaucoma. In Taiwan, according to a survey by the National Health Administration, the proportion of myopia among Grade 1 students has exceeded 81%.

There are many ways to control myopia progression. High concentrations of atropine have been reported highly effective in the control of the myopia progression. However the accompanied side effects such as photophobia and near blurred vision. Recent research shows that low-concentration atropine can achieve similar control effect and more acceptable with much minimal side effect compared to high concentration of atropine.

Multiple animal experiments have confirmed that giving retinal myopia defocus signals can effectively decrease the growth of the eye, thereby inhibiting the progression of myopia. Therefore, regarding lens design, myopic defocus does play an important role in myopia control, including orthokeratology lenses, multifocal soft contact lenses, and peripheral defocus lenses.

Stellest, a myopia control lens based on the myopia defocus theory, is equipped with highly aspheric lenslet technology. In a recent study, compared with single vision lenses, Stellest significantly slowed down the myopia progression reaching 67% and retard axial elongation reaching 64% The purpose of this study is to explore the effectiveness of Stellest Lenses in controlling myopia in Taiwanese children and whether Stellest Lenses combined with low-concentration atropine eye drops can increase the effect of myopia control. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Stellest Lenses name: Stellest Lenses+0.05% atropine name: Single vision Lenses+0.05% atropine measure: Spherical equivalent refraction power measure: Axial length sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Kaohsiung Chang Gung Memorial Hospital status: RECRUITING city: Kaohsiung zip: 833401 country: Taiwan name: Pei-Chang Wu role: CONTACT name: Pei-Chang Wu role: PRINCIPAL_INVESTIGATOR lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06344416 id: RXG-001-2024-CLP (Rex-002) briefTitle: Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-03-30 date: 2026-01-30 date: 2024-04-03 date: 2024-04-03 name: Dosentrx Ltd. class: INDUSTRY briefSummary: Primary Objective:

• To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation.

Secondary Objective:

• To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group. conditions: Any Solid Oral Medication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Study groups primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: A minimum of 50 and a maximum of 200 patient charts are expected to be reviewed for the control study group. whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Use of ReX to dispense and monitor solid oral medication therapy. measure: Outcome MeasureReX Platform Study Group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHC city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 hasResults: False

 nctId: NCT06344403 id: KY2024-045-02 briefTitle: Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Acute and Subacute Zoster Associated Pain overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2025-03-01 date: 2024-04-03 date: 2024-04-03 name: Beijing Tiantan Hospital class: OTHER briefSummary: Herpes zoster (HZ) is a skin infection disease which cause severe zoster-associated pain (ZAP) along sensory nerve in the corresponding segment. Evidence for the efficacy of existing local therapies for acute/subacute ZAP is limited. The hypothesis is that patients with acute/subacute ZAP treated with TPIs with local anesthetic and steroids under the basis of standard treatment will show better clinical outcomes compared with subjects treated with standard antiviral medicine treatment only. conditions: Herpes Zoster conditions: Local Infiltration conditions: Acute Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 136 type: ESTIMATED name: analgesic name: Tender point infiltration measure: The presence of postherpetic neuralgia using VAS score measure: visual analogue scale score at each time point measure: Proportion of patients receiving repeated TPIs and block points measure: Consumption of oral drugs at each time point measure: The presence of PHN 3 and month 6 post treatment measure: Patient satisfaction scores on the 5-point Likert scale measure: Quality of life on the Scores on the WHOQOL-BREF measure: Adverse reactions through study completion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing state: Beijing zip: 100070 country: China name: Luo Fang, M.D role: CONTACT phone: +86 13611326978 email: 13611326978@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06344390 id: 20210327 briefTitle: Effect of Pentoxifylline on Cognitive Impairment After Ischemic Stroke overallStatus: RECRUITING date: 2024-04-10 date: 2024-10-31 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: The First Hospital of Hebei Medical University class: OTHER briefSummary: Pentoxifylline can improve cognitive impairment after ischemic stroke, possibly by improving the level of cerebral blood flow, affecting the content of blood oxygen and metabolic substances in the brain, and then playing a protective role in the transmission of nerve electrical signals, and ultimately improving cognitive function. The patients with cognitive impairment and non-dementia PSCIND after ischemic stroke were randomly divided into two groups. In addition to the basic drugs of ischemic stroke, the patients were given pentothemine sustained release tablets and blank control respectively to observe the effects of pentothemine on cognitive function and neuronal electrical signals in the patients with ischemic PSCIND. It is expected to explore the possible internal biological mechanism by using transcranial Doppler, oxygen-dependent functional magnetic resonance imaging and craniocerebral magnetic resonance pop analysis. Finally, statistical correlation analysis was used to elucidate the specific mechanism of pentoxifylline in improving cognitive function of non-dementia patients with cognitive impairment after ischemic stroke. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Pentoxifylline measure: Pentoxifylline can improve cognitive impairment after ischemic stroke sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BHan status: RECRUITING city: Shijiazhuang country: China name: Jiaying Rong role: CONTACT phone: 15241876265 email: rjy19982023@163.com lat: 38.04139 lon: 114.47861 hasResults: False

 nctId: NCT06344377 id: BETadiposeWOMEN briefTitle: Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women overallStatus: NOT_YET_RECRUITING date: 2024-04-21 date: 2025-12-30 date: 2026-12-30 date: 2024-04-03 date: 2024-04-05 name: Poznan University of Life Sciences class: OTHER briefSummary: Obesity represents a serious global health issue with significant consequences, including an increased risk of chronic diseases. Statistics indicate a growing trend of obesity, highlighting the need to seek methods that improve fat tissue metabolism and reduce obesity-related complications. Previous research on animals has shown that betaine, a substance engaged in one-carbon metabolism, may enhance fat oxidation and lower adipose tissue. Therefore, the aim of the research will be to assess the impact of 8-week betaine supplementation on body composition and lipid metabolism markers, as well as expression of genes related to lipid metabolism, in a group of adult women with abdominal obesity.

This study is designed in a placebo-controlled, double-blinded, randomized fashion. The participants will be overweight or obese pre-menopausal females. Upon enrollment, participants will be randomly assigned to one of two parallel groups: betaine (3g/d) or placebo. The supplementation period will last for 8 weeks. There will be three study meetings: T1 before supplementation, T2 after 4 weeks of supplementation, and T3 after 8 weeks of supplementation. Blood will be drawn and body composition measured, and adipose tissue biopsy taken at meetings T1 and T3. The T2 meeting will involve only body composition measurement. Study outcomes will include body mass and composition (including body fat percent), lipid profile, and the expression of genes related to lipid metabolism in adipose tissue and peripheral blood mononuclear cells. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Betaine name: Placebo measure: Body composition measure: Body mass measure: Waist and hips circumference measure: Lipid profile measure: Gene expression measure: Liver function test measure: Dietary intake sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Poznan University of Life Sciences city: Poznań zip: 60-637 country: Poland name: Agata Chmurzynska role: CONTACT phone: +48 618466181 email: agata.chmurznska@up.poznan.pl name: Agata Chmurzynska role: PRINCIPAL_INVESTIGATOR name: Emilia Zawieja role: SUB_INVESTIGATOR name: Monika Młodzik-Czyżewska role: SUB_INVESTIGATOR name: Paweł Juszczak role: SUB_INVESTIGATOR lat: 52.40692 lon: 16.92993 hasResults: False

 nctId: NCT06344364 id: PHN 1-080-23 briefTitle: Digital Pathology and AI for Liver Outcomes in MASLD acronym: DPAILO-1 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-03 date: 2024-04-08 name: PharmaNest, Inc class: INDUSTRY name: Chinese University of Hong Kong name: University of Edinburgh name: University of Seville name: Imperial College London name: Icahn School of Medicine at Mount Sinai name: Fundacio Clinic Barcelona briefSummary: The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (MASH). conditions: Metabolic Dysfunction-associated Steatotic Liver Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS) measure: Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS measure: Performance of Hepatic Decompensation Event predictive value of the FIB-4 biomarker, a non-invasive test measure: Performance of Hepatic Decompensation Event predictive value of the elastography (Fibroscan) biomarker, a non-invasive test measure: Performance of Hepatic Decompensation Event predictive value of the FibroNest Parenchymal Tissue Adjusted Phenotypic Fibrosis Composite Score (Pt-Ph-FCS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Icahn School of Medicine at Mount Sinai city: New York state: New York zip: 10029 country: United States name: Meena Bansal, MD role: CONTACT email: meena.bansal@mssm.edu lat: 40.71427 lon: -74.00597 facility: The Chinese University of Hong Kong city: Sha Tin country: Hong Kong name: Vincent Wong, PhD role: CONTACT email: wongv@cuhk.edu.hk lat: 22.38333 lon: 114.18333 facility: Fundació de Recerca Clinic Barcelona city: Barcelona country: Spain name: Isabel Graupera, PhD role: CONTACT email: igraupera@hsph.harvard.edu lat: 41.38879 lon: 2.15899 facility: University of Seville city: Sevilla zip: 41004 country: Spain name: Manuel R Gómez, PhD role: CONTACT email: mromerogomez@us.es lat: 37.38283 lon: -5.97317 facility: University of Edinburgh city: Edinburgh state: Scotland country: United Kingdom name: Jonathan Fallowfield, PhD role: CONTACT email: Jonathan.Fallowfield@ed.ac.uk name: Timothy Kendall, PhD role: CONTACT email: Tim.Kendall@ed.ac.uk lat: 55.95206 lon: -3.19648 facility: University of Edinburgh city: Edinburgh state: Scotland country: United Kingdom name: Quentin Anstee, PhD role: CONTACT email: quentin.anstee@newcastle.ac.uk name: Jo Boyle role: CONTACT email: jo.boyle@newcastle.ac.uk lat: 55.95206 lon: -3.19648 facility: Imperial College London city: London country: United Kingdom name: Pinelopi Manousou, PhD role: CONTACT email: p.manousou@imperial.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06344351 id: TQB3006-I-01 briefTitle: A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer overallStatus: RECRUITING date: 2024-04-25 date: 2025-03 date: 2026-08 date: 2024-04-03 date: 2024-04-26 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer. conditions: Advanced Malignant Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 93 type: ESTIMATED name: TQB3006 tablets measure: Dose limiting toxicity (DLT) measure: Maximum tolerated dose (MTD) measure: Recommended phase II dose (RP2D) measure: Adverse events (AE) measure: Serious adverse events (SAE) measure: Time to reach maximum plasma concentration (Tmax) measure: Peak concentration (Cmax) measure: Half-life (t1/2) measure: Area under the concentration-time curve (AUC [0-infinity]) measure: Area under the concentration-time curve (AUC [0-t]) measure: Apparent clearance (CL/F) measure: Apparent volume of distribution (Vd/F) measure: Objective response rate (ORR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Harbin Medical University Cancer Hospital status: RECRUITING city: Harbin state: Heilongjiang zip: 150000 country: China name: Tongsen Zheng, Doctor role: CONTACT phone: 15134569619 email: zhengtongsen@126.com lat: 45.75 lon: 126.65 hasResults: False

 nctId: NCT06344338 id: Z211100002921030 briefTitle: Application of tDCS Stimulation in Controlling Refractory Status Epilepticus acronym: tDCS overallStatus: RECRUITING date: 2024-03-31 date: 2024-12-31 date: 2025-03-31 date: 2024-04-03 date: 2024-04-03 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus conditions: Refractory Status Epilepticus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 32 type: ESTIMATED name: tDCS stimulation name: TDCS sham-stimulation measure: Number of participants with status epilepticus termination between tDCS treatment group and tDCS sham--stimulation group as assessed by Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus measure: Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group sex: ALL minimumAge: 14 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Weibi Chen role: CONTACT phone: +8615010255903 email: chenweibi@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06344325 id: EDPP briefTitle: ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-03 date: 2024-04-19 name: Tongji Hospital class: OTHER briefSummary: Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia conditions: Elective Surgery studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 330 type: ESTIMATED name: fospropofol measure: Sedation score measure: Postoperative adverse reactions sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji hospital city: Wuhan state: Hubei zip: 430030 country: China name: Aijun Xu, Dr. role: CONTACT phone: +8618627784217 email: ajxu@tjh.tjmu.edu.cn lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06344312 id: M2023551 briefTitle: Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2025-06-01 date: 2024-04-03 date: 2024-04-03 name: Peking University Third Hospital class: OTHER briefSummary: Evaluate the effectiveness of Yangxue Qingnao Granules in preventing post thrombolytic hemorrhage transformation in patients with acute cerebral infarction, and explore its possible mechanism conditions: Stroke, Acute Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Yangxue Qingnao Granules measure: The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06344299 id: HuaDong Hosiptal of FUDAN briefTitle: Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-30 date: 2023-09-30 date: 2024-04-03 date: 2024-04-03 name: Fudan University class: OTHER briefSummary: More and more older adults are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but the rate of surgical resection in patients with resectable tumour is still low. Clinical workers need to take more attention to oncologic care in this group. It's significant to explore potential predictors for impacting elderly patients chose to abandon surgical resection. conditions: Pancreatic Ductal Adenocarcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 5302 type: ACTUAL name: potential predictors measure: ORs of potential predictors measure: Overall survival (OS) sex: ALL minimumAge: 75 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: Huadong Hospital affiliated to Fudan University city: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06344286 id: IstanbulTRH-DArman-002 briefTitle: The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE overallStatus: COMPLETED date: 2020-09-01 date: 2022-08-31 date: 2022-10-31 date: 2024-04-03 date: 2024-04-03 name: Istanbul Training and Research Hospital class: OTHER_GOV briefSummary: The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with hypoxic ischemic encephalopathy. The main question it aims to answer is:

1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH? Participants will be either fed with MEN during TH or given placebo. conditions: Hypoxic-Ischemic Encephalopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An enteral intake of breast milk with a volume of 10-20 mL/kg/day was defined as minimal enteral feeding. Minimal enteral feeding was initiated at postnatal 24 hours with breast milk via an orogastric tube. A total daily intake of 120 ml/kg/day was defined as full enteral feeding.

The babies were randomized into two groups based on whether they received MEN during TH. While the babies fed with MEN during TH constituted the study group, the control group was composed of the babies who were given the same amount of distilled water according to the same protocol. Two groups were compared in terms of demographic characteristics, clinical outcomes, NIRS and Doppler measurements. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: The feeding materials were prepared inside an opaque syringe and serially numbered by Total Parenteral Nutrition Department in our institution. The investigators who made all measurements, examinations and collected data, and the nurses of the babies were blinded. All of the infants in the study group were fed with breast milk during the trial. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Minimal enteral nutrition name: Distilled water measure: Cerebral and mesenteric blood flow velocities and oxygenation measure: Cerebral and mesenteric rSO2 values measure: Development of NEC measure: Feeding intolerance measure: Time to full enteral feeding sex: ALL minimumAge: 0 Days maximumAge: 1 Day stdAges: CHILD facility: IstanbulTRH city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06344273 id: Burcu01 briefTitle: The Effect of Lower Extremity ROM Exercises on Hypotension, Fatigue, and Hemodialysis Comfort in Individuals overallStatus: COMPLETED date: 2023-07-01 date: 2023-08-01 date: 2023-10-01 date: 2024-04-03 date: 2024-04-03 name: Duzce University class: OTHER briefSummary: Range of motion (ROM) is a term used to describe the amount of motion in each joint in our body. Every joint in the body has a normal range of motion. Maintaining the normal opening of the joints is achieved through movement. ROM exercises reduce contractures and are very important in terms of helping to preserve muscle movements. ROM exercises are an inexpensive method that can be applied in any environment, either as a group or individually, covering all muscle-joint groups. Individuals with disabilities can perform ROM exercises individually or receive support from healthcare professionals. It provides support to venous return by increasing muscle strength in patients who are immobilized for a long time.

Based on this information, the aim of our study is to investigate the effect of lower extremity ROM exercises during hemodialysis on hypotension, fatigue and hemodialysis comfort.

The patients will be divided into the intervention group (n=32) in which 20 minutes of ROM exercise was applied and the control group (n=32) in which routine nursing care was given. For the sample calculation of the study, G power analysis was performed, type 1 error was 0.05; type 2 error 0.20; With a power of 0.80, a minimum sample size of 64 people for the experimental and control groups. The case group will be given lower extremity ROM exercises for a total of two weeks. Each individual in the case group will have lower extremity ROM exercises, each of which will last 20 minutes, at the beginning of the session and at the beginning of the hour until the end of the session. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale" in the data collection form will be applied again at the end of the 1st and 2nd weeks after the sessions have started. The vital signs of the individual will be followed and recorded at each session. conditions: Hemodialysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients will be divided into the intervention group (n=32) in which 20 minutes of ROM exercise was applied and the control group (n=32) in which routine nursing care was given. For the sample calculation of the study, G power analysis was performed, type 1 error was 0.05; type 2 error 0.20; With a power of 0.80, a minimum sample size of 64 people for the experimental and control groups. The case group will be given lower extremity ROM exercises for a total of two weeks. Each individual in the case group will have lower extremity ROM exercises, each of which will last 20 minutes, at the beginning of the session and at the beginning of the hour until the end of the session. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale" in the data collection form will be applied again at the end of the 1st and 2nd weeks after the sessions have started. The vital signs of the individual will be followed and recorded at each session. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: You are completely free to participate in the research or not. Not participating in this research will certainly not affect the service you receive. You have the right to withdraw from the study at any time by giving notice; you may also be excluded from the study by the investigator, if deemed necessary, provided that no harm is done to your medical condition.

If you participate in the research, you will not be charged or paid any fees for the expenses to be made in the study. In addition, at the end of the research, your information will only serve scientific purposes without revealing your identity. whoMasked: PARTICIPANT count: 70 type: ACTUAL name: ROM exercises measure: follow-up form measure: Piper Fatigue Scale measure: comfort condition sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duzce University city: Düzce zip: 81000 country: Turkey lat: 40.83889 lon: 31.16389 hasResults: False

 nctId: NCT06344260 id: hNSCALSII briefTitle: Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis (STEMALS) acronym: STEMALS overallStatus: RECRUITING date: 2024-01-25 date: 2027-03 date: 2027-09 date: 2024-04-03 date: 2024-04-03 name: Casa Sollievo della Sofferenza IRCCS class: OTHER name: Ministry of Health, Italy briefSummary: A Not for Profit Phase II Study to Evaluate Safety, Efficacy and Biomarkers secondary endpoints of Human Neural Stem cell intracerebroventricular transplantation in amyotrophic lateral sclerosis patients: a randomized, placebo controlled, triple blind study.

This is an approximate 24-months study (PHASE B) consisting, per patient, of a 30-day screening period, 12-month enrollment and follow up period. A preliminary 3+3 dose-escalation open-label phase (PHASE A) will be performed in order to test the toxicity of the two proposed cell doses. The study will be stopped when all the subjects included in the treatment period complete the study visits. The study uses an ATMP, for that reason all the patients follow up will be prosecuted long life. conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an approximate 24-months triple-blinded, randomized, controlled vs placebo, in three arms study (PHASE B). A preliminary 3+3 dose-escalation open-label phase (PHASE A) will be performed in order to test the toxicity of the two proposed cell doses.

In the phase B three arms will be: 1) hNSCs 20 milion cells 2) hNSCs 40 milion cells 3) Saline (comparator) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In order to blind also the statistician that will analyse the results the protocol has been designed as a triple-blinded protocol. This means that both the researchers, which include neurologist, neurosurgeon and biologist, as well as the patients and the statisticians are unaware of whether the participant received the treatment or the placebo (only IMP Manufacturer QP is unblinded since release the cell drug to the use in the surgery room) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: human Neural Stem Cells (hNSC) name: Saline (Placebo) measure: Safety of treatment measure: Biological Endpoints sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Casa Sollievo Della Sofferenza IRCCS status: NOT_YET_RECRUITING city: San Giovanni Rotondo state: Foggia zip: 71013 country: Italy lat: 41.70643 lon: 15.7277 facility: Centro SLA Azienda Ospedaliera Università Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Letizia Mazzini, MD role: CONTACT phone: +39 0321 3733962 email: ambulatorio.sla@maggioreosp.novara.it lat: 45.44694 lon: 8.62118 facility: Azienda Ospedaliera di Padova status: NOT_YET_RECRUITING city: Padua zip: 35128 country: Italy name: Gianni Sorarù, MD role: CONTACT phone: +39049-8213645/646 email: cl.neurologica@aopd.veneto.it lat: 45.40797 lon: 11.88586 facility: Azienza Ospedaliera Universitaria - Policlinico "P. Giaccone" Università degli Studi di Palermo status: NOT_YET_RECRUITING city: Palermo zip: 90129 country: Italy name: Vincenzo La Bella, MD role: CONTACT phone: +39 091 6555158 email: info@centroslapalermo.it lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06344247 id: IIT-2023-0253 briefTitle: Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease overallStatus: RECRUITING date: 2023-09-01 date: 2025-09-01 date: 2025-12-01 date: 2024-04-03 date: 2024-04-03 name: RenJi Hospital class: OTHER briefSummary: The goal of this clinical trial is to exploring the changes in 24-hour urinary protein and renal function in obese patients with kidney disease after the application of sodium glucose cotransporter 2 inhibitors (SGLT2i) and glucagon like peptide-1 receptor agonists (GLP-1RA).

Eligible patients were randomly and non-blindly allocated to four groups in a 1:1:1:1 ratio.The first group is the optimized treatment group, and patients in this group maintain the maximum dose/maximum tolerated dose of RAS blocker therapy.

The second group is the optimized treatment + SGLT2i group. Participants in this group are titrated to the target dose (10 mg qd) in combination with dapagliflozin on the basis of optimized treatment.

The third group is the optimized treatment + GLP-1RA group. Participants in this group will be titrated to the target dose (1mg qw) in combination with semaglutide on the basis of optimized treatment.

The last group is the optimized treatment + SGLT2i + GLP-1RA treatment group, that is, based on the optimized treatment, combined with dapagliflozin titrated to the target dose (10 mg qd) and semaglutide titrated to the target dose (1 mg qw). conditions: Obesity conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: RAS inhibitors：Losartan®️/Valsartan®️ name: dapagliflozin：Forxiga®️ name: simagliptin：Forxiga®️ measure: Change of 24-hour urine protein quantification measure: Decline in glomerular filtration rate measure: Changes in BMI measure: changes in fasting blood glucose sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: wei jin role: CONTACT phone: +8615026696535 email: jinwei_xj@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06344234 id: 0049191 briefTitle: Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE) acronym: INSPIRE overallStatus: RECRUITING date: 2023-11-01 date: 2026-05-01 date: 2026-06-01 date: 2024-04-03 date: 2024-04-03 name: University of Bari class: OTHER briefSummary: The goal of this observational study is to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of P0.1, driving pressure, plateau pressure, pressure-muscle index, and diaphragm ultrasound as noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.

The main questions this trial aims to answer are:

- Primary Outcome: whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.

Secondary outcomes will include:

* Statistic metric of association between P0.1, ΔP, PMI and ΔPes
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF%
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort.

Participants will undergo the following tasks and treatments:

* Complete written informed consent before enrollment.
* Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks.
* Monitoring of esophageal pressure (in all patients the catheter will be placed before extubation, according to clinical judgment, and its correct position will be verified through a positive pressure occlusion test)
* Continuous recording of airway pressure, flow, and esophageal pressure (Pes), using a dedicated pneumotachograph and pressure transducer.
* Sudden end-inspiratory and end-expiratory occlusion maneuvers, to measure plateau pressure (Pplat) and end-expiratory airway occlusion pressure (ΔPocc), respectively.
* Collection of hemodynamic and arterial blood-gas parameters, performed according to clinical judgment, along with assessments of dyspnea and discomfort using a modified visual analogue scale (VAS).
* Diaphragm ultrasound during occlusion maneuvers, measuring diaphragm displacement, diaphragm thickening fraction (DTF%), and diaphragmatic excursion (Ex) under various conditions. conditions: Respiratory Disease conditions: Artificial Respiration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: End-inspiratory Maneuvers measure: Statistic metric of association between ΔPocc and ΔPes measure: Statistic metric of association between P0.1, ΔP, PMI and ΔPes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF% measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF% measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort measure: Reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda ospedaliero-universitaria consorziale policlinico di Bari status: RECRUITING city: Bari zip: 70124 country: Italy name: Salvatore Grasso, MD, Professor role: CONTACT email: salvatore.grasso@uniba.it name: Francesco Murgolo, MD role: PRINCIPAL_INVESTIGATOR name: Domenico Luca Grieco, MD role: PRINCIPAL_INVESTIGATOR lat: 41.11148 lon: 16.8554 hasResults: False

 nctId: NCT06344221 id: 2023-A00954-41 briefTitle: Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study acronym: HapticS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-07-15 date: 2024-07-15 date: 2024-04-03 date: 2024-04-03 name: Centre Hospitalier St Anne class: OTHER name: Brain & Spine Institute (ICM) name: Centre Hospitalier Régional d'Orléans briefSummary: The aim of this comparative and reliability study is to highlight a deficit in the use of vibrotactile sensory feedback (haptic effect) in the planning and execution of fine manual dexterity movements after stroke. The investigators will include 3 groups of subjects, 1 group of young healthy subjects, 1 of older subjects matched in age and sex to the group of chronic stroke patients. Participants will take part in clinical tests of fine motor skills and sensitivity and will use a device to assess the key components of manual dexterity, to which vibrotactile sensors will be added. If they so wish, participants will be able to take part in a transcranial magnetic stimulation (TMS) study to assess the facilitation of cortical excitability due to the haptic effect. conditions: Stroke conditions: Upper Extremity Paresis conditions: Manual Dexterity conditions: Sensory Integration Dysfunction conditions: Vibration; Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ESTIMATED name: Dextrain Manipulandum and haptic feedback device measure: Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence measure: Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index measure: Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity measure: Correlation between clinical assessment and haptic measure measure: Assessment of the feasibility of the haptic measures measure: Assessment of the benefits of the haptic measures measure: Study the test re-test reliability of the haptic device by comparing the haptic effect on dexterity assessed at the beginning and end of the session by the same evaluator measure: Assessment of the impact of age on the dexterity performances (Finger independence, force control of the index and rhythm capacity) measure: Measurement of the manual dexterity facilitation between tactile (haptic device with vibrations on the fingers) and auditory feedback (sounds during the dexterity tasks) measure: Transcranial magnetic stimulation (TMS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06344208 id: IEO 1647 briefTitle: Predicting Toxicity in Elderly Patients With Head and Neck Cancer acronym: PREtoxEL overallStatus: RECRUITING date: 2022-03-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: European Institute of Oncology class: OTHER briefSummary: Predicting toxicity in elderly patients with head and neck cancer:

validating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes. conditions: Head and Neck Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3 type: ESTIMATED measure: Predicting toxicity in elderly patients with head and neck cancer sex: ALL minimumAge: 70 Years maximumAge: 99 Years stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan state: MI zip: 20141 country: Italy name: maria Cossu Rocca, MD role: CONTACT phone: 00390294372900 email: maria.cossurocca@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06344195 id: 2517 briefTitle: Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening acronym: Antiviral overallStatus: RECRUITING date: 2024-03-27 date: 2024-04 date: 2024-05 date: 2024-04-03 date: 2024-04-10 name: Dow University of Health Sciences class: OTHER briefSummary: This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess .

There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Pain level will be assessed by using Numeric rating scale for 6 days conditions: Acute Apical Abscess studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 82 type: ESTIMATED name: Valacyclovir 500 mg name: Naproxen Sodium 550mg measure: Changes in pain score using Numeric Rating Scale (NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Yumna Shaheen Ali status: RECRUITING city: Karachi state: Sindh zip: 75290 country: Pakistan name: Dr. Yumna Shaheen Ali role: CONTACT email: yumna.shaheen@duhs.edu.pk lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06344182 id: STarkan briefTitle: Reliability, Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty overallStatus: COMPLETED date: 2021-02-01 date: 2021-05-15 date: 2021-05-15 date: 2024-04-03 date: 2024-04-03 name: Dokuz Eylul University class: OTHER briefSummary: The aim of the study is to measure the validity and reliability of the StUD test in patients with TKA. Forty-seven patients with primary TKA included in this study. The test-retest reliability of the StUD test was measured with 1-hour interval. Validity was assessed that the 30s Chair Stand Test (30sCS), the Hospital for Special Surgery score (HSS) and Short Form-12 Quality Life Questionnaire (SF-12) were used as comparator instruments. conditions: Total Knee Arthroplasty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 47 type: ACTUAL name: Step Up and Down Test measure: Step Up and Down Test measure: 30 Seconds Chair Stand Test measure: Hospital for Special Surgery (HSS) Knee Score measure: 12-Item Short-Form Health Survey sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dokuz Eylul University city: Izmir country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06344169 id: DTCRD112(2)-I-15 briefTitle: Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-14 date: 2026-06-14 date: 2024-04-03 date: 2024-04-22 name: Dalin Tzu Chi General Hospital class: OTHER briefSummary: Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Intrathecal morphine (ITM) injection is considered as the standard pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention, constipation, mental status change, and respiratory depression. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard ITM and prevent the development of CPSP. conditions: Postsurgical Pain conditions: Cesarean Section conditions: Chronic Post-surgical Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, open-label, non-inferiority trial primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Sebacoyl Dinalbuphine Ester name: Morphine measure: Intensity of surgical pain after operation as assessed by visual analogue scale measure: Rescue doses of analgesics administered after operation measure: Incidence of chronic post-surgical pain measure: Satisfaction of living after surgery as assessed by the HRQoL short-form (SF)-12 sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06344156 id: PDAC-Neoantigen briefTitle: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-03 date: 2024-04-03 name: Sichuan University class: OTHER briefSummary: The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer conditions: Pancreatic Cancer conditions: Adjuvant Therapy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 43 type: ESTIMATED name: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy measure: 18-month RFS measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability] measure: 18-month OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Zhong Wu, MD role: CONTACT phone: 028-85422851 email: wuzhong5555@126.com name: Zhong Wu role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06344143 id: 24-324 briefTitle: Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma acronym: MACS overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2029-11-01 date: 2030-12-31 date: 2024-04-03 date: 2024-04-26 name: The Cleveland Clinic class: OTHER name: Recordati Rare Diseases briefSummary: The aim of the proposed study is to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients with Adrenal Incidentaloma (AI) and evaluate the available diagnostic tests to determine the most sensitive and specific combination of tests for assessing MACS from adrenal adenoma for prediction of the phenotype associated with cortisol excess. As well as following the patients for 4 years and see if anything changes. conditions: Mild Autonomous Cortisol Secretion (MACS) studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Various labs and imaging tests measure: Evaluate best diagnostic test(s) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Foundation city: Cleveland state: Ohio zip: 44195 country: United States name: Maya Boyd role: CONTACT phone: 216-444-4919 email: boyda5@ccf.org name: jenkink@ccf.org Jenkins role: CONTACT phone: 216-445-4791 email: jenkink@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06344130 id: 10001859 id: 001859-C briefTitle: Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-12-31 date: 2027-12-31 date: 2024-04-03 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: Background:

Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.

Objective:

To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.

Eligibility:

People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.

Design:

Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.

Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.

Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.

Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.

Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years. conditions: Astrocytoma conditions: Glioma conditions: Recurrent Glioblastoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Radiation Therapy measure: MTD of daily re-irradiation in participants with recurrent grade 4 gliomas measure: Progression free survival measure: Overall survival measure: Compliance and feasibility of administering PRO in this participant population measure: Tolerability of treatment by assessing adverse events, cognitive function, physical function, and side effect bother measure: Longitudinally describe and evaluate disease and treatment-related symptom severity and interference with daily activities measure: Meaningful change in disease and treatment-related symptoms by using anchors sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: National Cancer Institute Referral Office role: CONTACT phone: 888-624-1937 lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06344117 id: MF3 UHN (IA) briefTitle: Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients acronym: UHN overallStatus: RECRUITING date: 2023-12-12 date: 2025-07 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Owlstone Ltd class: INDUSTRY briefSummary: Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD). conditions: Invasive Aspergillosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 45 type: ESTIMATED measure: Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and MSG/EORTC criteria. measure: Identifying a statistical relationship between the set of VOCs found in exhaled breath and the diagnosis of Aspergillus colonization as defined by ISHLT criteria sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M5G 2N2 country: Canada name: Shahid Husain, MD,MS role: CONTACT phone: (416) 340-3144 email: shahid.husain@uhn.ca name: Shahid Husain, MD,MS role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06344104 id: D6970C00008 briefTitle: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension acronym: BaxAsia overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2026-05-20 date: 2026-05-20 date: 2024-04-03 date: 2024-04-03 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets. conditions: Uncontrolled Hypertension conditions: Resistant Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: placebo control primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Baxdrostat name: Placebo measure: Change from baseline in siSBP at Week 12 measure: Change from baseline in siSBP at Week 12 measure: Change from RWD baseline (Week 24) in siSBP at Week 32 measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM measure: Change from baseline in siDBP at Week 12 measure: Achieving siSBP < 140 mmHg at Week 12 measure: Change from baseline in siDBP at Week 12 measure: Achieving siSBP < 140 mmHg at Week 12 measure: Change from baseline in siSBP at Week 12 measure: Change from baseline in siSBP at Week 12 measure: Number of participants with adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Caba zip: C1426 country: Argentina lat: -34.61315 lon: -58.37723 facility: Research Site city: Baotou zip: 014010 country: China lat: 40.65222 lon: 109.82222 facility: Research Site city: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 facility: Research Site city: Beijing zip: 100044 country: China lat: 39.9075 lon: 116.39723 facility: Research Site city: Bengbu zip: 233060 country: China lat: 32.94083 lon: 117.36083 facility: Research Site city: Changde zip: 415003 country: China lat: 29.04638 lon: 111.6783 facility: Research Site city: Changsha zip: 410015 country: China lat: 28.19874 lon: 112.97087 facility: Research Site city: Changsha zip: 430033 country: China lat: 28.19874 lon: 112.97087 facility: Research Site city: Changzhou zip: 272100 country: China lat: 31.77359 lon: 119.95401 facility: Research Site city: Chengdu zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Research Site city: Chongqing zip: 400010 country: China lat: 29.56278 lon: 106.55278 facility: Research Site city: Chongqing zip: 400042 country: China lat: 29.56278 lon: 106.55278 facility: Research Site city: Deyang zip: 618000 country: China lat: 31.13019 lon: 104.38198 facility: Research Site city: Guangzhou zip: 510100 country: China lat: 23.11667 lon: 113.25 facility: Research Site city: Ha'er Bin zip: 150001 country: China facility: Research Site city: Hangzhou zip: 310014 country: China lat: 30.29365 lon: 120.16142 facility: Research Site city: Hefei zip: 230601 country: China lat: 31.86389 lon: 117.28083 facility: Research Site city: Heze zip: 274099 country: China lat: 35.23929 lon: 115.47358 facility: Research Site city: Jiujiang zip: 332000 country: China lat: 29.70475 lon: 116.00206 facility: Research Site city: Luoyang zip: 471000 country: China lat: 34.68361 lon: 112.45361 facility: Research Site city: Meihekou zip: 135022 country: China lat: 42.52722 lon: 125.67528 facility: Research Site city: Nanchang zip: 330009 country: China lat: 28.68396 lon: 115.85306 facility: Research Site city: Nanchong zip: 637900 country: China lat: 30.79508 lon: 106.08473 facility: Research Site city: Nanjing zip: 210009 country: China lat: 32.06167 lon: 118.77778 facility: Research Site city: Ningbo zip: 315020 country: China lat: 29.87819 lon: 121.54945 facility: Research Site city: Panjin zip: 124009 country: China lat: 41.121 lon: 122.0739 facility: Research Site city: Puyang zip: 457000 country: China lat: 29.45679 lon: 119.88872 facility: Research Site city: Qiqihar zip: 161000 country: China lat: 47.34088 lon: 123.96045 facility: Research Site city: Sanya zip: 572000 country: China lat: 18.24306 lon: 109.505 facility: Research Site city: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 facility: Research Site city: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 facility: Research Site city: Shenyang zip: 110004 country: China lat: 41.79222 lon: 123.43278 facility: Research Site city: Shenyang zip: 110016 country: China lat: 41.79222 lon: 123.43278 facility: Research Site city: Taiyuan zip: 030024 country: China lat: 37.86944 lon: 112.56028 facility: Research Site city: Tianjin zip: 300457 country: China lat: 39.14222 lon: 117.17667 facility: Research Site city: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: Research Site city: Wuhan zip: 430010 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Wuhan zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Wuhan zip: 430060 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Xianyang zip: 712000 country: China lat: 34.33778 lon: 108.70261 facility: Research Site city: Xianyang zip: 750004 country: China lat: 34.33778 lon: 108.70261 facility: Research Site city: Xuzhou zip: 221000 country: China lat: 34.18045 lon: 117.15707 facility: Research Site city: Yangzhou zip: 225001 country: China lat: 32.39722 lon: 119.43583 facility: Research Site city: Yinchuan zip: 750001 country: China lat: 38.46806 lon: 106.27306 facility: Research Site city: Zhengzhou country: China lat: 34.75778 lon: 113.64861 facility: Research Site city: Zigong zip: 643021 country: China lat: 29.34162 lon: 104.77689 facility: Research Site city: Hong Kong zip: 00000 country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site city: Hong Kong zip: 0000 country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site city: Bangalore zip: 560 092 country: India lat: 12.97194 lon: 77.59369 facility: Research Site city: Belgaum zip: 590016 country: India lat: 15.85212 lon: 74.50447 facility: Research Site city: Kanpur zip: 208002 country: India lat: 26.46523 lon: 80.34975 facility: Research Site city: New Delhi zip: 110002 country: India lat: 28.63576 lon: 77.22445 facility: Research Site city: New Delhi zip: 110060 country: India lat: 28.63576 lon: 77.22445 facility: Research Site city: Surat zip: 395001 country: India lat: 21.19594 lon: 72.83023 facility: Research Site city: Chuo-ku zip: 103-0027 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site city: Chuo-ku zip: 260-0804 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site city: Kagoshima-shi zip: 890-8520 country: Japan lat: 31.56667 lon: 130.55 facility: Research Site city: Minato-ku zip: 108-0073 country: Japan lat: 34.2152 lon: 135.1501 facility: Research Site city: Tsukuba-shi zip: 305-0861 country: Japan lat: 36.2 lon: 140.1 facility: Research Site city: Utsunomiya-shi zip: 320-8580 country: Japan lat: 36.56667 lon: 139.88333 facility: Research Site city: Yokohama-shi zip: 234-0054 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site city: Yokohama-shi zip: 236-0004 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site city: Daejeon zip: 35015 country: Korea, Republic of lat: 36.32139 lon: 127.41972 facility: Research Site city: Seoul zip: 02841 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 04763 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 13620 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Iloilo City zip: 5000 country: Philippines lat: 10.69694 lon: 122.56444 facility: Research Site city: Quezon City zip: 1112 country: Philippines lat: 14.6488 lon: 121.0509 facility: Research Site city: St Petersburg zip: 197341 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Research Site city: Ankara zip: 06800 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site city: Kahramanmaras zip: 46100 country: Turkey lat: 37.5847 lon: 36.92641 facility: Research Site city: Kayseri zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 facility: Research Site city: Kocaeli zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 facility: Research Site city: Hanoi zip: 100000 country: Vietnam lat: 21.0245 lon: 105.84117 facility: Research Site city: Ho Chi Minh zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site city: Hochiminh city zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site city: Hochiminh zip: 70000 country: Vietnam hasResults: False

 nctId: NCT06344091 id: ZYWB-ZM-AHP-A-003 briefTitle: A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-06 date: 2026-09-28 date: 2026-10-12 date: 2024-04-03 date: 2024-04-03 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world. conditions: Local Analgesia Via Infiltration studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A single-arm study of liposomal bupivacaine injection primaryPurpose: PREVENTION masking: NONE count: 232 type: ESTIMATED name: Bupivacaine Liposome Injection measure: The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system measure: The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration measure: Time to first rescue analgesia of opioid measure: The proportion of patients who did not use rescue analgesia during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration measure: The proportion of patients using patient-controlled intravenous analgesia (PCIA) measure: Pain intensity score at rest after administration for children aged 6 to 7 years measure: Pain intensity score at rest after administration for children aged 8 years and older measure: Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years measure: Pain intensity score on movement (or cough) after administration for children aged 8 years and older measure: Length of Stay sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Guangzhou Women and Children's Medical Center city: Guangzhou state: Guangdong zip: 510000 country: China name: Xingrong Song role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06344078 id: SIGMA-d briefTitle: Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR). acronym: SIGMA-D overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: Societa Italiana di Chirurgia ColoRettale class: NETWORK briefSummary: This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months. conditions: Acute Diverticulitis conditions: Stoma Colostomy conditions: Stoma Ileostomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: sigmoid resection and anastomosis / stoma measure: adhesion to guidelines measure: stoma reversal sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda ospedaliera universitaria paolo giaccone status: RECRUITING city: Palermo country: Italy name: francesco ferrara, medicine and surgery role: CONTACT phone: +393343035829 email: frr.fra@gmail.com name: claudio guerci role: CONTACT phone: +393473898094 email: guerci.clau@gmail.com lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06344065 id: 20220102C briefTitle: Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants overallStatus: RECRUITING date: 2023-12-21 date: 2025-05-25 date: 2028-12-25 date: 2024-04-03 date: 2024-04-03 name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1584 type: ESTIMATED name: Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed) name: Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed) name: Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine measure: Immunogenicity results of experimental group and active control group (DTaP) measure: Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T) measure: Immunogenicity results of experimental group sex: ALL minimumAge: 3 Months maximumAge: 3 Months stdAges: CHILD facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention status: RECRUITING city: Nanning state: Guangxi zip: 530028 country: China name: Yi Mo role: CONTACT phone: +86-13788686968 email: 13647272@qq.com lat: 22.81667 lon: 108.31667 hasResults: False

 nctId: NCT06344052 id: SP-002-004 briefTitle: To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma overallStatus: RECRUITING date: 2024-04-09 date: 2026-09-30 date: 2029-03-30 date: 2024-04-03 date: 2024-04-10 name: Stamford Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy.

Researchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms.

* Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment.
* Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment.
* Arm 3 participants will receive daily hedgehog pathway inhibitor only. conditions: Basal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: SP-002 name: Vismodegib measure: Objective response rate measure: Duration of response measure: Progressive free survival measure: Overall survival (OS) measure: Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR) measure: Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity. measure: Number of subjects with delays to SP-002 and/or vismodegib dosing due to toxicity. measure: Incidence and severity of SP-002 and/or vismodegib related AEs. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85006 country: United States lat: 33.44838 lon: -112.07404 facility: Research Site status: NOT_YET_RECRUITING city: Lee's Summit state: Missouri zip: 64064 country: United States lat: 38.91084 lon: -94.38217 facility: Research Site status: RECRUITING city: Cedar Park state: Texas zip: 78613 country: United States lat: 30.5052 lon: -97.82029 facility: Research Site status: NOT_YET_RECRUITING city: Humble state: Texas zip: 77346 country: United States lat: 29.99883 lon: -95.26216 facility: Research Site status: NOT_YET_RECRUITING city: Longview state: Texas zip: 75601 country: United States lat: 32.5007 lon: -94.74049 hasResults: False

 nctId: NCT06344039 id: Floating hip briefTitle: Epidemiological Study of Floating Hip Injuries in Assiut University Hospitals overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-05 date: 2024-04-03 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: Aim of the study is to describe and study the patterns of floating hip injuries and assess the current management in Assiut University Hospitals Trauma Centre to help reach the best approach to plan treatment for these severe and difficult injuries. conditions: Hip Fractures conditions: Hip Injuries studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Incidence of floating hip injuries measure: Patterns of injury sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06344026 id: ANPD001-02 briefTitle: Phase 1/2a Study of ANPD001 in Parkinson Disease acronym: ASPIRO overallStatus: ENROLLING_BY_INVITATION date: 2024-01-23 date: 2025-10-30 date: 2030-04-30 date: 2024-04-03 date: 2024-04-19 name: Aspen Neuroscience class: INDUSTRY name: California Institute for Regenerative Medicine (CIRM) briefSummary: This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease. All participants will have ANPD001 cells manufactured from their own previously collected cells. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open label, dose escalation of bilateral injection of ANPD001 dopaminergic precursor cells to the putamen primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: ANPD001 name: Custom Device measure: Incidence and severity of treatment emergent adverse events (Safety and Tolerability) measure: "ON" time without troublesome dyskinesia measure: Post-injection change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Activities of Daily Living - ADL) and Part III (motor score) in the ON state (total score and scores for Parts I-IV) measure: Post-injection change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the practically defined OFF state measure: Post-injection change in the 18F-DOPA uptake in the putamen measure: Incidence and severity of treatment emergent adverse events during long term follow-up (Continued Safety and Tolerability) sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Arizona - Banner Health city: Tucson state: Arizona zip: 85724 country: United States lat: 32.22174 lon: -110.92648 facility: Scripps Health city: La Jolla state: California zip: 92037 country: United States lat: 32.84727 lon: -117.2742 facility: University of California, Irvine city: Orange state: California zip: 92868 country: United States lat: 33.78779 lon: -117.85311 facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 facility: Feinstein Institutes city: Manhasset state: New York zip: 11030 country: United States lat: 40.79788 lon: -73.69957 hasResults: False

 nctId: NCT06344013 id: 29BRC24.0034 - BUNDLE ABCDEF briefTitle: The ABCDEF Bundle in Critical Care: a French National Survey Still a Long Way to go! overallStatus: COMPLETED date: 2022-07-01 date: 2022-07-31 date: 2022-07-31 date: 2024-04-03 date: 2024-04-03 name: University Hospital, Brest class: OTHER briefSummary: The goal of this observational study is to evaluate the knowledge and compliance of French intensive care units with the ABCDEF (A: Assessment, Prevention, Management of Pain, B: Both Spontaneous Awakening Trials and Spontaneous Breathing Trials, C: Choice of Sedation and Analgesia, D: Delirium Assessment, Prevention, and Management, E: Early Mobility and Exercise, F: Family Engagement and Empowerment) bundle. French ICU doctors will be asked to answer a questionnaire available online. conditions: Delirium studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 341 type: ACTUAL measure: knowledge and compliance of French intensive care units with the ABCDEF sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Brest city: Brest zip: 29609 country: France lat: 48.3903 lon: -4.48628 hasResults: False

 nctId: NCT06344000 id: RICU20240323 briefTitle: Study on Disease Progression and Nutritional Status in Bronchiectasis overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2027-04-15 date: 2024-04-03 date: 2024-04-03 name: Wuhan Union Hospital, China class: OTHER briefSummary: Bronchiectasis is a common lung disease. The Bronchiectasis Severity Index (BSI) is a widely used assessment system. The body mass index (BMI) is a commonly used measure of nutritional status, but it has its limitations. To provide a more comprehensive assessment, the investigators also consider other nutrition-related indices such as upper arm circumference, calf circumference, skinfold thickness and grip strength. The investigators will specify the relationship between nutritional status and disease progression by measuring nutrition-related indicators and tracking participants' disease progression. conditions: Bronchiectasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: inapplicable measure: Frequency of acute exacerbations of bronchiectasis measure: Deterioration of lung function measure: Severity of dyspnoea measure: Bhalla scores on CT of participants' lungs measure: Frequency of hospitalisation measure: Death sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wuhan Union Hospital city: Wuhan state: Hubei zip: 430022 country: China name: Xiaorong Wang role: CONTACT phone: 18627195231 phoneExt: +86 email: rong-100@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06343987 id: 1-10-72-165-23 briefTitle: The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity overallStatus: RECRUITING date: 2024-02-19 date: 2024-12 date: 2025-03 date: 2024-04-03 date: 2024-04-09 name: Aarhus University Hospital class: OTHER name: Danish Cancer Society briefSummary: The goal of this clinical trial is to test a physical activity program in patients with metastatic breast cancer and overweight receiving endocrine-based treatment.

The aim of the study is to assess the feasibility and metabolic efficacy of a 12-week physical activity program in this patient group. The hypothesis is that improving metabolic health through physical activity can optimize cancer care.

Participants will randomized 2:1 to either a physical activity program or care as usual. conditions: Metastatic Breast Cancer conditions: Estrogen-receptor-positive Breast Cancer conditions: Adiposity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Continuous inclusion. Randomized 2:1 - intervention group and observational group, respectively. primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Physical Activity measure: Adherence as assessed by attendance rate measure: Metabolic efficacy assessed by change in metabolic score measure: Perceived satisfaction assessed by qualitative interviews measure: Health-related quality of life as assessed by EORTC-QLQ-30 measure: Cancer coping as assessed by CBI-12 measure: Sleep quality as assessed by PSQI measure: Insomnia as assessed by ISI measure: Change in C-reactive protein measure: Change in leukocytes measure: Change in HbA1c measure: Change in LDL cholesterol measure: Change in HDL cholesterol measure: Change in BMI measure: Fat mass measure: Muscle mass measure: Visceral fat measure: VO2 max measure: Handgrip strength measure: Sit-rising sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oncology, Aarhus University Hospital status: RECRUITING city: Aarhus N state: Central Denmark Region zip: 8200 country: Denmark name: Signe Borgquist, MD, PhD role: CONTACT phone: + 45 22 62 45 25 email: signe.borgquist@auh.rm.dk name: May W Nielsen, Bsc.Med. role: CONTACT phone: +45 29 90 66 05 email: maywni@gmail.com lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06343974 id: 0843 briefTitle: Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2026-05-01 date: 2024-04-03 date: 2024-04-03 name: Turku University Hospital class: OTHER_GOV briefSummary: The goal of this observational study is to compare fetal liver ultrasound radiomics between pregnancies complicated by type 1 diabetes and healthy controls.

The main questions it aims to answer are:

* Are fetal liver ultrasound radiomic features reproducible?
* Does fetal liver ultrasound radiomics differ between pregnancies complicated by type 1 diabetes and healthy controls?

Participants will undergo ultrasound examination to collect ultrasound data for the analyses. conditions: Pregnancy in Diabetic conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Fetal liver ultrasound texture measure: Birth weight in grams measure: Birth weight centile measure: Large for gestational age (LGA) measure: Interventricular septum (IVS) width measure: Number of pregnancies with neonatal hypoglycemia measure: Rate of neonatal hypoglycemia treated with oral dextrose gel measure: Rate of neonatal hypoglycemia treated with intravenous (IV) glucose measure: Length of treatment for neonatal hypoglycemia measure: Number of neonates admitted to neonatal intensive care unit (NICU) measure: Length of NICU admission measure: Number of pregnancies with neonatal respiratory complications related to maternal diabetes measure: Number of pregnancies with neonatal hyperbilirubinemia measure: Maternal HbA1c concentration measure: Glucose management indicator (GMI) measure: Time in glycemic range (TIR) measure: Time above glucose range measure: Time below glucose range sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Turku University Hospital city: Turku country: Finland lat: 60.45148 lon: 22.26869 hasResults: False

 nctId: NCT06343961 id: 2024-76 briefTitle: Intraoperative Application of Fluorescein Sodium Angiography in Vascular Retinopathy overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-12 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Jie Zhong class: OTHER briefSummary: The study used a new surgical technique: intraoperative fluorescence imaging,In the 1980s, some scholars proposed the concept of intraoperative fluorescein angiography.During vitrectomy, intraoperative fluorescein angiography under 3D microscope can guide the surgeon to observe the non-perfusion area and new blood vessels on the same screen for accurate retinal photocoagulation therapy.Through this technology, the primary retinal disease can be identified in time after the removal of vitreous hemorrhage during surgery, providing effective imaging evidence support for the design of further treatment. conditions: Vascular Retinopathy of Left Eye (Disorder) conditions: Vascular Retinopathy of Right Eye (Disorder) conditions: Diabetic Retinopathy conditions: Retinal Vein Occlusion conditions: Retinal Vasculitis conditions: Vitreous Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 80 patients with vitreous hemorrhage diagnosed in Sichuan Provincial People's Hospital from January 2024 to December 2025 were selected. The number of included cases was calculated according to the minimum sample size of 200 patients with vitreous hemorrhage in our hospital, 95% confidence level and 5% confidence interval, and the calculated result was 79. The included cases were equally divided by random number method. 40 patients in the control group were given vitrectomy and other conventional operations such as retinal laser photocoagulation. In contrast group, 40 patients were given vitrectomy combined with intraoperative fluorescein angiography and other conventional operations such as retinal laser photocoagulation. The diagnosis rate of primary disease cause, observation rate of neovascularization and non-perfusion area, visual acuity, visual field, thickness of macular fovea and postoperative complications (ciliary detachment, secondary vitreous hemorrhage, neovascu primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Intraoperative Fluorescein Angiography measure: best corrected visual acuity measure: Central retinal thickness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343948 id: BL-B01D1-306 briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-05 date: 2024-04-03 date: 2024-04-04 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+HER2- breast cancer after failure of at least one prior line of chemotherapy. conditions: HR+HER2- Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 382 type: ESTIMATED name: BL-B01D1 name: Eribulin name: Vinorelbine name: Gemcitabine name: Capecitabine measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Treatment Emergent Adverse Event (TEAE) measure: Anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences city: Beijing state: Beijing country: China name: Binghe Xu role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06343935 id: YY-20394-014 briefTitle: A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-04-30 date: 2025-04-30 date: 2024-04-03 date: 2024-04-03 name: Shanghai YingLi Pharmaceutical Co. Ltd. class: INDUSTRY briefSummary: This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode). conditions: Indolent B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 88 type: ESTIMATED name: Linperlisib measure: Progression free survival measure: Objective response rate measure: Overall survival measure: Adverse event measure: Serious adverse event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343922 id: Sadaf Riphah briefTitle: Oral Motor Facilitation Technique And Traditional Exercises on Children With Cerebral Palsy overallStatus: RECRUITING date: 2023-12-01 date: 2024-04 date: 2024-04 date: 2024-04-03 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21. conditions: Cerebral Palsy (CP) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1 will receive exercises by using oral motor facilitation technique protocol three times a week Group 2 will receive traditional oral motor exercises three times per week primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 10 type: ESTIMATED name: oral motor facilitation technique group name: traditional oral motor exercises group measure: Change in Drooling measure: Change in feeding skills sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD facility: Mobilty Quest status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Mobility Quest role: CONTACT phone: 03336596656 email: mobilityquest@outlook.com name: Nazia Mumtaz, PhD role: PRINCIPAL_INVESTIGATOR name: Sadaf Safdar, BS role: SUB_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06343909 id: REC/RCR & AHS/23/0197Ayesha briefTitle: Foot and Hip Abductor Strengthening in Patients With Knee Osteoarthritis. overallStatus: RECRUITING date: 2023-11-23 date: 2024-06-01 date: 2024-06-01 date: 2024-04-03 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: The study will be Randomized controlled trail, Subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups.

Pre assessment will be done using pain, ROM, function, foot arches and knee alignment as subjective measurement through KOOS questionnaire, goniometer, 2D frontal plane projection, Berkemann foot prints using ink and paper ,30s chair stand test, nine step stair climb,40m fast paced walk test,Global rating of change score respectively . One group will be treated with hip abductor strengthening exercise along with conventional exercises and second group will be treated with intrinsic foot muscle strengthening exercise along with conventional exercises. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Hip abductor strengthening exercise name: Intrinsic foot muscle strengthening along with conventional exercises measure: Knee Osteoarthritis Outcome Score (KOOS) measure: Berkemann foot prints measure: Frontal plane projection measure: Goniometer measure: 30 seconds chair stand test measure: Overall self-perception by Global Rating of Change Score measure: 9 step stairs climb test. measure: 40-m fast-paced walk test sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: THQ hospital KRK. status: RECRUITING city: Lahore state: Punjab country: Pakistan name: Ayesha Anwar, DPT role: CONTACT phone: 03340003448 email: ayeshaanwarali123@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06343896 id: AnkaraCHBilkent-tntaygurt briefTitle: Evaluation of Sedation Depth and Reliability With Integrated Pulmonary Index (IPI) Follow-up in Pediatric Radiological Interventions acronym: IPI overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-15 date: 2024-10-15 date: 2024-04-03 date: 2024-04-05 name: Ankara City Hospital Bilkent class: OTHER briefSummary: In this study, we aimed to investigate the predictability of possible respiratory complications and the effect of the addition of the integrated pulmonary (EPI) score to the evaluation of the patient's respiratory index status in addition to the SPO2 measurement available in standard ASA monitoring in pediatric patients undergoing interventional radiological procedures under sedoanesthesia. conditions: Sedation conditions: BIS conditions: Integrated Pulmonary Index studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 68 type: ESTIMATED name: monitorization reliability measure: EVALUATION OF IPI RELIABILITY IN PEDIATRIC PATIENTS measure: BİS correlation with the IPI measure: pulse oximetry correlation with the IPI measure: noninvasive blood pressure measure: heart rate measure: respiratory rate measure: end tidal carbondioxide measure: apnea and hypoxia conditions that develop in the patient during anesthesia measure: postoperative recovery time measure: intraoperative total dose of medication used measure: postoperative nausea and vomiting sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ankara City Hospital, Bilkent status: RECRUITING city: Ankara country: Turkey name: tugbanur taygurt role: CONTACT phone: +905322005632 email: tugbanurtaygurt@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06343883 id: 24-353 briefTitle: Investigation of Low-intensity Focused Ultrasound Pressure overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2026-07 date: 2024-04-03 date: 2024-04-03 name: Virginia Polytechnic Institute and State University class: OTHER briefSummary: Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI. conditions: Somatic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Primary cohort (safety) will be collected prior to full study collection. Primary collection will involve highest pressure application and follow-up safety scans (MRI) to be reviewed by a Neuroradiologist. Once cleared - parallel design will be utilized for eeg and fMRI cohorts. Both cohorts will receive 3 LIFU pressures randomized over 3 study visits. Electrical stimulations will be applied pre and post LIFU administration to induce somatosensory evoked potentials (SEPs). primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: No masking, no sham. All subjects will receive all conditions, all of which are active. count: 25 type: ESTIMATED name: low-intensity focused ultrasound - low pressure name: low-intensity focused ultrasound - medium pressure name: low-intensity focused ultrasound - high pressure measure: Report of Symptoms Questionnaire measure: MRI measure: EEG measure: fMRI sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fralin Biomedical Research Institute at VTC city: Roanoke state: Virginia zip: 24016 country: United States name: Jessica Florig, MPH role: CONTACT phone: 540-526-2261 email: jnw@vtc.vt.edu name: Wynn Legon, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.27097 lon: -79.94143 hasResults: False

 nctId: NCT06343870 id: ESTIME briefTitle: Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME) acronym: ESTIME overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-01-31 date: 2025-04-30 date: 2024-04-03 date: 2024-04-03 name: University of Sao Paulo General Hospital class: OTHER briefSummary: Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment. conditions: Menopause conditions: Testosterone Deficiency conditions: Estrogen Deficiency studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: testosterone pellet (100 mg) name: Placebo measure: Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms measure: Evaluate response in quality of life and sexual function sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06343857 id: CE-AVEC 878/2022/Oss/AOUFe briefTitle: Joint Self-Assessment Forms for Knee, Ankle and Shoulder overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-01 date: 2024-04-30 date: 2024-04-30 date: 2024-04-03 date: 2024-04-03 name: University Hospital of Ferrara class: OTHER briefSummary: The present study represents the pilot phase of the project aimed at developing anatomical site-specific self-assessment questionnaires (shoulder, knee and ankle) that can advise the subject of the need for an orthopaedic specialist examination.

The pilot phase of the project involves the collection of data from questionnaires in a population of subjects who have requested an orthopaedic consultation for the anatomical site covered by the questionnaire. Each questionnaire consists of questions designed to collect information about the patient's subjective condition.

The data collected from the questionnaires will be used to evaluate the statistical significance (p value) of each question in the questionnaire in relation to the outcome of the orthopaedic specialist visit. Through a multivariate logistic analysis of the answers given by the subject, it will be possible to 'weight' each answer to obtain a final value that gives an indication of an orthopaedic specialist visit. conditions: Osteoarthritis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: self-assessment questionnaire measure: Observation of the distribution of questionnaire responses for each anatomical site. measure: Therapeutic indication of the orthopaedic specialist for each subject participating in the study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica II city: Bologna state: BO country: Italy lat: 44.49381 lon: 11.33875 facility: Unità Operativa di Chirurgia della Spalla I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio city: Milan state: MI country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06343844 id: 49RC23_0070 briefTitle: Disparities in Myocardial Infarction Remodeling According to Gender acronym: REMOVE 2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2039-09-01 date: 2040-07-01 date: 2024-04-03 date: 2024-04-03 name: University Hospital, Angers class: OTHER_GOV briefSummary: Following myocardial infarction, female individuals demonstrate a poorer prognosis, characterized by elevated rates of mortality and heart failure. A primary hypothesis suggests unfavorable cardiac remodeling in women. This remodeling, defined as alterations in cardiac size and shape post-infarction, necessitates repeated non-invasive imaging for study. conditions: Myocardial Infarction conditions: Ventricular Remodeling studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 1650 type: ESTIMATED name: cardiac imaging to assess left ventricular volumes and function measure: Asses left ventricular remodeling disparities between genders measure: Evaluate the evolution of remodeling at Month 3 measure: Assess remodeling changes between inclusion and Month 12 measure: Assess the prevalence of comorbidities and their impact on the effect on the outcome: post-infarction cardiac remodeling with gender (cardiovascular risk factors, renal function, hepatic functionperipheral artery disease, way of life) measure: Explore prognostic disparities between men and women. measure: Evaluate lifestyle habits up to 10 years: outcome anxiety/depression measure: Evaluate lifestyle habits up to 10 years: outcome diet score measure: Evaluate lifestyle habits up to 10 years: outcome physical activity measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy measure: Assess the risk of remodeling based on specific parameters in female subjects: date of first period measure: Assess the risk of remodeling based on specific parameters in female subjects: pregnancy measure: Assess the risk of remodeling based on specific parameters in female subjects: children measure: Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event measure: Assess the risk of remodeling based on specific parameters in female subjects: menopause sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343831 id: IRB23-1646 briefTitle: Quantitative Assessment of Autologous Fat Transfer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-12 date: 2024-04-03 date: 2024-04-03 name: University of Chicago class: OTHER name: National Institutes of Health (NIH) name: University of Houston briefSummary: This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6. conditions: Autologous Fat Grafting studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, MRI, and US are routinely used in practice but will be performed for research purposes in this study. primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6) name: 3-Dimensional (3-D) Photographs (Visit 1- 6) name: Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6) name: Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6) name: BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6) measure: Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging. measure: Change from baseline in quality of life as measured by the BREAST-QTM survey. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343818 id: NIHR301578 briefTitle: Compassion Project: Developing an Empathy-Based Stress Intervention overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-01 date: 2027-08-31 date: 2024-04-03 date: 2024-04-03 name: University of Bath class: OTHER name: National Institute for Health Research, United Kingdom name: Oxford Health NHS Foundation Trust name: Central and North West London NHS Foundation Trust briefSummary: Compassion is recognising that someone is suffering and wanting to help them. Compassion fatigue is a reduction in capacity to feel compassion for others. Secondary trauma is the experience of traumatic responses to hearing about someone else's trauma. Burnout is depersonalisation, emotional exhaustion, and feeling less good at one's job. Compassion fatigue, secondary trauma and burnout can all be referred to as empathy-based stress. This is a problem for healthcare staff and their patients.

Staff experiencing empathy-based stress deliver less high quality care, which can lead to serious consequences for patients. Empathy-based stress is also associated with staff sickness, which is bad for staff and costly to the United Kingdom's National Health Service (NHS).

Child and adolescent mental health (CAMHS) wards are busy, high-pressure environments where families and young people are often upset, resources are stretched, and staff are managing high levels of patient risk of self-harm or suicide.

The principal investigator has already reviewed research on empathy-based stress and interventions to prevent and/or reduce it in mental health ward staff. This evidence has been presented to CAMHS ward staff, managers, commissioners, patients and families and these stakeholders have co-designed an intervention for wards, to reduce empathy-based stress. The intervention aims to help staff to feel better and care better.

This pilot study aims to test and improve our intervention on two CAMHS wards, measuring how useful and well-liked it is, and how feasible it would be to use it and to test it on more wards. Staff on CAMHS wards will be offered a modular intervention including psychoeducation about empathy based stress and ways of combatting it, and workplace stressor and management toolkits. NHS CAMHS ward staff and patients will be asked to complete questionnaires and a subsample of staff will be asked to complete interviews about the process of the intervention. conditions: Reduction of Empathy-Based Stress in Healthcare Staff studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The study uses a repeated AB design on two ward sites to assess feasibility, acceptability and usefulness of a novel intervention for empathy-based stress in staff, and to test feasibility of this study design. It is not assessing efficacy. The extended baseline measure is the control, there is no control group primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff measure: Acceptability of intervention measure: Feasibility of intervention measure: Perceived usefulness of intervention measure: Feasibility of Study measure: Feasibility of gathering data on staff empathy-based stress using the Professional Quality of Life Scale at multiple timepoints measure: Feasibility of assessing health economics data using a Health-related Quality of Life questionnaire measure: Process measures to assess potential mechanisms of change measure: Feasibility of gathering young person and parent/carer data on compassionate care measure: Feasibility of gathering young person and parent/carer data on experience of service measure: Ward-level contextual factors sex: ALL minimumAge: 13 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343805 id: AJX-101 briefTitle: A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i) overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2026-08-15 date: 2027-02-15 date: 2024-04-03 date: 2024-04-18 name: Ajax Therapeutics, Inc. class: INDUSTRY briefSummary: AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an orally administered type II JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor. conditions: Primary Myelofibrosis conditions: Post-Essential Thrombocythemia Myelofibrosis conditions: Post-Polycythemia Vera Myelofibrosis conditions: PMF conditions: PPV-MF conditions: PET-MF studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This dose escalation study will follow a 3+3 cohort design until the RP2D and/or MTD is determined. primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: AJ1-11095 measure: Number of patients with treatment-emergent adverse events as assessed by CTCAE v 5.0. measure: Number of patients with Dose Limiting Toxicities (DLTs) measure: To establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AJ1-11095 measure: To assess clinical response to AJ1-11095 evaluated by the Total Symptom Score (TSS). measure: To assess clinical response to AJ1-11095 evaluated by spleen volume assessments. measure: To assess clinical response to AJ1-11095 evaluated by spleen length assessments. measure: To assess clinical response to AJ1-11095 evaluated through spleen size improvement. measure: To evaluate the Area Under the Curve (AUC) of AJ1-11095 measure: To evaluate the Cmax of AJ1-11095 measure: To evaluate the Tmax of AJ1-11095 measure: To evaluate the half-life of AJ1-11095 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Cancer Center city: Tampa state: Florida zip: 33612 country: United States name: Andrew Kuykendall, MD role: CONTACT phone: 813-745-4639 email: Andrew.Kuykendall@moffitt.org lat: 27.94752 lon: -82.45843 facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States name: Abdulraheem Yacoub, MD role: CONTACT email: ayacoub@kumc.edu lat: 39.11417 lon: -94.62746 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Gabriela Hobbs, MD role: CONTACT phone: 617-724-1124 email: ghobbs@partners.org lat: 42.35843 lon: -71.05977 facility: Dana Farber Cancer Institute city: Boston state: Massachusetts zip: 02115 country: United States name: Jacqueline Garcia, MD role: CONTACT phone: 617-632-1906 email: jacqueline_garcia@dfci.harvard.edu lat: 42.35843 lon: -71.05977 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Stephen Oh, MD role: CONTACT phone: 314-362-8814 email: stoh@wustl.edu lat: 38.62727 lon: -90.19789 facility: Icahn School of Medicine at Mount Sinai city: New York state: New York zip: 10029 country: United States name: John Mascarenhas, MD role: CONTACT phone: 212-241-8839 email: john.mascarenhas@mssm.edu lat: 40.71427 lon: -74.00597 facility: Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States name: Michael Grunwald, MD role: CONTACT phone: 980-442-4363 email: michael.grunwald@atriumhealth.org lat: 35.22709 lon: -80.84313 facility: The Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Uma Borate, MD role: CONTACT phone: 614-685-9828 email: uma.borate@osumc.edu lat: 39.96118 lon: -82.99879 facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Prithviraj Bose, MD role: CONTACT phone: 713-792-7747 email: PBose@mdanderson.org lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06343792 id: RLS-0071-203 briefTitle: Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease acronym: AURORA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-09 date: 2024-04-03 date: 2024-04-03 name: ReAlta Life Sciences, Inc. class: INDUSTRY briefSummary: This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory. conditions: Steroid Refractory GVHD studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: RLS-0071 measure: Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) measure: Overall Response Rate (ORR) of RLS-0071 measure: Incidence of refractoriness (to RLS-0071 +/- ruxolitinib) measure: Overall corticosteroid use measure: Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent) measure: Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria measure: Attainment of Stage 0 or 1 lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD measure: Change or shift in overall Grade of aGvHD measure: Overall survival measure: Non-relapse mortality measure: Duration of hospital stay sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343779 id: PHA022121-C306 briefTitle: Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema acronym: RAPIDe-3 overallStatus: RECRUITING date: 2024-02-26 date: 2026-03 date: 2026-03 date: 2024-04-03 date: 2024-04-03 name: Pharvaris Netherlands B.V. class: INDUSTRY briefSummary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1 or type 2 (HAE-1/2), a proportion of whom are using long-term prophylactic medication for HAE. conditions: Hereditary Angioedema conditions: Hereditary Angioedema Type I conditions: Hereditary Angioedema Type II conditions: Hereditary Angioedema Types I and II conditions: Hereditary Angioedema Attack conditions: Hereditary Angioedema With C1 Esterase Inhibitor Deficiency conditions: Hereditary Angioedema - Type 1 conditions: Hereditary Angioedema - Type 2 conditions: C1 Esterase Inhibitor [C1-INH] Deficiency conditions: C1 Esterase Inhibitor Deficiency conditions: C1 Esterase Inhibitor, Deficiency of conditions: C1 Inhibitor Deficiency studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Deucrictibant, Placebo measure: Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment. measure: Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment. measure: Time to substantial symptom relief, defined as achieving PGI-C rating of at least "better" for 2 consecutive timepoints within 12 hours post-treatment. measure: Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S). measure: Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment. measure: Time to End of Progression (EoP) in attack symptoms within 12 hours. measure: Proportion of study drug-treated attacks requiring rescue medication within 24 hours post-treatment. measure: Proportion of attacks achieving symptom resolution. measure: Time to substantial symptom relief by Angioedema Symptom Rating Scale (AMRA). measure: Time to almost complete or complete symptom relief by AMRA. measure: Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA. measure: Time to EoP in attack symptoms within 12 hours. sex: ALL minimumAge: 12 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Study Site status: RECRUITING city: Paradise Valley state: Arizona zip: 85258 country: United States lat: 33.53115 lon: -111.94265 facility: Study Site status: RECRUITING city: Walnut Creek state: California zip: 94598 country: United States lat: 37.90631 lon: -122.06496 facility: Study Site status: RECRUITING city: Madison state: Mississippi zip: 39110 country: United States lat: 32.46181 lon: -90.11536 hasResults: False

 nctId: NCT06343766 id: RECO6U/24-2022 briefTitle: Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS. overallStatus: COMPLETED date: 2022-11-06 date: 2023-11-05 date: 2023-11-05 date: 2024-04-03 date: 2024-04-03 name: Amina Fouad Farag class: OTHER briefSummary: A Cross-Sectional Study aims to shed light on potential genetic determinants influencing dental caries susceptibility within this demographic and significantly understanding of genetic factors associated with dental caries, particularly within the context of the Egyptian population, providing valuable insights into the genetic aspects of oral health. The research methodology involved a comprehensive examination of these polymorphic loci ENAM, AMBN, TUFT1 and KLK4 and their prevalence, employing rigorous statistical analyses to establish potential correlations between these genetic variants and susceptibility to dental caries. conditions: Dental Caries Secondary to Polymorphisms conditions: Polymorphisms in Enamel Encoding Genes studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 204 type: ACTUAL name: DNA collation and genotyping measure: Polymorphisms in genes associated with enamel formation and mineralization and dental caries susceptibility. sex: ALL minimumAge: 15 Years maximumAge: 22 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Dentistry, October 6 University city: Giza zip: 12511 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06343753 id: FMASU MD46/2024 briefTitle: Quality of Recovery After Laparoscopic Cholecystectomy Comparing Opioid Free Analgesia Versus Opioid Free Anesthesia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-10-01 date: 2024-04-03 date: 2024-04-03 name: Ain Shams University class: OTHER briefSummary: The aim of this study is to compare the quality of recovery from general anesthesia and surgery using the quality of recovery 15 item scale (QoR-15) for participant's receiving opioid-Sparing anesthesia with those receiving standard opioid-containing anesthesia in Patients undergoing a scheduled laparoscopic cholecystectomy. conditions: Quality of Recovery conditions: Pain, Postoperative conditions: Elective Laparoscopic Cholecystectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Opioid free analgesia name: Opioid based Anesthesia measure: Quality of recovery measure: Post operative pain measure: Postoperative Hypoxia measure: Postoperative nausea and vomiting measure: Postoperative bradycardia measure: Postoperative hypotension measure: Postoperative hypertension sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain Shams University city: Cairo country: Egypt name: Ahmed El-ghanam role: CONTACT phone: 201116171706 lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06343740 id: PSY-2324-S-0136 briefTitle: First Evaluation of COMET-Y acronym: COMET-Y overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Accare class: OTHER briefSummary: The goal of this pilot study is to evaluate COMET-Y in 22 adolescents (11-18 years) with various mental health problems and low self-esteem. The main questions is: Does COMET-Y, parallel to care as usual (CAU), improve self-esteem?

Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Youth and therapists will be assessed to evaluate feasibility and acceptability of the COMET-Y training. conditions: Self Esteem conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This pilot study is a pre-post study. primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: COMET-Y measure: Self Esteem measure: Domain-specific Self Esteem measure: Mental Health Problems measure: Quality of life measure: Affect measure: Resilience measure: Ecological Momentary Assessments - Global self-esteem measure: Ecological Momentary Assesments - Goal Based Outcome (GBO) tool for young people measure: Ecological Momentary Assesments - Domain-specific self-esteem sex: ALL minimumAge: 11 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06343727 id: HS25870 (H2023:026) briefTitle: A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-03 date: 2024-04-03 name: Seven Oaks Hospital Chronic Disease Innovation Centre class: NETWORK name: University of Manitoba name: Manitoba Egg Farmers briefSummary: The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:

* To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible.
* To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements.
* To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks. conditions: Kidney Failure conditions: Frailty conditions: Kidney Disease, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is an open-label randomized controlled parallel arm feasibility tria primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Egg white protein pudding name: : Ensure Plus measure: Eligibility to randomization ratio measure: Weekly recruitment rate measure: Adherence to Egg pudding measure: Serum albumin measure: Hand grip strength measure: Change in gait speed measure: Five rep chair stand time measure: Tandem balance time measure: Serum bicarbonate measure: Calcium measure: Urine albumin measure: chloride measure: phosphorus measure: Potassium measure: Sodium measure: HbA1c sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343714 id: FB1003-04-101 briefTitle: A Study of FB1003 in Healthy Subject overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2025-06-30 date: 2025-06-30 date: 2024-04-03 date: 2024-04-03 name: 4B Technologies Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: FB1003 name: Placebo measure: The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with FB1003 or placebo. measure: FB1003 serum concentrations over time measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of FB1003 measure: Presence of anti-FB1003 antibodies over time sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06343701 id: BAİBÜ-SAT4 briefTitle: Investigation of Motor Imaging Skills in Children With Spastic Cerebral Palsy overallStatus: RECRUITING date: 2023-07-18 date: 2024-05-05 date: 2024-06-25 date: 2024-04-03 date: 2024-04-03 name: Abant Izzet Baysal University class: OTHER briefSummary: The aim of this study was to investigate implicit and explicit motor imagery skills in children with spastic cerebral palsy and typically developing children. The main questions it aims to answer are:

* There is a difference between the implicit motor imagery skills of children with bilateral and unilateral CP.
* There is a difference between the explicit motor imagery skills of children with bilateral and unilateral CP.
* There is a difference between the implicit motor imagery skills of children with cerebral palsy and typically developing children.
* There is a difference between the explicit motor imagery skills of children with cerebral palsy and typically developing children. conditions: Cerebral Palsy, Spastic studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Implicit motor imagery name: Explicit motor imagery measure: Explicit motor imagery -1 measure: Explicit motor imagery - 2 measure: Explicit motor imagery - 3 measure: Implicit motor imagery sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi status: RECRUITING city: Zonguldak state: Ereğli zip: 67300 country: Turkey name: Seda AYAZ TAŞ, Phd role: CONTACT phone: 05495458040 email: seda.ayaztas@ibu.edu.tr lat: 41.45139 lon: 31.79305 facility: Bolu Abant İzzet Baysal University status: RECRUITING city: Bolu state: Gölköy/ Bolu zip: 14030 country: Turkey name: Seda Ayaz Taş, Phd role: CONTACT phone: 05495458040 email: seda.ayaztas@ibu.edu.tr lat: 40.73583 lon: 31.60611 facility: Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi status: RECRUITING city: Düzce state: Merkez zip: 81100 country: Turkey name: Seda AYAZ TAŞ, Phd role: CONTACT phone: 05495458040 email: seda.ayaztas@ibu.edu.tr lat: 40.83889 lon: 31.16389 hasResults: False

 nctId: NCT06343688 id: BAIBU-FTR-SAT-5 briefTitle: "Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-04-01 date: 2024-04-03 date: 2024-04-03 name: Abant Izzet Baysal University class: OTHER briefSummary: " Study will investigate the immediate effect of DAFO usage on balance and gross motor functions in individuals with spastic diplegic cerebral palsy. The study is planned to be conducted with children aged 4-15 who have GMFCS levels 1 and 2 and who are willing to participate along with their families at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center. During the dates of the study, children who meet the inclusion criteria will be evaluated. Demographic information such as age, height, and weight will be obtained for the participating children. To classify the gross motor levels of the children, the Gross Motor Function Classification System (GMFCS), the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills will be used. In addition, the Gross Motor Function Measure (GMFM-88) items D and E for assessing motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be assessed in two different ways: with and without DAFO. Data analysis will be conducted by a blinded statistician who is not part of the research team. IBM SPSS 26 (Statistical Package for Social Sciences) will be used for statistical analysis of the data. Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. If continuous variables follow a normal (parametric) distribution, paired sample t-tests will be conducted on pre-test and post-test data. If the data are non-parametric, Wilcoxon test will be used. Pearson chi-square test or Spearman correlation coefficient will be used to determine the relationship between variables based on assumptions. Results will be evaluated at a significance level of p \< 0.05 with a 95% confidence interval." conditions: Diplegic Cerebral Palsy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 38 type: ESTIMATED name: "Assessment of Balance and Lower Extremity Gross Motor Function with and without DAFO" measure: Wii Balance Board measure: "The Gross Motor Function Measure-88 (D-E) (GMFM-88) measure: The Functional Reach Test measure: "The Pediatric Berg Balance Scale (PBBS) measure: "The Eating and Drinking Ability Classification System (EDACS) measure: "The Manual Abilities Classification System (MACS) measure: "The Gross Motor Function Classification System (GMFCS) measure: "The Communication Function Classification System (CFCS) sex: ALL minimumAge: 4 Years maximumAge: 15 Years stdAges: CHILD hasResults: False

 nctId: NCT06343675 id: Dnr 2024-00620-01 briefTitle: Systematic Health-promoting Work Environment Management in Dentistry overallStatus: RECRUITING date: 2024-04-04 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-05 name: Linkoeping University class: OTHER_GOV briefSummary: Research shows that the workplace is an important arena where much can be done to promote a sustainable working life while maintaining health. However, there is a lack of knowledge that is specific to dental care with regard to managers' and employees' perceptions of the work environment, systematic work environment management and work adaptations, as well as what measures in the workplace are necessary to create a health-promoting and sustainable work environment. There is also a lack of knowledge regarding what support employees and managers need in the systematic work environment management and what individual workplace adaptations that can work within dental care organizations. conditions: Occupational Health studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: There is no intervention measure: Work Ability Single Item Scale (WAS) measure: Work Ability physical demands measure: Work Ability mental demands measure: Sick leave measure: Structured Multidisciplinary Work Evaluation Tool (SMET) measure: Satisfaction with work measure: Global Health measure: Perceived stress measure: Health problems related to work measure: Pain during last 7 days measure: Psychological safety measure: Work environment problems measure: Health related problems measure: Questions about workplace improvements, work adjustments, and support in the workplace measure: Work adjustment and discomfort measure: Support and meaning in work measure: Sustainable work life measure: Systematic work environment management and safety measure: Targeted questions to managers measure: Work environment responsibility and measures measure: Work environment management support and education measure: Background data measure: Semi-structured individual interview study with managers, sub-study 2 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Occupational and Environmental Medicine Centre status: RECRUITING city: Linköping zip: 581 85 country: Sweden name: Anneli Peolsson, Prof., PhD role: CONTACT phone: +46700850599 email: Anneli.Peolsson@regionostergotland.se name: Carlotte Wåhlin, Assoc. Prof, PhD role: CONTACT phone: +46101036267 email: Charlotte.Wahlin@regionostergotland.se lat: 58.41086 lon: 15.62157 hasResults: False

 nctId: NCT06343662 id: Meraki_Acquired Brain Injury briefTitle: Group Music Therapy for Acquired Brain Injury acronym: Meraki_ABI overallStatus: RECRUITING date: 2024-03-01 date: 2024-07 date: 2025-07 date: 2024-04-02 date: 2024-04-15 name: University of Valencia class: OTHER briefSummary: The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI. conditions: Acquired Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: MERAKI_ABI measure: Change in Discomfort ( Baseline (3 Assessments), Pre- Post) measure: Barthel Index measure: Pfeiffer Short Form Mental State Questionnaire, SPMSQ measure: Charlson Comorbidity Index (CCI), sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Dr. Moliner status: RECRUITING city: Serra state: Valencia country: Spain name: Miguel Fombuena, PhD role: CONTACT email: fombuena_mig@gva.es name: Selene Valero-Moreno, PhD role: SUB_INVESTIGATOR name: Isabel Bellver Vercher role: SUB_INVESTIGATOR name: Ana Alegre Soler role: SUB_INVESTIGATOR name: José Jorge Botella Trellis, Dr. role: SUB_INVESTIGATOR name: Cristina Rocío Espejo Fernández, Dra. role: SUB_INVESTIGATOR name: María Carmen Badía Picazo, Dra. role: SUB_INVESTIGATOR lat: 39.68333 lon: -0.43333 hasResults: False

 nctId: NCT06343649 id: CEUMA 187-2023-H briefTitle: Explicit Motor Imagery in Persistent Pelvic Pain overallStatus: COMPLETED date: 2023-11-01 date: 2023-11-30 date: 2023-11-30 date: 2024-04-02 date: 2024-04-23 name: University of Valencia class: OTHER briefSummary: The goal of this clinical trial is to compare the response of Explicit Motor Imagery interventions in patients suffering Persistent Pelvic Pain. The main question it aims to answer is:

• Does the modality of application of Explicit Motor Imagery, either through visual or auditory stimuli, influence the response in patients suffering Persistent Pelvic Pain?

Participants will receive an online Explicit Motor Imagery program either through visual inputs or auditory inputs. They will be instructed to follow the program en register their response.

Researchers will compare visual Explicit Motor Imagery and auditory Explicit Motor Imagery to see if different inputs generate different responses in patients suffering Persistent Pelvic Pain. conditions: Pelvic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 49 type: ACTUAL name: Visual name: Auditory measure: Numerical Rating Scale measure: Pain Vigilance and Awareness Questionnaire measure: Movement Imagery Questionnaire-Revised sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06343636 id: VG3927-02.101 briefTitle: A Phase 1 Study of VG-3927 in Healthy Adults overallStatus: ENROLLING_BY_INVITATION date: 2023-09-27 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Vigil Neuroscience, Inc. class: INDUSTRY briefSummary: A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927 in Healthy Adults conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: VG-3927 name: Placebo measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Clinical Pharmacology of Miami city: Miami state: Florida zip: 33014 country: United States lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06343623 id: fac.med.2018.15 briefTitle: Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure overallStatus: COMPLETED date: 2018-10-12 date: 2022-10-16 date: 2022-10-16 date: 2024-04-02 date: 2024-04-02 name: Minia University class: OTHER briefSummary: Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall conditions: Velopharyngeal Insufficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 150 type: ACTUAL name: myomucosal resection and direct closure name: superiorly based flap measure: Improvement in the speech outcome measure: obstructive sleep apnea sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Faculty of medicine city: Minya zip: 61511 country: Egypt lat: 28.10988 lon: 30.7503 hasResults: False

 nctId: NCT06343610 id: VIST TO-UV 01-2024 briefTitle: The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose acronym: VIST-TO-UV overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-10 date: 2024-04-02 date: 2024-04-02 name: VIST - Faculty of Applied Sciences class: OTHER briefSummary: This is a double-blind, randomized, placebo-controlled interventional study of the effect of multiple-dose dietary intake on minimal erythema dose and other skin parameters. conditions: Minimal Erythema Dose studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Active product name: Placebo measure: Change of minimal erythema dose measure: Change of redness formation sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VIST - Faculty of Applied Sciences, Institute of Cosmetics status: RECRUITING city: Ljubljana zip: 1000 country: Slovenia name: Katja Zmitek, PhD role: CONTACT phone: 002831700 email: katja.zmitek@vist.si name: Katja Žmitek, PhD role: PRINCIPAL_INVESTIGATOR name: Tina Pogačnik, MSc role: SUB_INVESTIGATOR name: Petra Keršmanc, MSc role: SUB_INVESTIGATOR name: Sara Jereb, Msc role: SUB_INVESTIGATOR lat: 46.05108 lon: 14.50513 hasResults: False

 nctId: NCT06343597 id: 037.HPB.2020.R briefTitle: Volume Outcome Relationships and Effects overallStatus: RECRUITING date: 2020-06-15 date: 2025-06-15 date: 2025-06-15 date: 2024-04-02 date: 2024-04-02 name: Methodist Health System class: OTHER briefSummary: This is a retrospective analysis to assess if high-volume hospital facilities experience greater or lesser rates of incidence in patients with esophageal cancer than low-volume facilities. conditions: Esophageal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED measure: Esophageal Cancer resection in patients in high volume (more than 5 esophagectomy performed per year) and low volume (less than 5 esophagectomy performed per year) hospital facilities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Richardson Medical Center status: RECRUITING city: Richardson state: Texas zip: 75082 country: United States name: Crystee Cooper, DHEd role: CONTACT phone: 214-947-1280 email: clinicalresearch@mhd.com name: Zaid Haddadin, MS role: CONTACT phone: 2149471280 email: clinicalresearch@mhd.com name: Dhiresh Jeyarajah, MD role: PRINCIPAL_INVESTIGATOR lat: 32.94818 lon: -96.72972 hasResults: False

 nctId: NCT06343584 id: 023.NUR.2021.M briefTitle: Are Personal Smartphones Hurting Work-Life Balance for Nurse Managers? overallStatus: COMPLETED date: 2021-07-01 date: 2022-05-06 date: 2022-05-06 date: 2024-04-02 date: 2024-04-02 name: Methodist Health System class: OTHER briefSummary: For leadership positions with only a handful of staff under their direct chain of command, this may not be all-consuming and detrimental to work-life balance. But for NMs with upwards of 100 direct reports, this can make for a never-ending stream of contact points. This study will implement several communication and behavioral strategies to determine how using provided smartphone tools impact work-life balance and professional burnout. conditions: Burnout studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6 type: ACTUAL name: Study will conducted over a six-month period using a quasi-experimental Pre-test/Post-test design using Stamm's (2009) ProQOL Scale. measure: • Impact of smartphone tool utilization will be measured using a pre-study survey and post-study survey using the Professional Quality of Life (ProQOL) Scale (Stamm, 2009). measure: • Participants in Group 1 will self-report on the post-study survey (Appendix D1) the number of tools implemented during the study duration. measure: • Participants in Group 1 will self-report on the post-study survey (Appendix D1) the frequency of tool utilization during the study duration using a Likert scale. measure: • Participants in Group 2 will self-report on the post-study survey (Appendix D2) using the ProQOL Scale. measure: • Responses to the post-study survey from participants in Group 2 will be compared to participants in Group 1 to determine if utilizing a separate work smartphone during business hours has a greater improvement on work-life balance and burnout. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Mansfield Medical Center city: Mansfield state: Texas zip: 76063 country: United States lat: 32.56319 lon: -97.14168 hasResults: False

 nctId: NCT06343571 id: MED-EL_CRD_2022_12 briefTitle: Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode acronym: LOTOS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-08 date: 2024-04-02 date: 2024-04-02 name: MED-EL Elektromedizinische Geräte GesmbH class: INDUSTRY briefSummary: This retrospective study aims at analysing data from clinical routine as anonymized data sets. The study aims at analysing clinical data from MED-EL Cochlear Implant (CI) recipients using a FLEX electrode array. conditions: Cochlear Implants studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED measure: Evaluate short and long term longitudinal clinical performance data from MED-EL CIs to assess their clinical effectiveness and safety. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343558 id: 24C302 briefTitle: Gait and Balance Impairment in Rare and Very Rare Neurological Diseases acronym: GALVANISE overallStatus: RECRUITING date: 2023-05-30 date: 2027-05-01 date: 2027-05-01 date: 2024-04-02 date: 2024-04-02 name: Istituto Auxologico Italiano class: OTHER name: IRCCS Istituto Neurologico Carlo Besta briefSummary: Rare and very rare neurological diseases primarily or exclusively affect the nervous system with a prevalence of \< 5 out of 10'000 and 100'000 people, respectively. Besides these, there are undiagnosed neurological diseases: neurological conditions without a diagnosis after completing a full diagnostic examination.

Rare, very rare, and undiagnosed neurological diseases are complicated and progressive and often cause variegated motor signs, impairments, and syndromes.

Balance and gait are frequently affected in these conditions, already at the clinical examination. These balance and gait impairments limit activities and cause an increased risk of falling. Falls can eventually result in injuries, even severe.

There are only a few studies about these diseases, likely because of their rarity. Hence, the clinical presentation and the course of rare and very rare diseases are poorly known or even unknown. Essential information for these conditions' diagnosis, prognosis, treatment and rehabilitation is missing.

MaNeNeND is an observational study underway at the Fondazione IRCCS Istituto Neurologico "Carlo Besta" (Milano) aimed at detailing the clinical and biological features of very rare and undiagnosed neurological diseases.

Research questions:

1. Do patients with rare (Ra), very rare (V) and undiagnosed (U) neurological diseases suffer a balance and gait impairment?
2. Is there a correlation between the clinical and instrumental severity of the balance and gait impairment in RaVU neurological diseases?
3. Are instrumental measures more sensitive in detecting balance and gait impairments in patients affected by a RaVU neurological disease than the clinical measures?
4. Do the balance and gait impairments in RaVU neurological diseases worsen in time?

The current project aims at diagnosing, quantifying and detailing the balance and gait impairment in rare, very rare and undiagnosed neurological diseases.

To this aim, questionnaires, clinical scales and instrumental tests will be administered to these patients to collect a wide range of balance and gait measures.

These measures will also integrate those collected with MaNeNeND to provide a more detailed description of patients with rare, very rare and diagnosed neurological diseases.

Participants will complete two questionnaires: the Dizziness Handicap Inventory - short form (DHI-sf, an ordinal score of self-perceived balance) and the Modified Fatigue Impact Scale (MFIS, an ordinal score of self-perceived fatigue).

Moreover, a clinician will administer the Mini Balance Evaluation Systems Test (Mini-BESTest, an ordinal score of balance), the 10 m walking test (for measuring the gait speed and other gait parameters) and the Timed Up and Go test (an instrumental measure of mobility and balance). Walking and the Timed Up and Go tests will be recorded with a trunk-worn inertial measurement unit.

Finally, participants will be asked to complete an instrumental upright stance and gait assessment, the first consisting of standing on posturographic plates and the second of walking on a treadmill equipped with force sensors. When walking on the treadmill, an optoelectronic system will also record the position in time of limbs and trunk.

The quantification of the severity of the balance and gait impairment of the patients suffering a rare, very rare or undiagnosed neurological disease will highlight these persons' therapeutic and rehabilitative needs.

Comparing the balance and gait impairment of rare, very rare and undiagnosed diseases with those of multiple sclerosis, Parkinson's disease and peripheral neuropathy will highlight if the formers' balance and gait impairment has unique characteristics that could help ease the diagnosis of these uncommon conditions.

The longitudinal measurements on rare, very rare and undiagnosed diseases will be paramount to identifying prognostic factors.

In addition, the data collected in the current study will be crucial for future studies, for example, for estimating the sample size in clinical trials. conditions: Multiple Sclerosis conditions: Parkinson Disease conditions: Peripheral Neuropathy conditions: Rare Diseases conditions: Healthy conditions: Healthy Aging studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Questionnaires, clinical scales and instrumental tests measure: Balance (Mini-BESTest) measure: Balance (Timed Up and Go test) measure: Gait speed measure: Gait analysis - kinematic - stride length measure: Gait analysis - kinematic - duration measure: Gait analysis - kinematic - width of the base of support measure: Gait analysis - kinematic - dorsal ankle angle measure: Gait analysis - dynamic - reaction force measure: Gait analysis - dynamic - ankle power measure: Gait analysis - dynamic - energy measure: Posturography - static - centre of pressure position measure: Posturography - static - centre of mass position measure: Posturography - dynamic - centre of pressure position measure: Posturography - dynamic - centre of mass position sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano status: RECRUITING city: Milano state: Milan country: Italy name: Antonio Caronni, MD, PhD role: CONTACT phone: 02 619111 email: a.caronni@auxologico.it lat: 45.46427 lon: 9.18951 facility: IRCCS Istituto Neurologico Carlo Besta status: ACTIVE_NOT_RECRUITING city: Milano country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06343545 id: Rehab_PROADI briefTitle: Evaluation of the Impact of Rehabilitation Strategies and Early Discharge After Respiratory Failure acronym: Rehab overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-07-30 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: Hospital Israelita Albert Einstein class: OTHER briefSummary: To evaluate, through a randomized clinical trial in groups/clusters (stepped wedge), the impact of specific bundles for disability prevention and early rehabilitation, focused on 3 domains (ICU, Ward and post-discharge), on health-related quality of life and other long- and short-term outcomes in critically ill patients affected by hypoxemic acute respiratory failure with suspected COVID-19. conditions: Acute Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Cluster crossover randomized trial primaryPurpose: TREATMENT masking: NONE count: 2000 type: ESTIMATED name: Standard of Care name: Rehabilitation measure: Quality of life measure: Mortality measure: Days alive and free of hospital measure: Rehospitalization measure: Return to work measure: Anxiety and Depression measure: New disability measure: Disability measure: Clinical Status measure: Cognitive impairment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343532 id: NIDA-SXC-Ph1b-001 briefTitle: SXC-2023 Cocaine Interaction Study overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2024-12 date: 2024-04-02 date: 2024-04-02 name: National Institute on Drug Abuse (NIDA) class: NIH name: Promentis Pharmaceuticals, Inc. name: Altasciences Company Inc. name: Technical Resources International, Inc. briefSummary: The goal of this clinical trial is to determine whether there are any interactions between the study drug and cocaine. Researchers will compare a treatment group and a placebo group to see if they experience any effects when administered cocaine after taking the treatment/placebo. conditions: Cocaine Use Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: SXC-2023 name: SXC-2023 Placebo measure: Determine Safety and Tolerability of Oral SXC-2023 Co-administered with Intravenous Cocaine by Collecting Vital Signs and Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Altasciences Clinical Kansas, Inc. city: Overland Park state: Kansas zip: 66212 country: United States name: Debra J Kelsh, MD role: CONTACT phone: 913-696-1601 email: DKelsh@altasciences.com name: Debra J Kelsh, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 hasResults: False

 nctId: NCT06343519 id: Shocked Patients Monitoring briefTitle: Echocardiographic and Laboratory Findings in Hemodynamic Monitoring of Shocked Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-03 date: 2026-05 date: 2024-04-02 date: 2024-04-02 name: Assiut University class: OTHER briefSummary: Shocked patients require prompt and accurate assessment of their hemodynamic status to guide appropriate management. Echocardiography is a valuable tool for assessing cardiac function, while laboratory parameters such as mixed venous oxygen saturation and arterial blood lactate provide insights into tissue perfusion and oxygen metabolism. This study aims to compare echocardiographic findings, including cardiac index, speckle tracking parameters, and tissue Doppler indices, with laboratory findings in the evaluation of hemodynamic monitoring in shocked patients. conditions: Shock studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Echocardiography measure: Change in Shock Status After Fluid Therapy Based on Echocardiographic Assessment of Fluid Responsiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343506 id: 2023-929-EXPEDITED briefTitle: Ankle Dorsiflexion Changes With Assisted Stretching Device overallStatus: RECRUITING date: 2023-10-30 date: 2024-06-01 date: 2024-12-31 date: 2024-04-02 date: 2024-04-04 name: Montana State University class: OTHER briefSummary: Ankle range of motion is an important degree of freedom for performing activities of daily living. Limited range of ankle motion has been related to Achilles tendonitis, lower limb injury, and abnormal gait leading to overuse injury. While stretching and massage can help increase range of motion the amount and frequency of manual manipulation needed to affect range of motion is not accessible to an individual in their home. A new device has been developed to allow deep stretching of the ankle and surrounding muscles to help increase ankle dorsiflexion. This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The goal of this study is to determine the effect of using this device during a course of treatment to improve ankle dorsiflexion in individuals with decreased ankle range of motion. conditions: Physical Therapy Modality studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 10 type: ESTIMATED name: Grassroots Ankle Flex measure: Ankle Range of Motion measure: Ankle Strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neuromuscular Biomechanics Laboratory status: RECRUITING city: Bozeman state: Montana zip: 59717 country: United States name: Corey Pew, PhD role: CONTACT phone: 406-994-6769 email: Corey.Pew@montana.edu lat: 45.67965 lon: -111.03856 hasResults: False

 nctId: NCT06343493 id: JALTAF briefTitle: Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery overallStatus: COMPLETED date: 2023-06-16 date: 2023-12-15 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Rawalpindi Medical College class: OTHER briefSummary: Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50°C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure.

This randomized controlled trial was conducted on 60 patients divided into two groups (30 each). Group A was the interventional group in which patients were irrigated with saline of 50°C during surgery. Group B was the control group where room temperature saline was used. Operative field was assessed using the Boezaart score, duration of surgery and bleeding in ml.

KEY WORDS:

* Chronic rhinosinusitis (CRS)
* Endoscopic sinus surgery
* Boezaart score conditions: Rhinosinusitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Normal saline heated up to 50 °C measure: Boezaart Score measure: Bleeding in ml measure: Duration of Surgery sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Benazir Bhutto Hospital city: Rawalpindi state: Punjab zip: 46000 country: Pakistan lat: 33.6007 lon: 73.0679 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-16 uploadDate: 2024-03-29T12:12 filename: Prot_SAP_000.pdf size: 142077 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-06-16 uploadDate: 2024-03-24T04:58 filename: ICF_001.pdf size: 48384 hasResults: False

 nctId: NCT06343480 id: SMVOT2024CT briefTitle: Misoprostol Versus Oxytocin for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term overallStatus: COMPLETED date: 2020-09-01 date: 2021-08-31 date: 2021-11-30 date: 2024-04-02 date: 2024-04-02 name: Federal Teaching Hospital Abakaliki class: OTHER_GOV briefSummary: Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes. conditions: Labor Onset and Length Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 120 type: ACTUAL name: Labour Induction measure: Mean induction delivery interval sex: FEMALE minimumAge: 15 Years maximumAge: 44 Years stdAges: CHILD stdAges: ADULT facility: Alex Ekwueme Federal University Teaching Hospital city: Abakaliki state: Ebonyi zip: 480001 country: Nigeria lat: 6.32485 lon: 8.11368 facility: Federal Teaching Hospital, Abakaliki city: Abakaliki state: Ebonyi zip: 480001 country: Nigeria lat: 6.32485 lon: 8.11368 hasResults: False

 nctId: NCT06343467 id: A17-376 briefTitle: Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost? overallStatus: COMPLETED date: 2022-11-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-02 date: 2024-04-02 name: HealthPartners Institute class: OTHER briefSummary: Across orthopedics, the investigators will be using the generic volar locking plates for patients undergoing open reduction and internal fixation (ORIF) of the distal radius using a block schedule, meaning one month we the generic implants and one month we use conventional implants from the surgeon's brand of choice. At the end of each month the health system will switch which type of implants (generic vs. conventional) they will use at their facilities. From a quality perspective each patient will be monitored both short and long term for complication and reoperation. This will be done through chart review. conditions: Distal Radius Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Surgeons alternated between using generic implants and conventional implants in their distal radius fracture patients over the course of six months. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients underwent the standard surgical consent, however the specific plate vendor that was used, was not specified by the physician. whoMasked: PARTICIPANT count: 101 type: ACTUAL name: Generic Volar Locking Plate name: Conventional Volar Locking Plate measure: 90-day reoperation rate measure: 90-day readmission rate measure: 90-day mortality rate measure: Implant Cost measure: Tourniquet Time measure: Estimated Blood Loss sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Regions Hospital city: Saint Paul state: Minnesota zip: 55101 country: United States lat: 44.94441 lon: -93.09327 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-08-16 uploadDate: 2024-03-14T00:31 filename: Prot_SAP_000.pdf size: 218626 hasResults: False

 nctId: NCT06343454 id: 2023/04-03(KA-22111) briefTitle: The Effect of Different Head Positions on Occlusal Contacts During Digital Interocclusal Bite Registration overallStatus: COMPLETED date: 2023-10-25 date: 2024-01-27 date: 2024-03-03 date: 2024-04-02 date: 2024-04-02 name: Hacettepe University class: OTHER briefSummary: The goal of this clinical trial is to learn about different head position's effect on occlusal contacts during digital interocclusal record. The main question aims to answer is:

• Are different head positions in physiological limits can be affected the occlusal contact during interocclusal record? Participants will be asked to stand in three different physiological head positions (neutral, forward and backward) which are common in daily routine. In these positions, after maxillary and mandibular arch scans three different interocclusal records will be taken. Also for assessment of these records in digital occlusal analysis module (oJMA, zebras), three different oJMA record will be taken.

Researchers will compare neutral, forward and backward head positions to see if there are any difference in number, density and location of occlusal contacts. conditions: Occlusion studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 36 type: ACTUAL name: Digital Interocclusal Record In Different Head Positions measure: Number of Occlusal Contacts measure: Density of Occlusal Contacts measure: Location of Occlusal Contacts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-04-17 uploadDate: 2024-03-29T04:39 filename: Prot_SAP_000.pdf size: 212403 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-04-17 uploadDate: 2024-03-29T04:39 filename: ICF_001.pdf size: 97067 hasResults: False

 nctId: NCT06343441 id: SH9H-2024-T29-2 briefTitle: Accuracy of Two Methods of Making Impressions for Complete-arch Implant Supported Fixed Prosthesis overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis conditions: Edentulous Jaw studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: intraoral scan name: open tray impression measure: Grade of framework passive fit sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343428 id: IEO 1519 briefTitle: Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients acronym: TAPIOCA overallStatus: RECRUITING date: 2021-07-19 date: 2024-07-19 date: 2026-07-19 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: The 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated neuroendocrine neoplasms (NENs) that called neuroendocrine tumors (NETs) G3 in pancreatic NENs classification and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs.

The new classification made it possible to separate NETs G3 from high-grade, poorly-differentiated, NENs that are called neuroendocrine carcinomas (NECs).

However, in clinical practice, we observed that several clinical, pathological and radiological differences are arising among NET G3 patients, suggesting that a multiparametric definition of NET G3 is needed. conditions: Neuroendocrine Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Immunohistochemical characteristics analysis measure: Review of the functional imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Francesca Spada, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06343415 id: H-23052844 briefTitle: Robot-assisted Training After Traumatic Brain Injury and Disorders of Consciousness overallStatus: RECRUITING date: 2024-04-16 date: 2025-04-30 date: 2025-07-31 date: 2024-04-02 date: 2024-04-17 name: Christina Kruuse class: OTHER briefSummary: The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after traumatic brain injury and disorders of consciousness. The main questions it aims to answer are:

* Is the protocol feasible concerning inclusion in the study?
* Is the protocol feasible concerning protocol completion? Participants will randomly be assigned to either five days of robot-assisted gait training (GAIT), two days of pause, then five days of robot-assisted step training (STEP) or vice versa.

The investigators will explore and compare safety events, physiological measures and physical activity levels, behavioural measures, and functional disability outcomes. Further, the investigators report intervention and technical parameters in detail. conditions: Traumatic Brain Injury conditions: Disorders of Consciousness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: AB - BA primaryPurpose: OTHER masking: SINGLE maskingDescription: Assessors are blinded to allocation for the following exploratory clinical outcome scales: "Disability Rating Scale" and "Coma Recovery Scale-Revised".

Data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results. whoMasked: OUTCOMES_ASSESSOR count: 17 type: ESTIMATED name: GAIT-assisted training name: STEP-assisted training measure: Inclusion Rate measure: Completion Ratio of protocols measure: Exploratory Safety Outcomes measure: Disability Rating Scale (DRS) measure: Coma Recovery Scale-Revised (CRS-R) and level of consciousness measure: Early Functional Abilities (EFA) measure: Functional Independence Measure (FIM) measure: Physical activity intensity measure: Mean arterial pressure (MAP) measure: Heart Rate Variability (HRV) measure: Behavioural Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of brain and spinal cord injury status: RECRUITING city: Glostrup state: Greater Copenhagen zip: 2600 country: Denmark name: Christina Kruuse, Professor role: CONTACT email: christina.kruuse@regionh.dk name: Vibeke Wagner, MSc role: PRINCIPAL_INVESTIGATOR lat: 55.6666 lon: 12.40377 hasResults: False

 nctId: NCT06343402 id: TBBO8520-101 id: ONKORAS-101 type: OTHER domain: TheRas briefTitle: Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-04 date: 2027-08 date: 2028-02 date: 2024-04-02 date: 2024-04-22 name: TheRas, Inc class: INDUSTRY briefSummary: A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer conditions: Non-small Cell Lung Cancer conditions: Metastatic Non-Small Cell Lung Cancer conditions: NSCLC conditions: KRAS G12C conditions: Metastatic Lung Cancer conditions: Advanced Lung Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1a: sequential/parallel, Phase 1b: parallel primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: BBO-8520 name: Pembrolizumab measure: Adverse Events measure: Dose-limiting toxicities (DLTs) measure: To evaluate preliminary antitumor activity of BBO-8520 measure: To evaluate preliminary antitumor activity of BBO-8520 measure: Overall Survival (OS) measure: To characterize the pharmacokinetics (PK) of BBO-8520 measure: To characterize the pharmacokinetics (PK) of BBO-8520 measure: To characterize the pharmacokinetics (PK) of BBO-8520 measure: To characterize the pharmacokinetics (PK) of BBO-8520 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: SCRI Oncology Partners status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: NEXT Oncology status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 facility: Peter MacCallum Cancer Centre status: RECRUITING city: Melbourne state: Victoria zip: 3051 country: Australia lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06343389 id: Soh-Med-24-03-14MS briefTitle: Acute Kidney Injury in Patients With Liver Cirrhosis overallStatus: RECRUITING date: 2024-04 date: 2024-10 date: 2025-04 date: 2024-04-02 date: 2024-04-02 name: Sohag University class: OTHER briefSummary: In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at Sohag University Hospital. conditions: Acute Kidney Injury in Patients With Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: serum creatinine measure: Incidence of acute kidney injury in cirrhotic patients in Sohag University Hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag University Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06343376 id: I-3641523 id: NCI-2024-01818 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3641523 type: OTHER domain: Roswell Park Cancer Institute briefTitle: Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2029-04-15 date: 2024-04-02 date: 2024-04-02 name: Roswell Park Cancer Institute class: OTHER briefSummary: This phase I trial tests the safety, side effects, and best dose of genetically engineered cells called EGFRt/19-28z/IL-12 CAR T cells, and to see how they work in treating patients with hematologic malignancies that makes a protein called CD19 (CD19-positive) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Chimeric Antigen Receptor (CAR) T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. To improve the effectiveness of the modified T cells and to help the immune system fight cancer cells better, the modified T cells given in this study will include a gene that makes the T cells produce a cytokine (a molecule involved in signaling within the immune system) called interleukin-12 (IL-12). The researchers think that IL-12 may improve the effectiveness of the modified T cells, and it may also strengthen the immune system to fight cancer. Giving EGFRt/19-28z/IL-12 CAR T cells may be safe and tolerable in treating patients with relapsed or refractory CD19+ hematologic malignancies. conditions: Recurrent Chronic Lymphocytic Leukemia conditions: Recurrent Diffuse Large B-Cell Lymphoma conditions: Recurrent Follicular Lymphoma conditions: Recurrent High Grade B-Cell Lymphoma conditions: Recurrent Mantle Cell Lymphoma conditions: Recurrent Transformed Chronic Lymphocytic Leukemia conditions: Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma conditions: Refractory Chronic Lymphocytic Leukemia conditions: Refractory Diffuse Large B-Cell Lymphoma conditions: Refractory Follicular Lymphoma conditions: Refractory High Grade B-Cell Lymphoma conditions: Refractory Mantle Cell Lymphoma conditions: Refractory Transformed Chronic Lymphocytic Leukemia conditions: Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Bone Marrow Aspiration name: Bone Marrow Biopsy name: Computed Tomography name: Cyclophosphamide name: Echocardiography name: EGFRt/19-28z/IL-12 CAR T-lymphocytes name: Fludarabine Phosphate name: Leukapheresis name: Multigated Acquisition Scan name: Positron Emission Tomography measure: Incidence of adverse events measure: Maximal tolerated dose (MTD) of EGFRt/19-28z/IL-12 chimeric antigen receptor T-cells measure: Incidence of complete remission (CR)/complete remission with incomplete count recovery (CRi) measure: Incidence of CR/CRi + partial response (PR) (ORR) measure: Event free survival measure: Overall survival measure: Progression-free survival measure: Modified T-cell persistence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Francisco J. Hernandez-ILizaliturri role: CONTACT phone: 716-845-1642 email: Francisco.Hernandez@RoswellPark.org name: Francisco J. Hernandez-ILizaliturri role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06343363 id: 318352 briefTitle: Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety acronym: EARLY-Edge overallStatus: RECRUITING date: 2023-05-01 date: 2025-05 date: 2025-12 date: 2024-04-02 date: 2024-04-02 name: Oxford University Hospitals NHS Trust class: OTHER name: Edwards Lifesciences briefSummary: Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives.

Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay.

This prospective, observational cohort study will examine the safety and feasibility of this practice. conditions: Mitral Regurgitation conditions: Tricuspid Regurgitation conditions: Mitral Repair conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Early discharge protocol measure: Proportion of patients discharged 'early' after edge -to-edge repair measure: All - cause rehospitalisation after completion of procedure measure: All cause death after completion of procedure measure: Hospital length of stay measure: Proportion of patients requiring intensive care unit care measure: Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days measure: Symptomatic improvement measure: Heart failure hospitalisation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: John Radcliffe Hospital status: RECRUITING city: Oxford state: Oxfordshire zip: OX3 9DU country: United Kingdom name: Sam Dawkins, MBBS MRCP BSc DPhil role: CONTACT email: Sam.Dawkins@ouh.nhs.uk lat: 51.75222 lon: -1.25596 hasResults: False

 nctId: NCT06343350 id: OPTDR01P briefTitle: OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-02 name: Optain Health class: INDUSTRY briefSummary: In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates.

A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR. conditions: Diabetic Retinopathy conditions: Diabetes studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED name: OPTDR01 software application measure: Enrollment rate of eligible participants at clinical site sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Precision Research Institute city: San Diego state: California zip: 92114 country: United States name: Marie Inocentes role: CONTACT phone: 619-501-0371 phoneExt: 310 email: marie@prisandiego.com lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06343337 id: MSKUDİSCLİNİCALTRİALS_FYİLMAZ. briefTitle: The Effects of Pregnancy on Oral Health overallStatus: COMPLETED date: 2022-05-20 date: 2023-04-01 date: 2023-04-01 date: 2024-04-02 date: 2024-04-02 name: Muğla Sıtkı Koçman University class: OTHER briefSummary: The aim of this study was to evaluate the effects of pregnancy on salivary pH, flow rate, caries experience and periodontal status.

The main questions it aims to answer are:

* Does pregnancy affect caries experience and periodontal status?
* Does pregnancy affect salivary pH and flow rate?
* Is there a difference between pregnant and non-pregnant woman with respect to caries experience, periodontal status, salivary pH and flow rate?
* Is there a difference among first, second and third trimester with respect to caries experience, periodontal status, salivary pH and flow rate? conditions: Pregnancy Related conditions: Dental Caries conditions: Periodontal Diseases conditions: Saliva Altered studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: The individual who evaluates the salivary pH and flow rate. whoMasked: OUTCOMES_ASSESSOR count: 198 type: ACTUAL name: Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman measure: The effects of pregnancy on caries experience measure: The effects of pregnancy on periodontal status. measure: The effects of pregnancy on salivary pH. measure: The effects of pregnancy on salivary flow rate. sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Fatma Yilmaz city: Mentese state: Mugla zip: 48000 country: Turkey hasResults: False

 nctId: NCT06343324 id: 2023/012 briefTitle: Effect of Web-Based Adaptation and Insomnia Severity in Individuals Using Noninvasive Ventilators at Home overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-02-01 date: 2024-04-01 date: 2024-04-02 date: 2024-04-03 name: KTO Karatay University class: OTHER briefSummary: Home use of the NIV device, which is used to manage respiratory failure, one of the most disturbing symptoms due to COPD, will continue to increase. There is a need for studies evaluating the effectiveness of the use of WEB-based training programs in making patients and their families independent in the use of this device. This study will produce evidence for this effect and contribute to the awareness of healthcare professionals working in this field. The WEB-based training module to be developed aims to increase compliance with NIV in patients using NIV at home for a long time and to manage symptoms such as insomnia that may develop due to NIV. conditions: Noninvasive Ventilation conditions: COPD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Web-based education measure: Patient Identifiable Characteristics Form measure: S³-NIV Questionnaire measure: insomnia severity index measure: Expected behavioral changes in the individual survey sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University Konya Beyhekim Training and Research Hospital city: Konya state: Selçuklu zip: 42060 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06343311 id: EBUS22CD19AR100 briefTitle: T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) acronym: Starlight-1 overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-12-31 date: 2027-12-31 date: 2024-04-02 date: 2024-04-18 name: Estrella Biopharma, Inc. class: INDUSTRY name: Eureka Therapeutics Inc. briefSummary: This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase. conditions: B-Cell Non-Hodgkin's Lymphoma (NHL) conditions: Lymphoma, Non-Hodgkins conditions: Lymphomas Non-Hodgkin's B-Cell conditions: Non-Hodgkin Lymphoma conditions: Non-Hodgkin's Lymphoma conditions: Large B-Cell Lymphoma conditions: Lymphoma, Non-Hodgkin's, Adult conditions: Lymphoma conditions: Refractory Non-Hodgkin Lymphoma conditions: Relapsed Non-Hodgkin Lymphoma conditions: Lymphoma, Non-Hodgkin conditions: HIV Associated Lymphoma conditions: CNS Lymphoma conditions: High-grade B-cell Lymphoma conditions: Refractory B-Cell Non-Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: EB103 measure: To assess the Dose Limiting Toxicities of EB103. measure: Incidence rates of Treatment-Emergent Adverse Events of EB103. measure: Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103. measure: To determine the Recommended Phase II Dose (RP2D) of EB103. measure: To assess the Overall Response Rate of EB103 in our study subject population. measure: To assess the Disease Control Rate of EB103 in our study subject population. measure: To assess the Duration of Response of EB103 in our study subject population. measure: To assess the Progression-Free Survival rate of EB103 in our study subject population. measure: To assess the Event-Free Survival rate of EB103 in our study subject population. measure: To assess the Overall Survival rate of EB103 in our study subject population. measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the peak exposure (Cmax). measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the time to reach peak exposure (Tmax). measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the partial area under the curve (pAUC). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343298 id: ES_MANP_2001 briefTitle: To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-01 date: 2025-08-01 date: 2024-04-02 date: 2024-04-10 name: E-Star BioTech, LLC class: INDUSTRY name: Mayo Clinic name: PPD briefSummary: This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action. conditions: Difficult to Control Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: MANP name: Placebo Matched control measure: Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42. measure: Incidence and severity of Adverse events through 4- weeks post end of treatment. measure: Incidence and severity of Serious Adverse Events through 4- weeks post end of treatment. measure: Incidence and severity of Treatment Emergent Adverse Events through 4- weeks post end of treatment. measure: Change in Clinic sitting systolic blood pressure measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - Tmax measure: Anti-drug Antibody measure: Differential Outcomes in African-American Subject versus Non-African American Subjects measure: Metabolic biomarkers - Glucose measure: Metabolic biomarkers - Insulin measure: Metabolic biomarkers - HbA1C measure: Lipid biomarkers - HDL measure: Lipid biomarkers - LDL measure: Lipid biomarkers - TG sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343285 id: 20231215 briefTitle: Upper Limb Tremor Reduction in Essential Tremor Patients acronym: ULTRE overallStatus: RECRUITING date: 2024-01-01 date: 2024-05 date: 2024-06 date: 2024-04-02 date: 2024-04-03 name: Encora, Inc. class: INDUSTRY briefSummary: This study is designed to demonstrate the safety and tolerability of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor. conditions: Essential Tremor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Three different arms in a randomized order primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization schedule maintained by non-Clinical personnel whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Encora Therapeutics Tremor Reduction Device measure: Tolerability measure: Safety measure: Bain & Findley Activity of Daily Living (BF-ADL) #2 measure: BF-ADL #4 measure: BF-ADL #17 measure: BF-ADL #21 measure: Patient Global Impression of Change (PGI-C) measure: Clinician Global Impression of Change (CGI-C) measure: Tremor power as measured by gyroscope measure: The Essential Tremor Rating Scale (TETRAS) #2.4 measure: TETRAS #2.6 measure: TETRAS #2.8 measure: Patient Global Impression of Severity (PGI-S) measure: Clinician Global Impression of Severity (CGI-S) measure: Tremor power as measured by accelerometer sex: ALL minimumAge: 22 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Encora Therapeutics status: RECRUITING city: Cambridge state: Massachusetts zip: 02139 country: United States name: Kristi Winterfeldt, MSHS role: CONTACT phone: 763-248-1210 email: kristi@encoratherapeutics.com name: Taylor Robertson role: CONTACT phone: 7814221105 email: taylor@encoratherapeutics.com name: Kristi Winterfeldt, MSHS role: PRINCIPAL_INVESTIGATOR name: Fatta Nahab, MD role: SUB_INVESTIGATOR lat: 42.3751 lon: -71.10561 hasResults: False

 nctId: NCT06343272 id: LEGO briefTitle: Lymphocyte Enhancement in Gastroenteric Oncology overallStatus: RECRUITING date: 2022-03-22 date: 2024-12-22 date: 2025-02-28 date: 2024-04-02 date: 2024-04-03 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER name: University of Pavia briefSummary: LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens. conditions: Advanced Gastrointestinal Cancers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: EAA supplementation name: Isocaloric placebo measure: Exit from lymphopenia measure: The change in the % of lymphocytes over time measure: The proportion of patients with G3-G5 toxicity measure: The percentage of chemotherapy dose administered compared to that expected for the patients. measure: plasma aminoacids composition chang during treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Policlinico San Matteo status: RECRUITING city: Pavia zip: 27100 country: Italy name: Alessandra Ferrari role: CONTACT phone: 0382.503689 phoneExt: +39 email: alessandra.ferrari@smatteo.pv.it name: Salvatore Corallo role: PRINCIPAL_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06343259 id: 2534 briefTitle: The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-08-14 date: 2024-04-02 date: 2024-04-02 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: In this prospective, randomized, single-blind study, we aim to compare the effects of general anesthesia and spinal anesthesia on postoperative myocardial injury in elderly patients undergoing hip surgery. Cardiovascular events are a leading cause of mortality and morbidity following non-cardiac surgery, with myocardial injury after non-cardiac surgery (MINS) being a significant concern. MINS, characterized by asymptomatic elevation of troponin levels without accompanying ECG findings, is closely associated with postoperative mortality. With the increasing prevalence of comorbidities in the elderly population and the rising frequency of non-cardiac surgeries in this demographic, understanding the effects of different anesthesia types on postoperative myocardial injury is crucial. conditions: Myocardial Injury After Non-cardiac Surgery conditions: Hypotension During Surgery conditions: Anesthesia, General conditions: Anesthesia, Spinal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: General Anesthesia name: Spinal Anesthesia measure: Myocardial Injury After Non-Cardiac Surgery (MINS) measure: The duration of intensive care unit (ICU) stay measure: The duration of hospital stay sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Sisli Hamidiye Etfal Training and Research Hospital city: Istanbul zip: 34396 country: Turkey name: Mustafa Bilgehan AYIK role: CONTACT phone: +905377247984 email: drbilgehanayik@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06343246 id: MustafaKemalU briefTitle: Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension overallStatus: RECRUITING date: 2023-05-01 date: 2024-03-30 date: 2024-03-30 date: 2024-04-02 date: 2024-04-02 name: Mustafa Kemal University class: OTHER briefSummary: This study was planned to investigate the effectiveness of combined exercise training, that is, functional inspiratory muscle training, with breathing exercises to be applied with a portable, easy-to-use respiratory muscle strengthening device, on exercise capacity and peripheral muscle strength. conditions: Hypertension,Essential studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective Randomized Controlled Study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Inspiratory muscle training with device measure: Change of the exercise capacity from baseline to 8 week measure: Change of the peripheral muscle strenght from baseline to 8 week measure: change of the upper extremity exercise capacity from baseline to 8 week measure: change of the postural balance from baseline to 8 week measure: change of the physical activity from baseline to 8 week measure: change of the quality of life from baseline to 8 week measure: change of the Fev1/Fvc sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hatay Mustafa Kemal University status: RECRUITING city: Hatay state: Antakya country: Turkey name: İrem hüzmeli role: CONTACT email: fztirem@gmail.com lat: 38.40227 lon: 27.10486 hasResults: False

 nctId: NCT06343233 id: FATE briefTitle: FAiling HearT in the Elderly (FATE) Study acronym: FATE overallStatus: RECRUITING date: 2019-11-19 date: 2024-12 date: 2024-12 date: 2024-04-02 date: 2024-04-02 name: IRCCS Multimedica class: OTHER briefSummary: In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. The Cardiology Network, responding to the indications of the National Health Research Program, which includes research models oriented towards prevention studies with objectives and priority areas of intervention such as "acquiring scientific knowledge necessary for implementing both secondary and tertiary prevention programs for patients and primary prevention for contacts, where indicated, or for subjects exposed to specific risk factors", aims to identify strategies and/or prognostic and predictive factors of outcomes through the construction of thoroughly studied case series and systematic collection of biological materials, as well as the definition of research models based on clinical outcomes.

The Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure. conditions: Heart Failure conditions: Frailty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: usual care measure: Hospitalization or death at 12 months measure: Hospitalization or death at 6-12-18 months measure: hospitalizations and/or death from cardiovascular causes measure: association between events and patient characteristics sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT) status: RECRUITING city: Montescano state: Italy/Pavia zip: 27040 country: Italy name: Maria Teresa La Rovere, MD role: CONTACT phone: +39 0385 247290 email: mariateresa.larovere@icsmaugeri.it lat: 45.03196 lon: 9.28366 facility: IRCCS Centro Cardiologico Monzino status: RECRUITING city: Milan state: MIlano zip: 20138 country: Italy name: PierGiuseppe Agostoni, MD role: CONTACT phone: +39 02 58002772 email: piergiuseppe.agostoni@unimi.it lat: 45.46427 lon: 9.18951 facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: Milano zip: 20089 country: Italy name: Cristina Panico, MD role: CONTACT phone: +39 0282241 email: cristina.panico@humanitas.it lat: 45.38193 lon: 9.1559 facility: IRCCS MultiMedica status: RECRUITING city: Sesto San Giovanni state: Milano zip: 20099 country: Italy name: Gaia Cattadori, MD role: CONTACT phone: +39 02 8687 8889 email: gaia.cattadori@multimedica.it lat: 45.53329 lon: 9.22585 facility: Ospedale Policlinico San Martino IRCCS status: RECRUITING city: Genova zip: 16132 country: Italy name: Pietro Ameri, MD role: CONTACT phone: +39 0103538928 email: pietroameri@unige.it lat: 44.40478 lon: 8.94438 facility: IRCCS Auxologico status: RECRUITING city: Milano zip: 20149 country: Italy name: Gianluca Caldara, MD role: CONTACT phone: +39 02 61911 251 email: g.caldara@auxologico.it lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milan zip: 20100 country: Italy name: Marco Vicenzi, MD role: CONTACT phone: +39 02 503 20512 email: marco.vicenzi@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06343220 id: AWARE 2.0 briefTitle: Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research overallStatus: RECRUITING date: 2024-04-10 date: 2024-09 date: 2024-09 date: 2024-04-02 date: 2024-04-29 name: Huntington Study Group class: NETWORK name: Roche Products Limited briefSummary: The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted. conditions: Huntington Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: Examine awareness measure: Provide the HD research community with the insight. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huntington Study Group status: RECRUITING city: Rochester state: New York zip: 14618 country: United States name: Elise Kayson, MS role: CONTACT phone: 800-487-7671 email: info@myhdstory.org lat: 43.15478 lon: -77.61556 hasResults: False

 nctId: NCT06343207 id: 249637 briefTitle: Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability overallStatus: COMPLETED date: 2022-11-22 date: 2023-02-02 date: 2023-02-02 date: 2024-04-02 date: 2024-04-02 name: Charles University, Czech Republic class: OTHER briefSummary: To examine the acute effect of percussive therapy on peak calf muscle activation during standing heel raise in subjects with and without chronic ankle instability (CAI). conditions: Ankle Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Controlled Trial primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: INVESTIGATOR count: 39 type: ACTUAL name: Percussive massage gun therapy measure: Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability. sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of physical education and sport, Charles University city: Praha zip: 16252 country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06343194 id: 6162 briefTitle: Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism acronym: EMG_BRUX overallStatus: RECRUITING date: 2023-02-09 date: 2024-05-31 date: 2024-12-22 date: 2024-04-02 date: 2024-04-11 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.

The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.

The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.

The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients. conditions: Sleep Bruxism conditions: Masseter Muscle Hypertrophy conditions: Grinding Teeth studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: bruxism patients and non-bruxism patients primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Bruxoff ® measure: Change in potentials recorded by Bruxoff ® in bruxism patients. measure: Change of signs and symptoms of bruxism sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: UOC Odontoiatria Generale e Ortodonzia, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore status: RECRUITING city: Rome state: Lazio zip: 00168 country: Italy name: Massimo Cordaro, professor role: CONTACT phone: +39 0630154286 email: massimo.cordaro@unicatt.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06343181 id: IEO 1824 briefTitle: A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer overallStatus: RECRUITING date: 2022-10-03 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: Qualitative observational study with the aim to explore medication adherence in a sample of patients with metastatic breast cancer.

Patients with metastatic breast cancer receiving or having received oral oncologic therapy, and attending the Division of Medical Senology at the European Institute of Oncology, will be included and enrolled in this research project." conditions: Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Evaluation of factors influencing patients' adherence to medical therapy sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06343168 id: frailty briefTitle: Prevalence of Frailty and Associated Factors in Coronary Artery Bypass Patients overallStatus: COMPLETED date: 2021-02-18 date: 2022-02-18 date: 2022-02-18 date: 2024-04-02 date: 2024-04-02 name: Uşak University class: OTHER briefSummary: This study aimed to determine the prevalence of and factors affecting frailty in patients with coronary artery bypass graft.

The main question it aims to answer are:

What are the prevalence of and factors affecting frailty in patients with coronary artery bypass graft Type of study: descriptive cross-sectional study Participant population: coronary artery bypass grafting patients conditions: Frailty studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 96 type: ACTUAL name: prevalence of frailty measure: Prevalence of frailty measure: Activities of Daily Living measure: Nutritional Assessment measure: Comorbidity measure: Cognitive Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Usak University city: Usak state: Center zip: 64200 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False

 nctId: NCT06343155 id: E-10840098-202.3.02-235 briefTitle: Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder" overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2024-05-27 date: 2024-06-03 date: 2024-04-02 date: 2024-04-03 name: Medipol University class: OTHER briefSummary: According to the information obtained from clinical studies, it has been stated that Temporomandibular Disorder (TMD) is associated with chronic low back pain (LBP). In this study, participants will be divided into two groups. Only Rocabado's exercise will be given to the Rocabado's group (RG), and Rocabado's and therapeutic lumbar exercises will be given to the therapeutic group (TG). Warm-up exercises will be given before starting the exercises with the therapeutic group, and cool-down exercises will be given after the exercises with the therapeutic group. At the end of the sixth week, the effect of therapeutic lumbar exercises on TMD pain and function will be evaluated. conditions: Temporomandibular Disorder conditions: Chronic Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups: Therapeutic group and Rocabado's group. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Therapeutic Group name: Rocabado's Group measure: Temporomandibular Joint Range of Motion Measurement (ROM) measure: The Jaw Functional Limitation Scale 20 (JFLS-20) measure: Oral Health Impact Profile - 14 (OHIP-14) measure: The short-form McGill Pain Questionnaire (SF-MPQ) measure: Graded Chronic Pain Scale 2.0 total (GCPS 2.0) measure: Visual Analog Scale sex: ALL minimumAge: 23 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey name: İkra Çakıcı role: CONTACT phone: +90 05426696487 email: ikrabayraktar951@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06343142 id: 42038 briefTitle: Effects of Time of Day and Nut Intake on Cognitive Performance overallStatus: RECRUITING date: 2024-04-08 date: 2025-02-28 date: 2025-06-30 date: 2024-04-02 date: 2024-04-04 name: Monash University class: OTHER briefSummary: This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance. conditions: Cognitive Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 2 x 2-factor crossover design study primaryPurpose: PREVENTION masking: NONE count: 25 type: ESTIMATED name: Nuts name: Nut-free meal measure: N-back task - accuracy measure: N-back task - matched responses measure: N-back task - false alarm measure: N-back task - reaction time measure: Stroop test - congruent measure: Stroop test - incongruent measure: Stroop test - interference measure: Multitasking - pure blocks measure: Multitasking - mixed blocks measure: Multitasking - mixing cost measure: Satiety - hunger measure: Satiety - fullness measure: Satiety - satisfaction measure: Satiety - eating capacity measure: Satiety index sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Department of Nutrition, Dietetics and Food - Monash University status: RECRUITING city: Notting Hill state: Victoria zip: 3168 country: Australia name: Barbara R Cardoso, PhD role: CONTACT phone: +61499840472 email: barbara.cardoso@monash.edu name: Maxine Bonham, PhD role: CONTACT phone: +61418 234 292 email: maxine.bonham@monash.edu lat: -37.905 lon: 145.1427 hasResults: False

 nctId: NCT06343129 id: 3817 briefTitle: Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD overallStatus: COMPLETED date: 2020-10-26 date: 2022-12-12 date: 2022-12-12 date: 2024-04-02 date: 2024-04-17 name: University of Rochester class: OTHER name: Rochester Lifestyle Medicine Institute briefSummary: The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 43 type: ACTUAL name: Dietary education program measure: Mean change in systolic blood pressure measure: Mean change in diastolic blood pressure measure: Mean change in potassium levels measure: Proportion of participants developing hyperkalemia measure: Mean Change in energy/day measure: Mean change in energy/kg of body mass measure: Mean change in total fat measure: Mean change in % calories from fat measure: Mean change in % calories from carbohydrates measure: Mean change in % calories from protein measure: Mean change in Animal protein measure: Mean change in Vegetable protein measure: Mean change in cholesterol measure: Mean change in Total dietary fiber measure: Mean change in Total fiber per 1000 kcal measure: Mean change in calcium measure: Mean change in phosphorous measure: Mean change in magnesium measure: Mean change in sodium measure: Mean change in potassium measure: Mean change in body mass measure: Mean change in body mass index measure: Mean change in sodium measured in blood measure: Mean change in chloride measured in blood measure: Mean change in bicarbonate measured in blood measure: Mean change in blood urea nitrogen (BUN) measured measure: Mean change in creatinine measured in blood measure: Mean change in glucose measured in blood measure: Mean change in calcium measured in blood measure: Mean change in phosphorous measured in blood measure: Mean change in parathyroid hormome (PTH) measured in blood measure: Mean change in albumin measured in blood measure: Mean change in magnesium measured in blood measure: Mean change in erythrocyte sedimentation rate (ESR) measured in blood measure: Mean change in fibroblast growth factor (FGF)-23 measured in blood measure: Mean change in total cholesterol measured in blood measure: Mean change in low density lipoprotein (LDL) measured in blood measure: Mean change in high density lipoprotein (HDL) measured in blood measure: Mean change in triglycerides measured in blood measure: Mean change in 8-isoprostane measured in urine measure: Mean change in symptoms measure: Mean change in effects of kidney disease measure: Mean change in burden of kidney disease measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center of the University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 facility: University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 hasResults: False

 nctId: NCT06343116 id: BPL-Nim-CRC-3001 briefTitle: Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer acronym: NOTABLE-308 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-02 date: 2024-04-02 name: Biotech Pharmaceutical Co., Ltd. class: OTHER briefSummary: This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS). conditions: Refractory Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: Nimotuzumab injection name: Placebo name: Trifluridine/tipiracil measure: overall survival (OS) measure: dose-limiting toxicity (DLT) measure: Progression free survival (PFS) measure: time to progress (TTP) measure: overall response rate (ORR) measure: disease control rate (DCR) measure: duration of response (DoR) measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) measure: Adverse Events measure: tumor-related markers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343103 id: IEO 1735 briefTitle: Study Evaluating Occupational Exposure to Antineoplastic Drugs acronym: BRIC overallStatus: RECRUITING date: 2022-08-02 date: 2025-12-31 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed workers (administrative staff).

The control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics. conditions: Cytotoxicity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 500 type: ESTIMATED name: Workers exposed name: Workers not exposed measure: Evaluation of the difference in micronuclei frequency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova country: Italy name: Sabrina Beltramini role: CONTACT lat: 44.40478 lon: 8.94438 facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Emanuela Omodeo Salè role: CONTACT lat: 45.46427 lon: 9.18951 facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" status: RECRUITING city: Napoli country: Italy name: Piera Maiolino role: CONTACT lat: 40.85216 lon: 14.26811 facility: Istituto Oncologico Veneto Irccs status: RECRUITING city: Padova country: Italy name: Nicoletta Rigamonti role: CONTACT lat: 45.40797 lon: 11.88586 facility: Fondazione Policlinico Universitario Campus Bio-Medico status: RECRUITING city: Roma country: Italy name: Andrea Di Mattia role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06343090 id: BJGBYY-IIT-LCYJ-2023-003 briefTitle: Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients overallStatus: RECRUITING date: 2024-04-12 date: 2042-12-01 date: 2043-09-30 date: 2024-04-02 date: 2024-04-18 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is a single-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled. conditions: B-cell Acute Lymphoblastic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse conditions: Refractory Acute Lymphoid Leukemia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective cohort study primaryPurpose: TREATMENT masking: NONE count: 353 type: ESTIMATED name: CD19 CAR T-cell name: CD22 CAR T cells name: hematopoietic stem-cell transplantation measure: EFS in CD19 CAR and CD22 CAR-T sequential infusion (Sequential CAR group) and CD19 CAR T-cell infusion bridging to HSCT (CAR+HSCT group) measure: ORR in Sequential CAR group and CAR+HSCT group measure: DOR in Sequential CAR group and CAR+HSCT group measure: OS in Sequential CAR group and CAR+HSCT group measure: Adverse events (AEs) in Sequential CAR group and CAR+HSCT group measure: Levels of CD19 and CD22 CAR-T cells in Sequential CAR group measure: Levels of CD19 CAR-T cells in CAR+HSCT group measure: Levels of CD19 and CD22 CAR transgene in Sequential CAR group measure: Levels of CD19 CAR transgene in CAR+HSCT group measure: Quantification of B cells in Sequential CAR group and CAR+HSCT group measure: EFS in CD19 CAR T-cell infusion without consolidation therapies (Single CAR group) measure: DOR in Single CAR group measure: OS in Single CAR group measure: ORR in Single CAR group measure: Adverse events (AEs) in Single CAR group measure: Levels of CD19 CAR-T cells in Single CAR group measure: Levels of CD19 CAR transgene in Single CAR group measure: Quantification of B cells in Single CAR group sex: ALL minimumAge: 1 Year maximumAge: 39 Years stdAges: CHILD stdAges: ADULT facility: Beijing GoBroad Hospital status: RECRUITING city: Beijing state: Beijing zip: 102206 country: China name: Tengyu Wang role: CONTACT phone: 86+18333186020 email: tengyu.wang@gohealtharo.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06343077 id: STUDY-22-00106 briefTitle: Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance overallStatus: RECRUITING date: 2024-01-16 date: 2026-12-31 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: Ashutosh Kumar Tewari class: OTHER name: Oncovir, Inc. briefSummary: This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance. conditions: Prostate Cancer Patients on Active Surveillance studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Poly-ICLC intramuscular (IM) injection name: Poly-ICLC, Intertumoral (IT) injection measure: Proportion of subjects without Gleason group upgrade after treatment measure: Proportion of subjects without Gleason group upgrade after treatment measure: Proportion of subjects without Gleason group downgrade after treatment measure: Proportion of subjects without Gleason group downgrade after treatment measure: Number of subjects who experience adverse events per NCI-CTCAE 5.0 measure: Number of subjects who experience adverse events per NCI-CTCAE 5.0 measure: Number of subjects who receive prostate cancer treatment measure: Number of subjects who receive prostate cancer treatment sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Icahn School of Medicine at Mount Sinai (ISMMS) status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Monali Fatterpekar, PhD role: CONTACT email: monali.fatterpekar@mountsinai.org name: Sujit S Nair, PhD role: CONTACT phone: 212-241-7005 email: sujit.nair@mountsinai.org name: Ashutosh K Tewari, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06343064 id: PLB1001/PLB1004-NSCLC-Ib/II-01 briefTitle: Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI overallStatus: RECRUITING date: 2023-06-13 date: 2024-12-31 date: 2025-06-30 date: 2024-04-02 date: 2024-04-02 name: Avistone Biotechnology Co., Ltd. class: INDUSTRY briefSummary: Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC conditions: Non-Small-Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: Vebreltinib name: PLB1004 measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol. measure: Overall Response Rate (ORR） measure: Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC) measure: Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max) measure: Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max) measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Pulmonary Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Caichun Zhou, PHD role: CONTACT phone: +86-21-65115006 email: caicunzhoudr@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06343051 id: STUDY-23-01681 briefTitle: USCOM in Newly Diagnosed FGR Cases acronym: USCOM FGR overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-02 date: 2024-04-02 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: The purpose of this research study is to study the use of an ultrasound measurement system (USCOM) for patients with newly diagnosed fetal growth restriction (FGR). This system uses a technology to measure how much blood is being pumped in and out of the heart, which is important for understanding the heart's function in relation to pregnancy. conditions: Fetal Growth Restriction conditions: USCOM studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: USCOM measure: Systemic vascular resistance obtained from USCOM sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Hospital city: New York state: New York zip: 10029 country: United States name: Nicola F Tavella, MPH role: CONTACT phone: 212-241-3888 email: nicola.tavella@mssm.edu name: Rachel J Meislin role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06343038 id: 2023-01868; th23Nicolas briefTitle: Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study acronym: PROGNOSTICS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2028-06 date: 2024-04-02 date: 2024-04-02 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before.

In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time.

The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects.

The performance of different prostate cancer diagnostic methods is also in scope of the study. conditions: Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In Phase Ia:

Radiation dosimetry driven, head-to-head in cross-over design comparison of tumour and critical organ absorbed doses after sequential non-therapeutic injections of 161Tb-SibuDAB and 177Lu-PSMA-I\&T in the same mCRPC patients undergoing standard 177Lu-PSMA-I\&T RLT.

In Phase Ib:

Clinical and radiation dosimetry-based dose escalation study, with a classical 3+3 design, to identify the optimal biologic dose (injected activity) of 161Tb-SibuDAB for safe and effective RLT. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 25 type: ESTIMATED name: Injection, 161Tb-SibuDAB,1GBq name: Injection, 177Lu-PSMA-I&T, 1GBq name: Injection, 161Tb-SibuDAB, Dose Escalation measure: Phase Ia: Tumour absorbed dose measure: Phase Ib: Identification of the optimal biological dose of 161Tb-SibuDAB for mCRPC RLT measure: Phase Ia: Estimation of critical organ median absorbed doses measure: Phase Ia: Estimation of the median tumour-to-critical organ absorbed dose ratios measure: Phase Ib: Cumulative median tumour and organ absorbed doses after 4 cycles of 161Tb-SibuDAB RLT measure: Phase Ib: Estimation of the "therapy index" for 161Tb-SibuDAB RLT. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel city: Basel zip: 4031 country: Switzerland name: Alin Chirindel, MD role: CONTACT phone: +41 61 328 63 75 email: alin.chirindel@usb.ch name: Guillaume Nicolas, MD role: CONTACT phone: +41 61 265 47 02 email: guillaume.nicolas@usb.ch lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06343025 id: Hasan Kalyoncu University briefTitle: The Effects of Tai Chi and Pilates for Individuals With Prediabetes overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-09 date: 2024-04-02 date: 2024-04-02 name: Nigde Omer Halisdemir University class: OTHER name: Hasan Kalyoncu University briefSummary: The purpose of this study; To investigate the effects of Clinical Pilates and Tai Chi exercises on glycemic control, body composition, balance function and physical activity level in individuals with prediabetes. conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Individuals will be divided into 3 groups: Clinical Pilates group, Tai Chi group and Control group. 3 groups. 3 groups will be measured at the same time and then the exercise part will begin. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes ,Assesor, who will make the evaluations in the first week and after 12 weeks, will not know which group the people are in. whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Pilates Exercises Group name: Tai Chi Exercises Group measure: Glisemic Control measure: Body Composition measure: Balance measure: Physical Activity Level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06343012 id: 0305900 briefTitle: Caring Leadership Intervention Program for First-Line Nurse Managers overallStatus: COMPLETED date: 2022-07-01 date: 2022-12-31 date: 2022-12-31 date: 2024-04-02 date: 2024-04-02 name: Matrouh University class: OTHER briefSummary: Caring leadership can help first-line nurse managers create a healthy environment, resulting in a positive outcome for nurse staff, patients, and healthcare organizations. conditions: Intervention conditions: Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental study design utilized two groups, study and control groups primaryPurpose: OTHER masking: SINGLE maskingDescription: A quasi-experimental study design utilized two groups, study and control groups. whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Caring leadership Intervention program measure: Questionnaire to measure first-line nurse managers' knowledge measure: Questionnaire to measure the managerial actions of first-line nurse managers measure: Questionnaire to assess nurses' perceived first-line nurse managers' caring behavior measure: questionnaire to measure nurse outcomes sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Marsa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False

 nctId: NCT06342999 id: 22-012399 briefTitle: Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2035-07 date: 2035-07 date: 2024-04-02 date: 2024-04-10 name: Mauro H. Schenone class: OTHER briefSummary: The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS). conditions: Hypoplastic Left Heart Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Fetal Aortic Valvuloplasty Procedure name: Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter name: Trek RX and Mini Trek RX Coronary Dilatation Catheter measure: Number of cases in which the procedure was successful measure: Number of cases in which a biventricular repair was achieved measure: Number cases with pulmonary hypertension measure: Number of cases delivered prematurely measure: Number of cases with perinatal death measure: Number of maternal complications sex: FEMALE maximumAge: 45 Years stdAges: CHILD stdAges: ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06342986 id: 2023LS185 id: P01CA111412 type: NIH link: https://reporter.nih.gov/quickSearch/P01CA111412 briefTitle: Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2028-06-30 date: 2029-06-30 date: 2024-04-02 date: 2024-04-26 name: Masonic Cancer Center, University of Minnesota class: OTHER name: National Cancer Institute (NCI) briefSummary: This is a single center Phase I clinical trial of FT536 administered intraperitoneally (IP) 3 times a week for one week for the treatment of recurrent gynecologic cancers. A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer. conditions: Gynecologic Cancer conditions: Ovarian Cancer conditions: Fallopian Tube Cancer conditions: Primary Peritoneal Cavity Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A minimum of 28 days must separate each Dose Cohort. A minimum of 30 days must separate the 1st and 2nd patient. All patients are assessed for Dose Limiting Toxicity (DLT) primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: FT536 name: Fludarabine name: CY measure: Progression free survival (PFS) measure: Progression free survival (PFS) measure: Overall survival (OS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342973 id: 5591 briefTitle: Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Case Series overallStatus: RECRUITING date: 2024-03-27 date: 2025-05-30 date: 2025-05-30 date: 2024-04-02 date: 2024-04-02 name: Louisiana State University Health Sciences Center in New Orleans class: OTHER briefSummary: The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane. conditions: Alveolar Ridge Deficiency studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Xenograft and allograft measure: Horizontal bone gain measure: Vital bone percentage measure: Bone shrinkage measure: Surgical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LSUHSC School of Dentistry status: RECRUITING city: New Orleans state: Louisiana zip: 70119 country: United States name: Eswar Kandaswamy role: CONTACT phone: 504-941-8272 email: ekanda@lsuhsc.edu name: Eswar Kandaswamy, BDS, MS role: PRINCIPAL_INVESTIGATOR name: Vinayak Joshi, BDS, MS, PhD role: SUB_INVESTIGATOR name: Jeanne St Germain, RDH role: SUB_INVESTIGATOR lat: 29.95465 lon: -90.07507 hasResults: False

 nctId: NCT06342960 id: KYV101-003 briefTitle: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (KYSA-3) overallStatus: RECRUITING date: 2022-12-01 date: 2028-10 date: 2029-01 date: 2024-04-02 date: 2024-04-02 name: Kyverna Therapeutics class: INDUSTRY briefSummary: A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis conditions: Lupus Nephritis conditions: Lupus Nephritis - WHO Class III conditions: Lupus Nephritis - WHO Class IV studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: KYV-101 anti-CD19 CAR-T cell therapy name: Standard lymphodepletion regimen measure: Incidence adverse events (AEs) and laboratory abnormalities measure: Frequency of dose limiting toxicities measure: To characterize the pharmacokinetics (PK) measure: To characterize the pharmacodynamics (PD) measure: To characterize the pharmacodynamics (PD) measure: To evaluate disease related biomarkers measure: To evaluate disease related biomarkers measure: To evaluate efficacy measure: To evaluate efficacy measure: To evaluate efficacy measure: To evaluate the immunogenicity (humoral response) of KYV-101 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Carl Gustav Carus Dresden status: RECRUITING city: Dresden country: Germany name: Study Coordinator role: CONTACT lat: 51.05089 lon: 13.73832 facility: University Hospital Erlangen status: RECRUITING city: Erlangen country: Germany name: Study Coordinator role: CONTACT lat: 49.59099 lon: 11.00783 facility: University Hospital Hamburg-Eppendorf status: RECRUITING city: Hamburg country: Germany name: Study Coordinator role: CONTACT lat: 53.57532 lon: 10.01534 hasResults: False

 nctId: NCT06342947 id: ALG-055009-303 briefTitle: ALG-055009 in Non-cirrhotic Adults With MASH (HERALD) acronym: HERALD overallStatus: RECRUITING date: 2024-04-01 date: 2024-11-25 date: 2024-12-23 date: 2024-04-02 date: 2024-04-25 name: Aligos Therapeutics class: INDUSTRY briefSummary: This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin \[softgel\] capsule) for 12 weeks. conditions: NASH conditions: MASH conditions: Metabolic Dysfunction-Associated Steatohepatitis conditions: Nonalcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: ALG-055009 name: Placebo measure: Percent relative change from baseline in liver fat content measure: Absolute change from baseline in liver fat content measure: Proportion of subjects with ≥30% relative reduction in liver fat content measure: Proportion of subjects with ≥50% relative reduction in liver fat content measure: Proportion of subjects with ≥70% relative reduction in liver fat content measure: Proportion of subjects with normalization (<5%) in liver fat content measure: Change from baseline (absolute/percent) in lipid/lipoprotein levels measure: Change from baseline (absolute/percent) in SHBG measure: Change from baseline (absolute/percent) alanine aminotransferase (ALT) measure: Change from baseline (absolute/percent) aspartate aminotransferase (AST) measure: Safety and tolerability will be assessed by monitoring TEAEs measure: Safety and tolerability will be assessed by monitoring 12-lead electrocardiograms (ECGs) measure: PK parameters of ALG-055009 in plasma, AUCs measure: PK parameters of ALG-055009 in plasma, Tmax measure: PK parameters of ALG-055009 in plasma, Cmax measure: PK parameters of ALG-055009 in plasma, Cmin sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aligos Clinical Study Site 18 status: RECRUITING city: Chandler state: Arizona zip: 85224 country: United States name: Central contact role: CONTACT lat: 33.30616 lon: -111.84125 facility: Aligos Clinical Study Site 15 status: RECRUITING city: Peoria state: Arizona zip: 85301 country: United States name: Central contact role: CONTACT lat: 33.5806 lon: -112.23738 facility: Aligos Clinical Study Site 17 status: RECRUITING city: Tucson state: Arizona zip: 85641 country: United States name: Central contact role: CONTACT lat: 32.22174 lon: -110.92648 facility: Aligos Clinical Study Site 35 status: RECRUITING city: Chula Vista state: California zip: 91902 country: United States name: Central contact role: CONTACT lat: 32.64005 lon: -117.0842 facility: Aligos Clinical Study Site 1 status: RECRUITING city: Lincoln state: California zip: 95648 country: United States name: Central contact role: CONTACT lat: 38.89156 lon: -121.29301 facility: Aligos Clinical Study Site 37 status: RECRUITING city: Poway state: California zip: 92025 country: United States name: Central contact role: CONTACT lat: 32.96282 lon: -117.03586 facility: Aligos Clinical Study Site 10 status: RECRUITING city: Rialto state: California zip: 92316 country: United States name: Central contact role: CONTACT lat: 34.1064 lon: -117.37032 facility: Aligos Clinical Study Site 26 status: RECRUITING city: Bradenton state: Florida zip: 34205 country: United States name: Central contact role: CONTACT lat: 27.49893 lon: -82.57482 facility: Aligos Clinical Study Site 25 status: RECRUITING city: Clearwater state: Florida zip: 33755 country: United States name: Central contact role: CONTACT lat: 27.96585 lon: -82.8001 facility: Aligos Clinical Study Site 39 status: RECRUITING city: Fort Myers state: Florida zip: 33901 country: United States name: Central contact role: CONTACT lat: 26.62168 lon: -81.84059 facility: Aligos Clinical Study Site 2 status: RECRUITING city: Maitland state: Florida zip: 32751, 32794 country: United States name: Central contact role: CONTACT lat: 28.62778 lon: -81.36312 facility: Aligos Clinical Study Site 22 status: RECRUITING city: Ocoee state: Florida zip: 32703 country: United States name: Central contact role: CONTACT lat: 28.56917 lon: -81.54396 facility: Aligos Clinical Study Site 32 status: RECRUITING city: Port Orange state: Florida zip: 32119 country: United States name: Central contact role: CONTACT lat: 29.13832 lon: -80.99561 facility: Aligos Clinical Study Site 38 status: RECRUITING city: Sarasota state: Florida zip: 34230 country: United States name: Central contact role: CONTACT lat: 27.33643 lon: -82.53065 facility: Aligos Clinical Study Site 31 status: RECRUITING city: The Villages state: Florida zip: 32159 country: United States name: Central contact role: CONTACT lat: 28.93408 lon: -81.95994 facility: Aligos Clinical Study Site 3 status: RECRUITING city: Viera state: Florida zip: 32924 country: United States name: Central contact role: CONTACT lat: 28.24696 lon: -80.737 facility: Aligos Clinical Study Site 30 status: RECRUITING city: Winter Park state: Florida zip: 32789 country: United States name: Central contact role: CONTACT lat: 28.6 lon: -81.33924 facility: Aligos Clinical Study Site 23 status: RECRUITING city: Athens state: Georgia zip: 30601 country: United States name: Central contact role: CONTACT lat: 33.96095 lon: -83.37794 facility: Aligos Clinical Study Site 12 status: RECRUITING city: Topeka state: Kansas zip: 66546 country: United States name: Central contact role: CONTACT lat: 39.04833 lon: -95.67804 facility: Aligos Clinical Study Site 29 status: RECRUITING city: Louisville state: Kentucky zip: 40018 country: United States name: Central contact role: CONTACT lat: 38.25424 lon: -85.75941 facility: Aligos Clinical Study Site 24 status: RECRUITING city: Bastrop state: Louisiana zip: 71220 country: United States name: Central contact role: CONTACT lat: 32.75625 lon: -91.87235 facility: Aligos Clinical Study Site 5 status: RECRUITING city: Houma state: Louisiana zip: 70360 country: United States name: Central contact role: CONTACT lat: 29.59577 lon: -90.71953 facility: Aligos Clinical Study Site 4 status: RECRUITING city: Marrero state: Louisiana zip: 70072 country: United States name: Central contact role: CONTACT lat: 29.89937 lon: -90.10035 facility: Aligos Clinical Study Site 6 status: RECRUITING city: Metairie state: Louisiana zip: 70001 country: United States name: Central contact role: CONTACT lat: 29.98409 lon: -90.15285 facility: Aligos Clinical Study Site 14 status: RECRUITING city: Chesterfield state: Michigan zip: 48047 country: United States name: Central contact role: CONTACT lat: 42.66281 lon: -82.84242 facility: Aligos Clinical Study Site 7 status: RECRUITING city: New York state: New York zip: 10001 country: United States name: Central contact role: CONTACT lat: 40.71427 lon: -74.00597 facility: Aligos Clinical Study Site 8 status: RECRUITING city: Morehead City state: North Carolina zip: 28557 country: United States name: Central contact role: CONTACT lat: 34.72294 lon: -76.72604 facility: Aligos Clinical Study Site 21 status: RECRUITING city: Columbus state: Ohio zip: 43004 country: United States name: Central contact role: CONTACT lat: 39.96118 lon: -82.99879 facility: Aligos Clinical Study Site 16 status: RECRUITING city: Westlake state: Ohio zip: 44145 country: United States name: Central contact role: CONTACT lat: 41.45532 lon: -81.91792 facility: Aligos Clinical Study Site 36 status: RECRUITING city: East Greenwich state: Rhode Island zip: 02818 country: United States name: Central contact role: CONTACT lat: 41.66038 lon: -71.45589 facility: Aligos Clinical Study Site 9 status: RECRUITING city: Nashville state: Tennessee zip: 37011 country: United States name: Central contact role: CONTACT lat: 36.16589 lon: -86.78444 facility: Aligos Clinical Study Site 19 status: RECRUITING city: Austin state: Texas zip: 73301 country: United States name: Central contact role: CONTACT lat: 30.26715 lon: -97.74306 facility: Aligos Clinical Study Site 33 status: RECRUITING city: Bellaire state: Texas zip: 77401 country: United States name: Central contact role: CONTACT lat: 29.70579 lon: -95.45883 facility: Aligos Clinical Study Site 27 status: RECRUITING city: Brownsville state: Texas zip: 78520 country: United States name: Central contact role: CONTACT lat: 25.90175 lon: -97.49748 facility: Aligos Clinical Study Site 28 status: RECRUITING city: Edinburg state: Texas zip: 78504 country: United States name: Central contact role: CONTACT lat: 26.30174 lon: -98.16334 facility: Aligos Clinical Study Site 40 status: RECRUITING city: Farmers Branch state: Texas zip: 75006 country: United States name: Central contact role: CONTACT lat: 32.92651 lon: -96.89612 facility: Aligos Clinical Study Site 20 status: RECRUITING city: San Antonio state: Texas zip: 78015 country: United States name: Central contact role: CONTACT lat: 29.42412 lon: -98.49363 facility: Aligos Clinical Study Site 11 status: RECRUITING city: Waco state: Texas zip: 76633 country: United States name: Central contact role: CONTACT lat: 31.54933 lon: -97.14667 facility: Aligos Clinical Study Site 13 status: RECRUITING city: Manassas state: Virginia zip: 20108 country: United States name: Central contact role: CONTACT lat: 38.75095 lon: -77.47527 facility: Aligos Clinical Study Site 34 status: RECRUITING city: Seattle state: Washington zip: 98039 country: United States name: Central contact role: CONTACT lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06342934 id: INT157/20 briefTitle: Radiomics and Machine Learning in the Diagnosis of Ovarian Masses acronym: Multi-AROMA overallStatus: COMPLETED date: 2020-07-22 date: 2023-12-31 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER briefSummary: The correct differential diagnosis between benign and malignant adnexal masses is the main goal of preoperative ultrasound diagnostics and is very important to plan the correct treatment for the patient in terms of surgical team (gynecologist oncologist or benign pathology center), surgical access (laparoscopy / laparotomy) and type of surgery (conservative / demolitive).

Several ultrasound models have been developed to help gynecologists define the risk of malignancy of adnexal masses. In order to use the predictive models, the examiner had to collect certain ultrasound features of the lesion which, integrated with the patient's clinical and / or biochemical characteristics, provided a risk of malignancy of the mass.

Recently radiomics is emerging as an interesting tool to be applied to diagnostic imaging (computed tomography, magnetic resonance and even ultrasound). Radiomics is the evaluation of images through complex software that allows to 'read' the intrinsic characteristics of the tissue identifying aspects that are not visible by subjective interpretation of the operator, in a fully automated and therefore reproducible way.

Radiomics applied to artificial intelligence for the creation of predictive models represents an interesting tool to overcome the limitations of previous models, at least partly dependent on the operator's experience.

Among the serous ovarian cancer, those with BRCA gene mutation represent an interesting subgroup and are characterized by a different pathophysiological history than wild type tumors due to greater chemosensitivity and the possibility of targeted treatment with antiangiogenic drugs and PARP-inhibitors.

The application of radiomics to preoperative ultrasound images could identify BRCA mutated tumors before surgical planning (radiogenomic analysis) and allow a personalized treatment.

The aim of the study is to validate a predictive model to define the risk of malignancy of adnexal masses that the investigators developed at the Fondazione IRCCS Istituto Nazionale dei Tumori di Milano.

The model, based on the integration of radiomics and artificial intelligence, uses complex software capable of 'reading' the ultrasound images in a completely automatic way and is able to estimate the risk of malignancy of the mass.

If the patient decide to participate in the clinical study, the patient will undergo transvaginal ultrasound (eventually supplemented by transabdominal ultrasound in case of large adnexal masses, if the patients are virgo or if the patients will refuse transvaginal approach for any reason). This exam is part of the routine preoperative evaluation for adnexal pathology and therefore the patients don't have to undergo any additional clinical, biochemical or imaging examination, according to national and international guidelines.

Thereafter, the images stored during the preoperative ultrasound will be exported in anonymous format from the ultrasound system, and sent to the coordinating center (Fondazione IRCCS Istituto Nazionale dei Tumori di Milano). There, images will be submet to radiomic analysis through the application of a dedicated software; that will allow to evaluate the intrinsic characteristics of the tissue according to different parameters (shape, intensity, grade of heterogeneity and many others) of the 'pixels' (gray dots) that constitute the ultrasound image.

This analysis, once validated, will provide clinicians an additional tool to identify malignant adnexal masses prior to surgery.

If the final histological diagnosis is of serous epithelial ovarian cancer, through the use of the same radiomics software described above the investigators will try to identify the intrinsic characteristics of the tissue associated with the presence or absence of the BRCA 1 or 2 mutation conditions: Ovarian Cysts conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ACTUAL name: Ultrasound measure: Diagnosis of malignant ovarian tumor sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano city: Milano state: Lombardia zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06342921 id: ADC189-2022-01 briefTitle: ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection acronym: ADC overallStatus: RECRUITING date: 2022-12-07 date: 2024-06-30 date: 2024-06-30 date: 2024-04-02 date: 2024-04-02 name: Jiaxing AnDiCon Biotech Co.,Ltd class: INDUSTRY briefSummary: The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.

The main aim to answer:

* Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study.
* Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza.

Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days.

Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo. conditions: Safety Issues conditions: Effect of Drug studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 675 type: ESTIMATED name: 15 mg ADC189 name: 45 mg ADC189 name: Placebo measure: the severity of influenza measure: the safety of study drug sex: ALL minimumAge: 12 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rui Jin Hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: Haili Liu, Dr role: CONTACT phone: +862134188900 email: rjhfbgs@rjh.com.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06342908 id: 23-001700 id: NCI-2024-00210 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2027-03-08 date: 2028-01-09 date: 2024-04-02 date: 2024-04-02 name: Jonsson Comprehensive Cancer Center class: OTHER briefSummary: This phase I trial tests the safety and side effects, and best dose of a vaccine (neoantigen-target ppDC) in treating patients with H3 G34-mutant diffuse hemispheric glioma. Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Giving neoantigen-targeted ppDC may be safe, tolerable and/or effective in treating patients with diffuse hemispheric glioma with a H3 G34 mutation. conditions: Diffuse Hemispheric Glioma, H3 G34-Mutant studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Biospecimen Collection name: Dendritic Cell Therapy name: Leukapheresis name: Magnetic Resonance Imaging name: Poly ICLC measure: Incidence of regimen-limiting toxicities measure: Significant increase in gamma-interferon (IFN) gene expression signature measure: Significant clonal T cell expansion measure: Targets of clonal cytotoxic T cell expansion measure: Pro-inflammatory phenotypic changes in immune cell populations measure: Changes in immune cell subset expansion and contraction in T cell and myeloid-derived cell populations measure: Changes of immune cell markers profile in T cell and myeloid-derived cell populations sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: UCLA / Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90095 country: United States name: Sichen C. Li role: CONTACT phone: 310-592-9091 email: sichenli@mednet.ucla.edu name: Anthony C. Wang, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06342895 id: 2020_1113 id: 2022-A00103-40 type: OTHER domain: ID-RCB number, ANSM briefTitle: Interpretation and Optimization of Nutrition in the Intensive Care Units acronym: IONIC overallStatus: RECRUITING date: 2024-04-10 date: 2025-04 date: 2025-09 date: 2024-04-02 date: 2024-04-25 name: Dim3 class: INDUSTRY name: Baxter Healthcare Corporation name: University Hospital, Lille briefSummary: Despite recommendations, inadequate nutritional intake in intensive care unit (ICU) patients remains frequent and can lead to complications such as infections, increased length of stay, prolonged weaning from ventilation, increased long-term mortality, and decreased quality of life after intensive care. Studies have shown that patients only receive up to 50-60% of prescribed calories and proteins due to many factors leading to nutritional support interruptions such as ICU procedures, physical therapy, transport for imaging or invasive procedures outside the ICU, and nutrition intolerance.

Furthermore, this discrepancy between prescribed and delivered nutrition may go largely unnoticed, due to issues concerning inadequate manual or automated monitoring of delivered nutrition. A joint "Call to Action" by ASPEN, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house Clinical Decision Support Systems and the interfaces between electronic health records (EHRs), automated preparation devices and pharmacy systems.

Nutrow® is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements, real-time calculation and monitoring of calorie and protein prescriptions, real-time calculation and monitoring of calories and protein truly delivered to patients, and information feedback to prescribers. Feedim® is a Medical Device Data System (MDDS), designed by Dim3, which transmits information from enteral feeding pumps to third-party software, such as Nutrow®.

The aim of the study is to assess whether the joint use of Nutrow-Feedim improves the achievement of nutritional objectives in ICU patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein. conditions: Nutritional Support studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Usual use of standard clinical and biological information related to nutritional support as available through the ICU electronic health record (i.e. without any calculated information on recommended, prescribed, or received calories and protein, only information on prescribed products and volumes as collected by and presented in the ICU EHR) In this arm, participants, investigators, and healthcare professionals will be blinded to real-time enteral feed volumes that will be collected by the Feedim medical device and transmitted to the electronic study case report form. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 144 type: ESTIMATED name: Nutritional support prescription and delivery monitoring feedback name: Usual care measure: Mean total daily calories delivered/prescribed ratio (percent) measure: Mean total daily protein delivered/prescribed ratio (%) measure: Mean total daily calories delivered/recommended ratio (percent) measure: Mean total daily protein delivered/recommended ratio (percent) measure: Nutritional support duration (days) measure: Time to initiation of nutritional support (days) measure: Weight (Kg) measure: Day 28 mortality rate measure: ICU length-of-stay (days) measure: Days on ventilator (days) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Lille status: RECRUITING city: Lille zip: 59037 country: France name: Eric KIPNIS, MD, PhD role: CONTACT phone: +33 (0)3 20 44 59 62 email: eric.kipnis@chu-lille.fr lat: 50.63297 lon: 3.05858 hasResults: False

 nctId: NCT06342882 id: GO 19/833- A briefTitle: Dysphagia Severity and Functional Independence Level overallStatus: COMPLETED date: 2020-01-01 date: 2024-01-01 date: 2024-02-01 date: 2024-04-02 date: 2024-04-02 name: Atılım University class: OTHER briefSummary: Functional independence is the ability of a person to perform daily life activities safely without any restriction, as much as possible. The functional independence depends on physical, social, cognitive and psychological abilities of the person. Therefore, full functional independence requires the harmony of all these parameters.

Dysphagia can be seen in more than 50% of neurological patients, and it is called neurogenic dysphagia. Muscle weakness, tonus changes, sensory loss and coordination problems occur in these patients. Pain and fatigue are also frequently observe. These patients have problems with fine and gross motor movements, and thereby mobility and transfer activities become difficult. Life-threatening complications such as pulmonary problems, malnutrition and dehydration accompany when patients have dysphagia. Both neurological and dysphagia-related problems negatively affect the physical, psychological, emotional and cognitive functions of patients. Neurological patients with dysphagia may have more serious clinical situations due to more affected vital functions such as pulmonary functions and feeding.

Dysphagia-induced malnutrition adversely affects many systems, including the musculoskeletal system. In a study conducted in the elderly with dysphagia, atrophy in the total muscle mass and swallowing muscles, and increase in intramuscular adipose tissue were reported as a result of malnutrition. Decreases in the muscle mass may negatively affect the functional independence of patients with dysphagia. Other studies in geriatric population have shown that swallowing function is associated with hand grip strength and quadriceps muscle strength, which are indicators of functional independence in activities of daily living (ADL). These studies also suggest that dysphagia may be associated with functional independence in geriatric group. Therefore, functional independence may also reduce in patients with neurogenic dysphagia. However, there is no study investigating the relationship between dysphagia severity and the functional independence levels in patients with neurological diseases. Therefore, the investigators aimed to investigate the relationship between dysphagia severity and functional independence level in patients with neurological diseases. conditions: Dysphagia conditions: Neurologic Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ACTUAL name: dysphagia assessment name: functional independence level measure: dysphagia severity measure: functional independence sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atılım Uiveristy city: Ankara state: Incek zip: 06830 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06342869 id: 690 briefTitle: Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis overallStatus: COMPLETED date: 2022-04-01 date: 2022-10-01 date: 2022-12-01 date: 2024-04-02 date: 2024-04-02 name: Akdeniz University class: OTHER briefSummary: Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis.

Method: Among the patients who applied to Akdeniz University Faculty of Dentistry Endodontic Clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. Eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. Pain during the endodontic procedure was determined and recorded according to the Heft Parker visual analog scale. conditions: Fist and Second Molars With ırreversible Pulpitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: Anesthesia measure: Assessment of complementary palatinal anesthesia with VAS sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Akdeniz University city: Antalya zip: 07070 country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06342856 id: idiopathic infertility briefTitle: Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia acronym: infertility overallStatus: RECRUITING date: 2023-06-15 date: 2024-06-01 date: 2024-07-01 date: 2024-04-02 date: 2024-04-02 name: Ain Shams University class: OTHER briefSummary: Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia conditions: Infertility Unexplained conditions: Oligospermia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: co enzyme Q10 , L- Carnitine measure: Changes in Semen analysis parameters compared to baseline measure: Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ain Shams University status: RECRUITING city: Cairo zip: 002 country: Egypt name: ahmed ma maher, lecturer role: CONTACT phone: 01013340534 email: drwaleedabdelhamid@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06342843 id: SPLAsH id: NL81395.075.22 type: OTHER domain: CCMO briefTitle: Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH) acronym: SPLAsH overallStatus: RECRUITING date: 2024-02-13 date: 2026-08-30 date: 2026-11-30 date: 2024-04-02 date: 2024-04-02 name: Isala class: OTHER briefSummary: This study will compare postoperative pain, health related quality of life (HRQoL), function, rehabilitation, urinary incontinence, muscle atrophy and component positioning in total hip arthroplasty (THA) using the posterolateral approach (PLA) or the direct superior approach (DSA). In addition, the CT images will be used to validate a new metal artefact reduction technique. conditions: Osteoarthritis, Hip studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicenter, prospective, double blinded, randomized controlled intervention study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 211 type: ESTIMATED name: Total Hip Arthroplasty measure: Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form measure: Numeric Rating Scale (NRS) measure: Short Form-12 (SF-12) measure: Hip disability and Osteoarthritis Outcome Score (HOOS) measure: Euro Quality of Life (EQ-5D) measure: Global Rating of Change scale measure: Timed Up and Go test (TUG test) measure: 40 meter self-paced walk test for hip osteoarthritis measure: Stair climb test measure: Step count application on iPhone measure: Muscle atrophy by using Computer Tomography (CT) scanner measure: Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR) measure: Postoperative cup position on Computer Tomography (CT) image measure: Comparing definite cup position with preoperative planned cup position measure: Comparing definite component position with surgeon's perioperative estimation of component position measure: overall image quality measure: image diagnostic confidence measure: metal artifacts on images measure: Incontinence Severity Index (ISI) measure: Urinary Distress Inventory, Short Form (UDI-6) measure: Patient Global Impression of Severity (PGIS) measure: Incontinence Impact Questionnaire Short Form (IIQ-7) measure: Incontinence after Total Hip Arthroplasty sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amphia status: NOT_YET_RECRUITING city: Breda state: Brabant zip: 4818CK country: Netherlands name: Stefan BT Bolder, MD role: CONTACT lat: 51.58656 lon: 4.77596 facility: Medisch Centrum Leeuwarden status: NOT_YET_RECRUITING city: Leeuwarden state: Friesland zip: 8934AD country: Netherlands name: Wierd Zijlstra, MD/PhD role: CONTACT lat: 53.20139 lon: 5.80859 facility: Isala status: RECRUITING city: Zwolle state: Overijssel zip: 8000 GK country: Netherlands name: Diederik de Boer, MSc. role: CONTACT phone: 00316248117 email: die.de.boer@isala.nl name: Roelina Munnik, PhD role: CONTACT phone: 00316245375 email: r.munnik@isala.nl name: Harmen Ettema, MD/PhD role: PRINCIPAL_INVESTIGATOR lat: 52.5125 lon: 6.09444 hasResults: False

 nctId: NCT06342830 id: End 20-05 P briefTitle: Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-05 date: 2024-04-02 date: 2024-04-08 name: Ain Shams University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:

* Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:
* nanocurcumin gel
* curcumin gel
* ciprofloxacin +ibuprofen gel
* calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 6 months follow up periods conditions: Periapical Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: nanocurcumin gel name: Curcumin Gel name: Ciprofloxacin 500 mg +ibuprofen 400mg name: Metapaste [calcium hydroxide paste (control group)] measure: healing of periapical lesion measure: antibacterial effect (CFU) measure: Interappointment Pain sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: faculty of dentistry, Ain shams university city: Cairo zip: 11512 country: Egypt name: Rawda Baghdady role: CONTACT phone: 01142361074 email: RawdaBaghdady@dent.asu.edu.eg name: sarah H Fahmy role: CONTACT phone: 01005267999 name: Rawda M Baghdady, PHD student role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2020-09-20 uploadDate: 2024-03-01T05:02 filename: Prot_SAP_000.pdf size: 719008 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2020-09-20 uploadDate: 2024-03-01T05:04 filename: ICF_001.pdf size: 284949 hasResults: False

 nctId: NCT06342817 id: UFFS briefTitle: Effects of Meditation on Sleep Quality of Medical Students overallStatus: RECRUITING date: 2023-10-18 date: 2024-06-30 date: 2024-06-30 date: 2024-04-02 date: 2024-04-02 name: Universidade Federal da Fronteira Sul class: OTHER briefSummary: The objective of the study is to evaluate the effect of an 8-week online mindfulness-based meditation program on quality sleep status of undergraduate students medicine in the city of Passo Fundo/RS and Chapecó/SC In addition to sleep quality, secondary outcomes such as mindfulness, symptoms of depression, stress, anxiety and burnout will also be assessed conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Those students interested in participating in the study will leave their contact details (telephone and email) to the research coordinator, to whom it will be sent an online questionnaire containing the inclusion and exclusion criteria, and the free consent form through the Google forms platform. Collection instruments will only be made available after fulfilling the inclusion criteria and absence of exclusion criteria and agreement with the consent form. Responders will be randomly randomized 1:1 and subsequently communicated whether they will participate in the intervention group or the control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Responders will be randomly randomized 1:1 and subsequently communicated whether they will participate in the intervention group or the control group. count: 136 type: ESTIMATED name: online mindfulness based meditation program measure: Change in the quality of sleep of medical students on weeks 5, 9 and 17 by the PSQI and ESE measure: Change in the awareness of medical students on weeks 5, 9 and 17 by the MAAS measure: Change in the depression, anxiety and stress symptoms of medical students on weeks 5, 9 and 17 by the DASS-21 measure: Change in the burnout symptoms of medical students on weeks 5, 9 and 17 by CBI-S sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidade Federal Da Fronteira Sul status: RECRUITING city: Passo Fundo state: RS zip: 99010200 country: Brazil name: Tiago T Simon, MD role: CONTACT phone: +5554991843384 email: tiago.teixeira@uffs.edu.br lat: -28.26278 lon: -52.40667 hasResults: False

 nctId: NCT06342804 id: GIB-01-02-2023 briefTitle: Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg overallStatus: RECRUITING date: 2024-03-19 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Valenta Pharm JSC class: INDUSTRY briefSummary: Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).

Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets). conditions: Cholecystitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: 4-MUST, 2 tablets, fasted name: 4-MUST, 2 tablets, after meals measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - tmax measure: Pharmacokinetics - AUC0-t measure: Pharmacokinetics - AUC0-inf measure: Pharmacokinetics - AUC ratio measure: Pharmacokinetics - t1/2 measure: Pharmacokinetics - kel measure: Pharmacokinetics - MRT measure: Pharmacokinetics - Vd measure: Pharmacokinetics - Cmax/AUC0-t measure: Pharmacokinetics - f' measure: Pharmacokinetics - f'' measure: Bioavailability - ratio of Cmax measure: Bioavailability - ratio of AUC0-t measure: Bioavailability - ratio of AUC0-inf measure: Adverse event type measure: Adverse event frequency measure: Adverse event severety measure: Drop-outs associated with adverse events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Federal Budgetary Institution of Science "North-Western Scientific Center for Hygiene and Public Health" status: RECRUITING city: Saint Petersburg zip: 191036 country: Russian Federation name: Elena S Shalukho, MD role: CONTACT phone: +7 (903) 099 57 86 email: elena.shalukho@yandex.ru lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06342791 id: 004349 briefTitle: Effect of Laser Acupuncture on Menstrual Back Pain overallStatus: RECRUITING date: 2024-02-20 date: 2024-05-20 date: 2024-06-20 date: 2024-04-02 date: 2024-04-02 name: Cairo University class: OTHER briefSummary: effect of laser acupuncture on menstrual back pain conditions: Laser Acupuncture conditions: Low Back Pain conditions: Menstruation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two groups primaryPurpose: TREATMENT masking: SINGLE maskingDescription: laser acupuncture whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: laser acupuncture measure: back Pain intensity during menstruation measure: pain threshold measure: Ability to perform daily activities measure: back Pain intensity during menstruation measure: pain threshold measure: Ability to perform daily activities sex: FEMALE minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of physical therapy cairo university status: RECRUITING city: Cairo zip: 37617692 country: Egypt name: Mai Ali Galal El sayed role: CONTACT phone: 01152457470 email: Princessmai828@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06342778 id: DIP-05-02-2023 briefTitle: Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin overallStatus: RECRUITING date: 2024-02-27 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Valenta Pharm JSC class: INDUSTRY briefSummary: Comparative study of pharmacokinetics and bioequivalence of the study drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration certificate holder - Tzamal Bio-Pharma, Israel, manufacturer - Duchesnay Inc, Canada) in healthy volunteers after meals conditions: Nausea studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 28 type: ESTIMATED name: Doxylamine + Pyridoxine name: Diclectin measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - tmax measure: Pharmacokinetics - AUC0-t measure: Pharmacokinetics - AUC0-inf measure: Pharmacokinetics - AUCextr measure: Pharmacokinetics - t1/2 measure: Pharmacokinetics - kel measure: Pharmacokinetics - MRT measure: Bioequivalence - ratio of Cmax measure: Bioequivalence - ratio of AUC0-t measure: Bioequivalence - ratio of AUC0-inf measure: Adverse event type measure: Adverse event frequency measure: Adverse event severety sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation status: RECRUITING city: Yaroslavl zip: 150000 country: Russian Federation name: Sergey M Noskov, Prof. role: CONTACT phone: +7-4852-242332 email: Noskov-SM@mail.ru lat: 57.62987 lon: 39.87368 hasResults: False

 nctId: NCT06342765 id: SV009 briefTitle: Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment acronym: FixedD3 overallStatus: RECRUITING date: 2022-09-22 date: 2028-05-30 date: 2028-05-30 date: 2024-04-02 date: 2024-04-03 name: SpineVision class: INDUSTRY name: Slb Pharma briefSummary: The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.

Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery. conditions: Intervertebral Disc Degeneration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 330 type: ESTIMATED name: Pedicle fixation surgery measure: Incidence of serious and non-serious device- and/or procedure-related adverse events measure: Change of the Oswestry Disability Index (ODI) measure: Fusion success measure: Change of the Oswestry Disability Index (ODI) measure: Change of the back and leg Visual Analogue Score (VAS) measure: Incidence of revision surgery at implant site sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: DOSCEA Pôle Rachis status: RECRUITING city: Bayonne zip: 64100 country: France name: Jean Bernard role: CONTACT email: secretariatdoscea@outlook.fr lat: 43.48333 lon: -1.48333 facility: Clinique du dos Bordeaux-Terrefort status: RECRUITING city: Bruges zip: 33520 country: France name: Louis Boissière, Doctor role: CONTACT email: boissierelouis@gmail.com lat: 44.87981 lon: -0.61219 facility: Orthéo Neurochirurgie status: RECRUITING city: Saint-Étienne zip: 42199 country: France name: Benjamin Pommier, Doctor role: CONTACT email: benjamin.pommier@neurochirurgie.fr lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06342752 id: 6007 briefTitle: The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia acronym: INFANCY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-09 date: 2024-04-02 date: 2024-04-02 name: University Hospital, Antwerp class: OTHER briefSummary: Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.

Despite the well-established primordial role of inflammation and oxidative stress in the development of BPD, clinical practice does not incorporate the testing for biomarkers associated with the development of BPD. The diagnosis of BPD based on required respiratory support at 36 weeks PML, stresses the need for an early prediction tool which could identify patients with high levels of these biomarkers. This on its turn, could also improve treatment approaches in clinical practice which are currently mostly supportive or non-specific and do not target underlying pathophysiologic pathways.

Secondly, mucin expression aim to play a rol in other respiratory diseases, whereas in BPD only the potential role of MUC1 was explored.

Thirdly, the composition of the airway microbial composition of an infant is assumed to be influenced by different factors. From early on in pregnancy the airway microbiome of the infant is formed, offering a protective role against pathologies. On the other hand, the role of the airway microbiome in the development of BPD remains unclear and needs to be elucidated.

The threefold aim of this study is as follows:

I. The development of a non-invasive breath test that allows early detection of bronchopulmonary dysplasia, using the potential of VOCs in exhaled breath as biomarkers for inflammation and oxidative stress.

II. The exploration of the composition and diversity of the airway microbiome in infants with BPD, their association with exhaled VOCs and the exploration of the placental and vaginal microbiome.

III. The detection of potential alterations in airway mucin expression in BPD patients.

Through this comprehensive approach, we seek to gain a deeper understanding of how these mutual associations may contribute to the later development of BPD.

In total 140 preterm infants, including 70 BPD patients and 70 preterm controls, born below 30 weeks' gestation at the Antwerp University Hospital will be included. conditions: Bronchopulmonary Dysplasia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 140 type: ESTIMATED name: Breath test name: Throat swabs name: Placental samples name: Vaginal swab name: Endotracheal aspirates measure: Exhaled breath Volatile Organic Compounds (VOCs) measure: Airway mucin profiles measure: Airway microbial profiles measure: Placental headspace VOCs measure: Placental microbiome measure: Vaginal microbiome measure: Follow-up structural lung imaging measure: Hypercapnia sex: ALL minimumAge: 0 Days maximumAge: 3 Days stdAges: CHILD hasResults: False

 nctId: NCT06342739 id: IEO 1595 briefTitle: Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations overallStatus: RECRUITING date: 2022-03-23 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules. conditions: Thyroid Nodule studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06342726 id: 2024/714469 briefTitle: The Effect of Active External Rewarming on Rewarming Rate in Simulated Prehospital Accidental Hypothermia overallStatus: RECRUITING date: 2024-05-28 date: 2024-06-02 date: 2024-06-02 date: 2024-04-02 date: 2024-04-02 name: Haukeland University Hospital class: OTHER briefSummary: In this study, we aim to compare the effect of active external rewarming to passive rewarming in healthy research participants on core temperature.

The participants will be cooled to a core temperature of 35 degress C, the rewarmed using 2 different scenarios. Scenario 1 will be with passive rewarming, scenario 2 with active rewarming. Shivering will be pharmacologically inhibited using Buspirone and Meperidine. conditions: Accidental Hypothermia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. The research participants will be healthy volunteers providing both oral and written consent.

Before the start of experiment, the research participant will be cooled in an ice cave wearing wet clothing and with 2-3 m/s wind to a core temperature of 35.0 °C using the established protocol for inhibition of shivering. The maximum cooling time will be 2 hours (120 minutes). The order of interventions will be randomized.

When the research subjects reach the target temperature of 35.0°C or the maximum cooling time of 2 hours, they will be subjected to one of the two scenarios listed below, with a rewarming phase of maximum 60 minutes. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: PAX Warming Blanket name: Passive insulation measure: Core body temperature sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haukeland University Hospital status: RECRUITING city: Bergen zip: 5021 country: Norway name: Sigurd Mydske, MD role: CONTACT phone: 90659586 email: sigurd.mydske@norskluftambulanse.no name: Øyvind Thomassen, MD, PhD role: CONTACT phone: 977 18 721 email: oyvind.thomassen1@helse-bergen.no lat: 60.39299 lon: 5.32415 hasResults: False

 nctId: NCT06342713 id: BGB-45035-101 briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2025-04-30 date: 2025-04-30 date: 2024-04-02 date: 2024-04-02 name: BeiGene class: INDUSTRY briefSummary: This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants.

Study details include:

* The study duration will be up to 16 months.
* The treatment duration will be up to 14 days.
* Safety follow-up 30 days after last dose of study drug. conditions: Healthy Participants conditions: Healthy Subjects conditions: Healthy Volunteers conditions: Autoimmune Diseases conditions: Healthy Adult Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The cohorts in Part A, B, and C will be double-blinded, while the food effect study in Part D will be open-label whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 92 type: ESTIMATED name: BGB-45035 name: Placebo measure: Number of Participants Experiencing Adverse Events (AEs) measure: Number of participants with clinically significant changes from baseline in clinical laboratory values measure: Number of participants with clinically significant changes from baseline in vital signs measure: Number of participants with clinically significant changes from baseline in cardiac conduction intervals measure: Area under the plasma concentration time curve from time zero to last quantifiable time(AUClast) measure: Area under the plasma concentration time curve from time zero to infinite time (AUCinf) measure: Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau) measure: Maximum observed plasma concentration (Cmax) measure: Time to maximum plasma concentration (Tmax) measure: Trough plasma concentration (Ctrough) measure: Half life (t½) measure: Apparent systemic clearance (CL/F) measure: Apparent volume of distribution (Vz/F) measure: Accumulation Ratios sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06342700 id: PKM18138 id: U1111-1299-1906 type: REGISTRY domain: ICTRP briefTitle: A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants overallStatus: RECRUITING date: 2024-03-25 date: 2024-04-29 date: 2024-04-29 date: 2024-04-02 date: 2024-04-11 name: Sanofi class: INDUSTRY briefSummary: This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age.

The total study duration per participant is expected to be up to 36 days, including:

* Screening: up to 4 weeks
* Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods.
* Washout: One day washout is planned after each treatment period hence providing 2 days between doses.
* Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study. conditions: Autoimmune Disorder conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 28 type: ESTIMATED name: Rilzabrutinib crystalline form name: Rilzabrutinib amorphous form measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fasted state measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fasted state measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fasted state measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fed state measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fed state measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fed state measure: Food effects as assessed by rilzabrutinib Cmax following administration of the test and reference formulations under the fed versus fasted state measure: Food effects as assessed by rilzabrutinib AUClast following administration of the test and reference formulations under the fed versus fasted state measure: Food effects as assessed by rilzabrutinib AUC following administration of the test and reference formulations under the fed versus fasted state measure: Number of participants with adverse events, treatment-emergent adverse events, serious adverse events and adverse events of special interest sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Nucleus Network Site Number : 8400001 status: RECRUITING city: Saint Paul state: Minnesota zip: 55114 country: United States lat: 44.94441 lon: -93.09327 hasResults: False

 nctId: NCT06342687 id: JagiellonianU 1 briefTitle: Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment overallStatus: COMPLETED date: 2018-01-01 date: 2022-12-31 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Jagiellonian University class: OTHER briefSummary: The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection. conditions: Colorectal Cancer conditions: ERAS studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 468 type: ACTUAL name: High compliance with ERAS protocol measure: Post operative 5 year survival rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University Medical College city: Kraków state: Małopolskie zip: 31-008 country: Poland lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06342674 id: Nejla CANBULAT ŞAHİNER briefTitle: Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients acronym: The overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-01 date: 2025-07-31 date: 2024-04-02 date: 2024-04-02 name: Sakarya University class: OTHER briefSummary: The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason, or the mother starting to work. The content of breast milk varies according to gestational age and stages of lactation. However, it varies from day to day depending on the infant's needs. In recent literature, it is emphasized that the content of breast milk (carbohydrates, fats, proteins, vitamins, trace elements, etc.) varies according to circadian variation. In the literature review, no national or international study was found indicating whether the circadian properties of breast milk have an effect on the infant's growth parameters. This study was designed as a randomized controlled experimental study to determine the effect of the circadian properties of breast milk on the growth parameters of the infant and the absorption levels of nutrients by the baby in preterm newborns.

no effect on the infant's growth parameters and nutrient absorption levels by the infant.

Hypothesis 1 (H1): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the weight of the infants.

Hypothesis 2 (H2): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the height of the infants.

Hypothesis 3 (H3): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the head circumference of the infants.

Hypothesis 4 (H4): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the absorption levels of vitamins and trace elements measured in the infants' breast milk. conditions: Breast Feeding conditions: Breast Milk Collection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Single (participant) blinding was used in the study. For this purpose, it was not stated which group the participating mothers were in the research, but they were informed about the procedure to be performed. Therefore, a separate informed consent form was prepared for each group. Statistician blinding will also be applied. While coding the research data, the research group will be coded as A and B, and the statistician will be prevented from knowing which letter represents which group. whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: Giving breast milk to the newborn according to the circadian rhythm name: Usual care measure: Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups measure: Evaluation of the baby's height measurements in the study and control groups measure: Evaluation of the baby's head circumference in the study and control groups measure: Evaluation of nutritional absorption of infants in the study and control groups sex: ALL minimumAge: 32 Weeks maximumAge: 34 Weeks stdAges: CHILD hasResults: False

 nctId: NCT06342661 id: 2022IIT205 briefTitle: Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment overallStatus: RECRUITING date: 2023-03-01 date: 2028-11 date: 2028-11 date: 2024-04-02 date: 2024-04-02 name: First Affiliated Hospital of Harbin Medical University class: OTHER briefSummary: 1. Explore the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors; 2. Discuss the correlation between different risk factors (mainly hypertension, diabetes, smoking, hyperlipidemia, hyperhomocysteinemia, etc.) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cerebrovascular diseases and immune-inflammatory related diseases of the nervous system; 3. Explore the correlation between different immune inflammatory factors (IL1, IL6, IL10, INFγ, TNFα) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients; 4. Track and explore the dynamic changes of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors in 3 months, 1 year, 3 years, and 5 years. conditions: Cerebrovascular Disease Small Vessel studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Neuropsychological testing measure: Patient characteristics measure: VISTA expression in PBMCs in the VCI and control groups sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang zip: 150010 country: China name: LiJun Chi role: CONTACT phone: 13895783757 email: clj3757@163.com lat: 45.75 lon: 126.65 hasResults: False

 nctId: NCT06342648 id: Cutaneous water in renal colic briefTitle: Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-02 name: Suez Canal University class: OTHER briefSummary: Renal colic is a serious and excruciatingly painful condition that frequently presents itself in the emergency department. In this trial, patients with renal colic who have received intramuscular diclofenac sodium injection or intracutaneous sterile water injection will have their Visual Analogue Scale (VAS) measured and compared. conditions: Renal Colic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 570 type: ESTIMATED name: Sterile Water Injection name: Diclofenac Sodium injection measure: Visual Analogue Scale (VAS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342635 id: HYD/DENMARK-001/2023 briefTitle: Hydra Single-centre Experience - Copenhagen, Denmark overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2026-10-31 date: 2024-04-02 date: 2024-04-02 name: Sahajanand Medical Technologies Limited class: INDUSTRY name: Qmed Consulting A/S briefSummary: The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series. conditions: Aortic Valve Stenosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Hydra Transcatheter Aortic Valve (THV) Series measure: Primary safety endpoint measure: Primary performance endpoint measure: Technical success measure: Cardiovascular mortality measure: All-cause mortality measure: All stroke measure: Disabling stroke measure: Myocardial infarction measure: Major vascular complication measure: Acute kidney injury measure: New permanent pacemaker implantation due to procedure related conduction abnormalities measure: New-onset atrial fibrillation measure: Coronary artery obstruction requiring intervention measure: Re-hospitalization for procedure- or valve-related causes measure: Mean aortic valve gradient measure: Effective Orifice Area (EOA) measure: Paravalvular leak measure: New York Heart Association (NYHA) functional class measure: Quality-of-life evaluation measure: Bioprosthetic Valve Failure (BVF) measure: Bioprosthetic valve dysfunction (BVD) measure: Stroke or peripheral embolism measure: VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns measure: Rates of Hypoattenuated Leaflet Thickening (HALT) measure: Rates of Reduced leaflet motion (RLM) measure: Commissural alignment sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University Hospital, Rigshospitalet city: Copenhagen country: Denmark name: Dr. Ole De Backer role: CONTACT name: Dr. Ole De Backer, Copenhagen University Hospital, Rigshospitalet role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06342622 id: Weiguo Dong briefTitle: Young-onset Colorectal Cancer Screening Based on Artificial Intelligence overallStatus: COMPLETED date: 2023-12-01 date: 2024-01-10 date: 2024-01-25 date: 2024-04-02 date: 2024-04-02 name: Renmin Hospital of Wuhan University class: OTHER briefSummary: In this study, we aimed to develop, internally and temporally validate the machine learning models to help screen YOCRC bansed on the retrospective extracted Electronic Medical Records (EMR) data. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 11000 type: ACTUAL name: Using routine clinical data and machine learning models. measure: The performance of machine learning screening models sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Renmin Hospital of Wuhan University city: Wuhan state: Hubei zip: 430060 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06342609 id: 32857-01-EKSTROM briefTitle: Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease acronym: EKSTROM overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-15 date: 2024-09-07 date: 2024-09-07 date: 2024-04-02 date: 2024-04-02 name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center class: OTHER briefSummary: This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind Placebo controlled primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 84 type: ACTUAL name: Colchicine 0.5 MG measure: Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography measure: Effect of Colchicine on markers of inflammation using laboratory tests measure: Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA measure: Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA measure: Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD) sex: ALL minimumAge: 30 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center city: Torrance state: California zip: 90502 country: United States lat: 33.83585 lon: -118.34063 hasResults: False

 nctId: NCT06342596 id: 18597 id: J2O-MC-EKBD type: OTHER domain: Eli Lilly and Company briefTitle: A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-05 date: 2024-04 date: 2024-04 date: 2024-04-02 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate how much of the study drug (LY3473329), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: [14C]-LY3473329 name: [14C]-LY3473329 name: LY3473329 measure: Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered measure: Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered measure: Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329 measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329 measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329 measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity measure: Part 1: PK: Maximum Concentration (Cmax) of LY3473329 measure: Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity measure: Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) measure: Part 1: Total Number of Metabolites of LY3473329 measure: Part 2: PK: AUC (0-∞) of LY3473329 measure: Part 2: PK: AUC (0-∞) of [14C]-LY3473329 measure: Part 2: PK: AUC (0-∞) of Total Radioactivity measure: Part 2: PK: Cmax of LY3473329 measure: Part 2: PK: Cmax of [14C]-LY3473329 measure: Part 2: PK: Cmax of Total Radioactivity measure: Part 2: Total Radioactivity Recovered in Urine and Feces sex: MALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea Clinical Research Unit city: Holbeck state: Leeds zip: LS11 9EH country: United Kingdom lat: 53.25 lon: -1.18333 hasResults: False

 nctId: NCT06342583 id: CNR-IRIB-PRO-2024-004 briefTitle: Advanced Social Relations Training overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-17 date: 2026-02-10 date: 2024-04-02 date: 2024-04-02 name: Istituto per la Ricerca e l'Innovazione Biomedica class: OTHER name: Messina, Italy briefSummary: Advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (IQ) ≥ 80. There will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. The protocol will be carried out once a week for a duration of 45 minutes. The aim is to enhance communication and social skills within the group. A total of 23 sessions are planned. From the first to the third session the participants will acquire skills for communicating and conversing in an appropriate way. Thereafter from the fourth to the eleventh session social stories illustrating scenes from everyday life will be shown, with the aim of learning and managing the dynamics in which they find themselves on a daily basis. At the end of each story shown they will be asked to impersonate the protagonists depicted in the stories, each participant involved in turn will play all the roles shown in the stories, thus working in the mode of role playing.

The last part, which includes sessions from the twelfth to the twenty-third, will be dedicated to the correct and conscious use of social networks with a focus on the risks that can be encountered and the correct ways to make good use of them. conditions: Autism conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Advanced social relations training with technical device name: Advanced social relations training without technical device measure: Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form) measure: Eye contact measure: Smile in relation to group members' expressions measure: Greeting measure: Asking a question measure: Proposing an idea or activity to be carried out measure: Answering a question measure: Taking verbal initiative measure: Approval/sharing gestures sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) status: RECRUITING city: Messina zip: 98164 country: Italy name: Flavia Marino role: CONTACT phone: +393395798263 email: flavia.marino@irib.cnr.it name: Maria Valeria Maiorana role: CONTACT phone: +393285856656 email: mariavaleria.maiorana@irib.cnr.it name: Flavia Marino role: PRINCIPAL_INVESTIGATOR name: Giovanni Pioggia role: SUB_INVESTIGATOR name: Paola Chilà role: SUB_INVESTIGATOR name: Roberta Minutoli role: SUB_INVESTIGATOR name: Noemi Vetrano role: SUB_INVESTIGATOR name: Chiara Failla role: SUB_INVESTIGATOR name: Germana Doria role: SUB_INVESTIGATOR name: Ileana Scarcella role: SUB_INVESTIGATOR name: Cinzia Grasso role: SUB_INVESTIGATOR name: Mariaelena Franchina role: SUB_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False

 nctId: NCT06342570 id: 3-2023-0462 briefTitle: Quantitative Analysis of EEG Changes in Response to Nociception overallStatus: RECRUITING date: 2024-04-18 date: 2026-12-30 date: 2026-12-30 date: 2024-04-02 date: 2024-04-17 name: Gangnam Severance Hospital class: OTHER briefSummary: This study will quantify the nociception using Analgesia Nociception Index (ANI) during general anesthesia and analyze the differences in EEG depending on the degree of nociception. Additionally, the investigators will quantify the nociception during recovery and analyze the differences in EEG depending on the degree of nociception. conditions: Patients Undergoing Laparoscopic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 109 type: ESTIMATED name: There is no Intervention name to describe. measure: Correlation between changes in ANI and EEG band power in response to surgical stimulation. measure: Correlation between changes in ANI and EEG band power in response to tracheal intubation measure: Correlation between changes in ANI and EEG connectivity in response to surgical stimulation measure: Correlation between changes in ANI and EEG connectivity in response to tracheal intubation measure: Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration measure: Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI measure: Differences in EEG connectivity during surgery between groups with large and small changes in ANI measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI measure: Differences in EEG connectivity during recovery between groups with large and small changes in ANI measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic measure: Differences in EEG connectivity depending on the type of inhaled anesthetic measure: Differences in ANI depending on the type of inhaled anesthetic sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GangnamSeverance Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Myung Il Bae role: CONTACT phone: 82-2-2019-6611 email: BMI87@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06342557 id: FROM briefTitle: Transitional ePRO Diary Liver acronym: MACROLIVER overallStatus: RECRUITING date: 2024-03-28 date: 2034-02-21 date: 2034-02-21 date: 2024-04-02 date: 2024-04-16 name: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS class: OTHER briefSummary: The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and/or the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients. conditions: Liver Transplant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 250 type: ESTIMATED measure: four-item Morisky Medication Adherence Scale (MGLS) sex: ALL minimumAge: 14 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: ASST-Papa Giovanni XXIII status: RECRUITING city: Bergamo state: Milano zip: 24127 country: Italy name: Stefano Fagiuoli, MD role: CONTACT phone: 035.2674259 email: sfagiuoli@asst-pg23.it lat: 45.69601 lon: 9.66721 hasResults: False

 nctId: NCT06342544 id: AGN_2023_14 briefTitle: Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial. acronym: IMCOMG overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2029-06 date: 2024-04-02 date: 2024-04-02 name: Fondation Ophtalmologique Adolphe de Rothschild class: NETWORK briefSummary: Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness.

In the initial phase of the disease, 70% of patients present with ocular onset myasthenia (OMG), i.e. weakness limited to the oculomotor muscles. Generalization to skeletal, bulbar and axial muscles occurs in 20-40% of cases, with a higher frequency in the first and second years, respectively 46% and 60% of generalizations. This reflects the maturation of the autoimmune response in the early years of the disease, and represents a therapeutic window of opportunity to modify the course of the disease.

Generalization is a critical event, putting the patient at risk of admission to an intensive care unit and necessitating the use of long-term immunosuppressants.

There is currently no validated strategy for preventing generalization. On the one hand, a preventive role for corticosteroid therapy in ocular-onset myasthenia has been observed in some studies, but not confirmed by others. These contradictory results may be explained by the bias of retrospective observational studies and the use of different corticosteroid administration regimens.

On the other hand, recent data on the use of low-dose Rituximab in the early phase of the disease shows greater efficacy than later use, enabling prolonged remission of the disease with a very good tolerability profile.

We propose to compare in a randomized controlled trial the usual practice with a proactive strategy with a standardized corticosteroid regimen immediate at diagnosis.

Patients with ocular myasthenia are usually treated symptomatically with acetylcholinesterase inhibitors. The introduction of corticosteroids is delayed and limited to patients with persistent disabling diplopia or ptosis with occlusion. When corticosteroids are tapered off, ocular symptoms may recur. This level of corticosteroid dependence observed in patients treated for ocular myasthenia has not been specifically studied. In order to reduce the levels of corticosteroids administered and avoid recurrence of ocular symptoms and their delayed generalization, it is usually proposed to introduce another immunosuppressant.

The aim of this study is to evaluate the efficacy of a standardized proactive prevention strategy on the generalization of ocular onset myasthenias during the first 2 years. It will combine immediate treatment with corticosteroids at the time of diagnosis, with the addition of rituximab in the event of recurrence of ocular symptoms as corticosteroids are tapered off. conditions: Ocular Myasthenia Gravis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: immediate treatment with corticosteroids name: addition of rituximab if recurrence measure: proportion of patients who progressed to generalized myasthenia within 2 years of follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342531 id: 210324 briefTitle: More Effective Violence Risk Management - eDASA+APP FI acronym: eDASA+APP FI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: University of Turku class: OTHER name: Helsinki University Central Hospital briefSummary: The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care. conditions: Violence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A pre-post design (quasi-experimental), a cluster design primaryPurpose: SCREENING masking: NONE count: 26 type: ESTIMATED name: eDASA+APP FI measure: Workplace violence measure: Coercive measures measure: Job satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342518 id: MU ESWT briefTitle: ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation overallStatus: COMPLETED date: 2020-12-01 date: 2021-09-01 date: 2021-12-01 date: 2024-04-02 date: 2024-04-02 name: Istanbul Medeniyet University class: OTHER briefSummary: This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound. conditions: Lateral Epicondylitis conditions: Tennis Elbow studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ACTUAL name: Extracorporeal Shock Wave Therapy (ESWT) name: Sham ESWT name: Resting Splint , Exercises and ice measure: Hand Grip Strength measure: Pain severity measure: Functionality measure: Quality of life score measure: deep muscular tissue sensitivity measure: thickness of the common extensor tendon (CET) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department city: Istanbul zip: 34732 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06342505 id: MEC-2022-0037 briefTitle: Tacrolimus in CD3+ T Lymphocytes acronym: INTACT overallStatus: COMPLETED date: 2022-05-30 date: 2022-10-10 date: 2022-11-10 date: 2024-04-02 date: 2024-04-02 name: Erasmus Medical Center class: OTHER briefSummary: The goal of this study is to measure concentrations of the drug tacrolimus in both whole blood and within T lymphocytes. It will also learn on the correlation between the concentration in T lymphocytes and the effects of the drug. The main questions are:

(i) What is the ratio between the tacrolimus concentration within T lymphocytes and in whole blood?; (ii) What is the correlation between tacrolimus concentrations and the effects of the drug?

Participants will:

* Receive standard clinical care;
* Undergo two extra venipunctures for the collection of blood. conditions: Immunosuppression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 28 type: ACTUAL name: Venipunctures measure: The intracellular tacrolimus concentration in CD3+ T lymphocytes measure: Intracellular cytokine production sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC city: Rotterdam zip: 3015 GD country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06342492 id: KCHRRF_CS Lead Failure_0025 briefTitle: Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-12 date: 2024-04-02 date: 2024-04-02 name: Kansas City Heart Rhythm Research Foundation class: OTHER briefSummary: This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure. conditions: Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Coronary Sinus Lead Revision measure: Need for lead revision measure: Electrocardiography characteristics - QRS Interval sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Menorah Medical Center city: Overland Park state: Kansas zip: 66209 country: United States lat: 38.98223 lon: -94.67079 facility: Kansas City Heart Rhythm Institute - Roe Clinic city: Overland Park state: Kansas zip: 66211 country: United States lat: 38.98223 lon: -94.67079 facility: Overland Park Regional Medical Center city: Overland Park state: Kansas zip: 66215 country: United States lat: 38.98223 lon: -94.67079 facility: Centerpoint Medical Center Clinic city: Independence state: Missouri zip: 64057 country: United States lat: 39.09112 lon: -94.41551 facility: Centerpoint Medical Center city: Independence state: Missouri zip: 64057 country: United States lat: 39.09112 lon: -94.41551 facility: Research Medical Center Clinic city: Kansas City state: Missouri zip: 64032 country: United States lat: 39.09973 lon: -94.57857 facility: Research Medical Center city: Kansas City state: Missouri zip: 64032 country: United States lat: 39.09973 lon: -94.57857 hasResults: False

 nctId: NCT06342479 id: NM: 04.20.ND:30.03.2023 briefTitle: Discharge Training for Patients With Intertrochanteric Fracture overallStatus: RECRUITING date: 2023-09-01 date: 2024-06-01 date: 2024-07-01 date: 2024-04-02 date: 2024-04-02 name: Erzurum Technical University class: OTHER briefSummary: This study examines the effect of discharge training given to patients with intertrochanteric femur fractures on the wound healing process and readiness for discharge. In the study, patients were provided with certain educational content before and after discharge. The effect of training on wound healing, readiness for discharge and post-discharge recovery process will be evaluated statistically. conditions: Surgical Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Discharge Education measure: Toronto Wound Symptom Assessment System measure: Discharge readiness scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erzurum Technical University Faculty of Health Sciences status: RECRUITING city: Erzurum zip: 25000 country: Turkey name: Yasemin Erden role: CONTACT phone: 05303461516 email: yasemin.erden@erzurum.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06342466 id: 2023-358-02 briefTitle: Bortezomib, Pomalidomide, Dexamethasone For Systemic AL Amyloidosis overallStatus: RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: Jin Lu, MD class: OTHER briefSummary: This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months. conditions: Systemic Amyloidosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Bortezomib, pomalidomide, dexamethasone primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Bortezomib name: Pomalidomide name: Dexamethasone measure: Hematologic VGPR + CR rate at 6 months measure: Overall Hematologic response rate at 6 months measure: At least one organ response at 6 months measure: TTNT at 2 years measure: Estimated PFS at 2 years measure: Estimated OS at 2 years measure: TRAE sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100044 country: China name: Yang Liu role: CONTACT phone: +8613716926210 email: pkuphliuyang@bjmu.edu.cn name: Jin Lu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06342453 id: STUDY00026814 id: NCI-2024-01534 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00026814 type: OTHER domain: OHSU Knight Cancer Institute briefTitle: Examining Arts as Therapy in Children With Cancer, CREATe Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-30 date: 2026-03-30 date: 2024-04-02 date: 2024-04-02 name: OHSU Knight Cancer Institute class: OTHER name: Oregon Health and Science University name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer. conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ESTIMATED name: Art Therapy name: Discussion name: Media Intervention name: Survey Administration measure: Number of participants that complete all interventions and data collection time points measure: Number of eligible participants that enroll in the study (feasibility threshold of 60%) measure: Number of participants that complete all interventions and all surveys in the study. measure: Number of intervenor fidelity surveys that obtain at least 95% score. measure: Comparison of scores on the PRO-CTCAE between intervention arms measure: Comparison of scores on the PROMIS between intervention arms measure: Comparison of scores on the Faces between intervention arms sex: ALL minimumAge: 8 Years maximumAge: 13 Years stdAges: CHILD facility: OHSU Knight Cancer Institute city: Portland state: Oregon zip: 97239 country: United States name: Jennifer L. Raybin role: CONTACT phone: 503-418-5150 email: raybin@ohsu.edu name: Jennifer L. Raybin role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06342440 id: 23228/AACRC briefTitle: Early Detection of Advanced Adenomas and Colorectal Cancer acronym: AACRC overallStatus: RECRUITING date: 2020-03-15 date: 2025-12-15 date: 2025-12-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses. conditions: Colorectal Cancer conditions: Colorectal Neoplasms conditions: Colorectal Polyp conditions: Colorectal Adenocarcinoma conditions: Colorectal Disorders conditions: Colorectal Dysplasia conditions: Colorectal Cancer Stage I conditions: Colorectal Cancer Stage II conditions: Colorectal Cancer Stage III conditions: Colorectal Cancer Stage IV conditions: Colorectal Neoplasms Malignant conditions: Colorectal Serrated Adenocarcinoma conditions: Colorectal Adenoma With Severe Dysplasia conditions: Colorectal Adenoma With Mild Dysplasia conditions: Colorectal Adenoma With Moderate Dysplasia conditions: Colorectal Adenoma and Carcinoma 1 conditions: Colorectal Adenomatous Polyp conditions: Colorectal Adenocarcinoma Metastatic in the Liver studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: DENEB measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Monrovia state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR name: James Lin role: SUB_INVESTIGATOR name: Gregory Idos role: SUB_INVESTIGATOR name: Trilokesh Kadambi role: SUB_INVESTIGATOR lat: 34.14806 lon: -117.99895 facility: University of California San Diego status: RECRUITING city: San Diego state: California zip: 92093 country: United States name: C Richard Boland, MD, PhD role: CONTACT name: C Richard Boland, MD, PhD role: SUB_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: The First Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian country: China name: Jing Zhang role: CONTACT name: Jing Zhang role: SUB_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR lat: 38.91222 lon: 121.60222 facility: IRCCS San Raffaele status: RECRUITING city: Milan country: Italy name: Giulia Martina Cavestro, MD, PhD role: CONTACT email: cavestro.giuliamartina@hsr.it name: Giulia Martina Cavestro role: SUB_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Mie University status: RECRUITING city: Mie country: Japan name: Yuji Toiyama role: CONTACT name: Yuji Toiyama role: SUB_INVESTIGATOR name: Yoshinaga Okugawa role: SUB_INVESTIGATOR name: Tadanobu Shimura role: SUB_INVESTIGATOR facility: Barcelona University status: RECRUITING city: Barcelona country: Spain name: Francesc Balaguer, MD, PhD role: CONTACT email: fprunes@clinic.cat name: Francesc Balaguer role: SUB_INVESTIGATOR name: Miguel Pera role: SUB_INVESTIGATOR name: Lorena Moreno role: SUB_INVESTIGATOR name: Luis Bujanda role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06342427 id: 23228/DESTINEX briefTitle: Stomach Cancer Exosome-based Detection acronym: DESTINEX overallStatus: RECRUITING date: 2023-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer. conditions: Gastric Cancer conditions: Gastric Adenocarcinoma conditions: Gastric Cancer Stage conditions: Gastric Neoplasm conditions: Gastric Lesion conditions: Gastric Cancer in Situ conditions: Gastric Cancer Stage IV conditions: Gastric Cancer Stage IIIB conditions: Gastric Cancer Stage III conditions: Gastric Cancer Stage IB conditions: Gastric Cancer Stage IA conditions: Gastric Cancer, Stage 0 conditions: Gastric Cancer Stage IIIA conditions: Gastric Cancer Stage II conditions: Gastric Cancer TNM Staging conditions: Gastric Cancer Metastatic to Lung conditions: Gastric Cancer Metastatic to Liver conditions: Gastric Cancer Stage I conditions: Gastric Cancer TNM Staging Primary Tumor (T) T2B studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 800 type: ESTIMATED name: DESTINEX measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Silei Sui role: PRINCIPAL_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Nagoya University status: RECRUITING city: Nagoya country: Japan name: Yasuhiro Kodera role: CONTACT name: Yasuhiro Kodera role: SUB_INVESTIGATOR name: Mitsuo Kanda role: SUB_INVESTIGATOR lat: 35.18147 lon: 136.90641 facility: Mie University status: RECRUITING city: Tsu country: Japan name: Yuji Toiyama role: CONTACT name: Yuji Toiyama role: SUB_INVESTIGATOR name: Yoshinaga Okugawa role: SUB_INVESTIGATOR lat: 34.73333 lon: 136.51667 hasResults: False

 nctId: NCT06342414 id: 23228/ELUCIDATE briefTitle: An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer acronym: ELUCIDATE overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery. conditions: Hepatocellular Carcinoma conditions: Intrahepatic Cholangiocarcinoma conditions: Cholangiocarcinoma conditions: Primary Liver Cancer conditions: Primary Liver Carcinoma conditions: Hepatic Cancer conditions: Hepatic Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: ELUCIDATE measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Caiming Xu, MD, PhD role: SUB_INVESTIGATOR name: Yoh Asahi, MD role: PRINCIPAL_INVESTIGATOR name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Graduate School of Medical Sciences, Kyushu University status: RECRUITING city: Fukuoka country: Japan name: Tomoharu Yoshizumi role: CONTACT name: Tomoharu Yoshizumi role: SUB_INVESTIGATOR name: Takeo Toshima role: SUB_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: Graduate School of Medical Sciences, Kumamoto University status: RECRUITING city: Kumamoto country: Japan name: Hideo Baba role: CONTACT name: Hideo Baba role: SUB_INVESTIGATOR lat: 32.80589 lon: 130.69182 facility: Hokkaido University Graduate School of Medicine status: RECRUITING city: Sapporo country: Japan name: Akinobu Taketomi role: CONTACT name: Akinobu Taketomi role: PRINCIPAL_INVESTIGATOR name: Yoh Asahi role: PRINCIPAL_INVESTIGATOR name: Tatsuhiko Kakisaka role: SUB_INVESTIGATOR lat: 43.06667 lon: 141.35 facility: Tokushima University status: RECRUITING city: Tokushima country: Japan name: Mitsuo Shimada role: CONTACT name: Mitsuo Shimada role: SUB_INVESTIGATOR name: Katsuki Miyazaki role: SUB_INVESTIGATOR lat: 34.06667 lon: 134.56667 hasResults: False

 nctId: NCT06342401 id: 23228/ENCODE briefTitle: Early Onset Colorectal Cancer Detection acronym: ENCODE overallStatus: RECRUITING date: 2023-04-15 date: 2025-04-15 date: 2025-10-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.

This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid) conditions: Colorectal Cancer conditions: Colorectal Neoplasms conditions: Colorectal Adenocarcinoma conditions: Colorectal Cancer Stage I conditions: Colorectal Cancer Stage IV conditions: Colorectal Cancer Stage II conditions: Colorectal Cancer Stage III conditions: Colorectal Neoplasms Malignant studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: ENCODE measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Alessandro Mannucci, MD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: IRCCS San Raffaele status: RECRUITING city: Milan country: Italy name: Giulia Martina Cavestro, MD, PhD role: CONTACT email: cavestro.giuliamartina@hsr.it name: Alessandro Mannucci, MD role: PRINCIPAL_INVESTIGATOR name: Giulia Martina Cavestro, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Kawasaki University status: RECRUITING city: Kawasaki country: Japan lat: 35.52056 lon: 139.71722 facility: Mie University status: RECRUITING city: Mie country: Japan facility: National Cancer Center Hospital status: RECRUITING city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Tokyo Medical and Dental University status: RECRUITING city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Yamagata University status: RECRUITING city: Yamagata country: Japan lat: 38.23333 lon: 140.36667 facility: Barcelona University status: RECRUITING city: Barcelona country: Spain name: Francesc Balaguer, MD, PhD role: CONTACT email: fprunes@clinic.cat lat: 41.38879 lon: 2.15899 facility: University of La Laguna status: RECRUITING city: La Laguna country: Spain lat: 28.4853 lon: -16.32014 facility: Salamanca Biomedical Research Institute status: RECRUITING city: Madrid country: Spain name: Jose Perea, MD role: CONTACT email: josepereag@hotmail.com name: Jose Perea, MD role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06342388 id: 2024-0427 id: A538500 type: OTHER domain: UW- Madison id: Protocol Version 3/20/2024 type: OTHER domain: UW- Madison id: SMPH/POP HEALTH SCI/POP HLTH type: OTHER domain: UW- Madison briefTitle: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage overallStatus: WITHDRAWN date: 2024-07 date: 2026-03 date: 2026-06 date: 2024-04-02 date: 2024-04-09 name: University of Wisconsin, Madison class: OTHER name: Covering Wisconsin briefSummary: The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:

1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?
2. What is the effectiveness of outreach using a live call rather than a pre-recorded call? conditions: No Medicaid Coverage studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 0 type: ACTUAL measure: Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call measure: Duration of coverage gaps measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342375 id: 2024-0434 id: A538500 type: OTHER domain: UW- Madison id: Protocol Version 3/20/2024 type: OTHER domain: UW- Madison id: SMPH/POP HEALTH SCI/POP HLTH type: OTHER domain: UW- Madison briefTitle: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-03 date: 2026-06 date: 2024-04-02 date: 2024-04-05 name: University of Wisconsin, Madison class: OTHER name: Covering Wisconsin briefSummary: The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:

1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?
2. What is the effectiveness of outreach using a live call rather than a pre-recorded call? conditions: No Medicaid Coverage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 425000 type: ESTIMATED name: Outbound phone call measure: Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call measure: Duration of coverage gaps measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342362 id: SICHN/IRB-001/2024 briefTitle: Magnesium Sulfate in Neonatal HIE" overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-10-02 date: 2024-12-02 date: 2024-04-02 date: 2024-04-02 name: Sindh Institute of Child Health and Neonatology class: OTHER briefSummary: The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital. Using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe HIE. Data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. The study aims to provide insights into improving patient outcomes and clinical practice for neonatal HIE management. conditions: Neonates With HIE studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 102 type: ESTIMATED name: Magnesium sulfate name: placebo or standard treatment) measure: Neuroprotective effects sex: ALL minimumAge: 1 Day maximumAge: 30 Days stdAges: CHILD facility: SICHN city: Karachi state: Sindh zip: 74201 country: Pakistan name: Naseem Ahmed, FCPS role: CONTACT phone: 03003145554 email: drnaseemkubar@gmail.com lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06342349 id: SIBP-V03-I briefTitle: A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above. overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-12-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-02 name: Shanghai Institute Of Biological Products class: INDUSTRY name: Shaanxi Provincial Center for Disease Control and Prevention briefSummary: To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above. conditions: Influenza studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a single center, randomized, double-blind, controlled phase I clinical trial. primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Quadrivalent influenza virus split vaccine (MDCK cells) name: Quadrivalent influenza virus split vaccine (Chicken embryo) name: Phosphate buffer solution measure: Solicited Adverse Events (AEs) measure: Unsolicited Adverse Events measure: Serious Adverse Events (SAE) measure: Seroconversion rate measure: Ratio of ≥1:40 measure: Geometric mean increase (GMI) sex: ALL minimumAge: 6 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342336 id: HS-IT101ST01-I briefTitle: HS-IT101 Injection in the Treatment of Advanced Solid Tumors overallStatus: RECRUITING date: 2024-01-18 date: 2026-03-31 date: 2028-03-31 date: 2024-04-02 date: 2024-04-02 name: Qingdao Sino-Cell Biomedicine Co., Ltd. class: INDUSTRY name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences name: The First Hospital of Jilin University name: West China Hospital briefSummary: Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: HS-IT101 Injection measure: Adverse Events (AE) measure: Serious Adverse Events (SAE) measure: Objective Response Rate (ORR) measure: Time-to-response (TTR) measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Progression-Free-Survival (PFS) measure: Overall Survival (OS) measure: Lymphocyte subpopulation measure: TCR repertoire sex: ALL minimumAge: 18 Days maximumAge: 75 Days stdAges: CHILD facility: Cancer Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Ning Li, MD role: CONTACT phone: 86-010-87788713 email: lining@cicams.ac.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06342323 id: IRB00006761-M2023235 id: ONFM-SBRT type: OTHER domain: Peking university third hospital briefTitle: The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy acronym: ONFM-SBRT overallStatus: RECRUITING date: 2023-10-08 date: 2024-10-07 date: 2025-10-07 date: 2024-04-02 date: 2024-04-02 name: Peking University Third Hospital class: OTHER briefSummary: This is a clinical study focused on the use of fiducial marker-guided stereotactic body radiotherapy (SBRT) for treating malignant tumors, including lung, liver, pancreatic, and kidney/adrenal cancers. Here's a breakdown of the key components of the study:

Study Design: Prospective, single-center, exploratory clinical study.

Patient Enrollment: The study intends to enroll patients diagnosed with malignant tumors requiring fiducial marker-guided SBRT. Each tumor type (lung, liver, pancreatic, kidney/adrenal) aims to include 15 cases.

Informed Consent: Patients are required to sign informed consent before participating in the study, indicating their understanding of the procedures, risks, and benefits involved.

Intervention: Enrolled patients will undergo stereotactic radiotherapy for their respective malignant tumors. During this process, fiducial markers will be implanted according to the study protocol.

Monitoring: Following implantation of fiducial markers, the study will monitor adverse events associated with the procedure. This includes any complications or side effects resulting from the marker implantation process.

Success Rate: The study will assess the success rate of fiducial marker implantation. This likely involves evaluating the accuracy and reliability of marker placement for guiding SBRT treatment.

SBRT Treatment Error: The study will also monitor SBRT treatment errors. This involves tracking any deviations or inaccuracies in the delivery of stereotactic radiotherapy, potentially caused by issues such as improper fiducial marker placement or technical errors in treatment administration.

Overall, the study aims to explore the feasibility and effectiveness of using fiducial marker-guided SBRT for treating various types of malignant tumors to assess both the safety and the efficacy with a focus on patient outcomes and treatment accuracy. conditions: Lung Cancer conditions: Liver Cancer conditions: Pancreatic Cancer conditions: Renal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 57 type: ESTIMATED name: SBRT measure: success rate measure: Treatment error sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Qiu Bin role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06342310 id: RE104-201-PPD briefTitle: RE104 Safety and Efficacy Study in Postpartum Depression overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-04-02 date: 2024-04-03 name: Reunion Neuroscience Inc class: INDUSTRY briefSummary: The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo. conditions: Postpartum Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: RE104 for Injection measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline) measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10) measure: RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I) measure: RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S) measure: RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) measure: RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06342297 id: OLL-1003043 briefTitle: Dermatoscopy Guided Resection for Skin Cancer overallStatus: RECRUITING date: 2024-01-14 date: 2025-12-15 date: 2026-01-14 date: 2024-04-02 date: 2024-04-02 name: Region Örebro County class: OTHER briefSummary: In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report. conditions: Basal Cell Carcinoma conditions: Cutaneous Squamous Cell Carcinoma conditions: Surgical Margin studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Dermatoscopy measure: Pathology resection side margin (radical/not radical) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Örebro University Hospital status: RECRUITING city: Örebro zip: 70375 country: Sweden name: Örebro U Hospital role: CONTACT phone: 0729655663 email: fredrik.landstrom@regionorebrolan.se lat: 59.27412 lon: 15.2066 hasResults: False

 nctId: NCT06342284 id: NYPC ERC# 2021-030 briefTitle: Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer acronym: PGHD overallStatus: RECRUITING date: 2024-03-22 date: 2026-03-21 date: 2031-03-21 date: 2024-04-02 date: 2024-04-02 name: The New York Proton Center class: OTHER briefSummary: This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards. conditions: Thoracic Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Proton Beam Radiation with or without concurrent chemotherapy measure: Demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer, based on the quantity of data collected from the day of radiotherapy initiation to the day of radiotherapy completion. measure: Demonstrate the face validity of physical activity and vital sign data collected in this trial by reviewing the distribution of values obtained for each measure quantitatively using descriptive statistics. measure: Assess associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes using inferential statistical analyses. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New York Proton Center status: RECRUITING city: New York state: New York zip: 10035 country: United States name: Ryan Holder, BS role: CONTACT phone: 646-968-9055 email: rholder@nyproton.com name: Thomas Mistretta, MS role: CONTACT phone: 646-568-5675 email: tmistretta@nyproton.com name: Nitin Ohri, MD role: PRINCIPAL_INVESTIGATOR name: Charles Simone, MD role: SUB_INVESTIGATOR name: Annemarie Shepherd, MD role: SUB_INVESTIGATOR name: Stanislav Lazarev, MD role: SUB_INVESTIGATOR name: Alexandra Hanlon, PhD role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06342271 id: 24-2023 briefTitle: Effects of Nordic Walking and Free Walking on Arm Swing Parameters and Gait in Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-30 date: 2025-06-30 date: 2024-04-02 date: 2024-04-02 name: University of Talca class: OTHER briefSummary: People with Parkinson's Disease(PD) present a series of alterations such as muscle stiffness and motor slowing, which gradually affect the swinging movement of the arms and legs, altering the ability to walk, increasing the risk of falling, and reducing functionality. This implies a higher energy cost and a greater probability of developing freezing of the gait.

Nordic walking (NW) is a form of physical exercise characterized by the use of walking poles, which could contribute positively to arm swing movement and, thus, gait.

This clinical trial aims to compare Nordic Walking with free walking (FW) protocol training and investigate their effects on arm swing and gait parameters in people with PD.

The study hypothesizes that NW training will reduce asymmetry and increase arm swing amplitudes during gait to a greater extent than FW. Also, improvements in arm swing could positively influence lower limb performance during regular gait, increasing gait speed, stride length, functional mobility, and quality of life.

People with PD will complete 24 supervised NW or FW training sessions for 12 weeks. Both trainings will be identical in volume and intensity, the only difference will be the use of poles in the NW group. Blinded researchers will conduct evaluations at baseline (T0), post-intervention (T1), and in one-month follow-up (T2). conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: Nordic walking training name: Free Walking training measure: Change in the amplitude of arm swing measure: Change in the arm swing asymmetry measure: Change in the temporospatial measurements during walking including measurements of Gait speed [m/s] and step length [m]. measure: Change in the functional mobility will be measured through the Timed up and go (TUG). measure: Change in the quality of life sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342258 id: HS-23-00611 briefTitle: COES: Curing Order Effects on Sealants acronym: COES overallStatus: RECRUITING date: 2024-02-23 date: 2026-06-30 date: 2026-06-30 date: 2024-04-02 date: 2024-04-11 name: University of Southern California class: OTHER briefSummary: Background: Sealants are a great tool in the prevention of caries in the pediatric population. It has been shown that up to 71% of occlusal decay is preventable after a single sealant application in a fissure, and thus is the standard of care due to difficulty for pediatric patients in hygiene, diet, and overall home care until manual dexterity increases.

Purpose: This prospective randomized case control study aims to look at the longevity of sealants with bonding agent cured prior to sealant placement vs those with uncured bond. The study will be performed by USC graduate pediatric personnel.

Methods: A split mouth prospective randomized control study will be performed on pediatric dental patients at Long Beach Memorial's Children's Dental Health Clinic and USC Pediatric Dental Clinic, placing sealants with cured bond on half of a mouth and sealants with uncured bond on the contralateral half. Intraoral photos will be obtained at the initial visit and recalls to evaluate the overall retention/longevity of the sealant placement. The goal of this study is determine which sealant has higher longevity and to provide recommendations for future pediatric dentists regarding sealant procedures. conditions: Dental Sealant conditions: Sealant Retention studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: After baseline examination, a randomized generator, will be used in order to issue which side will bonding agent cured prior to sealant placement. Randomization will be a simple randomization, and will be determined by the provider flipping a coin. Randomization will be performed to ensure graders of sealants will be blinded to which side of bond is cured prior to sealant placement.

Heads indicates the RIGHT side of mouth WILL be cured prior to sealant placement. The left side of the mouth will have bond and sealant cured together after.

Tails indicates the LEFT side of the mouth WILL be cured prior to sealant placement. The right side of the mouth will not have bond cured prior to sealant placement. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 217 type: ESTIMATED name: Ultradent Ultra Seal XT Plus measure: Sealant Longevity measure: Caries measure: Molar hypomineralization sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: Herman Ostrow School of Dentistry of USC status: RECRUITING city: Los Angeles state: California zip: 90089 country: United States name: Catherine Pham, DDS, MPH role: CONTACT phone: 213-740-0412 email: cmpham@usc.edu lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06342245 id: 2023.568 briefTitle: Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy acronym: AT RCT overallStatus: NOT_YET_RECRUITING date: 2024-06-11 date: 2027-06-10 date: 2027-06-11 date: 2024-04-02 date: 2024-04-02 name: Chinese University of Hong Kong class: OTHER briefSummary: This is a prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only). Adults (age \>18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. All participants will undergo a 12-week eccentric exercise program taught by a registered physiotherapist / athletic trainer. Undergo Endoscopic Achilles debridement and Radiofrequency coblation micro-tenotomy intervention. Criteria for discontinuing or modifying allocated interventions, Strategies to improve adherence to interventions, Relevant concomitant care permitted or prohibited during the trial and Provisions for post-trial care. Outocme measure will use VISA-A, pain scores, ultrasound measurement of thickness and vascularity, calf muscle strength, and ankle range of motion. conditions: Achilles Tendinopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a multicentre prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only).

Investigators will obtain written consent from all participants before the commencement of this study. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: Radiofrequency coblation micro-tenotomy measure: Victorian Institute of Sports Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342232 id: BEH1986 id: 423629 type: OTHER_GRANT domain: Saskatchewan Health Research Foundation briefTitle: The Efficacy of Neurofeedback Mindfulness in Migraine Management overallStatus: COMPLETED date: 2021-09-09 date: 2022-12-24 date: 2023-03-01 date: 2024-04-02 date: 2024-04-02 name: University of Saskatchewan class: OTHER name: Saskatchewan Health Research Foundation briefSummary: This longitudinal randomized controlled trial explored how long-term practice of neurofeedback mindfulness would be helpful for migraine management when compare dot a similar controlled intervention. All the participants went through assigned 10 minutes practices on a daily basis for 8 weeks. Behavioural reports and migraine characteristics were compared before and after the intervention. conditions: Migraine Headaches studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 101 type: ACTUAL name: Neurofeedback mindfulness name: Simple attention controlled task measure: Migraine Disability measure: Migraine Severity measure: Headache Management Self-efficacy measure: Anxiety measure: Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Saskatchewan city: Saskatoon state: Saskatchewan zip: S7N5A2 country: Canada lat: 52.13238 lon: -106.66892 hasResults: False

 nctId: NCT06342219 id: 423629 briefTitle: Chronic Migraines and Neurofdeeback Mindfulness overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2025-12 date: 2026-06 date: 2024-04-02 date: 2024-04-02 name: University of Saskatchewan class: OTHER name: Saskatchewan Health Research Foundation briefSummary: As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study. conditions: Chronic Migraine, Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 135 type: ESTIMATED name: Neurofeedback Mindfulness name: Attention Task measure: Migraine Disability measure: Migraine Severity measure: Headache management self-efficacy measure: Dependence on medicine measure: Anxiety measure: Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Saskatchewan city: Saskatoon state: Saskatchewan zip: S7N5A2 country: Canada lat: 52.13238 lon: -106.66892 hasResults: False

 nctId: NCT06342206 id: CMUH111-REC2-144 briefTitle: The Assessment of Acute /Chronic Phase in Patients With Ischemic Cerebral Stroke Using TCM Diagnostic Tools overallStatus: RECRUITING date: 2022-09-08 date: 2022-09-21 date: 2024-09-07 date: 2024-04-02 date: 2024-04-02 name: China Medical University Hospital class: OTHER briefSummary: Cerebral infarction is the second cause of death and the third cause of disability. More than 13.7 million patients worldwide are diagnosed with stroke every year, and the number of deaths is 5.5 million, of which ischemic stroke is the major type, accounting for 87%. Sequelae of stroke are problems that require long-term medical care. If we can intervene and assist with Traditional Chinese Medicine (TCM) at early stage, it will be a great boon for patients. In clinical practice, TCM collects data as the basis for diagnosis through the four diagnostic methods-look, listen, question, and feel the pulse. Among these, tongue diagnosis and pulse diagnosis belong to the categories of look and feel the pulse. At present, the objective examination instruments of TCM developed are mainly tongue diagnostic instruments and pulse diagnostic instruments. Therefore, we hope to utilize tongue and pulse diagnoses as the main reference to analyze the changes in ischemic stroke stages. The data of this study are collected from China Medical University Hospital and YuanRung Hospital-for further statistical analysis. Ischemic stroke patients (ICD-10: I63) who were hospitalized within 1 week from the date of diagnosis were eligible to join this research project. Tongue and pulse examinations were collected once per week within 1 month. A total of 4 tongue-pulse examinations were collected in each case, which were categorized into acute stage (24 hours to 1 week), subacute stage (1 to 3 weeks) and chronic stage (more than 3 weeks). \[30\] This research is to study the changes of tongue and pulse diagnoses in acute, subacute and chronic stages among ischemic patients who receive TCM diagnosis and treatment. Through utilizing objective evaluation of Chinese and Western medical examination instruments, we hope to establish clear diagnostic standards for TCM syndrome types, so as to evaluate the efficacy of clinical diagnosis and treatment. The goal is to improve the quality of TCM care and to provide Chinese and Western integrated treatment for stroke patients in the future. This research can also serve as a reference for related TCM research and development. conditions: Stroke, Ischemic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 24 type: ESTIMATED measure: Differences between tongue diagnosis and pulse diagnosis in acute and chronic stroke patients sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: YuanRung Hospital status: RECRUITING city: Changhua zip: 510 country: Taiwan name: LI-CHI TSAI role: CONTACT phone: 0919688481 name: YEN-HUA YANG role: CONTACT phone: 0912587467 lat: 24.07327 lon: 120.56276 hasResults: False

 nctId: NCT06342193 id: virtual reality briefTitle: Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial overallStatus: RECRUITING date: 2024-03-14 date: 2024-06-15 date: 2024-06-15 date: 2024-04-02 date: 2024-04-02 name: Uşak University class: OTHER briefSummary: The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia. conditions: Cystoscopy conditions: Virtual Reality conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: virtual reality group measure: anxiety sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Usak Training and Research Hospital status: RECRUITING city: Uşak state: Center zip: 64100 country: Turkey name: Yucel Can Danisman role: CONTACT phone: +905532864569 email: 202201023@ogr.usak.edu.tr name: Fatma Susam, PhD role: SUB_INVESTIGATOR name: Yucel Can Danisman role: PRINCIPAL_INVESTIGATOR name: Ozan Ozavci role: SUB_INVESTIGATOR name: Shahnaza Mahmudova role: SUB_INVESTIGATOR name: Erkan Arslan, MD role: SUB_INVESTIGATOR name: Adem Tuncekin, MD role: SUB_INVESTIGATOR name: Bilgen Arikan, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.67351 lon: 29.4058 hasResults: False

 nctId: NCT06342180 id: Usakupcos1 briefTitle: Metabolic Differences Between Subtypes of Polycystic Ovary Syndrome overallStatus: COMPLETED date: 2022-01-01 date: 2022-09-01 date: 2023-07-20 date: 2024-04-02 date: 2024-04-02 name: Uşak University class: OTHER briefSummary: We aimed to investigate serum uric acid levels in patients with different phenotype of policystic ovary syndrome and to compare healthy controls. conditions: Uric Acid Concentration, Serum, Quantitative Trait Locus 7 conditions: Polycystic Ovary Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ACTUAL name: Serum uric acid level measure: Uric acid levels in PCOS subtypes sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Usak Egitim Ve Araştırma Hastanesi city: Uşak zip: 64100 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False

 nctId: NCT06342167 id: NCC4409 briefTitle: Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-14 date: 2026-07-01 date: 2026-12-01 date: 2024-04-02 date: 2024-04-03 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC).

Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT. conditions: Locally Advanced Esophageal Squamous Cell Carcinoma conditions: Sintilimab conditions: Radiotherapy conditions: Concurrent Chemoradiotherapy conditions: Immunonutrition studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: Radiotherapy name: Programmed Cell Death Protein 1 Inhibitor name: Immunonutrition support measure: 1-year Progression-free survival rate (PFS) measure: Objective response rate measure: Progression-free survival measure: Overall survival rate measure: Overall survival measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College city: Beijing state: Beijing zip: 100021 country: China lat: 39.9075 lon: 116.39723 facility: Department of Radiation Oncology，Clinical Oncology School of Fujian Medical University，Fujian Cancer Hospital city: Fujian state: Fujian country: China facility: Department of Oncology, Affiliated Hospital, Hebei University of Engineering city: Handan state: Hebei country: China lat: 36.60056 lon: 114.46778 facility: Department 1st of Radiation Oncology, Anyang Tumor Hospital city: Anyang state: Henan country: China lat: 36.096 lon: 114.38278 facility: Department of Radiation Oncology the first affiliated hospital of Xinxiang Medical University city: Xinxiang state: Henan country: China lat: 35.19033 lon: 113.80151 facility: Department of Radiation Oncology, General Hospital of Ningxia Medical University city: Yinchuan state: Ningxia country: China lat: 38.46806 lon: 106.27306 facility: Department of Radiation Oncology，Fei County People's Hospital city: Feixian state: Shandong country: China facility: Department of Radiation Oncology, Affiliated hospital of Jining Medical University city: Jining state: Shandong country: China lat: 35.405 lon: 116.58139 facility: Taizhou hospital of Wenzhou Medical University city: Taizhou state: Zhejiang zip: 317000 country: China lat: 32.49069 lon: 119.90812 hasResults: False

 nctId: NCT06342154 id: MCBU-SBF-YC-03 briefTitle: Does Endorphin Massage Reduce the Anxiety of Pregnant Women? overallStatus: RECRUITING date: 2023-10-09 date: 2024-10-09 date: 2024-12-10 date: 2024-04-02 date: 2024-04-02 name: Celal Bayar University class: OTHER briefSummary: Before cesarean section surgery, researchers will demonstrate endorphin massage to the husbands of pregnant women, and they will be asked to apply the massage before the surgery. The stress levels and pain levels of women will be compared before and after the massage. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized study with experimental and control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 68 type: ESTIMATED name: Endorphin Massage measure: visual analog scale (VAS) measure: State and Trait Anxiety Scales measure: cortisol level sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi status: RECRUITING city: Manisa zip: 45060 country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False

 nctId: NCT06342141 id: 24-1423 briefTitle: Empagliflozin for No-reflow Phenomenon in PCI for STEMI acronym: EMPA-PCI overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-01-15 date: 2025-03-15 date: 2024-04-02 date: 2024-04-02 name: Instituto Nacional de Cardiologia Ignacio Chavez class: OTHER briefSummary: Myocardial infarction remains, in our current era, a leading cause of morbidity and mortality both domestically and globally. A significant contributor to this issue is reperfusion injury, which enlarges the infarction, deteriorates ventricular function, leads to poorer outcomes, and currently has no specific treatment. Originally developed as an antidiabetic, empagliflozin has shown significant benefits in other organs and systems. Recent years have seen the demonstration of its cellular and vascular effects in animal models, potentially contributing to the reduction of reperfusion damage. However, no human studies have yet confirmed these effects.

Consequently, this double-blind, randomized, parallel-arm clinical trial was designed to evaluate the effect of empagliflozin treatment, administered from the pre-intervention period through to 3 days post-intervention, on the incidence of the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty compared to a placebo.

Before entering the hemodynamics room, participants in the intervention group will receive a loading dose of 25 mg of empagliflozin or a placebo. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group, while the control group will receive a placebo. Patients will be monitored weekly during the first month and bi-weekly during the second and third months.

The primary outcome will be the incidence of the no-reflow phenomenon, measured through the Thrombolysis in Myocardial infarction (TIMI) flow scale in the coronary angiography performed to treat the infarction. Secondary outcomes will include the reduction of ST segment on the electrocardiogram, troponin levels, differences in the longitudinal strain by echocardiogram, and infarct size by magnetic resonance imaging. conditions: STEMI conditions: No-Reflow Phenomenon studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 162 type: ESTIMATED name: Empagliflozin 25 milgrams (Mg) name: Empagliflozin 10 Mg name: Placebo 25 Mg name: Placebo 10 Mg measure: Non-Reflow Phenomenon measure: Infract size measure: Longitudinal Strain measure: High-sensitivity Troponin Clearance measure: Creatine Kinase-myocardial band Clearance measure: Adverse Cardiovascular Events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342128 id: MVI_Kidney_001 briefTitle: Molecular Landscape of Microvascular Inflammation in Kidney Allografts overallStatus: RECRUITING date: 2022-01-01 date: 2024-06 date: 2024-12 date: 2024-04-02 date: 2024-04-03 name: Paris Translational Research Center for Organ Transplantation class: OTHER briefSummary: Microvascular inflammation in kidney allografts has been widely reappraised in the recent update of Banff classification. There is a critical need to better understand the pathophysiological mechanisms associated with the various phenotypes of microvascular inflammation that are observed in kidney transplants, particularly in order to develop targeted therapeutic approaches. conditions: Kidney Rejection Transplant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: No intervention measure: RNA-based molecular signatures assessed using bulk and spatial transcriptomics measure: Probability of graft survival based on outcome data measure: Probability of patient survival on outcome data sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris status: RECRUITING city: Paris zip: 75010 country: France name: Carmen Lefaucheur, MD PhD role: CONTACT email: carmen.lefaucheur@aphp.fr lat: 48.85341 lon: 2.3488 facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris status: RECRUITING city: Paris zip: 75015 country: France name: Alexandre Loupy, MD PhD role: CONTACT phone: +33612491082 email: alexandreloupy@inserm.fr lat: 48.85341 lon: 2.3488 facility: Bichat Hospital, Assistance Publique - Hôpitaux de Paris status: RECRUITING city: Paris zip: 75018 country: France name: Aurélie Sannier, MD PhD role: CONTACT email: aurelie.sannier@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06342115 id: CLEMENT TRIAL briefTitle: Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens acronym: CLEMENT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-04 date: 2025-04 date: 2024-04-02 date: 2024-04-02 name: Beneficência Portuguesa de São Paulo class: OTHER name: Merck Sharp & Dohme LLC briefSummary: The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is:

- Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection.

Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes. conditions: Febrile Neutropenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Ceftolozane-Tazobactam name: Meropenem measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population measure: Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population measure: Incidence of microbiologically documented infections and identification of causative organisms in culture measure: In-hospital mortality measure: Occurrence of graft versus host disease (GVHD) measure: Frequency of multidrug resistant-pathogen infections or colonization measure: Faecal microbiota analysis measure: Percentage of Participants Who Report 1 or More Adverse Event (AE) measure: Percentage of Participants With Any Serious Adverse Event (SAE) measure: Percentage of Participants Discontinuing Study Drug Due to an Adverse Event (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A Beneficência Portuguesa de São Paulo city: São Paulo country: Brazil name: João Prats, MD role: CONTACT phone: +55 11 3505 5031 lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06342102 id: ID 4286 briefTitle: PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis Focused on Movement (Retro-PvF) acronym: Retro-PvF overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2024-03-26 date: 2024-04-30 date: 2024-04-02 date: 2024-04-04 name: Ospedale Edoardo Bassini class: OTHER briefSummary: Total hip arthroplasty is a major surgical procedure performed on a growing number of patients. Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation, thus expediting hospital discharge. Amongst the many peripheral nerve blocks, FIB (fascia iliaca block) has been recommended as the block of choice by many international guidelines since it offers the best pain control with a relatively low risk of motor block. PENG (pericapsular nerve group) and its association with LFCN (lateral femoral cutaneous nerve) has been proposed as an effective alternative that offers comparable, If not better, pain control with a considerably lower risk for motor block compared to FIB. Given the novelty of this block, there are few published papers on the subject, mostly case series or case reports thus justifying the need for retrospective study. conditions: Regional Anesthesia Block conditions: Regional Anesthesia conditions: Total Hip Replacement Surgery conditions: Total Hip Arthroplasty \(THA\) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED name: PENG + LFCN block name: FIC block measure: Movement of the lower limb affected by surgery measure: pain control measure: pain control measure: pain control measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses measure: time to first opioid request measure: time to first postoperative ambulation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342089 id: NCT06342089 briefTitle: Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus. overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-11 date: 2025-05 date: 2024-04-02 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: * Determine the association between molar incisor hypomineralization and type I diabetes millutes, its severity and treatment need via clinical examination of children with type I diabetes millutes .
* Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth.
* Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.
* The severity and treatment needs of each case with MIH will be recorded in patient's chart.
* The results of the study will be regularly monitored by the supervisors who will have full access to these results. conditions: Molar Incisor Hypomineralization studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 238 type: ESTIMATED name: Type I diabetes milletus measure: Association between molar incisor Hypomineralization and type I diabetes milletus measure: Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus. measure: Treatment need sex: ALL minimumAge: 8 Years maximumAge: 14 Years stdAges: CHILD hasResults: False

 nctId: NCT06342076 id: 2023-596 briefTitle: Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery overallStatus: COMPLETED date: 2024-01-01 date: 2024-03-01 date: 2024-03-01 date: 2024-04-02 date: 2024-04-02 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.

The main question(s) it aims to answer are:

\[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? \] \[Is there a difference in pain scores at 24 hours after surgery? \] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods. conditions: Postoperative Pain conditions: Postoperative Complications conditions: Analgesia conditions: Regional Anesthesia Morbidity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective randomize study primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Prospective randomize study count: 50 type: ACTUAL name: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block name: Patients undergoing rectus sheat block and posterior transversus abdominis plane block measure: visuel analog scale measure: amount of opioid used sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Başakşehir Çam and Sakura City Hospital city: Istanbul state: Basaksehir country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06342063 id: 20-0070-E briefTitle: The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction acronym: BFRACL overallStatus: COMPLETED date: 2021-04-01 date: 2023-10-31 date: 2024-01-31 date: 2024-04-02 date: 2024-04-02 name: Women's College Hospital class: OTHER briefSummary: This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial. conditions: ACL Injury conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were recruited and randomized to one of the two treatment arms. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome measurement was blinded to participant intervention. whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: Blood Flow Restriction Therapy name: Blood Flow Restriction Therapy Sham measure: Biodex Strength Testing measure: Short Form Health Survey 12 (SF-12) measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G 1X5 country: Canada lat: 43.70011 lon: -79.4163 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2022-10-28 uploadDate: 2024-03-07T20:51 filename: Prot_000.pdf size: 303762 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-10-28 uploadDate: 2024-03-23T13:30 filename: ICF_001.pdf size: 892575 hasResults: False

 nctId: NCT06342050 id: STU-2023-0548 id: R01MD011686 type: NIH link: https://reporter.nih.gov/quickSearch/R01MD011686 briefTitle: Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-08 date: 2024-04-02 date: 2024-04-02 name: University of Texas Southwestern Medical Center class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS.

The main aims / objectives of this sub-study are:

* Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants.

Hypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory.

* Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups.

Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups. conditions: Obesity conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: Gut Microbial Composition measure: Blood Microbial Composition measure: Body Weight (kg) measure: Body Height (meters) measure: Fat Mass (Kg) measure: Fat-free Mass (Kg) measure: Body water (%) measure: Skeletal Muscle Mass (kg) measure: Fasting Glucose (mg/dL) measure: Fasting Insulin (mIU/L) measure: Lipopolysaccharides (%) measure: Lipopolysaccharides binding protein (mIU/L) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-19 uploadDate: 2024-03-27T14:38 filename: Prot_SAP_000.pdf size: 316789 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-19 uploadDate: 2024-03-27T14:39 filename: ICF_001.pdf size: 297665 hasResults: False

 nctId: NCT06342037 id: N22TON briefTitle: NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial acronym: TONIC-3 overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-04-01 date: 2030-04-01 date: 2024-04-02 date: 2024-04-18 name: The Netherlands Cancer Institute class: OTHER name: Hoffmann-La Roche briefSummary: This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer. conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Tiragolumab name: Atezolizumab name: Ipilimumab measure: PFS-12 measure: Incidence of adverse events measure: Objective response rate measure: Clinical benefit rate measure: Progression-free survival measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06342024 id: 23-871 briefTitle: Pistachio Consumption on Inflammatory Markers and Lean Body Mass overallStatus: RECRUITING date: 2024-02-20 date: 2025-05-30 date: 2025-08-31 date: 2024-04-02 date: 2024-04-02 name: Virginia Polytechnic Institute and State University class: OTHER briefSummary: Pistachio nuts (Pistacia vera L.) are a nutrient- and energy-dense food, and are a significant source of 15 different micronutrients. In addition to an excellent micronutrient profile, pistachios are a good source of monounsaturated and polyunsaturated fats (linoleic acid, oleic acid, and plant sterols). Pistachios have the lowest amount of total fat, and the highest protein, fiber, and phytosterol content compared to other nuts. They possess a high antioxidant content. Specifically, pistachios have high amounts of lutein, zeaxanthin, and phenolic compounds (e.g., anthocyanins, flavonoids, and proanthocyanidins). These aforementioned compounds are known for their anti-inflammatory effects. Pistachios also have been shown to reduce the risk of cardiovascular disease, metabolic syndrome, and all-cause mortality.

The purpose of this study will be to determine the effects of consuming 1.5 ounces of pistachios per day compared to consuming no pistachios per day on inflammatory markers (creatine kinase, C-reactive protein, cortisol, Interleukin-8, tumor necrosis factor-alpha, copper-zinc superoxide dismutase, and glutathione peroxidase concentrations) and lean body mass in women and men, 40 to 60 years of age, who have been recreationally active for at least six months (exercising three to five days per week). It is hypothesized that pistachio consumption will significantly lower inflammatory response and significantly increase lean body mass.

This will be a randomized study where participants will first complete a two-week baseline run-in period during which they will consume their typical diet. Following this, participants will be randomized to one of two groups for six months: consuming 1.5 ounces of pistachios per day or a control group (consuming no pistachios). Those consuming pistachios will be in addition to their usual diet.

The overall goal of this study is to evaluate the effects of pistachio consumption on inflammatory markers and lean body mass in women and men, 40 to 60 years of age, who exercise three to five days per week. This study could provide a simple, healthy way for recreationally active individuals to decrease inflammation and improve body composition. conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible participants will be randomized to one of two groups (pistachio vs. control) using permuted block randomization with stratification to balance assignment by sex. Randomization allocation tables will be created by a biostatistician not involved in the clinical trial using SAS software, version 9.4 (SAS Institute, Cary, NC, USA). The tables will be stored within the REDCap system at Virginia Tech, in such a way that only the biostatistician will be able to view them. Study outcomes will be analyzed blind to allocation status. primaryPurpose: OTHER masking: NONE maskingDescription: Not apply count: 144 type: ESTIMATED name: Pistachio group measure: C-reactive protein concentrations in the blood measure: Creatine kinase concentrations in the blood measure: Cortisol concentrations in the blood measure: Interleukin-8 concentrations in the blood measure: Tumor necrosis factor-alpha concentrations in the blood measure: Copper-zinc superoxide dismutase concentrations in the blood measure: Glutathione peroxidase concentrations in the blood measure: Lean body mass measure: Body weight measure: Height measure: Body Mass Index measure: Magnesium concentrations in the blood measure: Iron concentrations in the blood measure: Zinc concentrations in the blood sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Virginia Polytechnic Institute and State University status: RECRUITING city: Blacksburg state: Virginia zip: 24061 country: United States name: Stella L Volpe, PhD role: CONTACT phone: 540-231-3805 email: stellalv@vt.edu name: Alexandra Hanlon, PhD role: CONTACT phone: 540-231-5657 email: alhanlon@vt.edu lat: 37.22957 lon: -80.41394 hasResults: False

 nctId: NCT06342011 id: KY-2024-039 briefTitle: Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 88 type: ESTIMATED name: Anti-inflammatory diet group measure: C-reactive protein measure: Erythrocyte sedimentation rate (ESR) measure: Leukocyte measure: Self-Rating Anxiety Scale，SAS measure: Self-Rating depression scale，SDS measure: Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ) measure: Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES) measure: Body Mass Index sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine city: Yiwu state: Zhejiang zip: 322000 country: China name: Xia Qian, BA role: CONTACT phone: 15968110117 email: 1632936247@qq.com lat: 29.31506 lon: 120.07676 hasResults: False

 nctId: NCT06341998 id: HERO2020 briefTitle: Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children acronym: SCRRYST overallStatus: COMPLETED date: 2020-06-01 date: 2024-01-01 date: 2024-02-01 date: 2024-04-02 date: 2024-04-02 name: Shandong First Medical University class: OTHER briefSummary: Remarkable progress has been made in treating germ-cell tumor (GCT) through the use of platinum-based regimens. However, part of yolk sac tumor (YST) with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment. This leaves a gap in effective treatment, which needs to be filled by novel therapeutic approaches. This paper is the first one to report the treatment combining sirolimus with nab-paclitaxel, ifosfamide, and carboplatin (S-TIC) for children with repeated relapsed or refractory yolk sac tumor (rrrYST). conditions: Germ Cell Tumor conditions: Yolk Sac Tumor studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children measure: Objective Response Rate Allocation 'Non-Randomized' implies that this is a multi-arm study, but only one arm has been specified. Objective Response Rate measure: Progression-free Survival sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Shandong Cancer Hospital and Institute city: Jinan state: Shandong zip: 250117 country: China lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06341985 id: IEO 1593 briefTitle: DOsimetry and Radiation Induced NAusea in Head and Neck Cancers acronym: DORIAN overallStatus: RECRUITING date: 2021-11-15 date: 2024-11-15 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT).

The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer. conditions: Head and Neck Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Exclusive radiotherapy measure: Evaluation of nausea (acute toxicity) using CTCAE V5.0 measure: Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire measure: Identification of the organs at risk most strongly correlated with the onset of nausea measure: Identification of dosimetric cutoffs for the onset of nausea measure: Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques measure: Development of machine-learning predictive models for the onset of nausea sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona status: RECRUITING city: Ancona country: Italy name: Giovanna Mantello role: CONTACT email: clelia.dicarlo@ospedaliriuniti.marche.it lat: 43.5942 lon: 13.50337 facility: Ospedale "Mons. Dimiccoli" status: RECRUITING city: Barletta country: Italy name: Alessia Di Rito role: CONTACT email: aledirito@yahoo.it lat: 41.31429 lon: 16.28165 facility: Azienda Ospedaliera S.Pio status: RECRUITING city: Benevento country: Italy name: Angela Argenone role: CONTACT email: angela.argenone@ao-rummo.it lat: 41.1307 lon: 14.77816 facility: Ospedale MultiMedica status: RECRUITING city: Castellanza country: Italy name: Gianpiero Catalano role: CONTACT email: gianpiero.catalano@multimedica.it lat: 45.61079 lon: 8.89616 facility: IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova country: Italy name: Liliana Belgioia role: CONTACT email: liliana.belgioia@unige.it lat: 44.40478 lon: 8.94438 facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Stefania Volpe role: CONTACT lat: 45.46427 lon: 9.18951 facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan country: Italy name: Italo Dell'Oca role: CONTACT email: delloca.italo@hsr.it lat: 45.46427 lon: 9.18951 facility: Azienda Ospedaliero-Universitaria di Modena status: RECRUITING city: Modena country: Italy name: Elisa D'Angelo role: CONTACT email: dangelo.elisa@policlinico.mo.it lat: 44.64783 lon: 10.92539 facility: Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara status: RECRUITING city: Novara country: Italy name: Carla Pisani role: CONTACT email: carla.pisani@maggioreosp.novara.it lat: 45.44694 lon: 8.62118 facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: Sara Colombo role: CONTACT email: s.colombo@smatteo.pv.it lat: 45.19205 lon: 9.15917 facility: Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata status: RECRUITING city: Roma country: Italy name: Giuseppina Apicella role: CONTACT email: gapicella@hsangiovanni.roma.it lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero Universitaria Policlinico Umberto I status: RECRUITING city: Roma country: Italy name: Francesca De Felice role: CONTACT email: francesca.defelice@uniroma1.it lat: 41.89193 lon: 12.51133 facility: Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina status: RECRUITING city: Roma country: Italy name: Orietta Caspiani role: CONTACT email: o.caspiani@gmail.com lat: 41.89193 lon: 12.51133 facility: I.R.C.C.S. MultiMedica - Sesto San Giovanni status: RECRUITING city: Sesto San Giovanni country: Italy name: Gianpiero Catalano role: CONTACT email: gianpiero.catalano@multimedica.it lat: 45.53329 lon: 9.22585 hasResults: False

 nctId: NCT06341972 id: IRB00247005 id: K23HL155735 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL155735 briefTitle: Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention acronym: SMARA overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2027-02-01 date: 2027-09-01 date: 2024-04-02 date: 2024-04-02 name: Johns Hopkins University class: OTHER name: Francis Family Foundation name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant.

The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients.

The main question\[s\] it aims to answer are:

* Is this intervention feasible and acceptable in ARF patients?
* Is this intervention in the ICU and hospital associated with reduced anxiety symptoms?

Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up. conditions: Respiratory Failure conditions: Anxiety conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pilot randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Cognitive behavioral therapy based self-management for anxiety measure: Treatment Satisfaction Questionnaire measure: average accrual rate of 2 patients/month across all patients measure: treatment feasibility as assessed by sessions completed measure: treatment feasibility as assessed by drop out rate measure: Visual Analog Scale - Anxiety measure: State Anxiety Inventory measure: Hopkins Rehab Engagement Scale measure: Self Efficacy for Managing Chronic Disease Rating Scale measure: Hospital Anxiety and Depression Scale measure: Quality of Life as assessed by the European Quality of Life Scale (EQ-5D) measure: Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6 measure: Healthcare Utilization as assessed by Healthcare Utilization interview measure: Montreal Cognitive Assessment - Blind sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341959 id: GerodentPLUS1 briefTitle: Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit? overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-26 name: University Ghent class: OTHER briefSummary: There is little research on the effect of oral screening campaigns for improving oral health in older people. Therefore, the aim of this study is to investigate the effect of a low-threshold contact with an oral health professional, including an oral health examination, on dental attendance of older people (65 years of age or older). conditions: Oral Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group will be provided with tools to facilitate dental contact and will be informed about the importance of regular dental visits. Participants are given the opportunity to receive an oral examination. Afterwards, each participant will receive brochures with oral hygiene instructions to take home. Participants will receive information about any identified oral pathology. A referral letter for the dentist and a report for the general practitioner will also be prepared to increase social influence. If the participant doesn't have a dentist, the participant will receive a list of contact information for dentists in the area.

In the control group, no oral examination will be performed. However, participants will be given a list of nearby dentists and flyers with oral hygiene instructions. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 194 type: ESTIMATED name: Oral screening measure: Contacted a dentist sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-03-25 uploadDate: 2024-03-25T05:59 filename: Prot_SAP_ICF_000.pdf size: 743439 hasResults: False

 nctId: NCT06341946 id: Soh-Med-24-02-05MD briefTitle: Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2025-10-01 date: 2025-11 date: 2024-04-02 date: 2024-04-02 name: Sohag University class: OTHER briefSummary: The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV). conditions: Hydrocephalus conditions: Shunt Malfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All patients with malfunctioning VP shunt will be included in this study primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Endoscopic third ventriculostomy measure: Glasgow Coma Scale (GCS) measure: visual analogue scale( VAS ) measure: visual acuity measure: radiological CT brain and or MRI brain sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341933 id: 2024-BÇEK/41 briefTitle: Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-15 date: 2025-04-15 date: 2024-04-02 date: 2024-04-02 name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital class: OTHER briefSummary: This study aims to investigate the potential factors contributing to the development of Acute Kidney Injury (AKI) in patients undergoing pulmonary resection with Video Assisted Thoracoscopic Surgery (VATS) for lung malignancy. The study will focus on demographic data, laboratory parameters, perioperative fluid management, and haemodynamics.

The research will be conducted at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital. The study will involve patients who have given informed consent and will undergo VATS with standard anaesthesia monitoring. Anaesthesia management will follow our routine protocol in our clinic.

Patients will be divided into two groups based on whether they have a more than 25% decrease in estimated glomerular filtration rate (t-GFH) and/or a 1.5-fold increase in serum creatinine and/or a 6-hour urine volume of less than 0.5 ml/kg/h. The patients will be divided into two groups based on this definition, and the risk factors between these groups will be analysed.

The preoperative routine blood values, demographic data (age, gender, height, weight, and BMI), ASA physical status, smoking and alcohol habits, comorbidities, and regular medication use will be recorded. Intraoperative urine output and haemodynamic parameters will also be monitored. Routine blood gas analysis, blood urea nitrogen (BUN), glomerular filtration rate (GFR), albumin, haemoglobin, sodium, potassium, chlorine, and magnesium will be measured and recorded, along with urine output and t-GFH. Patients will be evaluated in the hospital on the day the surgeon calls for a postoperative check-up and on the 30th postoperative day to see if there are any complications. conditions: Acute Kidney Injury conditions: Surgery conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Duration of Surgery name: Volume of Fluid in Surgery name: Blood Loss measure: Glomerular Filtration Rate measure: Serum Creatinine measure: Amount of Urine sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Atatürk Sanatorium Training and Research Hospital city: Ankara state: Keçiören zip: 06290 country: Turkey name: Ali ALAGÖZ, professor role: CONTACT phone: 5079193765 phoneExt: +9 email: mdalagoz@gmail.com name: Fatma ÖZTÜRK YALÇIN, specialist role: SUB_INVESTIGATOR name: Onur KÜÇÜK, specialist role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06341920 id: RS198 - 332551 briefTitle: BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery acronym: BoneFit overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-07-01 date: 2027-12-01 date: 2024-04-02 date: 2024-04-02 name: University of Hull class: OTHER name: Hull University Teaching Hospitals NHS Trust briefSummary: To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery. conditions: Orthopedic Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention v control primaryPurpose: TREATMENT masking: NONE maskingDescription: Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not. count: 50 type: ESTIMATED name: Experimental: BoneFit intervention name: Placebo Comparator: Control measure: Recruitment measure: Adherence and attendance measure: Acceptability measure: Physical fitness measure: Length of stay measure: Readmission rates measure: Overall quality of life measure: Knee or hip specific pain, function and quality of life sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-13 uploadDate: 2024-03-12T06:12 filename: Prot_000.pdf size: 218343 hasResults: False

 nctId: NCT06341907 id: SAHoWMU-CR2024-07-107 briefTitle: Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: Second Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: The goal of this clinical trial is as follows:(1) Establish a clinical technical system for ctDNA dynamic monitoring of MRD in postoperative EOC patients, providing a new technical means for postoperative recurrence prevention and monitoring of EOC patients.(2) Establish a clinical technical system for adjuvant treatment of postoperative recurrence prevention for EOC patients with conventional protocols combined with personalized vaccines, so as to provide a new treatment method for postoperative recurrence prevention for EOC patients, with a view to obtaining a better survival prognosis.(3) To establish and improve the prediction process of Neoantigen for ovarian cancer and the in vitro evaluation system of the effectiveness of neoantigen vaccine, achieve independent innovation of tumor neoantigen vaccine treatment technology, and cultivate a group of technical forces to master the development of modern tumor vaccine drugs.(4) The new technology system has been promoted and applied in 5 hospitals in the province. conditions: Epithelial Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Neoantigen polypeptide vaccine measure: ORR measure: PFS measure: OS measure: CA 125 measure: Safety Index sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang zip: 325000 country: China name: Xinxin Zhang role: CONTACT phone: +86 150 6781 0815 email: zhxinxin1122@163.com lat: 27.99942 lon: 120.66682 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-13 uploadDate: 2024-03-13T05:17 filename: Prot_SAP_000.pdf size: 541225 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-16 uploadDate: 2024-03-13T05:18 filename: ICF_001.pdf size: 254239 hasResults: False

 nctId: NCT06341894 id: OBU-II-BC-126 briefTitle: Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer overallStatus: RECRUITING date: 2023-11-17 date: 2027-06 date: 2029-06 date: 2024-04-02 date: 2024-04-02 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer. conditions: Early Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1163 type: ESTIMATED name: Dalpiciclib name: Endocrine therapy measure: invasive Disease-free Survival (iDFS) measure: Disease-free Survival (DFS) measure: AEs and SAEs sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China name: Xiaoan Liu, Professor role: CONTACT phone: 025-68308162 email: liuxiaoan@126.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06341881 id: KMU/DIR/CTU/2024/006 id: KMU-CTU-2024-2001 type: OTHER domain: Khyber Medical University Clinical Trial Unit briefTitle: Understanding the Need and Feasibility of Transitional Care Training Program Among Family Caregivers of Geriatric Stroke Survivors in Pakistan overallStatus: RECRUITING date: 2024-02-27 date: 2024-05 date: 2025-01 date: 2024-04-02 date: 2024-04-02 name: Khyber Medical University Peshawar class: OTHER briefSummary: The main intention of the study is to understand the need and feasibility of transitional care training program among family caregivers of geriatric stroke survivors in Pakistan conditions: Stroke conditions: Stroke, Ischemic conditions: Stroke Hemorrhagic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The most commonly two armed parallel study design would be used to conduct the current study. The study participants in an intervention group would be compared with that of a control group. Equal number of Participants would be allocated with random assignment in the two groups. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The study participants would not be informed of what group they are in. Independent outcome assessors would be utilized for the assessment. Further outcomes assessors and data analysts' would be kept unaware of intervention or group allocations to carry out their assessment after inclusion of participants into the study. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Transitional Care Training Program measure: Physical care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire measure: Psychological care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire measure: Social Care measured via Training Evaluation Assessment Checklist (TEAC) measure: Training Need Assessment measure: Training Program Development sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Khyber Medical University status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Sardar Ali, PHD Scholar role: CONTACT phone: +92 349-5182270 email: sardar.ins@kmu.edu.pk lat: 34.008 lon: 71.57849 facility: MTI-HMC (Medical Teaching Institution-Hayatabad Medical Complex), -Peshawar status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Awal Khan, MSN role: CONTACT phone: +92 343 9757103 email: awalkhanmsn@gmail.com name: Sardar Ali, PHD Scholar role: PRINCIPAL_INVESTIGATOR lat: 34.008 lon: 71.57849 facility: MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Asmat Pasha, MSN role: CONTACT phone: +92 3319205016 email: asmat.pasha@kth.edu.pk lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06341868 id: KACH.2023.0067 id: 23KACH008 type: OTHER domain: Keller Army Community Hospital briefTitle: Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-09-01 date: 2024-04-02 date: 2024-04-02 name: Keller Army Community Hospital class: FED name: Medical Technology Enterprise Consortium briefSummary: The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are:

* Examine the effects of KneeStim wear on cadets' post-operative gait
* Examine changes in site-specific skeletal muscle mass
* Examine the changes in patient-reported outcomes
* Assess time to return to full duty
* Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume)
* Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture)

Participants will undergo body composition analysis, MRI, strength testing, standard of care rehabilitation, gait analysis, and complete surveys. Participants will wear the KneeStim during their standard of care rehabilitation visits for the first 5 weeks post-operative, and throughout daily tasks from 6-12 weeks.

Researchers will compare a control group (standard of care + KneeStim controlled low intensity) to an experimental group (standard of care + KneeStim flexible intensity) to assess the aims previously mentioned.. conditions: Anterior Cruciate Ligament Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: KneeStim measure: Change in gait post-operatively assessed by the KneeStimTM Device measure: change in gait post-operatively assessed by 3D Motion capture measure: change in gait post-operatively assessed by force plate instrumented treadmill measure: change in muscle volume assessed by MRI measure: ACL graft healing assessed by MRI measure: Change in isometric muscle strength assessed by CSMi HUMAC NORM measure: Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA) measure: Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA) measure: Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA) measure: Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS) measure: Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) measure: Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29) measure: Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE) measure: Change in knee function assessed by the Marx Activity Rating Scale (MARS) measure: Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL) measure: Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI) measure: Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS) measure: Time to return to full duty sex: ALL minimumAge: 17 Years maximumAge: 27 Years stdAges: CHILD stdAges: ADULT facility: Keller Army Community Hospital status: RECRUITING city: West Point state: New York zip: 10996 country: United States name: Natalia B Prando, BA role: CONTACT phone: 845-938-5325 email: natalia.b.prando.ctr@health.mil name: Paige A McHenry, MS role: CONTACT phone: 845-938-2630 email: paige.a.mchenry.ctr@health.mil lat: 41.39148 lon: -73.95597 hasResults: False

 nctId: NCT06341855 id: 23K294001 briefTitle: Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer overallStatus: RECRUITING date: 2024-01-25 date: 2026-01-30 date: 2026-01-30 date: 2024-04-02 date: 2024-04-02 name: The First Hospital of Jilin University class: OTHER name: Geneplus-Beijing Co. Ltd. briefSummary: Patients with high-risk endometrial cancer may have MRD after surgical treatment, which is a potential source of follow-up early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be reliable to detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial carcinoma. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: MRD-ctDNA measure: monitoring recurrence and evaluating prognosis measure: Treatment benefit sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the 1st hospital of Jilin University status: RECRUITING city: Chang Chun state: Jilin country: China name: Xiaosen Li Li role: CONTACT phone: +8618343116682 email: xiaosensen@jlu.edu.cn lat: 42.74694 lon: 126.24667 hasResults: False

 nctId: NCT06341842 id: EudraCT 2022-003377-28 briefTitle: Potential Protective Role of SGLT-2 Inhibitors for Chemotherapy-induced Cardiotoxicity acronym: PROTECT overallStatus: RECRUITING date: 2023-10-19 date: 2025-04-19 date: 2025-04-19 date: 2024-04-02 date: 2024-04-02 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER briefSummary: The purpose of this study is to evaluate whether dapagliflozin reduces chemotherapy-induced cardiotoxicity in participants with breast cancer treated with (neo-)adjuvant Anthracycline-based chemotherapy +/- trastuzumab. The study aims to describe the efficacy for dapagliflozin as compared to standard of care. Participants will be recruited in participating centers, where they are planning on starting (neo-) adjuvant ACT-based chemotherapy and/or trastuzumab for stage I-III breast cancer. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Investigator initiated Phase II "proof of concept", multicentre, randomized 1:1, open label, parallel-groups study, designed to evaluate if dapagliflozin reduces chemotherapy induced cardiotoxicity in participants with breast cancer treated with (neo-) adjuvant Anthracycline-based chemotherapy +/- trastuzumab. primaryPurpose: TREATMENT masking: NONE count: 316 type: ESTIMATED name: Dapagliflozin 10mg Tab measure: Assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months during a 18 months follow-up. measure: Difference in severe, moderate and mild asymptomatic CTRCD between the two groups during 18 months according to the background therapy with AC with or without TZ and with or without the use of any of ACEi, angiotensin receptor blockers, or b-blockers measure: Difference in symptomatic CTRCD between the two groups during 18 months according to the background therapy with AC with or without TZ (subgroup analysis) measure: Change from baseline in end diastolic and systolic left ventricular volumes and in left atrial volume during 18 months measure: Change from baseline of at least of one grade of diastolic disfunction (according to ESC guidelines during 18 months. measure: Change in plasma levels of the bio-humoral marker NT-pro-BNP between baseline and follow-up measure: Change in plasma levels of the bio-humoral marker hsTNI between baseline and follow-up measure: Change in plasma levels of the bio-humoral marker CKD-EPI eGFR between baseline and follow-up measure: Change in plasma levels of the bio-humoral marker hsCRP between baseline and follow-up measure: Safety Outcomes: TEAE incidence measure: Toxicity: renal failure evaluation. measure: Toxicity: hypoglycaemia evaluation measure: Tolerability: genito-urinary tract infections measure: Tolerability: symptomatic hypotension measure: Quality of Life questionaire: EQ-5D-5L sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia zip: 27100 country: Italy name: Gianpiero Rizzo, Oncologist role: CONTACT phone: +390382502094 email: g.rizzo@smatteo.pv.it name: Alessandra Greco, Cardiologist role: CONTACT phone: +390382501326 email: a.greco@smatteo.pv.it lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06341829 id: PRISM1 briefTitle: Visuospatial and Affective Abilities in Parkinson Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-17 date: 2024-04-18 date: 2026-02-28 date: 2024-04-02 date: 2024-04-16 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: The aim of the study is to investigate whether prismatic adaptation (AP), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG). conditions: Parkinson Disease conditions: Alexithymia conditions: Visuospatial/Perceptual Abilities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 63 type: ESTIMATED name: Prismatic adaptation measure: Improve visuospatial skills; measure: Modulate alexithymia; measure: Investigation of brain activity; measure: Improve the quality of life with PDQ-39 questionnaire sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341816 id: VEXUS2 briefTitle: Treatment According to Venous Excess Ultrasound Score in Patients With Heart Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-10-01 date: 2024-12-01 date: 2024-04-02 date: 2024-04-23 name: Inonu University class: OTHER briefSummary: Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3).

Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4).

Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. conditions: Heart Failure conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: VEXUS score name: NGAL measure: acute kidney injury measure: mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341803 id: DSRB 2023/00397 briefTitle: Personalized Transcranial Magnetic Stimulation Treatment for Depression acronym: APIC-TMS overallStatus: RECRUITING date: 2024-03-01 date: 2025-04-01 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: Institute of Mental Health, Singapore class: OTHER name: National University of Singapore briefSummary: This proposal seeks to conduct a pragmatic single arm, open label pilot implementation to validate our individualized functional Magnetic Resonance Imaging (fMRI) connectome-guided localization approach for accelerated TMS among Asian patients with depression.

Participants will be patients with Major Depressive Disorder not responding to standard treatment, with no exclusions to fMRI or transcranial magnetic stimulation (TMS) (essentially metal implants in the head) and willing to participate in the pilot.

All participants will undergo MRI scans before and after the accelerated TMS treatment. The multi-session hierarchical Bayesian model (MS-HBM) approach will be used to estimate individualized connectome-guided target locations.

Patients will undergo accelerated TMS applied to individualized connectome-guided target locations (based on the MS-HBM approach).

Patients will undergo 10 sessions (each session lasting 10 min) spread out over 10 hours each day for 5 consecutive working days.

All clinical outcome data will be collected for each patient by a pre-defined questionnaire at four time points: at baseline, post-treatment, 1 month and 3 months during follow-up.

The clinical outcome data will be analyzed using linear regression or repeated analysis of variance (ANOVA) after adjusting for baseline clinical characteristics and socio-demographics. Trajectories of the clinical outcome data at baseline, post-treatment and all follow-up time points will be plotted and compared with time series statistical analysis models with the other clinical and socio-demographic characteristics included as confounders. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Individually Neuronavigated accelerated intermittent theta burst stimulation with Magpro X100 measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-16) measure: Montreal Cognitive Assessment (MoCA), measure: EuroQol- 5 Dimension (EQ-5D) measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF) measure: Correlation of changes in functional connectivity with changes in MADRS scores sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Mental Health status: RECRUITING city: Singapore country: Singapore name: Phern-Chern Tor, MBBS role: CONTACT lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06341790 id: NAFLD-02 briefTitle: Effect of Consumption of Millet Diet in Patients With NAFLD overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2026-07-05 date: 2026-07-05 date: 2024-04-02 date: 2024-04-02 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: With NAFLD fast rising its ranks in becoming a major non communicable disease in India and across the globe, this study aims at primary prevention of the condition. NAFLD is a spectrum of diseases characterised by the deposition of fat within hepatocytes and is a precursor of liver inflammation. Global estimates peg the prevalence to be around 30 to 40%, but there are not many studies which have documented the prevalence in India. With the epidemiological transition, the cases of NAFLD are also on a rise as metabolic syndrome is an important risk factor.

It is apparent that the westernized way of our lifestyle especially the junk food culture comprising of super portions of loads of calories, sugars and salts is the main driver of this nutritional pandemic. The traditional diets in India were rich in fruits and vegetables, low in simple carbohydrates and high in fibre. Cereals are the main source of calories in any diet, forming the base of the food pyramid. Managing our cereals from being refined to the more complex ones being rich in fibre, protein and good quality fat could be a major player in the whole game of dietary modifications not just therapeutically but also prophylactically. Hence our therapeutic focus should be in increasing the consumption of cereals that are not only high in fibre, low in carbohydrates but also that have the potential to modulate the intestinal bacterial ecology to a more favourable type thus helping in intensifying the effects of overall dietary modifications.

Gut microbiota is currently explored for its role in NAFLD and there are gaps in knowledge which preclude having therapeutic strategies through its modulation. Millets, which were once considered to be poor man's diet are now becoming a part of the plate more frequently, especially for its unique nutritive content, with increased fiber, low carbohydrates, high protein and good quality fats. The processing methods may alter glycemic responses. Thus, the present study is proposed to look into the effect of millet based diets in reduction of hepatic steatosis and the resultant alterations in the gut microbiota . conditions: NAFLD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: jowar based products measure: Assessment of hepatic steatosis in NAFLD patients measure: Assessment of blood sugar measure: Assessment of lipid function measure: Assessment of liver transaminases measure: Assessment of body composition measure: Assessment of Gut Microbiota sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: ILBS city: New Delhi zip: 110070 country: India name: Nida Athar, Msc role: CONTACT phone: 8601079163 email: nidaathar.20@gmail.com lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06341777 id: 25M621 briefTitle: Multisensory Telerehabilitation for Visual Field Defects acronym: MUST overallStatus: COMPLETED date: 2020-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Istituto Auxologico Italiano class: OTHER name: IRCCS Fondazione Stella Maris name: Azienda Ospedaliero, Universitaria Meyer briefSummary: Brain injuries may cause the loss of the ability to see portions of the visual field, the so-called visual field defects (VFDs). VFDs significantly impact the survivors' functional recovery and quality of life, with the majority of patients displaying no spontaneous recovery or being left with residual deficits. Among the available therapies for VFDs, the compensatory scanning training is considered the most promising. Yet, current evidence is insufficient to recommend it in clinical practice, and the scientific community has stressed the need of more high-quality research. The present randomized clinical trial in patients with chronic VFDs caused by brain lesions aims at verifying the feasibility and efficacy of a novel telerehabilitation using a multisensory scanning therapy, by measuring its effects on visual functions and daily activities, and by looking for neural indicators of the therapy-induced improvements. conditions: Visual Field Defect Following Cerebrovascular Accident conditions: Hemianopia conditions: Brain Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: Audio-visual training (AVT) telerehabilitation measure: Change from baseline in Accuracy on the EF Task measure: Change from baseline in Response Times (RTs) on the EF Task measure: Change from baseline in Accuracy on the Triangle Task measure: Change from baseline in RTs on the Triangle Task measure: Change from baseline in RTs on the Numbers Task measure: Change from baseline in omissions on the Bell Test (only children) measure: Change from baseline in RTs on the Bell Test (only children) measure: Change from baseline in Accuracy on the Small Faces Test (only children) measure: Change from baseline in RTs on the Small Faces Test (only children) measure: Change from baseline in Daily Living Dependent on Vision Questionnaire (total score) measure: Change from baseline in the Reading test (reading time) measure: Change from baseline in the Hamilton Anxiety Scale (total score; only adults) measure: Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults) measure: Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children) measure: Change from baseline in the Children Depression Inventory (CDI; total score; only children) measure: Change from baseline in the visual field size (only adults) measure: Change from baseline in the amplitude of Visual Evoked Potentials (VEPs) measure: Change from baseline in the latency of Visual Evoked Potentials (VEPs) measure: Change from baseline in the connectivity of the Inferior Longitudinal Fasciculus measure: Change from baseline in the connectivity of the Superior Longitudinal Fasciculus measure: Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus measure: Change from baseline in the connectivity of the Optic Radiations measure: Change from baseline in the connectivity of the Optic Tracts sex: ALL minimumAge: 6 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS city: Milan state: Lombardia zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06341764 id: CITATION id: 7/23 type: OTHER domain: IRCCS I.N.T. "G. Pascale" briefTitle: Neo-adjuvant Chemo and Immunotherapy in The Pre-operAtive Treatment of Locally Advanced cholangIOcarciNoma overallStatus: RECRUITING date: 2023-09-01 date: 2024-09 date: 2025-09 date: 2024-04-02 date: 2024-04-02 name: National Cancer Institute, Naples class: OTHER briefSummary: Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery. conditions: Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Durvalumab 1120 mg name: Durvalumab 1500 mg name: Tremelimumab i.v. at 300 mg name: Cisplatin (CDDP) 25 mg/mq i.v name: Gemcitabine (GEM) 1000 mg/mq i.v. measure: Recurrence rate of CCA measure: Rate of R0 resections measure: Radiologic responses measure: Pathologic responses measure: Toxicity assessed measure: PFS measure: OS measure: Exploratory objectives measure: Exploratory objectives sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale status: RECRUITING city: Napoli state: Italia zip: 80131 country: Italy name: Alessandro Ottaiano role: CONTACT phone: 08117770344 email: a.ottaiano@istitutotumori.na.it name: Alessandro Ottaiano role: PRINCIPAL_INVESTIGATOR name: Guglielmo Nasti role: SUB_INVESTIGATOR name: Francesco Izzo role: SUB_INVESTIGATOR name: Andrea Belli role: SUB_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Ospedale Cardarelli, Napoli status: NOT_YET_RECRUITING city: Napoli state: Italia zip: 80131 country: Italy name: Giovanni Vennarecci role: CONTACT phone: 0817472372 email: giovanni.vennarecci@aocardarelli.it name: Giovanni Vennarecci role: PRINCIPAL_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Università di Napoli "Federico II", Napoli status: NOT_YET_RECRUITING city: Napoli state: Italia zip: 80131 country: Italy name: Roberto Bianco role: CONTACT phone: 0817462061 email: robianco@unina.it name: Roberto Bianco role: PRINCIPAL_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Ospedale san Camillo Forlanini/Spallanzani, Roma status: NOT_YET_RECRUITING city: Roma state: Italia zip: 00152 country: Italy name: Viola Barucca role: CONTACT phone: 3391333211 email: viola.barucca.scf@gmail.com name: Viola Barucca role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Ospedale Mauriziano, Umberto I° status: NOT_YET_RECRUITING city: Torino state: Italia zip: 10128 country: Italy name: Massimo Di Maio role: CONTACT phone: 0115082032 email: massimo.dimaio@unito.it name: Massimo Di Maio role: PRINCIPAL_INVESTIGATOR lat: 45.07049 lon: 7.68682 facility: Università di Verona, Ospedale Borgoroma, Verona status: NOT_YET_RECRUITING city: Verona state: Italia zip: 37134 country: Italy name: Alessandra Auriemma role: CONTACT phone: 3483148292 email: alessandra.auriemma@aovr.veneto.it name: Alessandra Auriemma role: PRINCIPAL_INVESTIGATOR lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06341751 id: 2024-00393-01 briefTitle: Psychological Treatment for Persistent Fatigue overallStatus: RECRUITING date: 2024-04-11 date: 2024-12 date: 2025-04 date: 2024-04-02 date: 2024-04-12 name: Karolinska Institutet class: OTHER name: Forte name: The Swedish Research Council name: Region Stockholm briefSummary: This is a non-randomized pilot study to investigate the feasibility and acceptability of a transdiagnostic psychological intervention for primary care patients in Region Stockholm, Sweden, who suffer from persistent and disabling fatigue. conditions: Fatigue conditions: Fatigue Syndrome, Chronic conditions: Exhaustion; Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Psychological treatment for persistent fatigue measure: Treatment adherence and completion measure: Treatment credibility measure: Patient satisfaction measure: Working alliance measure: Negative effects of treatment measure: Open-ended questions regarding treatment content and presentation measure: Feasibility of study inclusion procedures and data-collection measure: Fatigue severity, primary self-rated symptom outcome measure: Problems concentrating measure: Reduced physical activity measure: Reduced motivation measure: Depressive symptoms measure: Somatic symptoms measure: General anxiety measure: Insomnia measure: Perceived Stress measure: Burnout measure: Self-rated health measure: Cognitive and behavioral responses to symptoms measure: General self-efficacy measure: Functional disability measure: Work and Social Adjustment measure: Treatment fidelity measure: Evaluation of participants' experience of treatment measure: Acceptability, Appropriateness, and Feasibility from the perspective of the clinic sex: ALL minimumAge: 18 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustavsberg University Primary Care Clinic status: RECRUITING city: Stockholm zip: 134 40 country: Sweden name: Jacob Andersson Emad, MD, PhD role: CONTACT phone: 0736566876 phoneExt: +46 email: jacob.andersson-emad@regionstockholm.se name: Kersti Ejeby, MD, PhD role: CONTACT phone: 0704848104 phoneExt: +46 email: kersti.ejeby@regionstockholm.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06341738 id: 421/215/404.102.28/VI/2023 briefTitle: The Efficacy of Digital Educational Interventions on Parental HPV Knowledge and Attitude, and Their Children's Vaccination Rates overallStatus: COMPLETED date: 2023-07-05 date: 2024-02-01 date: 2024-02-29 date: 2024-04-02 date: 2024-04-02 name: Kaohsiung Medical University class: OTHER briefSummary: The goal of this clinical trial is to examine in the parental HPV knowledge and attitude, and their children's completion rates in Indonesia. The main question\[s\] it aims to answer are:

* Is the digital educational intervention in improving parent's HPV knowledge in the intervention group compared to the control group?
* Is the digital educational intervention in improving parent's attitude toward HPV vaccine in the intervention group compared to the control group?
* Is the digital educational intervention more effective in increasing children's HPV vaccine completion rates in the intervention group compared to the control group?

Participants in intervention group will:

* watch a 8 minutes video in front of class at once.
* after video education intervention, in 2 weeks, participants received 2 reminder messages before first and second vaccination event, respectively.

Participants in control group will:

• Receive usual announcement regarding vaccine by staff conditions: Health Services Research studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 10 units are divided into 2 arms (e.g. intervention and control) by cluster randomisation using the number of units into a sealed envelope. the participants are unaware of which group they were placed in primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 374 type: ACTUAL name: Video education about HPV and HPV vaccine name: Electronic reminder messages name: Usual Information Service measure: Human Papillomavirus Knowledge Scale (HPV-KS) measure: Attitude towards HPV vaccine scale by Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS) measure: Vaccine completion rate sex: ALL minimumAge: 17 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Elementary school city: Ngawi state: East Java zip: 63271 country: Indonesia lat: -7.4038 lon: 111.4461 hasResults: False

 nctId: NCT06341725 id: LinfoK EUS 2016 briefTitle: EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging overallStatus: TERMINATED date: 2018-02-15 date: 2018-02-15 date: 2018-09-11 date: 2024-04-02 date: 2024-04-02 name: Paolo Giorgio Arcidiacono, MD class: OTHER briefSummary: Aim of the study will be to investigate if Endoscopic Ultrasound (EUS) with elastography can be purposed between the routine staging examinations in patients with pancreatic adenocarcinoma without distant metastasis for the staging of lymph nodes status ("N" in TNM classification)

* in RESECTABLE pancreatic cancer the investigators will evaluate the concordance with EUS elastography and histological findings of lymph nodes obtained during surgery, in order to assess the sensibility, specificity and the positive and negative predictive value of EUS with elastography, the disease-free survival, the percentage of metastatic patients and the overall survival (in patients with or without metastatic lymph nodes).
* in "BORDERLINE resectable" and UNRESECTABLE non-metastatic ("advanced" locally") disease, the investigators will evaluate if the malignant lymph nodes samples during EUS with elastography and fine needle aspiration (FNA) will be related to a decreased survival.

Secondary aim will be to register the prognosis (in terms of survival) of the patients with para-aortic and mediastinal pathological lymph nodes (related to a decreases survival in some series in literature) conditions: Pancreatic Adenocarcinoma conditions: Lymph Node Metastasis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 2 type: ACTUAL name: malignant lymph nodes measure: CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report measure: OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence measure: OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence measure: OVERALL SURVIVAL (MONTHS) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Hospital city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06341712 id: CLIN-60000-461 id: 2023-506229-12-00 type: OTHER domain: Ipsen briefTitle: Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma acronym: CabOSTar overallStatus: NOT_YET_RECRUITING date: 2024-06-13 date: 2026-10-26 date: 2028-06-15 date: 2024-04-02 date: 2024-04-02 name: Ipsen class: INDUSTRY briefSummary: The participants of this study will be children, adolescents, and young adults with residual osteosarcoma, which cannot be removed completely through surgery.

Participants will have achieved a partial response or stable disease at the end of conventional chemotherapy. Osteosarcoma is cancer of the bone. The cancer cells make immature bone cells, known as osteoid.

Osteosarcoma is very rare, but it is the most common type of bone cancer in children and teens. It is most common in teens and young adults.

In this study, participants will receive either cabozantinib and best supportive care or the best supportive care alone. Best supportive care will be provided at the investigator's discretion and according to institutional guidelines.

It includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including radiotherapy), etc. but does not include tumor specific therapy.

Cabozantinib will be taken by mouth (orally), as a tablet, once a day. Cabozantinib will be provided to participants who tolerate it for as long as their disease does not progress. Participants in the study receiving best supportive care alone may switch to treatment with cabozantinib and best supportive care if their disease progresses and if other eligibility criteria are met.

Participants may withdraw consent to participate at any time.

The estimated duration of the study for participants is 24 months, however a participant could remain in the study longer if demonstrating treatment benefit. conditions: Osteosarcoma conditions: Osteosarcoma in Children conditions: Osteosarcoma in Adolescents and Young Adults studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Cabozantinib name: Best Supportive Care (BSC) name: Best Supportive Care (BSC) measure: Progression-free Survival (PFS) assessed by Blinded Independent Radiology Committee (BIRC) measure: Progression-free survival (PFS) rate assessed by BIRC measure: Objective response rate (ORR) assessed by BIRC measure: Disease control rate (DCR) assessed by BIRC measure: PFS assessed by investigator measure: PFS rate assessed by investigator measure: ORR assessed by investigator measure: DCR assessed by investigator measure: Overall survival (OS) measure: 1-year overall survival rate measure: Percentage of participants with Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs). measure: Area Under Curve (AUC) at steady state. measure: Average concentration (Cavg) at steady state measure: Minimum concentration (Cmin) at steady state measure: Maximal concentration (Cmax) at steady state measure: Acceptability and palatability in children and adolescents assessed using a horizontal visual assessment scale. measure: Change from baseline in score for all Paediatric QoL Inventory (PedsQL) Scales including Generic Core Scales and Cancer Modules. measure: Change from baseline in European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) for adult participants sex: ALL minimumAge: 5 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06341699 id: 05C308 briefTitle: Study of the Steroid Hormone Milieu in Obese Patients acronym: MiSterO overallStatus: RECRUITING date: 2023-05-16 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Istituto Auxologico Italiano class: OTHER name: Ministry of Health, Italy briefSummary: The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity.

It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients.

Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism.

Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis. conditions: Obesity, Morbid studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 180 type: ESTIMATED measure: Association of androgen milieu with the severity of obesity measure: Association of cortisol milieu with the severity of obesity measure: Algorithm fo CV risk in obesity measure: Prevalence of hypogonadism in morbid obesity measure: Prevalence of patients with morbid obesity unresponsive to overnight suppression test measure: Enrichment in rare HH variants in obese patients with central hypogonadism measure: Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo status: RECRUITING city: Oggebbio state: Verbania zip: 28824 country: Italy name: Biagio Cangiano, MD role: CONTACT phone: 3343177491 email: b.cangiano@auxologico.it name: Massimo Scacchi, Professor role: CONTACT email: massimo.scacchi@unimi.it lat: 45.99088 lon: 8.64663 hasResults: False

 nctId: NCT06341686 id: 75471023.2.0000.0082 briefTitle: Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2025-03 date: 2025-05 date: 2024-04-02 date: 2024-04-02 name: Hospital do Rim e Hipertensão class: OTHER briefSummary: The two main cytomegalovirus (CMV) prevention strategies are prophylaxis and preemptive therapy. Prophylaxis effectively prevents CMV infection after solid organ transplantation (SOT), but is associated with high rates of neutropenia and late onset of post-prophylactic disease. In contrast, preemptive therapy has the advantage of leading to lower rates of CMV disease and robust humoral and T-cell responses. It is widely used in hematopoietic cell transplant recipients, but is rarely used after solid organ transplant recipients due to logistical considerations. conditions: CMV Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. Patients randomized to the prophylaxis group: Letermovir 480mg, 1x/day, from D14 to D98. Letermovir prophylaxis will start on day 14 after the kidney transplant.
2. Patients randomized to the preemptive treatment group: Preemptive treatment (PET) will begin on day 21, evaluating CMV DNAnemia weekly until D98.CMV DNAnemia weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98). The threshold for starting treatment with Ganciclovir is a CMV DNAemiaDNAemia \> 5,000 IU in a single measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (CMV syndrome or disease).
3. In both groups, CMV DNAemia will be monitored weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98), and after any acute rejection treatment occurring between 3 months and 6 months after kidney transplantation. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Letermovir 480 MG name: Ganciclovir measure: Incidence of CMV syndrome or disease measure: Incidence of patients with plasma CMV DNAemia > 200 IU measure: Incidence of patients with CMV infection/syndrome/disease sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341673 id: IRB-2023-O3-442 briefTitle: Impact of TTNS on Bladder Symptoms Among People With MS, A RCT overallStatus: RECRUITING date: 2024-03-15 date: 2024-04-28 date: 2024-06-30 date: 2024-04-02 date: 2024-04-02 name: Hawra Al-Dandan class: OTHER briefSummary: Background: Neurogenic lower urinary tract dysfunction is common among people with multiple sclerosis (MS). Recent studies showed that bladder storage symptoms are predominant among MS with a pooled prevalence of frequency at 73.45% followed by urgency at 63.87%. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment to manage bladder storage symptoms; however, the effectiveness of TTNS is based on a small number of studies with the absence of high-quality evidence. This study aims to investigate the effectiveness of TTNS on bladder storage symptoms compared with sham TTNS among people with MS.Methods: The investigators will use a randomised sham controlled double blind study to explore the effectiveness of TTNS in the treatment of bladder storage symptoms in MS. the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) was followed to standardize the conduct and reporting of the current protocol. The recruitment plan is twofold: 1) Open recruitment for people with MS through King Fahd Hospital of the University communication channels; 2) people with any type of MS attending their routine appointments in MS clinic at King Fahd Hospital of the University, Al Khobar. The investigators will investigate the effectiveness of TTNS compared to sham TTNS on bladder storage symptoms and the effect on quality of life using ICIQ-OAB, ICIQ 3-day bladder diary, ICIQ-LUTS qol, and PSQI. Participant's perception of change post intervention will be evaluated using GPE. Outcomes will be measured at 0, 6 weeks and at 6 months post intervention. A sample size of 72 patients (36 in each group) is required to achieve 90% power with two-tailed tests at an alpha level of 0.05.

Conclusion: Multiple sclerosis is a long-term condition, and self-management is important. TTNS provide a safe, non-invasive intervention that can be administered at home. Should the trial determine that TTNS is effective compared to sham TTNS, the investigators will plan to integrate TTNS into standard clinical care pathways in MS. conditions: Overactive Bladder Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, sham-controlled, double blind study with 1:1 allocation ratio. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants and those who undertake data input and data analysis will be blind to group allocation to reduce the risk of performance bias. A principal investigator and co-investigator will insert data into SPSS so that the researchers can analyse data without having access to the allocation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: Active Transcutaneous Electrical Nerve Stimulation (TENS) name: Sham Transcutaneous Electrical Nerve Stimulation (TENS) measure: The International Consultation of Incontinence Questionnaire- Overactive Bladder (ICIQ- OAB) measure: 3- day Bladder diary measure: Urinary sensation scale. measure: The International Consultation of incontinence Questionnaire, Lower Urinary Tract Symptoms, Quality of life (ICIQ - LUTS,Qol) measure: Pittsburgh Sleep Quality Index (PSQI)-item 6 measure: Global Perceived Effect (GPE) Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Fahd Hospital of the University status: RECRUITING city: Khobar state: Eastern Providence country: Saudi Arabia name: Dr Hawra Al Dandan, PhD role: CONTACT phone: +966555901977 email: hdandan@iau.edu.sa name: Dr Saad Al Saadi, PhD role: CONTACT phone: +966552519515 email: ssaadi@iau.edu.sa lat: 26.27944 lon: 50.20833 hasResults: False

 nctId: NCT06341660 id: CROC202313 briefTitle: To Evaluate the Safety and Tolerability of Carbognilumab Combined With Chemotherapy as the First-line Treatment for Patients With KEAP1 Mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC) overallStatus: RECRUITING date: 2023-05-25 date: 2025-06 date: 2025-07 date: 2024-04-02 date: 2024-04-02 name: Guangzhou Institute of Respiratory Disease class: OTHER briefSummary: To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as first-line treatment in patients with KeAP1-mutated advanced or postoperative recurrent non-small cell lung cancer. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: cadonilimab measure: Safety assessments and ORR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangdong state: Guangzhou zip: 510000 country: China name: zhou chegnzhi, doctor role: CONTACT phone: 13560351186 email: doctorzcz@163.com hasResults: False

 nctId: NCT06341647 id: AB-201-01 id: 103300 (HREC 233/23) type: OTHER domain: TGA (Australia) briefTitle: Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2027-04 date: 2029-02 date: 2024-04-02 date: 2024-04-02 name: GC Cell Corporation class: INDUSTRY briefSummary: This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases, which are phase 1a and phase 1b. The primary objective of phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors. conditions: Breast Cancer conditions: Gastric Cancer conditions: Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: * Safety: incidence and severity of AE and SAE \[Time Frame: From the time of consent through End of Study (up to 18 months per patient)\]
* Determination of Recommended Phase 2 Dose (RP2D) primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: AB-201 name: Cyclophosphamide name: Fludarabine measure: Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability] measure: Determination of Recommended Phase 2 Dose (RP2D) measure: To determine the preliminary efficacy, by the objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1, of AB-201 in subjects with advanced HER2+ solid tumors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peter MacCallum Cancer Centre city: Melbourne state: Victoria zip: 3000 country: Australia name: Michael Michael role: CONTACT phone: +6138559-5000 email: Michael.Michael@petermac.org lat: -37.814 lon: 144.96332 facility: The Alfred Hosptial city: Melbourne state: Victoria zip: 3004 country: Australia name: Mark Voskoboynik role: CONTACT phone: +613-9076-3129 email: m.voskoboynik@alfred.org.au lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06341634 id: VISIA id: TED2021-130747B-C22 type: OTHER_GRANT domain: European Union id: 3494130747-130747-28-521 type: OTHER domain: Ministry of Science and Innovation briefTitle: Surveillance of Suicide Ideation in Adolescents (VISIA) acronym: VISIA overallStatus: ENROLLING_BY_INVITATION date: 2024-02-06 date: 2024-11-24 date: 2024-11-24 date: 2024-04-02 date: 2024-04-02 name: Servicio Gallego de Salud class: OTHER_GOV name: University of Vigo name: Complejo Hospitalario Universitario de Vigo name: Complexo Hospitalario de Ourense name: Fundacin Biomedica Galicia Sur briefSummary: The goal of this observational study is to validate an AI algorithm's capability to differentiate the population with suicidal ideation from a control population using various multimodal variables, including voice analysis, facial emotions, natural language, and proteomics data.

The primary research question it aims to answer is:

Is it possible to identify suicidal ideation and suicide risk in adolescents early and non-intrusively using multimodal data analysis through digital instruments equipped with artificial intelligence?

Participants in this study will be asked to:

Complete psychometric instruments to establish a gold standard for detecting suicide risk and suicidal ideation.

Provide voice recordings, facial emotion data, and linguistic content in natural and specific contexts.

Participate in salivary proteomics data collection.

This study compares three distinct groups:

Ideation: Adolescent patients with current suicidal ideation. Clinical Population: Psychological or psychiatric patients of the same age and gender without suicidal ideation.

General Population: Adolescents without known psychological or psychiatric pathology of the same age and gender, without suicidal ideation.

Researchers will compare these groups to determine if the AI algorithm is effective in differentiating individuals with suicidal ideation (Group 1) from both a clinical control group (Group 2) and a general population control group (Group 3) using the collected multimodal data. The study aims to assess the algorithm's ability to identify early signs of suicide risk in these distinct participant populations. conditions: Suicide conditions: Distress, Emotional conditions: Adolescent Behavior conditions: Healthy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 339 type: ESTIMATED measure: Strengths and Difficulties Questionnaire (SDQ) measure: Mood and Feelings Questionnaire (MFQ) measure: Paykel Suicide Scale (PSS) measure: Facial microexpressions, voice and linguistic content analysis measure: Proteomic and stress level analysis measure: Millon Adolescent Clinical Inventory - II (MACI-II) measure: Problematic Internet Use Scale in Adolescents (EUPI-A) measure: European Bullying Intervention Project Questionnaire (EBIP-Q) and European Ciberbullying Intervention Project Questionnaire (ECIP-Q) measure: Oviedo Response Infrequency Scale-Revised (INF-OV-R) sex: ALL minimumAge: 11 Years maximumAge: 16 Years stdAges: CHILD facility: Servizo Galego de Saúde city: Santiago De Compostela state: A Coruña zip: 15703 country: Spain lat: 42.88052 lon: -8.54569 facility: Hospital Álvaro Cunqueiro city: Vigo state: Pontevedra zip: 36211 country: Spain lat: 42.23282 lon: -8.72264 facility: University of Vigo city: Vigo state: Pontevedra zip: 36310 country: Spain lat: 42.23282 lon: -8.72264 facility: University Hospital Complex of Ourense city: Ourense zip: 36002 country: Spain lat: 42.33669 lon: -7.86407 hasResults: False

 nctId: NCT06341621 id: SCHBCC-N071 briefTitle: Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib acronym: Rainbow overallStatus: RECRUITING date: 2024-04-02 date: 2027-02-25 date: 2029-01-01 date: 2024-04-02 date: 2024-04-10 name: Fudan University class: OTHER briefSummary: This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Arm 1# endocrine drug plus 3-year abemaciclib without chemotherapy Arm 2# treatment of physician's choice primaryPurpose: TREATMENT masking: NONE count: 1900 type: ESTIMATED name: 3-year abemaciclib without chemo name: treatment of physician's choice measure: Invasive disease free survival measure: disease free survival measure: distant disease free survival measure: overall survival measure: Time Frame: 5 years] 5. adverse effects adverse effects sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhimin Cancer Shao status: RECRUITING city: Shanghai zip: 200032 country: China name: Zhimin Shao, MD, PhD role: CONTACT phone: +8664175590 email: zhimingshao@yahoo.com name: Yin Liu, MD role: CONTACT phone: +8664175590 email: liuyinfudan@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06341608 id: K23DA057528 type: NIH link: https://reporter.nih.gov/quickSearch/K23DA057528 briefTitle: Improving Access to Opioid Use Disorder Treatment Among Marginalized Patients With a Tailored Telehealth Intervention overallStatus: RECRUITING date: 2023-12-08 date: 2028-04 date: 2028-04 date: 2024-04-02 date: 2024-04-02 name: University of Pennsylvania class: OTHER briefSummary: The goal of this pilot trial is to develop and test a telehealth intervention for OUD care delivery and refine measurement strategies.

The specific aims are to: 1) identify components of an effective telehealth intervention and barriers to implementation, 2) partner with an advisory board of OUD treatment stakeholders from different settings to develop a telehealth intervention for OUD treatment with buprenorphine, and 3) conduct a pilot trial of the telehealth intervention for OUD treatment.

The investigators will enroll 60 patients, 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine, with a treatment episode duration of 1-3 months, and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by an OUD treatment clinician, to receive the telehealth for OUD care delivery intervention. The investigators will measure clinical, implementation, and patient satisfaction outcomes. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: Telehealth for opioid use disorder treatment delivery measure: Treatment Engagement measure: Days of medication for OUD measure: Opioid and non-opioid substance use measure: Feasibility of intervention measure: Acceptability measure: Fidelity measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Shoshana Aronowitz, PhD role: CONTACT phone: 781-266-8571 email: visho@nursing.upenn.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06341595 id: 123322 briefTitle: Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy.

Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher. conditions: Gastric Cancer conditions: Gastric Cancer Metastatic to Regional Lymph Nodes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Sintilimab name: Extraperitoneal radiation therapy name: Oxaliplatin name: S-1 measure: Recurrence free survival (RFS) measure: R0 resection rate measure: Objective response rate (ORR) measure: Major pathological response rate (MPR) measure: Overall survival (OS) measure: Adverse reactions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangsu Province Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Yang Yan role: CONTACT lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06341582 id: 2023-10-14 briefTitle: Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort acronym: PREVENT overallStatus: RECRUITING date: 2023-12-11 date: 2025-11 date: 2025-11 date: 2024-04-02 date: 2024-04-02 name: Guangzhou Women and Children's Medical Center class: OTHER briefSummary: The hemolytic disease of newborns (HDN) is one of the most significant risk factors for hyperbilirubinemia. Studies have shown that end-tidal carbon monoxide-corrected (ETCOc) correlated with the rate of bilirubin production in the body and thus can be a good surrogate to quantify hemolysis and identifying the high-risk infants. However, there is insufficient clinical evidence regarding the early prediction of hemolytic hyperbilirubinemia using ETCOc. This study hypothesizes that early postnatal ETCOc levels are significantly associated with the risk of hemolytic hyperbilirubinemia requiring treatments within 14 days after birth, and early postnatal ETCOc can be a good indicator for early prediction of hemolysis. In addition, the investigators aim to investigate the relationship between the characteristics of treatments for hyperbilirubinemia and ETCOc. conditions: Neonatal Jaundice conditions: Neonatal Hyperbilirubinemia conditions: Hemolysis Neonatal studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2700 type: ESTIMATED name: End-tidal carbon monoxide-corrected (ETCOc) measure: The incidence of hemolytic hyperbilirubinemia within 14 days of life (DOL) measure: The incidence of neonatal hyperbilirubinemia within 14 days of life (DOL) measure: The incidence of hemolytic diseases of newborns within 14 days of life (DOL) measure: The rate of readmission due to neonatal hyperbilirubinemia within 28 days of life (DOL) sex: ALL minimumAge: 1 Hour maximumAge: 72 Hours stdAges: CHILD facility: Dongguan Maternity and Child Healthcare Hospital status: NOT_YET_RECRUITING city: Dongguan state: Guangdong zip: 523700 country: China name: Minxu Li, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.01797 lon: 113.74866 facility: Foshan Shunde Women and Children Health Care Hospital status: NOT_YET_RECRUITING city: Foshan state: Guangdong zip: 528300 country: China name: Runzhong Huang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.02677 lon: 113.13148 facility: Guangdong Maternity and Child Healthcare Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510010 country: China name: Chuan Nie, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The First affiliated Hospital, Sun Yat-sen University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510080 country: China name: Muxue Yu, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Guangzhou Women and Children's Medical Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510623 country: China name: Ge Yang, M.D. role: CONTACT phone: (86)020-38076329 email: geyang99@outlook.com name: Huayan Zhang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Jinan University, Guangzhou Overseas Chinese Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510632 country: China name: Bingxiao Li, M.D. role: PRINCIPAL_INVESTIGATOR name: Shasha Han, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Shenzhen Maternity and Child Healthcare Hospital status: NOT_YET_RECRUITING city: Shenzhen state: Guangdong zip: 518000 country: China name: Chuanzhong Yang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 hasResults: False

 nctId: NCT06341569 id: 11/07.03.2024 briefTitle: Physical Therapy Students: Well-being overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2024-08-29 date: 2024-10-30 date: 2024-04-02 date: 2024-04-10 name: University of Medicine and Pharmacy "Victor Babes" Timisoara class: OTHER briefSummary: This study aims to explore various psychosocial aspects and the potential benefits of respiratory techniques for physical therapy students. conditions: Anxiety State conditions: Motivation conditions: Life Stress conditions: Sleep, Inadequate studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This study uses a multiple-group design to investigate various psychosocial aspects of physical therapy students and to explore the potential benefits of breathing techniques as a well-being-promoting intervention. The study involves three groups:

Intervention group: second-year physical therapy students participating in a 14-week breathing techniques program.

Control group: second-year physical therapy students who do not participate in the program but complete the same questionnaires.

Comparison groups: 1st, 2nd, and 3rd year physical therapy students participating in assessments only. primaryPurpose: SCREENING masking: NONE count: 150 type: ESTIMATED name: Respiratory breathing techniques group measure: Assessing intrinsic and extrinsic motivation levels among physical therapy students. measure: Assessing the happiness levels of the students participating in the study. measure: Assessing the positive and negative emotional states of the students participating in the study. measure: Assessing the well-being of the students participating in the study. measure: Assessing the overall life satisfaction levels of the students participating in the study. measure: Assessing the subjective happiness levels of the students participating in the study. measure: Assessing the sleep quality of the students participating in the study. measure: Assessing the worry and anxiety levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the intrinsic and extrinsic motivation levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the happiness levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the students' positive and negative emotional states. measure: Assessing the effects of the respiratory techniques program on the students' well-being. measure: Assessing the effects of the respiratory techniques program on the overall life satisfaction levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the subjective happiness levels of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the quality of sleep of the students participating in the study. measure: Assessing the effects of the respiratory techniques program on the worry and anxiety levels of the students participating in the study. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341556 id: iNHL-03 briefTitle: A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma overallStatus: RECRUITING date: 2024-04 date: 2026-03 date: 2028-06 date: 2024-04-02 date: 2024-04-02 name: Fudan University class: OTHER briefSummary: This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy conditions: Mantle Cell Lymphoma conditions: Maintenance Therapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Zanubrutinib measure: 2-year progression-free survival (PFS) measure: 2-year event-free survival (EFS) measure: overall survival measure: Hematology and non hematology toxicity measure: Quality of life questionnaire measure: Exploratory biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Yizhen Liu role: CONTACT phone: 021-64175590 phoneExt: 85100 email: aliuyz@126.com lat: 31.22222 lon: 121.45806 facility: Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Yizhen Liu role: CONTACT phone: 021-64175590 phoneExt: 85100 email: aliuyz@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06341543 id: QUANTIFOT id: PHRCI-2021-68 type: OTHER_GRANT domain: DGOS (France) briefTitle: Quantiferon CMV to Identify Treatment Need For Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT) acronym: QUANTIFOT overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2026-06-15 date: 2026-06-15 date: 2024-04-02 date: 2024-04-10 name: University Hospital, Grenoble class: OTHER briefSummary: Context

Cytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients.

Most of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and/or disease, and who ill benefit the most from antiviral therapy.

As CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France).

Aim of the study

The aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy.

Methods

Participation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU/mL.

The QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation).

* In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices.
* in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive.

In the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect).

The participants will be sampled:

* 5 to 12 days after QF-CMV sampling (V2) ;
* 7 to 14 days days after V2 (V3 - between D12 and D26) ;
* 7 to 14 days days after V3 (V4 - between D19 and D40) .

Endpoints

The primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows:

* Blood CMV viral load \>10,000 IU/mL \[4 log\];
* And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise \>5000 IU/mL;
* And/or the onset of CMV disease.

The secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity). conditions: Cytomegalovirus Infections conditions: Heart Transplantation conditions: Kidney Transplantation conditions: Lung Transplantation conditions: Liver Transplantation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 288 type: ESTIMATED name: Quantiferon CMV (assay that determine the presence of CMV-specific T lymphocytes). name: Communication of the result of the QF-CMV to the clinician in charge measure: proportion of participants with CMV viral load (>10,000 IU/mL, or increase ≥0.5 log IU/mL) measure: proportion of participants with CMV disease measure: proportion of participants with antiviral-associated anemia measure: proportion of participants with antiviral-associated leucopenia measure: proportion of participants with antiviral-associated thrombopenia measure: proportion of participants with antiviral-associated tubulotoxicity (hypokaliemia) measure: antiviral-associated kidney failure (creatininemia) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Olivier EPAULARD city: Grenoble state: Isere zip: 38043 country: France name: Olivier Epaulard role: CONTACT phone: +00476765291 email: oepaulard@chu-grenoble.fr lat: 45.16667 lon: 5.71667 hasResults: False

 nctId: NCT06341530 id: SURPASS-1 briefTitle: Anlotinib Combined With Penpulimab as Front-line Treatment in Advanced Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-01-31 date: 2024-12-31 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: The First Affiliated Hospital of Zhengzhou University class: OTHER briefSummary: In recent years, with the emergence and clinical application of anti-angiogenesis therapy, the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase. Anti-angiogenic therapy can improve the hypoxia state of tumor tissue, normalize blood vessels, relieve immune suppression in tumor microenvironment, increase the degree of infiltration of immune cells, and fully activate immune cells to achieve the effect of tumor immunity. Previous studies have shown that penpulimab injection combined with anlotinib in the treatment of NSCLC can induce the normalization of tumor blood vessels and reshape the tumor immunosuppressive microenvironment, and the combination of the two can have synergistic effects.

This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients, and has important clinical value for the treatment of advanced lung cancer. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: anlotinib combined with penpulimab measure: Progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhe Cheng status: RECRUITING city: Zhengzhou state: Henan zip: 450000 country: China name: Zhe Cheng role: CONTACT phone: 18638027777 email: cz711010@163.com lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06341517 id: IRB_in_progress briefTitle: Brain Circuitry Therapeutics for Schizophrenia acronym: ATHENA overallStatus: NOT_YET_RECRUITING date: 2024-11-05 date: 2026-01-05 date: 2027-12-12 date: 2024-04-02 date: 2024-04-02 name: Indrit Begue class: OTHER briefSummary: This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia conditions: Schizophrenia; Psychosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The subjects, care providers, investigators and outcome assessors will all be blinded as to the randomization sequence, and thus will be blinded as to sham vs active TMS status. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: iTBS measure: Brief Negative Symptoms Scale - apathy subscale (BNSS-Apathy) at follow-up (FU) at T3. The primary endpoint will be assessed at baseline and all follow-up visits at week 1, 6 and 12. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indrit Bègue city: Geneva zip: 1202 country: Switzerland name: Indrit Bègue, MD, PhD role: CONTACT phone: +41589440300 email: indrit.begue@unige.ch lat: 46.20222 lon: 6.14569 hasResults: False

 nctId: NCT06341504 id: ALVMsg2023 id: 263472 type: OTHER_GRANT domain: Fonds de recherche du Québec - Société et culture briefTitle: Prevention Messages for EGMs: Effects on Behaviours and Cognitions overallStatus: RECRUITING date: 2024-02-27 date: 2024-09 date: 2024-09 date: 2024-04-02 date: 2024-04-02 name: Benjamin Galipeau class: OTHER name: Fonds de recherche du Québec - Société et culture name: Fonds pour la prévention et le traitement du jeu briefSummary: The goals of this randomized controlled trial are to test the manifold effects of prevention pop-up messages on participants' behaviours, cognitions and affects. This study is conducted among regular EGMs' players (defined as having played EGMs at least once every two weeks for the past 12 months) who are not classified as probable pathological gamblers by the PGSI.

After answering a series of short questionnaires by phone, participants are asked to schedule a gambling session which is done in a laboratory on the university's campus. This laboratory replicates a typical bar, and is equipped with real EGMs. Participants are recruited under the false pretense of giving their opinion on the realism of the bar replica, and on the overall feeling of the gambling session in it. They are told that: (a) they are free to gamble as much and for as long as they like; (b) they are allowed to take breaks; (c) gambling is to be done with their own money; (d) the only compensation for participation are the potential winnings made while gambling; (e) net winnings across their whole session are paid, but losses are real. There is only one participant at a time in the laboratory for the gambling session.

After having stopped by their own volition (some exceptions apply, see "Detailed Description" for further details), participants are debriefed on the real goals of this study and reimbursed any incurred losses while gambling. They are then be asked to answer another series of questionnaires. conditions: Gambling studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Stratified block randomization assignment. Blocks are size 4 and strata are divided on problem gambling severity using PGSI categories. Two conditions:

* Experimental: Regular gambling session + Prevention pop-up messages
* Active Comparator: Regular gambling session

Three assessment phases:

* Pre-experiment. Telephone interview before the gambling session. Measures baseline characteristics and schedule the gambling session. Usually done within a couple of days following an application to participate.
* Experiment. Gambling session in the laboratory. Behaviour is continuously measured starting with the first time the participant puts money in the EGM to participant choosing to end their gambling session. Duration is limited to 2 hrs (unbeknownst to participant). Session is scheduled days to weeks after the Pre-experiment, depending on participant's availability.
* Post-experiment. Debriefing and post-experiment interview. Done right after the gambling session is ended. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants are recruited under the false pretense of evaluating the realism of a gambling session in a laboratory replicating a bar environment. While the participants in the experimental group should notice the novel prevention messages, before debriefing, for all they know, there are no groups to be assigned to. Therefore they would not be aware, that there are two different groups, nor that this study tests the effects of prevention pop-up messages.

Note that masking becomes "open label" after debriefing. Indeed, after being informed of the true goals of this study, participants will easily be able to determine in which group they were assigned based on what occured during their gambling session. Though, gambling behaviours are recorded before debriefing and won't be affected by unmasking.

There is no functional way to mask group assignment to the members of the research team. However, the randomization procedure assures that allocation is purely random. whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Prevention pop-up messages name: Mandatory time limit name: Responsible gambling information name: Electronic gambling machine (model IGT GL20) name: Square terminal measure: Gambling behaviour (between group) - Gambling session's total duration measure: Gambling behaviour (between group) - Total time effectively spent gambling measure: Gambling behaviour (between group) - Number of breaks taken measure: Gambling behaviour (between group) - Mean breaks' duration measure: Gambling behaviour (between group) - Total breaks duration measure: Gambling behaviour (between group) - Mean time elapsed between breaks measure: Gambling behaviour (between group) - Number of different games played measure: Gambling behaviour (between group) - Money betted (physical) measure: Gambling behaviour (between group) - Money betted (all) measure: Gambling behaviour (between group) - Number of bets placed measure: Gambling behaviour (between group) - Gambling speed measure: Gambling behaviour (between group) - Gambling intensity (physical) measure: Gambling behaviour (between group) - Gambling intensity (all) measure: Perceived self-control while gambling on EGMs (between group) measure: General level of fun while gambling on EGMs (between group) measure: Psychological reactance to prevention pop-up messages (between group) measure: Perceived behavioural effectiveness of prevention pop-up messages (between group) measure: Change in gambling behaviours (within group) - Money betted (physical) measure: Change in gambling behaviours (within group) - Total time effectively spent gambling measure: Change in perceived self-control while gambling on EGMs (within group) measure: Change in general level of fun while gambling on EGMs (within group) measure: Perceived realism - Gambling location type most resembling the session in the laboratory measure: Perceived realism - Session in the laboratory VS gambling on EGMs in a bar/restaurant measure: Perceived realism - Similarities between session in the laboratory VS gambling on EGMs in a bar/restaurant measure: Perceived realism - Differences between session in the laboratory VS gambling on EGMs in a bar/restaurant measure: Perceived realism - What could be done to heighten realism of the session in the laboratory measure: Perceived realism - Effect of using one own money on realism measure: Perceived realism - Effect of using one own money on realism (free) measure: Perceived correspondence between habitual gambling behaviour and gambling behaviour during the session in the laboratory measure: Perceived correspondence between habitual gambling behaviour and gambling behaviour during the session in the laboratory (free) measure: Protocol credibility measure: Protocol credibility (free) measure: Recruitment potential - Volunteers measure: Recruitment potential - Recruited measure: Recruitment potential - Rejected measure: Recruitment potential - Refusal measure: Attrition measure: Prevention pop-up messages recall - Free recall (Y/N) measure: Prevention pop-up messages recall - Free recall (number) measure: Prevention pop-up messages recall - Free recall (content) measure: Prevention pop-up messages recall - Cued recall (Y/N) measure: Prevention pop-up messages recall - Cued recall (number) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre québécois d'excellence pour la prévention et le traitement du jeu status: RECRUITING city: Québec zip: G1V 0A6 country: Canada name: Benjamin Galipeau role: CONTACT email: benjamin.galipeau.1@ulaval.ca name: Christian Jacques, M.Ps. role: CONTACT email: christian.jacques@psy.ulaval.ca name: Benjamin Galipeau role: PRINCIPAL_INVESTIGATOR name: Isabelle Giroux, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Serge Sévigny, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Christian Jacques, M.Ps. role: SUB_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06341491 id: obs. Delay Discounting briefTitle: The Study of Delay Discounting Among Beneficiaries of the Pé-de-Meia Program overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-30 date: 2025-12-01 date: 2024-04-02 date: 2024-04-02 name: Federal Institute of Education, Science and Technology of the State of Mato Grosso class: OTHER briefSummary: The aim of this observational study is to explore how the "Pé-de-Meia" Program, a policy of the Brazilian Federal Government designed to encourage the retention and completion of studies by students from low-income families, affects both the students' tendency towards delay discounting and their academic performance. The study seeks to answer the following questions:

How does the "Pé-de-Meia" Program affect the students' propensity for delay discounting? Is there a relationship between the level of delay discounting among students, their academic performance, and school attendance? Participants in the study, high school students enrolled in the "Pé-de-Meia" Program, will undergo assessments to measure their level of delay discounting. The academic performance and school attendance of the participants will be monitored and analyzed in relation to their propensity for delay discounting conditions: Delay Discounting studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Pé-de-Meia Program measure: Delay discounting measure: Academic performance - grades measure: School attendance sex: ALL minimumAge: 14 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06341478 id: IG-2022-27746 briefTitle: Investigator Grant (IG) 2022 27746 overallStatus: RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2027-03-15 date: 2024-04-02 date: 2024-04-02 name: IRCCS San Raffaele class: OTHER briefSummary: Background:

Muscle-invasive bladder cancer (MIBC) is a systemic disease as \>40% of patients (pts) ultimately develop recurrence after radical cystectomy (RC). For pts who cannot receive or refuse cisplatin-based chemotherapy there is no standard-of-care neoadjuvant therapy. Single-agent pembrolizumab, given neoadjuvantly in patients with T2-4N0M0 MIBC, documented a 42% pathologic complete response-rate (ypT0N0) in a previous AIRC-supported trial (PURE-01, NCT02736266; PMID: 30343614). However, there is a huge proportion of pts who do not benefit from single-agent immunotherapy. Antibody-drug conjugates (ADC) represent the next wave of MIBC treatment revolution. An umbrella of various neoadjuvant therapies including the ADC Sacituzumab govitecan (SG), SG plus pembrolizumab, and chemoimmunotherapy combination has been established to improve our knowledge on MIBC biology and to improve the outcomes.

Hypothesis:

By developing a robust biomarker program associated with therapeutic benefit of novel therapies or their combinations, along with an imaging biomarker development, the investigators will be able to identify suitable tumor characteristics for personalizing perioperative therapies in MIBC, coupled with the possibility to predict the pathological response to treatment.

Aims:

The project is aimed at characterizing the tumor and microenvironment characteristics of muscle-invasive bladder cancer, with a special focus on their changes induced by various neoadjuvant therapies preceding radical cystectomy.

The investigators will aim to evaluate the tumor and immune profile on matched pre- vs post-therapy samples and noninvasively monitor the response to treatment with the use of radiological assessments.

Experimental design:

The investigators will access tumor samples from matched pre-therapy (transurethral resection of the bladder tumor) and post-therapy (radical cystectomy) surgical interventions. They will also analyze the imaging analyses of combined bladder multiparametric MRI/Fluorodeoxyglucose Positron Emission Tomography (PET) scans pre-post neoadjuvant therapies, and will associate the data with the pathological response to treatment, expanding our previously reported work (PMID: 31882281).

Biomarker analyses will include the following: i.) multiplex immunofluorescence assays will allow the investigators defining the immune contexture of tumor lesion; ii.) multiparametric flow cytometry will allow the phenotypic and functional analysis of peripheral blood cells at single cell level; iii.) a whole transcriptome assay will enable investigators to assign specific molecular subtypes to pathological response and outcome, as previously reported (PMID: 33785257; 32165065).

Expected results:

The investigators will expect to identify the tumor characteristics and immune-profiling enabling them to delineate the selection of patients most suited for certain novel perioperative therapies, thus anticipating the developments in clinical research that are being conducted worldwide in MIBC.

The investigators will be also able to develop noninvasive tools for pathological complete response identification, thus enabling them to develop a next-generation of clinical trials aimed at sparing any radical local therapy on the bladder tumor.

Impact on cancer:

In principle, the present personalized strategy yields the potential to enhance the therapeutic standards achievable with RC alone as well as with single-agent immunotherapy and RC. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Post-hoc biomarker analyses of ongoing phase 2 studies primaryPurpose: OTHER masking: NONE count: 153 type: ESTIMATED name: various neoadjuvant therapies measure: Predictors of immune response to experimental combination therapies in MIBC. measure: Genomic predictors of response to experimental combination therapies in MIBC. measure: Transcriptomic predictors of response to experimental combination therapies in MIBC. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Mi zip: 20132 country: Italy name: Andrea Necchi, MD role: CONTACT phone: +390226435789 email: necchi.andrea@hsr.it name: Rossella Miotti, PhD role: CONTACT email: miotti.rossella@hsr.it lat: 45.46427 lon: 9.18951 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-02-02 uploadDate: 2024-03-19T18:02 filename: Prot_000.pdf size: 1464434 hasResults: False

 nctId: NCT06341465 id: HÜ- FTR- BD- 3 briefTitle: Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities and Serum Markers in Individuals With Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2024-07-04 date: 2024-07-04 date: 2024-04-02 date: 2024-04-02 name: Hacettepe University class: OTHER briefSummary: The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Trunk rotation will be assessed using the Adams Forward Bend Test with scoliometer, quality of life will be evaluated with the SRS-22 Quality of Life questionnaire and Quality of life profile for spinal deformities questionnaire, perception of deformity will be measured using the Walter Reed Visual Assessment Scale, and Cobb angles will be evaluated from anterior-posterior X-ray images. conditions: Scoliosis conditions: Scoliosis Idiopathic conditions: Musculoskeletal Deformity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3 groups. Schroth exercise group (n=19), schroth exercise and kinesiological taping group (n=19), healthy people (n=19). primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: Just Exercise name: Exercise name: Taping measure: Trunk rotation measure: Cobb angles measure: Serum markers measure: Quality of life with scoliosis people measure: Body image assessment sex: ALL minimumAge: 18 Years maximumAge: 21 Years stdAges: ADULT hasResults: False

 nctId: NCT06341452 id: HD-NaM-01-EU briefTitle: Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis acronym: SODIAH overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2025-12 date: 2024-04-02 date: 2024-04-02 name: Fresenius Medical Care Deutschland GmbH class: INDUSTRY briefSummary: The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing. conditions: End Stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, open, controlled, parallel, randomized, interventional, multi-center, explorative primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control measure: Interdialytic weight gain measure: Intradialytic hemodynamic stability measure: Intradialytic hemodynamic stability measure: Intradialytic morbid events measure: Fluid status measure: Fluid status measure: PRO: Thirst feeling measure: PRO: Thirst feeling measure: PRO: Fatigue measure: PRO: Hypotensive episodes measure: PRO: HRQOL measure: PRO: Health status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341439 id: Prot. 001_2023 briefTitle: Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX® overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-18 date: 2024-01-18 date: 2024-03-30 date: 2024-04-02 date: 2024-04-02 name: University of L'Aquila class: OTHER briefSummary: The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are:

* Is the response to periodontal therapy better if mouthwash containing Citrox is used?
* What is the patients' perception?

Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Mouthwash with chlorhexidine 0,12% and CITROX name: Mouthwash with chlorhexidine 0,12% measure: Probing Depth (PD) measure: Gingival Index (GI) measure: Plaque Index (PI) measure: Full mouth plaque score (FMPS) measure: Full mouth bleeding score (FMBS) measure: Patient Reported Outcome Measure (PROMS) sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of L'Aquila, division of periodontology city: L'Aquila zip: 67100 country: Italy lat: 42.35055 lon: 13.39954 hasResults: False

 nctId: NCT06341426 id: 23-5872 briefTitle: Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin acronym: PSI-1V2 overallStatus: RECRUITING date: 2024-02-05 date: 2028-02-01 date: 2028-08-01 date: 2024-04-02 date: 2024-04-02 name: University Health Network, Toronto class: OTHER name: Centre for Addiction and Mental Health briefSummary: The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered. conditions: Major Depressive Disorder conditions: Depression conditions: Treatment-Resistant Depression conditions: Mood Disorders studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to two groups for the first dosing session in a 1:1 allocation: 1) non-psychedelic/placebo dose (psilocybin 1mg) or 2) psychedelic dose (psilocybin 25mg). All participants will receive a psychedelic dose (psilocybin 25mg) for their second dosing session. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The first dose will be randomized and blinded (1mg psilocybin versus 25mg psilocybin), while the second dose will be open-label (25mg psilocybin). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Single Psychedelic Dose Psilocybin name: Two Psychedelic Doses Psilocybin measure: Antidepressant Efficacy measure: Self-Reported Depression Symptoms measure: Anxiety Symptoms measure: Self-Reported Quality of Life measure: Subjective Functioning measure: Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) measure: Cognitive Dysfunction measure: Psychomotor Performance measure: Phonemic Word Fluency measure: Psychomotor Speed, Visual search, and Attention measure: Verbal Learning and Memory measure: Working Memory, Attention and Executive Function measure: Effort-Based Decision Making measure: Participant Blinding Success measure: Expectancy Effects measure: Quality of Clinician-Patient Therapeutic Relationship measure: Qualitative Narrative Feedback measure: Percentage Restarting Antidepressants measure: EEG Predictors of Response sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toronto Western Hospital status: RECRUITING city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Danica Johnson, BScH role: CONTACT email: danica.johnson@uhn.ca name: Zoe Doyle, RN role: CONTACT email: zoe.doyle@uhn.ca name: Joshua Rosenblat, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06341413 id: 2023-1281 id: A539500 type: OTHER domain: UW- Madison id: SMPH/SLEEP CENTER/SLEEP CTR type: OTHER domain: UW- Madison id: Protocol version 1/17/2024 type: OTHER domain: UW- Madison id: 1R01MH132221 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH132221 briefTitle: Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-10 date: 2024-10 date: 2024-04-02 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth.

Participants will attend 4 study visits:

* A clinical and trauma assessment visit
* A testing day that may include cognitive testing, surveys, and an MRI.
* An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition
* An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ESTIMATED name: SmartSleep device measure: Change in Emotional Regulation - arousal measure: Change in Emotional Regulation - recall measure: Change in Slow-wave Activity (SWA) measure: Change in Positive and Negative Affect Schedule (PANAS) sex: ALL minimumAge: 15 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States name: Sara Heyn, JD, PhD role: CONTACT phone: 303-296-2116 email: sheyn@wisc.edu name: Stephanie Jones, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06341400 id: 2024-KY-030-01 briefTitle: RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients overallStatus: RECRUITING date: 2024-05-20 date: 2026-05-01 date: 2027-05-01 date: 2024-04-02 date: 2024-04-02 name: Zhujiang Hospital class: OTHER briefSummary: A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy. conditions: Bladder Cancer conditions: Muscle-Invasive Bladder Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 55 type: ESTIMATED name: DisitamabVedotinForIicction Toripalimab measure: PcR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Peng Xu, doctor role: CONTACT phone: 18665073650 lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06341387 id: R178522-ieo1906 briefTitle: Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer overallStatus: RECRUITING date: 2023-05-05 date: 2024-05-30 date: 2024-07-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER name: University of Rome Tor Vergata briefSummary: The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are:

* Which are the "omics" biomarkers that characterize the early stage of lung cancer?
* How to Translate Laboratory Data into Clinical Data?

For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile. conditions: Lung Cancer conditions: Non-small Cell Lung Cancer Stage I conditions: Non-small Cell Lung Cancer Stage II conditions: Lung Cancer Diagnosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Breath, urine and blood analysis measure: Comparison of the proteomic and volatolomic signature in samples of respiratory exhalation, serum, and urine from patients with lung cancer (stage I/II) and healthy individuals at high risk. measure: Omics-Data intagration. sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Europen insitute of Oncology- Division of Thoracic Surgery status: RECRUITING city: Milan zip: 20141 country: Italy name: Roberto Gasparri, MD, PhD role: CONTACT phone: 0257489499 email: roberto.gasparri@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06341374 id: 2023/5079 briefTitle: Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients overallStatus: RECRUITING date: 2023-11-06 date: 2024-03-30 date: 2024-09-30 date: 2024-04-02 date: 2024-04-02 name: Parc Taulí Hospital Universitari class: OTHER briefSummary: Sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (OSA)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents.

The objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of COVID-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response. conditions: Apnea, Obstructive Sleep conditions: SARS CoV 2 Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Influvac Tetra measure: Immunological study: cytokines. measure: Innate cells: monocytes, classical dendritic cells and Natural Killer cells. measure: Epigenetic modification. measure: Diagnostic of obstructive sleep apnea in selected cohort sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Parc Tauli status: RECRUITING city: Sabadell state: Barcelona zip: 08208 country: Spain name: Andrea F Grau, Medicine role: CONTACT phone: +34608151458 email: andreagrau94@gmail.com name: Miguel D Gallego, Medicine role: CONTACT phone: +34616315290 email: mgallego@tauli.cat lat: 41.54329 lon: 2.10942 hasResults: False

 nctId: NCT06341361 id: OCT-FFR briefTitle: OCT-based Machine Learning FFR for Predicting Post-PCI FFR overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-04-30 date: 2025-10-15 date: 2024-04-02 date: 2024-04-02 name: Yonsei University class: OTHER name: Gangnam Severance Hospital name: Severance Hospital briefSummary: This study aims to compare the diagnostic accuracy of the fractional flow reserve (FFR) model derived by machine learning based on optical coherence tomography (OCT) exam after coronary artery stent implantation with the wire-based FFR. conditions: Tomography, Optical Coherence conditions: Fractional Flow Reserve, Myocardial studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 82 type: ESTIMATED name: OCT-based machine learning FFR measure: Correlation of OCT-based machine learning FFR compared to wire-based FFR measure: Diagnostic performance of OCT-based machine learning FFR compared to wire-based FFR measure: Diagnostic performance of OCT-based machine learning FFR according to the coronary artery (LAD, LCx or RCA) compared to wire-based FFR sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341348 id: Dalin Tzuchi Hospital briefTitle: Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan overallStatus: COMPLETED date: 2016-01-01 date: 2018-06-30 date: 2018-12-31 date: 2024-04-02 date: 2024-04-02 name: Dalin Tzu Chi General Hospital class: OTHER briefSummary: Case management (CM) has been recommended as a way of inspiring measurable changes in individual behaviors and improving clinical outcomes for patients with chronic diseases. However, data on its effectiveness for Taiwanese patients with rheumatoid arthritis (RA) are limited. This study aimed to determine the long-term effectiveness of CM that focused on nurses' role among Taiwanese RA patients.

A quasi-experimental pre-post test, control-group study with purposive sampling recruited RA patients from a hospital in Taiwan during 2016-2017. CM program was composed of health education sessions and follow-up telephone consultations over a six-month period. A review of medical records and structured questionnaires yielded data about patient demographics and disease characteristics, and included Chinese version of the Arthritis Self-Efficacy Scale and the Taiwanese Depression Questionnaire. A comparison of the long-term effectiveness of the CM program was made using generalized estimating equation.

This evidence-based study may be beneficial to characterize the long-term effectiveness of CM for Taiwanese patients with RA, and may be a reference for healthcare providers in facilitating the provision of appropriate interventions to improve the adaptation processes and clinical outcomes for them. conditions: Case Management conditions: Rheumatoid Arthritis conditions: Effectiveness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: A trained interviewer, who was blind with the study design and participants, was assigned to collect the participants' information on demographic and disease characteristics. count: 96 type: ACTUAL name: Case management measure: Depressive symptoms measure: Self-efficacy level measure: Sexual dysfunctionform-14 measure: DAS28 sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341335 id: AK109-301 briefTitle: A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11 date: 2027-07 date: 2024-04-02 date: 2024-04-02 name: Akeso class: INDUSTRY briefSummary: This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy. conditions: Gastric and Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 506 type: ESTIMATED name: cadonilimab name: pulocimab name: paclitaxel name: placebo measure: Progression-free survival (PFS) assessed by blinded independent central review (BICR) measure: Overall survival (OS) measure: Progression-free survival (PFS) assessed by investigator measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341322 id: ERC0003996 briefTitle: Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia overallStatus: RECRUITING date: 2024-03-05 date: 2024-04 date: 2024-07 date: 2024-04-02 date: 2024-04-02 name: Veerle Snijders class: OTHER name: Croatian Institute of Public Health name: Andrija Štampar School of Public Health briefSummary: Colorectal cancer (CRC) is one of the leading causes of death in Croatia. An average of 3600 cases are diagnosed and an average of 2100 people die from the disease every year. Since 2007, Croatia has invited every man and woman aged 50-74 to participate in the home testing screening programme every two years. Currently only around 36% of the invited request the test-kit and 25% complete the home testing procedure, far below the target of 40-60%.

The Croatian Institute of Public Health with technical support from World Health Organization (WHO) Regional Office for Europe is undertaking a mixed-methods research study with the aim to increase the completion of colorectal cancer home testing and improve our knowledge of the barriers and drivers to do so. The study has a quantitative and a qualitative component:

1. Quantitative: testing the introduction of a reminder letter to encourage people to respond to the initial invite to participate in the CRC home test program and test which elements of a reminder letter improve response rates.

   The quantitative component consists of a four-arm reminder letter randomized controlled trial (RCT) comparing no letter, standard letter, behaviorally informed letter, and behaviorally informed letter sent with a home testing kit to investigate the effectiveness of reminders in increasing uptake of home-testing for colorectal cancer. Recruitment and data collection for the reminder letter trial will be conducted utilizing the routine screening process and routinely collected screening data.
2. Qualitative: conducting in-depth interviews with people from the target population who did or did not respond to the CRC invite letter and reminder to better understand the barriers and drivers to participation.

The qualitative component consists of 24 in-depth interviews (IDIs) conducted with members of the target population to identify barriers and drivers to completing colorectal cancer screening home-testing. Data collection for IDIs will be face-to-face, using discussion guides, and will be audio recorded. The audio-recordings will then be analyzed using a rapid analysis approach based on by the modified Capability-Opportunity-Motivation-Behavior (COM-B) framework. conditions: Colorectal Cancer conditions: Behavior Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either control (no reminder screening invitation) or one of three treatments (standard reminder letter, behaviorally informed reminder letter, behaviorally informed letter with home testing kit included). primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 13000 type: ESTIMATED name: Standard letter name: Behaviorally informed letter name: Home testing colorectal cancer kit measure: Home test kit ordered measure: Completed colorectal cancer screening measure: Opted out measure: Qualitative feedback sex: ALL minimumAge: 50 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Croatian Institute of Public Health status: RECRUITING city: Zagreb country: Croatia name: Ivana Brkić Biloš, MD role: CONTACT email: ivana.brkic@hzjz.hr name: Nataša Antoljak, Prof role: CONTACT email: natasa.antoljak@hzjz.hr lat: 45.81444 lon: 15.97798 hasResults: False

 nctId: NCT06341309 id: CSPC-DEY-CRC-K09 briefTitle: Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-08-01 date: 2024-04-02 date: 2024-04-02 name: West China Hospital class: OTHER briefSummary: To evaluate the progression-free survival (PFS1), objective response rate (ORR), disease control rate (DCR), progression-free survival from first-line treatment initiation (PFS2), overall survival (OS), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Irinotecan Liposome name: Bevacizumab measure: Progression free survival -1 measure: Progression free survival -2 measure: Objective response rate measure: Disease control rate measure: Overall survival measure: Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341296 id: CSPC-DEY-CRC-K07 briefTitle: Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: West China Hospital class: OTHER briefSummary: To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 86 type: ESTIMATED name: Irinotecan Liposome name: 5-FU name: LV name: Bevacizumab measure: Objective response rate measure: Disease control rate measure: Progression free survival measure: Overall survival measure: Percentage of patients undergoing surgery. measure: R0 resection measure: Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341283 id: BCOOS2024 briefTitle: A Retrospective Real-world Study of Abemaciclib Tablets Based on HIS System in HR+ Breast Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2025-07-01 date: 2024-04-02 date: 2024-04-02 name: The Affiliated Hospital of Qingdao University class: OTHER briefSummary: The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive breast cancer. conditions: Breast Cancer conditions: Neoplasms conditions: Breast Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Abemaciclib and Letrozole/Anastrozole name: Letrozole or Anastrozole name: Abemaciclib and Fulvestrant name: Fulvestrant measure: Progression-free survival measure: Objective Remission Rate measure: Disease Control Rate measure: Toxicity rate measure: Cost-utility analysis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center city: Qingdao state: Shandong country: China lat: 36.06488 lon: 120.38042 hasResults: False

 nctId: NCT06341270 id: 2024HX1564 briefTitle: Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2026-12-20 date: 2024-04-02 date: 2024-04-18 name: West China Hospital class: OTHER briefSummary: The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy conditions: Liver Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups using a computer-generated random number table. After the randomization, use the opaque envelope, hide each group envelope into an opaque envelope, the envelope outside the code, will be sealed to the researcher, when the study, if the inclusion criteria, then open the corresponding numbered envelope, and intervene according to the group scheme in the envelope. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinding of participants will be maintained throughout the observation period. The sham group will receive electrode attachment but without stimulation,Throughout the study, for adequate blinding, an opaque tape will be applied to the patient's skin above the electrodes, and the patient's target acupoints will be wrapped in a blanket. All patients will be informed that they might or might not feel a tingling sensation around the acupoints when the TEAS device is working. The patients should not be unblinded until the statistical analysis of the study data is completed. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 524 type: ESTIMATED name: transcutaneous electrical acupoint stimulation name: sham transcutaneous electrical acupoint stimulation measure: The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery measure: The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 48 and 72 hours after surgery measure: The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24, 48 and 72 hours after surgery measure: Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours measure: Pain scores of pain at rest at 24, 48 and 72 hours postoperatively measure: The cumulative morphine consumption at 24, 48, and 72 hours postoperatively measure: The incidence of postoperative nausea and vomiting during the first 24,48,72 hours measure: The incidence of a composite of postoperative pulmonary complications during hospitalization measure: Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery measure: Time of Bowel function recovery measure: Length of hospital stay measure: The postoperative sleep quality score measure: The anxiety and depression scores measure: The incidence of chronic postsurgical pain (CPSP) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital city: Chengdu state: Sichuan zip: 610041 country: China name: Chunling Jiang, PhD role: CONTACT phone: 18980601096 email: jiang_chunling@yahoo.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06341257 id: VGHTCCTC_SCART001 briefTitle: Efficacy and Toxicity of SCART overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2029-12-31 date: 2024-04-02 date: 2024-04-02 name: Taichung Veterans General Hospital class: OTHER briefSummary: This study is expected to enroll patients for a period of five years, with a total of 30 participants. It is a prospective observational study involving cancer patients with tumors having a longest diameter greater than or equal to 5 cm. Systemic drug therapy may be administered concurrently. The following inclusion criteria must be met for participation in the study: age greater than or equal to 18 years, Eastern Cooperative Oncology Group (ECOG) score ≤ 2, pathological confirmation of cancer diagnosis, tumor with a maximum diameter greater than or equal to 5 cm, one or more lesions, not suitable for surgery, patient has provided informed consent, patient receives SCART, and reproductive-age women must agree to take adequate contraceptive measures during the study and for six months after discontinuation of medication. The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor gross target volume (GTV) boundary. For certain patients, an additional two fractions of 5 Gy each were added using Stereotactic Body Radiotherapy (SBRT), resulting in a total dose of 5 Gy × 5 for the GTV boundary. conditions: Tumor Size Greater Than or Equal to 5 cm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Stereotactic Central/Core Ablative Radiation Therapy (SCART) measure: Local Control (LC) measure: Progression-Free Survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Veterans General Hospital status: RECRUITING city: Taichung zip: 407 country: Taiwan name: Hao-Shen Cheng, MD role: CONTACT phone: 886975871151 email: mark89050921@gmail.com lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06341244 id: UNIFESP briefTitle: Air Stacking Technique Efficacy on Peak of Expiratory Flow and Cough Peak Flow in Non-cardiac Thoracic Surgery overallStatus: COMPLETED date: 2019-08-20 date: 2020-11-05 date: 2022-12-15 date: 2024-04-02 date: 2024-04-02 name: Universidade Cidade de Sao Paulo class: OTHER name: Federal University of São Paulo briefSummary: After thoracic surgical intervention, patients often feel intense pain with respiratory movements reduction making coughing less effective. The air stacking improves peak of expiratory flow (PEF) and cough peak flow (CPF) in neuro myopathies, thus raising the hypothesis that may also be effective in patients undergoing thoracic surgeries. Objectives: To evaluate the effectiveness, safety and feasibility of air stacking on postoperative PEF and CPF in patients undergoing thoracic surgeries. Methods: Patients undergoing thoracic surgery underwent air stacking on 3th PO. Dyspnea, pain, SpO2, maximum inspirational pressure (MIP), maximum expiratory pressure (MEP), PEF and CPF were evaluated in pre and postoperatory. conditions: Postoperative Care studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Air Stacking Technique measure: Peak of expiratory flow (PEF) measure: Cough peak flow (CPF) measure: Maximum Inspiratory Pressure ( MIP) measure: Maximun Expiratory Pressure (MEP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Luciana Chiavegato city: São Paulo zip: 04115000 country: Brazil lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06341231 id: 202400248 briefTitle: Personalized Anticoagulant Therapy for Pulmonary Thromboembolism overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-02 date: 2024-04-02 name: Xiangya Hospital of Central South University class: OTHER briefSummary: The goal of this prospective observational study is to explore the influencing factors of the efficacy and safety of anticoagulant therapy for pulmonary thromboembolism in special populations with older age, renal insufficiency or co-existing malignancy, and establish a predictive model to guide clinical practice. The main questions it aims to answer are:

* To analyze the influencing factors of the efficacy and safety of anticoagulant therapy for specific populations with pulmonary thromboembolism (PTE) in the real world (such as the elderly, those with impaired kidney function, and individuals with malignant tumors).
* Whether we can use machine-learning models to predict bleeding events and VTE recurrence in special populations following anticoagulant therapy in the real world? Participants will receive diagnostic and therapeutic measures for pulmonary thromboembolism in accordance with clinical guidelines, including anticoagulant therapy. Some patients need to have peripheral blood samples collected at the time of enrollment and 3 months after anticoagulant therapy. conditions: Pulmonary Thromboembolisms conditions: Anticoagulants; Increased studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4700 type: ESTIMATED measure: Major bleeding measure: Clinically relevant non-major bleeding measure: Recurrent VTE measure: All-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xiangya Hospital status: RECRUITING city: Changsha state: Hunan zip: 410008 country: China name: Juan Jiang, MD role: CONTACT phone: +8615388078713 email: juanjiang@csu.eud.cn lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06341218 id: 21-5T/3 briefTitle: The Effect Of Simulation-Supported Pediatric CPR Training Based On CRM On Knowledge, Attitude, And Performance overallStatus: COMPLETED date: 2021-02-25 date: 2023-09-30 date: 2023-11-15 date: 2024-04-02 date: 2024-04-02 name: Zonguldak Bulent Ecevit University class: OTHER name: Ege University briefSummary: Crew Resource Management is a training system that aims to use all available resources effectively and increase safety by improving technical knowledge and skills as well as non-technical skills in risky tasks such as CPR. In safe critical patient management, the healthcare team should have interpersonal skills such as communication, stress management, teamwork, and leadership, cognitive skills such as situational awareness, task completion, planning, monitoring the situation, and rapid response to critical incidents, in addition to technical skills. To improve outcomes after pediatric cardiac arrest, many systems have been developed for performance measurement and quality improvement initiatives of the healthcare team. However, studies are needed to evaluate the effects of these systems. This study was planned to evaluate the effectiveness of simulation-supported pediatric cardiopulmonary resuscitation training based on team resource management on knowledge, attitude, and performance of the healthcare team in the pediatric intensive care unit. conditions: Cardiopulmonary Resuscitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ACTUAL name: Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource Management measure: Socio-demographic data of the healthcare team measure: Pediatric KPR knowledge level measure: Pediatric KPR team attitude level measure: Pediatric KPR team performance level sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: İzmir state: Bornova zip: 35100 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06341205 id: 22-APN-01 briefTitle: Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX) acronym: iRITUX overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2031-08-31 date: 2031-09-30 date: 2024-04-02 date: 2024-04-02 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Membranous nephropathy is an autoimmune disease affecting the kidney, and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. The course of this disease is highly variable from one individual to another, ranging from spontaneous remission to progressive chronic kidney disease.

The identification of autoantibodies - e.g., the phospholipase A2 receptor type 1 (PLA2R1) - has promoted the use of immunosuppressive drugs such as rituximab which is now a safe and effective first-line treatment for the management of membranous nephropathy. However, up to 40% of patients do not respond to a first course of rituximab treatment. In nephrotic patients, due to urinary drug loss, rituximab blood level is lower than in other autoimmune diseases treated with rituximab without proteinuria. This high urinary drug loss decreases the drug exposure, potentially explaining why rituximab regimen with low dose infusions (375 mg/m2) did not demonstrate efficacy after month-6 compared to a non-immunosuppressive antiproteinuric treatment in a previous study. In contrast, a regimen of two 1-g infusions two weeks apart was associated with a significantly greater remission rate after 6 months.

Recently, the investigators have shown that after two 1-g rituximab infusions, the rituximab blood level 3 months after the first rituximab infusion, was correlated with the likelihood of remission after 6 and 12 months of the rituximab treatment. Patients with positive rituximab blood level 3 months after treatment had a higher chance of remission at month-6 and at month-12 than patients with an undetectable rituximab level at month-3.

Nowadays, machine learning algorithms are increasingly used in medicine, especially in pharmacology, to predict the exposure to a drug, the initial dose to administer or the interval between two infusions.

The objective of this study is to use a machine learning algorithm predicting the risk of having an undetectable residual level of rituximab 3 months after treatment, in order to propose a personalized treatment management with early additional doses of rituximab for the patients at risk. conditions: Membranous Nephropathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: RiTUXimab Injection measure: Clinical remission (complete or partial) after 6 months of rituximab initiation measure: Complete clinical remission after 12 months of rituximab initiation measure: Partial clinical remission after 12 months of rituximab initiation measure: Immunological remission: anti-PLA2R1 depletion measure: Change in urine protein/creatinine ratio (UPCR) measure: Change in serum creatinine measure: Change in renal function measure: Change in the immunological status of the disease measure: Appearance of anti-drug antibodies after rituximab treatment measure: Rituximab underdosed patients measure: Serious adverse events measure: Adaptation of symptomatic treatment measure: Model improvement through machine learning measure: Effect of rituximab on immune profiles sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341192 id: ChangGungMH ALL SB DB briefTitle: Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction acronym: ALLR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-08-31 date: 2026-10-31 date: 2024-04-02 date: 2024-04-26 name: Chang Gung Memorial Hospital class: OTHER briefSummary: The goal of this clinical trial is to test and compare different surgical techniques in patients with anterior cruciate ligament (ACL) injuries. The main questions it aims to answer are:

* What are the optimal criteria for selecting between single-bundle ACL reconstruction combined with anterolateral ligament (ALL) reconstruction versus double-bundle ACL reconstruction combined with ALL reconstruction?
* How do these two surgical techniques compare in terms of post-operative knee stability, functional outcomes, and reducing re-tear rates?

Participants will:

* Undergo pre-operative MRI imaging, ligament stability testing, and motion analysis evaluations
* Be randomly assigned to either:

  * Single-bundle ACL + ALL reconstruction
  * Double-bundle ACL + ALL reconstruction
* Receive the assigned surgical procedure
* Participate in post-operative follow-ups, ligament stability testing, and motion analysis at 6 months and 1 year

Researchers will compare the single-bundle ACL + ALL group and the double-bundle ACL + ALL group to see if one technique demonstrates superior knee stability, functional outcomes (e.g. return to sport ability), and lower ACL re-tear rates. conditions: Anterior Cruciate Ligament Injuries conditions: Anterior Cruciate Ligament Reconstruction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-Bundle ACL + ALL Reconstruction Group:

* Patients in this group will undergo reconstruction of the anterior cruciate ligament (ACL) using a single-bundle graft technique.
* In addition, they will have the anterolateral ligament (ALL) reconstructed using a portion of the same graft material.
* For the ALL reconstruction, a commonly used technique is the Sonnery-Cottet ALL reconstruction using a split graft.

Double-Bundle ACL + ALL Reconstruction Group:

* Patients in this group will undergo anatomic double-bundle ACL reconstruction using two graft bundles to more anatomically replicate the native ACL's anteromedial and posterolateral bundles.
* Like the single-bundle group, they will also have supplemental ALL reconstruction performed using a portion of the graft material.
* The double-bundle ACL reconstruction aims to better restore the ACL's complex anatomic footprint and bundles' tension patterns. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Single-bundle ACL combined anterolateral ligament reconstruction name: Double-bundle ACL combined anterolateral ligament reconstruction measure: Patient-reported outcome measures (PROMs) measure: Patient-reported outcome measures (PROMs) measure: Patient-reported outcome measures (PROMs) measure: Knee ligament stability: measure: Knee ligament stability clinical evaluation measure: Knee ligament stability clinical evaluation measure: Knee ligament stability clinical evaluation measure: Functional performance and return to sport measure: Functional performance and return to sport measure: Imaging measure: Imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung memorial hospital city: Taoyuan zip: 333 country: Taiwan name: Cheng-Pang Yang, Dr role: CONTACT email: ronnie80097@gmail.com lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06341179 id: M2S id: H-23063352 type: OTHER domain: Vek.dk briefTitle: Effect of Sleep Extension on Overweight and Learning in Children acronym: More2Sleep overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-02 date: 2024-04-02 name: University of Copenhagen class: OTHER name: Novo Nordisk A/S name: Faculty of Health, Medicine and Life Sciences, Maastricht University name: Center for Obesity Research & Education, Temple University name: Danish Research Centre for Magnetic Resonance name: University of Southern Denmark briefSummary: More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 300 school-aged children (6-9 years) who are mildly overweight or obese and habitually sleep for ≤ 9 h/night. Data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). The collection of data is mainly related to the main study. However, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-I (metabolic mechanisms, n=60) and substudy-II (learning mechanisms, n=150).

The primary objective is to assess the effects of sleep extension by \~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who are overweight or obese, and sleep less than recommended for their age. conditions: Sleep Duration conditions: Child Obesity conditions: Child Development conditions: Child Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Sleep extension measure: BMI Z-score measure: Learning ability: skill learning measure: Learning ability: Explicit memory measure: Body fat percent measure: Total fat mass (FM) measure: Total lean mass (LM) measure: Bone mineral content (BMC) measure: Bone mineral density (BMD) measure: Dietary energy intake measure: Dietary protein, carbohydrate, fiber, and fat intakes measure: Subjective hunger measure: Physical activity (PA) time: total PA and MVPA measure: Resting metabolic rate (RMR) measure: Thermic effect of food (TEF) measure: Weight measure: Height measure: Total energy expenditure (TEE) measure: Fasting and postprandial glucose concentration measure: Fasting and postprandial insulin concentration measure: Fasting and postprandial total, HDL and LDL cholesterol concentrations measure: Fasting and postprandial triglyceride concentration measure: Fasting and postprandial C-reactive protein concentration measure: Fasting and postprandial tumor necrosis factor alpha concentration measure: Fasting and postprandial ghrelin concentration measure: Fasting and postprandial leptin concentration measure: Fasting and postprandial glucagon like peptide 1 concentration measure: Fasting and postprandial peptide YY concentration measure: Fasting and postprandial cholecystokinin concentration measure: Fasting and postprandial interleukin 6 concentration measure: Cognitive functions: processing speed measure: Cognitive functions: Sustained attention measure: Cognitive functions: Spatial working memory measure: Cognitive functions: Inhibitory control measure: Cognitive functions: Cognitive flexibility measure: School performance: mathematics performance measure: School performance: reading comprehension measure: Neurophysiological Measurement 1 - ERP Amplitude measure: Neurophysiological Measurement 2 - Cortical activity during skill learning measure: Neurophysiological Measurement 3 - Muscle activity during skill learning measure: Neurophysiological Measurement 4 - corticocortical functional connectivity measure: Neurophysiological Measurement 5 - corticomuscular connectivity measure: Health-related quality of life: child-reported measure: Health-related quality of life: parent-reported measure: Mental health: parent-reported measure: Parental Stress Scale: parent-reported measure: Perceived Stress Scale: child-reported measure: Demographics: income measure: Demographics: education measure: Wakefulness measure: Handedness measure: Fine Motor Control measure: Muscle strength measure: Brain myelination measure: Brain structural connectivity and microstructure measure: Brain functional connectivity measure: Vital signs: blood pressure measure: Vital signs: heart rate measure: Vital signs: temperature measure: Sleep quality: self-reported sleep duration measure: Sleep quality: self-reported latency measure: Sleep quality: self-reported awakenings measure: Sleep quality: self-reported tiredness/sleepiness measure: Sleep quality and architecture: Sleep stages measure: Sleep quality and architecture: sleep duration measure: Sleep quality and architecture: sleep latency measure: Sleep quality and architecture: awakenings measure: Sleep quality and architecture: arousals measure: Sleep: duration measure: Sleep: movements measure: Sleep: awakenings measure: Brain structure: cortical thickness measure: Brain structure: volume measure: Brain structure: Surface measure: Brain structure: volumes of subcortical grey matter structures sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD facility: University of Copenhagen city: Copenhagen zip: 1958 country: Denmark name: Faidon Magkos, PhD role: CONTACT phone: +45 35 33 36 71 email: fma@nexs.ku.dk name: Cecilie Rasmussen, MSc role: CONTACT phone: +45 35 33 58 27 email: chr@nexs.ku.dk name: Faidon Magkos, PhD role: PRINCIPAL_INVESTIGATOR name: Jesper Lundbye-Jensen, PhD role: SUB_INVESTIGATOR name: Poul Jennum, MD role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: University of Copenhagen city: Copenhagen zip: 2200 country: Denmark name: Faidon Magkos, PhD role: CONTACT phone: +45 35 33 36 71 email: fma@nexs.ku.dk name: Jesper Lundbye-Jensen, PhD role: CONTACT phone: +45 35 32 73 30 email: jlundbye@nexs.ku.dk name: Faidon Magkos, PhD role: PRINCIPAL_INVESTIGATOR name: Jesper Lundbye-Jensen, PhD role: SUB_INVESTIGATOR name: Poul Jennum, MD role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Faidon Magkos city: Hvidovre zip: 2650 country: Denmark name: Faidon Magkos, PhD role: CONTACT phone: +45 35 33 36 71 email: fma@nexs.ku.dk name: Faidon Magkos, PhD role: PRINCIPAL_INVESTIGATOR name: Jesper Lundbye-Jensen, PhD role: SUB_INVESTIGATOR name: Kathrine Madsen, PhD role: SUB_INVESTIGATOR name: Hartwig Siebner, MD role: SUB_INVESTIGATOR name: Poul Jennum, MD role: SUB_INVESTIGATOR lat: 55.65719 lon: 12.47364 hasResults: False

 nctId: NCT06341166 id: CCM1959 briefTitle: Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse acronym: SCIMITAR overallStatus: RECRUITING date: 2023-06-19 date: 2025-06-19 date: 2025-06-19 date: 2024-04-02 date: 2024-04-02 name: Centro Cardiologico Monzino class: OTHER name: Treviso Regional Hospital name: Humanitas Hospital, Italy name: IRCCS Ospedale San Raffaele briefSummary: This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP. conditions: Mitral Valve Prolapse studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 300 type: ESTIMATED measure: Prediction of fibrosis by CMR measure: Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Cardiologico Monzino status: RECRUITING city: Milan zip: 20131 country: Italy name: Chiara Centenaro role: CONTACT phone: 0258002031 phoneExt: +39 email: chiara.centenaro@cardiologicomonzino.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06341153 id: SelcukUni2542 briefTitle: The Effect Of Breast Milk Sniffing And Tasting On Early Feeding Tips overallStatus: COMPLETED date: 2022-07-15 date: 2022-09-15 date: 2023-11-15 date: 2024-04-02 date: 2024-04-02 name: Sibel Küçükoğlu class: OTHER name: Health Institutes of Turkey briefSummary: The study aimed to investigate the effects of breast milk sniffing and breast milk tasting and sniffing on sucking success and early feeding cues in term newborns who were started to breastfeed for the first time. conditions: Breastfeeding conditions: Odors, Body conditions: Newborn; Vitality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The stratification and blocking method was used to assign the mothers who would participate in the study to the experimental and control groups, taking into account factors such as normal or cesarean delivery and breastfeeding experience. In order to ensure homogeneity in the groups, mothers were stratified as mode of delivery (Normal-Cesarean) and breastfeeding experience (Present-Non-existent). After the blocks were formed, the groups included in the study were randomly assigned to the strata with the letters A, B and C using the random numbers table obtained in the computer environment (www.random.org). Which letter would be in which group was determined by lot (A=Odor Stimulation, B=Odor+Taste Stimulation, C=Control Group). primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: According to the a priori power analysis with a pairwise hypothesis, effect size of 0.409, significance level of 0.05 and power of 0.80; it was determined that the inclusion of a total of 72 newborns (Odor Stimulation: 24, Odor+taste stimulation: 24, Control: 24) in the study would provide sufficient sample size.

Inclusion Criteria; For the mother;

* Having a term and healthy baby,
* No communication and language problems,
* No maternal illness preventing breastfeeding (active chemotherapy, HIV positive, neurological or psychological problems, etc.),
* Willingness to breastfeed, For the baby;
* Not having a disease condition that prevents breastfeeding (cleft palate, cleft lip, galactotemia, choanal atresia, etc.),
* Being at normal birth weight (2500gr-4000gr),
* Apgar score of 7 and above. whoMasked: INVESTIGATOR count: 72 type: ACTUAL name: Breast Milk Odor Stimulation name: Stimulation of Breast Milk Smell and Taste measure: Introductory Information Form measure: Early Feeding Tips Scale measure: Breastfeeding Identification and Assessment Scale (LATCH) measure: Early Feeding Tips Scale measure: Breastfeeding Identification and Assessment Scale (LATCH) measure: Early Feeding Tips Scale measure: Breastfeeding Identification and Assessment Scale (LATCH) sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Selcuk University city: Konya state: Selcuklu zip: 42100 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06341140 id: secil koken briefTitle: The Effect of Breastfeeding Support on Exclusive Breastfeeding, Occurrence of Breast Problems and Breastfeeding Self-Efficacy overallStatus: COMPLETED date: 2021-08-01 date: 2022-11-30 date: 2023-02-06 date: 2024-04-02 date: 2024-04-02 name: Celal Bayar University class: OTHER name: Manisa Celal Bayar University briefSummary: The aim of the study is to determine the effect of individual breastfeeding support on the lactation process. The research is a randomized controlled experimental study. The sample of the study consisted of pregnant women who applied to the Obstetrics Polyclinic of a university hospital (intervention=51, control=51). In the study, individual breastfeeding education was given to the intervention group during the antenatal period, and a training booklet was given to the control group. In the postpartum period, home visits and phone follow-ups were carried out for both groups between the fifth day and the sixth month. The effect of breastfeeding counseling on the lactation process; The duration of exclusive breastfeeding, breast problems and breastfeeding success was evaluated with. The data of the study were collected using the Pregnant, Postpartum-Newborn Information Form, Breastfeeding Questionnaire, Breast Problems Diagnosis Form, LATCH Breastfeeding Diagnostic Tool and Breastfeeding Self-Efficacy Scale. conditions: Breastfeeding conditions: Breastfeeding, Exclusive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 102 type: ACTUAL name: Breastfeeding support and Booklet containing information about breastfeeding name: Booklet containing information about breastfeeding measure: Situation of mothers feeding their babies exclusively with breast milk measure: Mothers experiencing breast problems measure: Determination of mothers' breastfeeding self-efficacy sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manisa Celal Bayar University city: Manisa country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False

 nctId: NCT06341127 id: 2023-01 briefTitle: Fluoxetine in KCNC1-related Disorder overallStatus: ENROLLING_BY_INVITATION date: 2024-01-17 date: 2024-12-01 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: Holland Bloorview Kids Rehabilitation Hospital class: OTHER name: The Hospital for Sick Children briefSummary: This is a single patient study of oral powdered fluoxetine to target developmental outcomes in a child with KCNC1-related disorder. This trial will be conducted at Holland Bloorview Kids Rehabilitation Hospital over 32 to 42 weeks, using a quasi experimental ABA phase design (placebo-fluoxetine-placebo) with randomized and blinded active treatment start and stop moments. conditions: KCNC1 Related Disorder conditions: Genetic Disease conditions: Rare Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: This quasi experimental design involves masking of transition moments, but the investigator and participant are aware of the order of cross-over. count: 1 type: ESTIMATED name: Fluoxetine measure: Motor development measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Adaptive skills measure: Cognitive skills measure: Family priority outcome targets measure: Clinical Global Impression- Improvement Scale (CGI-I) sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Holland Bloorview Kids Rehabilitation Hospital city: Toronto state: Ontario zip: M5G1R8 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06341114 id: BAT-8008-1308-001-CR briefTitle: A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2026-04-03 date: 2026-07-28 date: 2024-04-02 date: 2024-04-02 name: Bio-Thera Solutions class: INDUSTRY briefSummary: The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors.

This study aims to explore the safety, tolerability, and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the antitumor efficacy.

The study is divided into two stages. The first stage will use a "3+3" dose escalation design to explore the safety and tolerability of the investigational drugs. In the second stage, based on the preliminary safety and efficacy results from the first stage, appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008+BAT1308 and provide evidence for subsequent clinical studies. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: BAT8008 injection name: BAT1308 injection measure: Dose-limiting toxicity (DLT) measure: vital signs measure: Physical examination measure: Adverse events measure: Clinical laboratory tests measure: Clinical auxiliary tests measure: Objective response rate (ORR) measure: Duration of Response(DOR) measure: Disease Control Rate (DCR) measure: Progression Free Survival(PFS) measure: Overall Survival(OS) measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06341101 id: 2022-503135-33-00 id: 2022-503135-33-00 type: OTHER domain: EU trial number briefTitle: Timely Recovery After Subclinical Heart Failure acronym: TREASURE overallStatus: RECRUITING date: 2024-03-26 date: 2026-03-01 date: 2026-03-01 date: 2024-04-02 date: 2024-04-02 name: Academisch Ziekenhuis Maastricht class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: The goal of this randomized controlled trial is to assess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women on:

1. Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
2. The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
3. Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
4. Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.

Eligible subjects will be counselled and upon informed consent randomized for either medication group (n=65) or care as usual group (n=65). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). Thereafter, standard medical check-ups (blood pressure, ECG, kidney function, transthoracic cardiac ultrasound, endothelial function, quality of life questionnaires, medical history taking, blood and urine banking) will be performed every six months for two years.

Researchers will compare ACE inhibitor (Perindopril 2 mg) and care as usual (i.e. no medication) to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure. conditions: Heart Failure conditions: Diastolic Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Perindopril measure: No left Ventricular Hypertrophy measure: No concentric remodeling measure: No impaired systolic function measure: Normal diastolic function sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AZMaastricht status: RECRUITING city: Maastricht state: Limburg zip: 6202AZ country: Netherlands name: Marc Spaanderman, Prof role: CONTACT phone: +31(0)43-3874145 email: zenab.mohseni@mumc.nl lat: 50.84833 lon: 5.68889 hasResults: False

 nctId: NCT06341088 id: B.30.2.ATA.0.01.00/132 briefTitle: Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations overallStatus: RECRUITING date: 2024-04-05 date: 2024-07-05 date: 2024-10-05 date: 2024-04-02 date: 2024-04-02 name: Ataturk University class: OTHER briefSummary: The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations. conditions: Pelvic Organ Prolapse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: unilateral suture sacro-hysteropexy name: bilateral suture sacro-hysteropexy measure: anatomical success of the operations measure: evaluation of the sexual functions of the patients sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Atatürk University status: RECRUITING city: Erzurum state: Palandöken country: Turkey name: Gamze Nur Cimilli Senocak role: CONTACT phone: +905305880025 email: gncimilli@gmail.com lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06341075 id: KY2024-053-02 briefTitle: Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy overallStatus: ENROLLING_BY_INVITATION date: 2024-03-14 date: 2025-03-14 date: 2026-03-14 date: 2024-04-02 date: 2024-04-02 name: Beijing Tiantan Hospital class: OTHER briefSummary: The goal of the real-world study is to evaluate the long-term seizure control outcomes, postoperative complications, long term impact on cognitive, memory function outcomes, quality-of-life measures, and healthcare resource utilization of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) on patients with drug-resistant epilepsy (DRE). conditions: Drug Resistant Epilepsy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) measure: Seizure-freedom rate measure: Seizure frequency reduction measure: ILAE classification of outcome measure: Seizure severity measure: Rate of mild complications measure: Cognitive function evaluation measure: Memory function evaluation measure: The quality of life measure: Length of hospital stay measure: Rate of reoperations measure: Rate of antiepileptic drug reduction or withdrawn sex: ALL minimumAge: 12 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital city: Beijing state: Beijing zip: 100070 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06341062 id: M2024078 briefTitle: The Application of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-06-30 date: 2026-06-30 date: 2024-04-02 date: 2024-04-02 name: Peking University Third Hospital class: OTHER briefSummary: The goal of this study is to quantitatively assess renal microcirculation changes by contrast-enhanced ultrasound and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore its predictive value in renal function recovery in patients with critical acute kidney injury. The main questions it aims to answer are:

1. To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation.
2. To explore the relationship between renal microcirculation and systemic hemodynamics.
3. To explore the value of renal microflow changes quantitatively evaluated by contrast-enhanced ultrasound in predicting renal function recovery. conditions: Intensive Care Unit conditions: Acute Kidney Injury conditions: Ultrasound studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 44 type: ESTIMATED name: Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound measure: Serum creatinine values and/or urine output sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ultrasound Diagnosis, Peking University Third Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06341049 id: 2024-03/14 briefTitle: Effect of Three Different Postcesarean Analgesic Techniques on QbsQor-10 Score: Prospective, Randomized Trial overallStatus: RECRUITING date: 2024-03-12 date: 2024-06-12 date: 2025-09-12 date: 2024-04-02 date: 2024-04-02 name: Ataturk University class: OTHER briefSummary: The aim of this study is to evaluate the effects of three different postsesarean analgesia techniques, including instillation of local anesthetic into the peritoneum with infiltration into all layers of the anterior abdominal wall, intrathecal morphine injection with local anesthetic, and quadrotus lumborum type 1 block, on the postoperative recovery of women using the ObsQoR-10 score.. conditions: Postoperative Recovery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Intraperitoneal local anasthetic application + local anesthetic wound infiltration name: Intrathecal morphine application name: Quadratus lumborum block tip 1 application measure: obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hours sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Ataturk University status: RECRUITING city: Erzurum state: Palandoken country: Turkey name: Aysenur Dostbil role: CONTACT phone: +905333676696 email: adostbil@hotmail.com lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06341036 id: Thrombocytosis in Children briefTitle: Aetiology And Outcome Of Children With Thrombocytosis Admitted to Assiut University Children Hospital overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2025-03-03 date: 2026-03-03 date: 2024-04-02 date: 2024-04-02 name: Assiut University class: OTHER briefSummary: The primary Aim :to determine the etiology of thrombocytosis in children and frequency, outcome of thrombocytosis in Children. conditions: Thrombocytosis in Children studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 42 type: ESTIMATED measure: Aetiology And Outcome Of children with Thrombocytosis admitted to Assiut University children hospital sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06341023 id: 2023-1430 briefTitle: Functional Balance Intervention in Multiple Sclerosis acronym: FBIinMS overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2026-01-09 date: 2027-01-09 date: 2024-04-02 date: 2024-04-03 name: University of Illinois at Chicago class: OTHER briefSummary: This project involves two sub-parts:

Study 1: Effect of lab-based Functional Balance Intervention (FBI) for physical and cognitive symptoms of Multiple Sclerosis.

Study 2: Feasibility of home-based FBI for physical and cognitive symptoms of Multiple Sclerosis.

Each study involves a 2-arm, Phase-1, randomized controlled clinical trial to evaluate the effect of FBI on physical, cognitive function, and daily living among people with MS (PwMS). Study 1 is conducted in a lab setting, while Study 2 is conducted at home with additional safety measures. A total of 150 people with multiple sclerosis will be recruited and telephone screened, with an expected enrollment of 120 (60 per phase). After in-person screening, 96 eligible participants (48 per phase) will undergo pre-training assessment and randomization into FBI or Stretching groups. Training sessions will occur twice a week for four months. Anticipating a 15-17% attrition rate, the target sample size is 80 (40 per phase) for completion of the study. Post-training assessments will be conducted after four months to evaluate FBI's impact on physical and cognitive functions. This evidence-based protocol, previously successful with neurological and older adult populations, intends to provide a low-cost, safe, and effective intervention for PwMS in clinical and community settings, including rural areas. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Subjects will be blinded to group existence and assignment and outcome assessors will be blinded to group assignment whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Functional Balance Intervention name: Stretching measure: Change in physical function measure: Change in cognitive function measure: Change in dual task balance performance measure: Change in dual task gait performance measure: Change in measured community mobility measure: Change in self-reported community mobility measure: Change in self-reported quality of Life measure: Change in walking performance measure: Change in walking speed measure: Change in balance confidence measure: Change in functional independence sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois at Chicago city: Chicago state: Illinois zip: 60612 country: United States name: Tanvi Bhatt, PhD role: CONTACT phone: 312-355-4443 email: tbhatt6@uic.edu name: Rudri Purohit, MS role: CONTACT phone: 3128773640 email: rpuroh2@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06341010 id: The Role of Angiojet Rheolytic briefTitle: The Role of Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-01-01 date: 2026-09-01 date: 2024-04-02 date: 2024-04-02 name: Abdelrahman Ibrahim Sayed Mohamed Abdalla class: OTHER briefSummary: The aim of this study is to evaluate the efficacy and safety of rheolytic thrombectomy in restoring venous patency DVT, periprocedural complications and development of PTS after tratment of iliofemoral DVT. conditions: Iliofemoral Deep Vein Thrombosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis measure: Technical success measure: Incidence of PTS sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06340997 id: Mitral Stenosis briefTitle: Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis. overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-10-01 date: 2027-08-01 date: 2024-04-02 date: 2024-04-02 name: Assiut University class: OTHER briefSummary: • Evaluation of the effect of PTMC on LAA function by TEE at least one month after the procedure and its effectiveness in prevention of thrombi formation and cerebrovascular complications. conditions: Mitral Stenosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 25 type: ESTIMATED name: Transesophageal echocardiography measure: Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients with Mitral Stenosis. measure: Prevention of left atrial appendage thrombus. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340984 id: sICAM-1 in acne vulgaris briefTitle: Serum Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-11 date: 2025-02 date: 2024-04-02 date: 2024-04-03 name: South Valley University class: OTHER briefSummary: The aim of this study is to:

1. Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris and compare it to control group
2. Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity
3. Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris conditions: Acne Vulgaris studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Montelukast 10 Mg Oral Tablet measure: Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe ) measure: Montelukast in treatment of acne vulgaris patients sex: ALL minimumAge: 15 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06340971 id: 331247 briefTitle: Air Pollution and Pregnancy acronym: PTB overallStatus: RECRUITING date: 2024-09-01 date: 2029-08-31 date: 2029-08-31 date: 2024-04-02 date: 2024-04-02 name: Queen Mary University of London class: OTHER name: University College London Hospitals briefSummary: We are an inter-disciplinary team of UK scientists with expertise in obstetrics, women's and child health, epidemiology, climate science, inflammation, computational modelling, machine learning and artificial intelligence. Together we have a long history with existing strengths underlying preterm birth research that crosses multiple disciplines and an excellent track record of publications and awards leading research in preterm birth.

We aim to develop and validate a deep learning model to predict the risk of preterm birth and other adverse pregnancy outcomes using data from EPIC electronic health records at University College London Hospital Trust (UCLH) for a cohort of 18000 patients. We will obtain corresponding data on exposure to ambient pollution using non-identifiers for postcode (area) and date of delivery (month). The model will review the temporal sequence of events within a patient's medical history and current pregnancy, identifying significant interactions and will predict the risk of preterm birth. It will also determine the threshold and gestation at which pollution exposure has the greatest impact. conditions: Premature Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 200000 type: ESTIMATED name: Policy measure: Machine learning model to predict the risk of preterm birth and adverse birth outcomes measure: Machine learning model to predict how air quality increases the risk of preterm birth and adverse birth outcomes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tina Chowdhury status: RECRUITING city: London zip: E14NS country: United Kingdom name: Tina Chowdhury role: CONTACT phone: 0207882 phoneExt: 7560 email: t.t.chowdhury@qmul.ac.uk name: Rhona Atkins role: CONTACT phone: 0207882 phoneExt: 7272 email: rhona.atkin@nhs.net lat: 51.50853 lon: -0.12574 facility: Anna David status: RECRUITING city: London zip: NW1 2PG country: United Kingdom name: Yaa Acheampong role: CONTACT phone: 020 3447 phoneExt: 6164 email: y.acheampong@nhs.net name: Anna David role: CONTACT phone: 0203 447 phoneExt: 9400 email: a.david@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06340958 id: CLE100-MDD-202 briefTitle: A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder acronym: SOLEO overallStatus: RECRUITING date: 2024-03-18 date: 2025-07-11 date: 2026-01-10 date: 2024-04-02 date: 2024-04-10 name: Clexio Biosciences Ltd. class: INDUSTRY briefSummary: The study is a Phase 2, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 (oral esketamine) for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants. conditions: Adjunctive Treatment of Major Depressive Disorder (MDD) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: CLE-100 name: Placebo measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score measure: Change from Baseline in the Clinical Global Impression - Severity (CGI-S) measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score measure: Safety Outcomes: Assessment of the safety and tolerability of CLE-100 compared to placebo sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Site 105 status: RECRUITING city: Lauderhill state: Florida zip: 33319 country: United States lat: 26.14036 lon: -80.21338 facility: Clinical SIte 112 status: RECRUITING city: Miami Lakes state: Florida zip: 33016 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site 118 status: RECRUITING city: Atlanta state: Georgia zip: 30030 country: United States lat: 33.749 lon: -84.38798 facility: Clinical Site 128 status: RECRUITING city: Marlton state: New Jersey zip: 08054 country: United States lat: 39.89122 lon: -74.92183 facility: Clinical Site 101 status: RECRUITING city: Toms River state: New Jersey zip: 08755 country: United States lat: 39.95373 lon: -74.19792 hasResults: False

 nctId: NCT06340945 id: S2023-761-01 briefTitle: The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-31 date: 2029-12-31 date: 2024-04-02 date: 2024-04-02 name: Chinese PLA General Hospital class: OTHER briefSummary: 1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules conditions: Thyroid Nodules studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 1500 type: ESTIMATED name: ultrasound-guided thermal ablation measure: volume reduction rate measure: rate of nodule regrowth measure: rate of complications measure: cosmetic score measure: symptom score measure: vital volume measure: total volume sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340932 id: CRS-119 (Pro00077191) briefTitle: Impact of Opioid Avoidance Protocol for ACL Reconstruction overallStatus: NOT_YET_RECRUITING date: 2024-03-28 date: 2024-08-15 date: 2024-10-01 date: 2024-04-02 date: 2024-04-02 name: Matthew Varacallo class: OTHER name: Pacira Biosciences briefSummary: This is a prospective, quasi-experimental, cohort study comparing patients treated with one of two postoperative pain management protocols. The two protocols assessed will be the current standard of care protocol for ACLR postoperative pain control utilized by Dr. Matthew Varacallo and then an opioid avoidance protocol that is planned to be implemented on the Spring of 2024. The study is voluntary, however all patients will be treated with either of the two protocols depending on their date of surgery. This study will include patients aged 15 years and older who consent to the participation in the study. Patients will be identified utilizing the operative surgeon's appointment calendar and will be screened and offered inclusion in the study if applicable at their pre-operative visit. Data will be collected via patient medication and pain diary, phone call, and clinician administration of standardized outcome questionnaires. Patients will be included in the standard of care group if ACLR is performed prior to the change in protocol in the Spring of 2024 or the opioid avoidance group if performed after the protocol change.

The primary objective of this study is to evaluate the effect of the opioid avoidance protocol on opioid use in MME from POD0-7 after ACLR compared to the current standard of care pain management protocol.

Secondary objectives are to:

* evaluate the effects of an opioid avoidance protocol on the daily average NRS pain scores from POD0-7
* evaluate the effects of an opioid avoidance protocol on the daily worst NRS pain score from POD0-7
* evaluate the ability to recover opioid free through 7, 30, and 60 days
* evaluate the QoR-15 scores on POD2
* assess the number of opioid prescriptions required by patients in the 60 day recover period
* assess KOOS pain and symptom scales at 8 weeks post-operatively between groups. conditions: ACL Tear conditions: Post Operative Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Iovera name: Celecoxib name: Acetaminophen name: Oxycodone name: Tramadol name: Bupivacaine Hydrochloride name: Acetaminophen 500Mg Cap measure: Opioid consumption from POD0-POD7 measure: Average daily pain (NRS) measure: Average daily worst pain (NRS) measure: KOOS Pain Subscale Score measure: Quality of Recovery-15 measure: Pittsburgh Rehabilitation Participation Scale Score sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Penn Highlands Dubois city: DuBois state: Pennsylvania zip: 15801 country: United States name: Samantha Morgan, DAT role: CONTACT phone: 814-496-3141 email: slmorgan@phhealthcare.org name: Christopher Varacallo role: SUB_INVESTIGATOR name: Samantha Morgan role: SUB_INVESTIGATOR lat: 41.11923 lon: -78.76003 hasResults: False

 nctId: NCT06340919 id: 1406014978-241 briefTitle: Hearing Aid Algorithms for Sudden Sounds overallStatus: ENROLLING_BY_INVITATION date: 2024-02-21 date: 2024-09-30 date: 2025-05-31 date: 2024-04-02 date: 2024-04-02 name: Purdue University class: OTHER name: Oticon briefSummary: This study explores the impact of hearing aid settings for managing sudden sounds on speech comprehension and recall in individuals with hearing loss. Participants will undergo a comprehensive audiological evaluation, case history, and cognitive assessments. Subsequently, they will participate in listening experiments designed to measure sentence recognition, storage, and retrieval under various sudden sound reduction conditions recorded through a hearing aid. The experiment will be complemented by subjective preference ratings to identify participant comfort and listening clarity associated with different sudden sound reduction settings. conditions: Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Sudden Sound Reduction Setting measure: Speech recognition measure: Recall measure: Preference sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Purdue University city: West Lafayette state: Indiana zip: 47907 country: United States lat: 40.42587 lon: -86.90807 hasResults: False

 nctId: NCT06340906 id: 4573 id: UCI 23-29 type: OTHER domain: CFCCC briefTitle: Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-11-15 date: 2026-01-30 date: 2024-04-02 date: 2024-04-03 name: University of California, Irvine class: OTHER briefSummary: The investigators are conducting this research study is to evaluate the feasibility (recruitment, compliance, safety, and acceptance) of using electroacupuncture (EA) to manage complex symptoms such as pain, nausea/vomiting, diarrhea, and insomnia in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. Additionally, the investigators are aiming to determine the effectiveness of EA in reducing these symptoms, and to examine how EA impacts important biomarkers, or proteins in the blood, that can be used as indicators or signs of these symptoms. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single-arm, prospective pilot/feasibility study. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Electroacupuncture measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Patients Recruited measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Patient Recruitment Rate measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Reasons for Abstaining from Participation measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Recruitment Duration measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Completed Electroacupuncture Sessions measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Proportion of Completed Electroacupuncture Sessions measure: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30 measure: Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30 measure: Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3 measure: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3 measure: Biomarkers - Plasma (pg/mL) measure: Vital Signs - Blood Pressure (mmHg) measure: Vital Signs - Heart Rate (bpm) measure: Vital Signs - Body Temperature (C) measure: Vital Signs - Respiration Rate (breaths/minute) measure: Vital Signs - Oxygen Saturation Rate (%) measure: Height (feet and inches) measure: Weight (kg) measure: Incidence of Treatment-Emergent Adverse Events - Safety Monitoring measure: Biomarkers - Plasma BDNF (pg/ml) measure: Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL) measure: Mitochondrial DNA content sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCI Health Susan Samueli Integrative Health Institute city: Irvine state: California zip: 92697 country: United States name: Matthew Heshmatipour, BSc role: CONTACT email: mheshmat@hs.uci.edu lat: 33.66946 lon: -117.82311 hasResults: False

 nctId: NCT06340893 id: 76117 briefTitle: Exercise Training in Children With Communication Impairments overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-08-31 date: 2024-04-02 date: 2024-04-02 name: Marquette University class: OTHER name: University of Arizona briefSummary: This clinical trial study has two goals. The first goal is to establish fitness levels, participation in physical activities, and fine/gross motor abilities for children with development language disorder (DLD). DLD occurs in 1/13 children and children with DLD often have poorer fine/gross motor skills than those with typical development. The second goal is to determine whether physical exercise helps children with DLD and typical development to learn better and improve fitness and fine/gross motor abilities more than participating in restful play activities.

All children (DLD and typically developing) will undergo communication, fine/gross motor and fitness testing. Children will be randomly assigned to participate in an exercise program (n =20) or to a restful play program (n = 20). Both programs will take place 3x/week for 6 weeks and children will only participate in one of the two programs.

Children in the exercise program will do activities to train cardiovascular fitness, agility, balance, strength, and endurance while children in the restful play condition will do things like play with legos and color.

Researchers will compare changes in learning tasks and fitness levels for children (DLD and typically developing) who participated in the exercise program vs. restful play program. conditions: Developmental Language Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to the exercise intervention group or to the restful play (sham) condition. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessors will be blinded to group and will be different to those conducting the interventions. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Exercise name: Restful Play measure: Changes to cognitive-linguistic performance: Word learning accuracy (% correct) measure: Changes to cognitive-linguistic performance: Reaction time on the Serial Reaction Time task (milliseconds) measure: Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min) measure: Motor Performance (scaled scores) measure: Enjoyment of Intervention sex: ALL minimumAge: 6 Years maximumAge: 8 Years stdAges: CHILD facility: Marquette U city: Milwaukee state: Wisconsin zip: 53201 country: United States name: Jenya Iuzzini-Seigel, PhD role: CONTACT phone: 585-489-4683 email: jenya.iuzzini-seigel@marquette.edu lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06340880 id: SAPB briefTitle: Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided. overallStatus: RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-04-02 date: 2024-04-02 name: Menoufia University class: OTHER briefSummary: This prospective, double-blinded randomized controlled trial aims to compare the efficacy of the serratus anterior plane block (SAPB) ultrasound guided versus anatomical landmark guided for gynecomastia surgery. And to detect if the anatomical landmark technique is inferior or not to the ultrasound guided technique. We hypothesize that anatomical landmark guided SAPB is not inferior to ultrasound guided SAPB. conditions: Serratus Anterior Plane Block studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Serratus anterior plane block measure: visual numerical rating score (NRS) measure: first call of analgesia measure: incidence of complications measure: patient satisfaction sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Menoufia University Hospitals status: RECRUITING city: Shibīn Al Kawm state: Menoufia country: Egypt name: Menoufia U Hospitals role: CONTACT phone: +20482228303 email: info@menofia.edu.eg lat: 30.55258 lon: 31.00904 hasResults: False

 nctId: NCT06340867 id: 30723 briefTitle: Intraoral Scanner With and Without Orthodontic Brackets overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-03-24 date: 2024-04-01 date: 2024-04-02 date: 2024-04-02 name: Cairo University class: OTHER briefSummary: this study aim to evaluate the effect of two different intraoral scanners on the scanning Quality and Time in Patients With/Without Orthodontic Brackets conditions: Intra-oral Scanner conditions: Adolescent Behavior studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 10 type: ACTUAL name: CEREC primescan intra-oral scanner measure: The effect of the different scanning techniques on the scanning quality and time measure: The effect of the bracket presence on the scanning quality sex: ALL minimumAge: 14 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Dentistry, Cairo university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06340854 id: NN1436-7724 id: U1111-1292-6151 type: OTHER domain: World Health Organization (WHO) id: 2023-506084-34 type: OTHER domain: European Medical Agency (EMA) briefTitle: A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes overallStatus: RECRUITING date: 2024-04-19 date: 2025-05-16 date: 2025-06-20 date: 2024-04-02 date: 2024-04-25 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months. conditions: Diabetes, Type 2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 404 type: ESTIMATED name: Insulin icodec name: Insulin glargine measure: Change in glycated hemoglobin (HbA1c) measure: Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL)) measure: Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction measure: Number of severe hypoglycaemic episodes (level 3) measure: Number of clinically significant hypoglycaemic episodes (level 2) (less than (<) 3.0 millimoles per litre (mmol/L) (54 mg/dL), confirmed by blood glucose (BG) meter) measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL),confirmed by BG meter) or severe hypoglycaemic episodes (level 3) measure: Time spent < 3.0 mmol/L (54 mg/dL) measure: Change in time spent > 10.0 mmol/L (180 mg/dL) measure: Mean weekly insulin dose measure: Change in body weight sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Investigative Medicine, Inc. status: RECRUITING city: Hawthorne state: California zip: 90250 country: United States lat: 33.9164 lon: -118.35257 facility: Scripps Whittier Diabetes Inst status: RECRUITING city: La Jolla state: California zip: 92037 country: United States lat: 32.84727 lon: -117.2742 facility: Clinical Trials Research status: RECRUITING city: Lincoln state: California zip: 95648 country: United States lat: 38.89156 lon: -121.29301 facility: Northeast Research Institute of Florida status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States lat: 30.0933 lon: -81.71898 facility: South Broward Research LLC status: RECRUITING city: Miramar state: Florida zip: 33027 country: United States lat: 25.98731 lon: -80.23227 facility: Endo Res Solutions Inc status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States lat: 34.02316 lon: -84.36159 facility: Cotton-Oneill Diabetes and End status: RECRUITING city: Topeka state: Kansas zip: 66606-2806 country: United States lat: 39.04833 lon: -95.67804 facility: International Diabetes Center status: RECRUITING city: Minneapolis state: Minnesota zip: 55416 country: United States lat: 44.97997 lon: -93.26384 facility: Jefferson City Medical Group, PC status: RECRUITING city: Jefferson City state: Missouri zip: 65109 country: United States lat: 38.5767 lon: -92.17352 facility: Univ of Nebraska Medical CTR status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68198-3020 country: United States lat: 41.25626 lon: -95.94043 facility: Palm Research Center Inc-Vegas status: RECRUITING city: Las Vegas state: Nevada zip: 89148 country: United States lat: 36.17497 lon: -115.13722 facility: Southern NH Diabetes and Endo_Nashua status: RECRUITING city: Nashua state: New Hampshire zip: 03060 country: United States lat: 42.76537 lon: -71.46757 facility: PharmQuest Life Sciences LLC status: RECRUITING city: Greensboro state: North Carolina zip: 27408 country: United States lat: 36.07264 lon: -79.79198 facility: Accellacare Wilmington status: RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Trial Management Associates status: RECRUITING city: Myrtle Beach state: South Carolina zip: 29572 country: United States lat: 33.68906 lon: -78.88669 facility: Amarillo Medical Specialists status: RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Victorium Clinical Research status: RECRUITING city: Houston state: Texas zip: 77024 country: United States lat: 29.76328 lon: -95.36327 facility: PlanIt Research, PLLC status: RECRUITING city: Houston state: Texas zip: 77079 country: United States lat: 29.76328 lon: -95.36327 facility: Chrysalis Clinical Research status: RECRUITING city: Saint George state: Utah zip: 84790 country: United States lat: 37.10415 lon: -113.58412 facility: Rainier Clin Res Ctr Inc status: RECRUITING city: Renton state: Washington zip: 98057 country: United States lat: 47.48288 lon: -122.21707 facility: "Medical Center Viva Feniks" Ood status: RECRUITING city: Dobrich zip: 9300 country: Bulgaria lat: 43.56667 lon: 27.83333 facility: MHAT "Knyaginya Klementina" -Sofia EAD status: RECRUITING city: Sofia zip: 1233 country: Bulgaria lat: 42.69751 lon: 23.32415 facility: UMHAT Aleksandrovska status: RECRUITING city: Sofia zip: 1431 country: Bulgaria lat: 42.69751 lon: 23.32415 facility: Medical Institute of Ministry of interior status: RECRUITING city: Sofia zip: 1606 country: Bulgaria lat: 42.69751 lon: 23.32415 facility: InnoDiab Forschung GmbH status: RECRUITING city: Essen zip: 45136 country: Germany lat: 51.45657 lon: 7.01228 facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose status: NOT_YET_RECRUITING city: Münster zip: 48145 country: Germany lat: 51.96236 lon: 7.62571 facility: MedicalCenter am Clemenshospital status: NOT_YET_RECRUITING city: Münster zip: 48153 country: Germany lat: 51.96236 lon: 7.62571 facility: RED-Institut für medizinische Forschung und Fortbildung GmbH status: RECRUITING city: Oldenburg in Holstein zip: 23758 country: Germany lat: 54.29576 lon: 10.90156 facility: Institut für Diabetesforschung Osnabrück status: NOT_YET_RECRUITING city: Osnabrück zip: 49080 country: Germany lat: 52.27264 lon: 8.0498 facility: Zentrum für klinische Studien Allgäu Oberschwaben status: NOT_YET_RECRUITING city: Wangen zip: 88239 country: Germany lat: 48.72933 lon: 9.61175 facility: Lifecare Hospital and Research Centre status: NOT_YET_RECRUITING city: Bangalore state: Karnataka zip: 560092 country: India lat: 12.97194 lon: 77.59369 facility: Belgaum Diabetes Centre status: NOT_YET_RECRUITING city: Belgaum state: Karnataka zip: 590001 country: India lat: 15.85212 lon: 74.50447 facility: Manipal Hospital, Old Airport Road, Bengaluru status: NOT_YET_RECRUITING city: Bengaluru state: Karnataka zip: 560017 country: India lat: 12.97194 lon: 77.59369 facility: Amrita Institute Of Medical Sciences & Research Centre status: NOT_YET_RECRUITING city: Kochi state: Kerala zip: 682041 country: India lat: 9.93988 lon: 76.26022 facility: Seth GS Medical College & KEM Hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: Grant Medical Foundation Ruby Hall Clinic status: NOT_YET_RECRUITING city: Pune state: Maharashtra zip: 411001 country: India lat: 18.51957 lon: 73.85535 facility: Malla Reddy Narayana Multispeciality Hospital status: NOT_YET_RECRUITING city: Hyderabad state: Telangana zip: 500055 country: India lat: 17.38405 lon: 78.45636 facility: Gandhi Hospital & Medical college status: NOT_YET_RECRUITING city: Hyderabad state: Telengana zip: 500003 country: India lat: 17.38405 lon: 78.45636 facility: Government Institute of Medical Sciences status: NOT_YET_RECRUITING city: Noida state: Uttar Pradesh zip: 201310 country: India lat: 28.58 lon: 77.33 facility: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh status: NOT_YET_RECRUITING city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 facility: Christian Medical College and Hospital status: NOT_YET_RECRUITING city: Ludhiana zip: 141008 country: India lat: 30.91204 lon: 75.85379 facility: Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) status: NOT_YET_RECRUITING city: Puducherry zip: 605006 country: India lat: 11.93381 lon: 79.82979 facility: Heiwadai Hospital status: RECRUITING city: Miyazaki-shi state: Miyazaki zip: 880-0034 country: Japan lat: 31.91667 lon: 131.41667 facility: Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology status: NOT_YET_RECRUITING city: Shinjuku-ku state: Tokyo zip: 1600023 country: Japan lat: 35.2946 lon: 139.57059 facility: Futata Tetsuhiro Clinic Meinohama status: RECRUITING city: Fukuoka-shi, Fukuoka zip: 819-0006 country: Japan lat: 33.6 lon: 130.41667 facility: Oyama East Clinic status: RECRUITING city: Tochigi zip: 323-0022 country: Japan lat: 36.38333 lon: 139.73333 facility: Noritake Clinic status: RECRUITING city: Ushiku-shi, Ibaraki zip: 300-1207 country: Japan facility: Uniwersytecki Szpital Kliniczny w Opolu status: RECRUITING city: Opole state: Opolskie zip: 45-401 country: Poland lat: 50.67211 lon: 17.92533 facility: Uniwersytecki Szpital Kliniczny w Opolu status: NOT_YET_RECRUITING city: Opole state: Opolskie zip: 45-401 country: Poland lat: 50.67211 lon: 17.92533 facility: NZOZ Vita-Diabetica Malgorzata Buraczyk status: RECRUITING city: Bialystok state: Podlaskie Voivodeship zip: 15-879 country: Poland lat: 53.13333 lon: 23.16433 facility: NZOZ Vita-Diabetica Malgorzata Buraczyk status: NOT_YET_RECRUITING city: Bialystok state: Podlaskie Voivodeship zip: 15-879 country: Poland lat: 53.13333 lon: 23.16433 facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska status: RECRUITING city: Bialystok state: Podlaskie zip: 15-435 country: Poland lat: 53.13333 lon: 23.16433 facility: Centrum Medyczne Pratia Gdynia status: NOT_YET_RECRUITING city: Gdynia state: Pomorskie zip: 81-338 country: Poland lat: 54.51889 lon: 18.53188 facility: Centrum Medyczne Pratia Katowice status: RECRUITING city: Katowice zip: 40-081 country: Poland lat: 50.25841 lon: 19.02754 facility: Centrum Medyczne Pratia Katowice status: NOT_YET_RECRUITING city: Katowice zip: 40-081 country: Poland lat: 50.25841 lon: 19.02754 facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji status: RECRUITING city: Warszawa zip: 02-507 country: Poland lat: 52.22977 lon: 21.01178 facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji status: NOT_YET_RECRUITING city: Warszawa zip: 02-507 country: Poland lat: 52.22977 lon: 21.01178 facility: Trialmed CRS status: RECRUITING city: Piotrków Trybunalski state: Łódzkie zip: 97-300 country: Poland lat: 51.40547 lon: 19.70321 facility: Advanced Clinical Research LLC status: RECRUITING city: Bayamon zip: 00959 country: Puerto Rico lat: 18.39856 lon: -66.15572 facility: Manati Ctr For Clin Research status: RECRUITING city: Manati zip: 00674 country: Puerto Rico lat: 18.42745 lon: -66.49212 facility: Hemant Makan status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 1827 country: South Africa lat: -26.20227 lon: 28.04363 facility: Dr Moosa's Rooms status: NOT_YET_RECRUITING city: Lenasia state: Gauteng zip: 1827 country: South Africa lat: -26.32052 lon: 27.83564 facility: Botho ke Bontle Health Services status: NOT_YET_RECRUITING city: Pretoria state: Gauteng zip: 0184 country: South Africa lat: -25.74486 lon: 28.18783 facility: Dr Mahesh Duki Research And Trial Site status: NOT_YET_RECRUITING city: Durban state: KwaZulu Natal zip: 4339 country: South Africa lat: -29.8579 lon: 31.0292 facility: Dr A Amod status: NOT_YET_RECRUITING city: Durban state: KwaZulu-Natal zip: 4092 country: South Africa lat: -29.8579 lon: 31.0292 facility: Dr MB Moosa's Practice status: NOT_YET_RECRUITING city: Durban state: KwaZulu-Natal zip: 4092 country: South Africa lat: -29.8579 lon: 31.0292 facility: Hospital de Basurto status: NOT_YET_RECRUITING city: Bilbao state: Vizcaya zip: 48013 country: Spain lat: 43.26271 lon: -2.92528 facility: Hospital Clinic i Provincial status: RECRUITING city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 facility: ABS La Roca del Vallés status: RECRUITING city: La Roca del Vallés zip: 08430 country: Spain lat: 41.58333 lon: 2.33333 facility: Hospital Clínico Virgen de la Victoria status: RECRUITING city: Málaga zip: 29010 country: Spain lat: 36.72016 lon: -4.42034 facility: Hospital Quirón status: NOT_YET_RECRUITING city: Pozuelo de Alarcón zip: 28223 country: Spain lat: 40.43293 lon: -3.81338 hasResults: False

 nctId: NCT06340841 id: LEMURS SSI 24 briefTitle: LEMURS SSI: Evaluation of Behavioral Incentives acronym: LEMURSSI overallStatus: RECRUITING date: 2024-02-12 date: 2024-05-31 date: 2028-05-31 date: 2024-04-02 date: 2024-04-02 name: University of Vermont class: OTHER briefSummary: The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities. conditions: Incentives studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Participants will be randomized to one of four incentive conditions and receive rewards based on their completion of such activities. There are two main factors (Recipient x Restoration) that will create four distinct groups. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 200 type: ESTIMATED name: Personal Incentives name: Personal Restorative Incentives name: Charity Incentives name: Charity Restorative Incentives measure: Activity Completion measure: Depression, Anxiety, Stress Scale - 21 measure: Depression, Anxiety, Stress Scale - 21 measure: Depression, Anxiety, Stress Scale - 21 measure: Warwick-Edinburgh Mental Well-being Scale measure: Oura Ring Sleep Index sex: ALL minimumAge: 18 Years maximumAge: 20 Years stdAges: ADULT facility: University of Vermont status: RECRUITING city: Burlington state: Vermont zip: 05405 country: United States name: Matthew Price, PhD role: CONTACT phone: 802-656-9196 email: Matthew.Price@uvm.edu lat: 44.47588 lon: -73.21207 hasResults: False

 nctId: NCT06340828 id: 2023-KY-186-01 briefTitle: Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2027-07-20 date: 2027-07-20 date: 2024-04-02 date: 2024-04-03 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:

* The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests.
* The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria.
* The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.
* The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.

Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment. conditions: Diabetic Gastroparesis conditions: Diabetic Gastropathy conditions: Diabetic Gastroenteropathy conditions: Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Washing Microbiota Transplantation measure: Gastrointestinal Symptom Rating Scale measure: Gut Microbiome Sequencing measure: Gastroparesis Cardinal Symptom Index measure: Composite Autonomic Symptom Score 31 measure: Gastrointestinal Motility measure: Heart Rate Variability measure: Serum Metabolites sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Dafa Ding, Professor role: CONTACT phone: +8615850514014 email: dingdafa@njmu.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06340815 id: VAR-2022-02 briefTitle: Varian ProBeam Proton Therapy System Clinical Trial (Shandong) overallStatus: COMPLETED date: 2022-07-20 date: 2023-03-08 date: 2023-03-10 date: 2024-04-02 date: 2024-04-02 name: Varian, a Siemens Healthineers Company class: INDUSTRY briefSummary: This study is prospective, single-center, single-arm objective performance criteria.

This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration. conditions: Tumor, Solid studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: a clinical study of prospective, single-arm objective performance criteria primaryPurpose: TREATMENT masking: NONE count: 47 type: ACTUAL name: Radiation: Proton Therapy System (ProBeam) measure: Effectiveness evaluation: Local tumor control rate at 90 days after the proton radiation treatment completion measure: Safety evaluation: Incidence of Acute radiation injury measure: Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sophia Shao city: Shanghai zip: 230001 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06340802 id: SYG001 briefTitle: A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl acronym: AURORA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: Synergia Medical class: INDUSTRY briefSummary: This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM. conditions: Drug Resistant Epilepsy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: VNS Treatment measure: Treatment emergent adverse events measure: Procedure and/or device related adverse events measure: Device-related treatment emergent adverse events measure: Device deficiencies measure: Procedural Success measure: Change in seizure frequency measure: Proportion of responders measure: Change in seizure severity measure: Change in quality of life measure: Changed in mood measure: Usability measure: Exploratory Endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340789 id: A-BR-110-49 briefTitle: Neurotransmitters in Treatment Resistant Schizophrenia Patients With add-on Sodium Benzoate overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-04-30 date: 2025-04-30 date: 2024-04-02 date: 2024-04-15 name: National Cheng-Kung University Hospital class: OTHER briefSummary: Although antipsychotic is effective for schizophrenia, however, still certain proportion of patients were not responsive to treatment. Treatment resistant schizophrenia (TRS) is accompanied by function decline and heavy burden. In recent decades, the biological mechanism of schizophrenia extended from dopamine theory to the role of glutamate system. This shift could be an alternative pathway to developing the treatment of TRS. Sodium benzoate (SB) could be an option as a glutamatergic agent for the patients with TRS. However, most evidence of SB is for treating patients with schizophrenia and other mental disorders but the evidence for treating patients with TRS is scarce. To predict the treatment response of SB will be an urgent topic in the future. Little is known about the precise medicine for treating patients with TRS. The present project will extend our pilot randomized clinical trial on SB for TRS. A total of 90 patients with TRS will be enrolled from three centers and will be assigned to 8 weeks of treatment with SB or placebo (2:1). A comprehensive battery of potential markers will be employed, including 1H- magnetic resonance spectroscopy (MRS), brain functional connectivity, genotyping, immune biomarkers, cognitive function, and clinical characteristics. The efficacy of SB on TRS will be confirmed in this project. Predictors for treatment response will be identified. Artificial intelligence algorithms will be used for probing the feasibility of precision medicine. conditions: Symptom, Cognitive conditions: Schizophrenia conditions: Schizo Affective Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The design and instrument are identical for two years. This add-on sodium benzoate randomized, double-blinded, placebo-controlled trial which is a two-arm, 6-week follow-up trial. The 90 patients will be 2:1 (SB: placebo) randomly assigned to 1. Treatment with sodium benzoate (A); or 2. placebo (P). The group of sodium benzoate treatment will be divided into two subgroups: 1. Responder (AR), and nonresponder (AN), as illustrated in Figure 4. The response criteria is defined the improvement of 20% total PANSS score after 6-week SB treatment. The participants with TRS will be enrolled in this trail from 3 hospitals(National Cheng Kung University Hospital, Tainan Hospital, Ministry of Health and Welfare, Chia-Yi branch, Taichung Veteran General Hospital). primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Sodium Benzoate 2gram/day name: Placebo measure: Brain imaging, functional MRI measure: Clinical psychiatric condition, Positive and Negative Symptoms Scale (PANSS) measure: Wechsler adult intelligence scales 4th edition (WAIS-IV) measure: Continuous performance test third edition (CPT-3) measure: Wisconsin card sorting test (WCST) sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06340776 id: 81321 briefTitle: The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy overallStatus: COMPLETED date: 2021-08-15 date: 2023-06-20 date: 2023-09-28 date: 2024-04-02 date: 2024-04-25 name: Istanbul Medipol University Hospital class: OTHER briefSummary: Aim This randomized controlled trial was conducted to evaluate the effect of acupressure application on gastrointestinal functions and pain after abdominal hysterectomy.

Materials and methods After undergoing hysterectomy, 39 women were randomised into acupressure (n=19), and control groups (n=20). Women in the acupressure group received acupressure on the mide meridian (ST36), the heart meridian (HT7), large intestine meridian (LI4), intersection of the spleen, liver and kidney meridians 6(SP6) and pericardium meridian (PC6) acupoints 30 min after admission to the clinic, for a period of 15 min, whereas those in the sham group received acupressure on locations 1-1.5 cm away from these points. The control group received standard treatment. The patient information form, Visual analog scale, the Rhodes Index of Nausea, Vomiting and Retching, and daily follow-up form were used for data collection. conditions: Pain Management conditions: Hysterectomy conditions: Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Acupressure groupThose who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery.

Control group:The control group was evaluated for two days without any application. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Acupressure measure: the score of nausea, vomiting and retching experiences measure: gas output and stool formation of the participants measure: postoperative pain measure: Systolic Blood pressure measure: Heart rate measure: Diastolic blood pressure sex: FEMALE minimumAge: 35 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yeliz Yildirim Varişoğlu city: Istanbul state: Beykoz zip: 34413 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06340763 id: ABT-CIP-10466 id: CRD_1058 type: OTHER domain: Abbott briefTitle: JETi Hong Kong Post Market Study (PMS) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-02 date: 2024-04-01 date: 2024-04-04 name: Abbott Medical Devices class: INDUSTRY briefSummary: The JETi Hong Kong PMS is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the lower extremity peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days after the JETi procedure. conditions: Peripheral Artery Thrombosis conditions: Peripheral Venous Thrombosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: JETi Hydrodynamic Thrombectomy System measure: For Arterial Subjects: Clot removal grade for each JETi-treated vessel measure: For Arterial Subjects: Composite of JETi-related major adverse events (MAEs) measure: For Venous Subjects: Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder score (limb basis). measure: For Venous Subjects: Composite of JETi-related major adverse events (MAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Wales Hospital city: Hong Kong country: Hong Kong name: Guangming TAN, Prof. role: CONTACT phone: +852 3505 2211 name: Guangming TAN, Prof. role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06340750 id: LMY-920-003 briefTitle: BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-10-15 date: 2026-04-15 date: 2024-04-01 date: 2024-04-01 name: Luminary Therapeutics class: INDUSTRY name: Nationwide Children briefSummary: This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: LMY-920 measure: Safety of the Treatment measure: Recommended Phase 2 Dose (RP2D) measure: Efficacy of the Treatment: SELENA-SLEDAI measure: Efficacy of the Treatment: BILAG measure: Efficacy of the Treatment: PGA sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340737 id: IRB-73394 briefTitle: AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas overallStatus: RECRUITING date: 2024-03-29 date: 2031-04 date: 2031-04 date: 2024-04-01 date: 2024-04-03 name: Stanford University class: OTHER name: The Leukemia and Lymphoma Society briefSummary: This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion. conditions: Follicular Lymphoma conditions: Mantle Cell Lymphoma conditions: Hairy Cell Leukemia conditions: Lymphoplasmacytic Lymphoma conditions: Burkitt Lymphoma conditions: Marginal Zone Lymphoma conditions: Waldenstrom Macroglobulinemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: CD22CART Infusion measure: Determine the manufacturing feasibility of CD22 CART by assessing the target dose level and release specifications in each disease cohort. measure: Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) measure: Determine the overall response rate (ORR) in adults with follicular lymphoma (FL) and mantle cell lymphoma (MCL) measure: Evaluate Progression Free Survival (PFS) measure: Evaluate Overall Survival (OS) measure: Evaluate Duration of Response (DOR) measure: Assess the response rate in adults with relapsed/refractory Hairy cell leukemia (HCL), Lymphoplasmacytic lymphoma (Waldenstrom macroglobulemia) (WM), Burkitt lymphoma (BL), and Marginal Zone lymphoma (MZL). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University status: RECRUITING city: Palo Alto state: California zip: 94304 country: United States name: Kelly Chyan role: CONTACT phone: 650-625-8130 email: kchyan@stanford.edu name: Matthew Frank, MD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False

 nctId: NCT06340724 id: KY20240123-08 briefTitle: Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2025-03 date: 2024-04-01 date: 2024-04-01 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical effiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail. conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Vonoprazan name: Amoxicillin name: Banxiaxiexin decotion measure: Change from Baseline in functional dyspepsia symptoms at 6 weeks measure: Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks measure: Adverse reactions that occur after taking medication measure: Patients' drug compliance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospitai city: Nanjing state: Jiangsu zip: 210006 country: China name: Wenjuan Wei, Doctorate role: CONTACT phone: +8618851009006 email: wjwei.hf@hotmail.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06340711 id: 23-06026219 briefTitle: Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2028-04 date: 2024-04-01 date: 2024-04-01 name: Weill Medical College of Cornell University class: OTHER name: Merck Sharp & Dohme LLC name: Oncolys BioPharma Inc briefSummary: The goal of this study is to learn about of the research study drug, telomelysin (OBP-301), in combination with pembrolizumab in advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. The main question it aims to answer is whether this combination is safe and effective in this type of cancer.

Participants will receive 5 injections of OBP-301, approximately every 2 weeks. OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy (EGD). At the same time as the injection, a tumor biopsy will be taken. Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years. Pembrolizumab infusions will occur on different days than OBP-301 injections. conditions: Esophageal Adenocarcinoma conditions: Gastric Adenocarcinoma conditions: Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: OBP-301 name: Pembrolizumab measure: Overall response rate as assessed by the RECIST v1.1 measure: Number of serious adverse events (SAEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 measure: Number of adverse events (AEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 measure: Disease control rate (DCR) measure: Duration of response (DoR) measure: Overall Survival (OS) measure: Progression free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Medicine/NewYork-Presbyterian Hospital city: New York state: New York zip: 10065 country: United States name: Casey Owens role: CONTACT email: cdo4001@med.cornell.edu name: Manish Shah, M.D. role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06340698 id: GRF-11606221 briefTitle: An RCT to Improve HRQoL of HIV+ Mothers and Children overallStatus: RECRUITING date: 2024-02-20 date: 2024-10 date: 2025-02 date: 2024-04-01 date: 2024-04-01 name: City University of Hong Kong class: OTHER briefSummary: The goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (HRQoL) among perinatally infected HIV positive children and their HIV positive mothers in China.

The main questions it aims to answer are:

1. Whether baseline resilience and treatment adherence are associated with the HRQoL;
2. Whether the resilience intervention will improve the mediators associated with intervention sessions, such as positive coping and social support, the proximal outcome of resilience factors, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;
3. Whether the adherence intervention will improve the mediators associated with intervention sessions, such as adherence information and behavioral skills, the proximal outcome of self-reported adherence, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;
4. Whether the enhanced mediators (e.g., positive coping and social support) associated with the resilience-intervention sessions at the end of the intervention will transmit the effect of the resilience intervention on the increases in resilience factors during follow-ups;
5. Whether the improved mediators (e.g., adherence information and behavioral skills) associated with the adherence-intervention sessions at the completion of the intervention will transmit the effect of the adherence intervention on the increases in adherence in follow-ups.

Participating mother-child dyads in the two intervention arms will receive two sessions of dyadic intervention. Researchers will compare the above-described outcomes between participants in the two intervention arms and the control arm (treatment as usual) to see the effectiveness of the interventions. conditions: HIV conditions: Perinatal HIV Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ESTIMATED name: Resilience intervention name: Adherence intervention measure: Change of health-related quality of life (HRQoL) measure: Change of depressive and anxiety symptoms measure: Change of resilience factors measure: Change of HAART adherence measure: Change of mediators in the resilience intervention: Perceived stigma measure: Change of mediators in the resilience intervention: Emotional regulation measure: Change of mediators in the resilience intervention: Positive coping measure: Change of mediators in the resilience intervention: Social support measure: Change of mediators in the resilience intervention: Self-efficacy measure: Change of mediators in the adherence intervention: Adherence information, motivation, and behavioral skills measure: Change of mediators in the adherence intervention: Illness perception measure: Change of mediators in the adherence intervention: Adherence efficacy measure: Change of mediators in the adherence intervention: Children's medication-taking responsibility measure: Change of mother-child relationship and interaction: Dyadic coping measure: Change of mother-child relationship and interaction: Mother-child closeness measure: Change of mother-child relationship and interaction: Family harmony measure: Change of mother-child relationship and interaction: Mother-child conflict measure: Change of mother-child relationship and interaction: Relationship satisfaction sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Guangxi Center for Disease Prevention and Control status: RECRUITING city: Nanning state: Guangxi zip: 530027 country: China name: Xiaoliang Zeng, Dr. role: CONTACT phone: +86 13457089643 email: 41045926@qq.com lat: 22.81667 lon: 108.31667 hasResults: False

 nctId: NCT06340685 id: STUDY23050042 id: UX007-IST236 type: OTHER_GRANT domain: Ultragenyx Pharmaceutical Inc. briefTitle: Triheptanoin for Children With Primary-Specific Pyruvate Dehydrogenase Complex (PDC) Deficiency overallStatus: RECRUITING date: 2024-05 date: 2026-12-31 date: 2027-06-30 date: 2024-04-01 date: 2024-04-04 name: Jirair Krikor Bedoyan class: OTHER name: Ultragenyx Pharmaceutical Inc briefSummary: This is a medical research study to test a medication in patients with a disease called Pyruvate Dehydrogenase Complex (PDC) Deficiency. The medication is triheptanoin, which is currently FDA approved for the treatment of Long-Chain Fatty Acid Oxidation Disorders. Previous research suggests that triheptanoin may also be effective in the treatment PDC Deficiency. This study will investigate the safety and efficacy (how well it works) of triheptanoin in patients with PDC Deficiency. conditions: Pyruvate Dehydrogenase Complex Deficiency studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Triheptanoin measure: Number of participants who report side-effects related to gastrointestinal (GI) distress measure: Normalization of biochemical markers of disease (lactate) measure: Normalization of biochemical markers of disease (pyruvate) measure: Normalization of biochemical markers of disease (β-hydroxybutyrate level) measure: Normalization of biochemical markers of disease (Alanine/Leucine ratio) measure: Normalization of biochemical markers of disease (Alanine/Lysine ratio) measure: Normalization of biochemical markers of disease (Alanine/Proline ratio) measure: More efficacious seizure control measure: More efficacious metabolic control measure: More efficacious disease control measure: Improved quality of life measure: Improved long-term maintenance and tolerance of diet measure: Improved quality of life sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: UPMC Children's Hospital of Pittsburgh status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15224 country: United States name: Danielle Black, MPH role: CONTACT phone: 412-692-6893 email: danielle.black@chp.edu name: Jirair Bedoyan, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06340672 id: STUDY24010034 briefTitle: The Effect of AR in Patient Pre-operative Education overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-01 date: 2025-02-01 date: 2024-04-01 date: 2024-04-01 name: University of Pittsburgh class: OTHER briefSummary: The purpose of this clinical trial is to analyze the effect of augmented reality (AR) on patient education and overall satisfaction when used during preoperative counseling in older adults undergoing spinal surgery. The main aims of this study are:

Aim 1: To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction, higher levels of confidence in surgeons, lower levels of preoperative anxiety, and lower patient reported pain scores.

Aim 2: To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals.

This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices. conditions: Anterior Cervical Discectomy and Fusion conditions: Transforaminal Lumbar Interbody Fusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Augmented Reality Enhanced Preoperative Counseling name: Standard preoperative counseling measure: Amsterdam Preoperative Anxiety and Information Score (APAIS) survey measure: Simulator Sickness Questionnaire (SSQ) measure: Evaluation of the Experience of General Anesthesia (EVAN-G) Survey measure: Time of preoperatively patient counseling measure: Degree of knowledge acquisition questionnaire at baseline measure: Degree of knowledge acquisition questionnaire 2 weeks post-operative measure: Degree of knowledge acquisition questionnaire 3 months post-operative measure: Degree of knowledge acquisition questionnaire 6 months post-operative measure: Participant age measure: Participant gender measure: Participant's indication for surgery measure: Participant education measure: Participant's past surgeries measure: Names of pain medications measure: Doses of pain medications measure: Prior experience with simulated environments measure: Patient understanding of surgery at baseline measure: Patient understanding of surgery 2 weeks post-operative measure: Patient understanding of surgery 3 months post-operative measure: Patient understanding of surgery 6 months post-operative measure: Patient pain level at baseline measure: Patient pain level 2 weeks post-operatively measure: Patient pain level 3 months post-operatively measure: Patient pain level 6 months post-operatively measure: Confidence in surgeon at baseline measure: Confidence in surgeon 2 weeks post-operatively measure: Confidence in surgeon 3 months post-operatively measure: Confidence in surgeon 6 months post-operatively measure: Patient preoperative visit satisfaction level measure: Patient satisfaction level with the surgical explanation at baseline measure: Patient postoperative visit satisfaction level 2 weeks post-operatively measure: Patient surgery satisfaction level 2 weeks post-operatively measure: Patient postoperative visit satisfaction level 3 months post-operatively measure: Patient surgery visit satisfaction level 3 months post-operatively measure: Patient postoperative visit satisfaction level 6 months post-operatively measure: Patient surgery satisfaction level 6 months post-operatively measure: Patient referral rates measure: Patient retention rates measure: Patient preference on the type of pre-operative counseling received for the AR-specific participants sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Edward Andrews, MD role: CONTACT phone: 412-232-5666 email: andrewse2@upmc.edu name: Edward Andrews, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06340659 id: AE and CT briefTitle: Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study) overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-01 date: 2027-07-01 date: 2024-04-01 date: 2024-04-01 name: University of Minnesota class: OTHER briefSummary: Significance of Research Question/Purpose: Subjective cognitive decline (SCD) is regarded as the first clinical manifestation in the AD-dementia continuum and currently has a prevalence of 11.2% in adults over the age of 45, with incidence increasing with greater age. Furthermore, population-based studies suggest that between 50% and 80% of older individuals (aged 70 years and older) who perform normally on cognitive tests, report some form of perceived decline in cognitive functioning when asked. The SCD state is unique as this population is more likely than their healthy peers to present with AD biomarkers such as neurodegeneration and amyloid burden, and therefore represents probable preclinical AD relative to other causes of SCD. Likewise, growing evidence suggests that a significant proportion of those adults are subsequently found to develop MCI, or AD, following the classic SCD-MCI-AD trajectory, with SCD increasing MCI risk 1.5-3 fold. Preventing Alzheimer's disease (AD) is arguably the most important approach to address the dementia epidemic worldwide because 99.6% of drug trials failed and no drugs can yet prevent, cure, or even slow AD. A treatment that delays the onset of AD by five years could save $89 billion in 2030.This highlights an urgent and pressing need to develop behavioral interventions to prevent AD and slow its progression.

The first purpose is to develop a fully-featured version of the Virtual Reality Cognitive Training (VRCT) aspect of the Exergame that can be installed and updated remotely. We will build on the Phase II Exergame by creating the capability that allows it to be installed and updated remotely to facilitate home-based use, especially by older adults. This also helps address a strong preference from our Phase II participants to minimize interaction with outsiders due to the ongoing COVID-19 pandemic, indicating a home- based solution will greatly facilitate commercialization. The second purpose is to determine the efficacy of the Home-based (Hb)Exergame on cognition and aerobic fitness in older adults at risk for AD using a 2:2 factorial design clinical trial. We will measure the following outcomes quantitatively: a) cognition: fluid cognition (global cognition) as the primary outcome, processing speed and other cognitive domains as secondary outcomes; b) aerobic fitness, c) neuroprotective blood biomarkers. conditions: AD-dementia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This study will use a single-blind, randomized, 2:2 factorial design. will randomize 104 community-dwelling older adults to one of four arms for 3 months: home-based (asynchronous) Exergame (HbExergame), supervised Exergame, home-based asynchronous aerobic exercise (HbAEx, or supervised aerobic exercise (supervised AEx). Randomization will allocate subjects on a 1:1:1:1 allocation ratio within each age stratum (65-74 and ≥75) in random blocks of 8 or 4 primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Supervised AEx name: HbAEx name: Supervised Exergame name: HbExergame measure: fluid cognition (global cognition) measure: Cognitive Function measure: Aerobic fitness measure: Neuroprotective biomarkers and ApoE status. measure: Exergame-specific usability and satisfaction measure: Standing balance measure: Four-meter walking velocity measure: Repeated chair raise measure: Quality of Life (QoL) measure: SCD Symptoms sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340646 id: 202106129 id: U2CCA252981 type: NIH link: https://reporter.nih.gov/quickSearch/U2CCA252981 briefTitle: Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS) overallStatus: RECRUITING date: 2022-10-18 date: 2027-01-31 date: 2027-01-31 date: 2024-04-01 date: 2024-04-01 name: Washington University School of Medicine class: OTHER name: National Cancer Institute (NCI) name: The Foundation for Barnes-Jewish Hospital briefSummary: The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict. conditions: Cholangiocarcinoma conditions: Multiple Myeloma conditions: Colon Cancer conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 990 type: ESTIMATED name: Return of Genetic Results: Biomarker information from cancer cells name: Return of Genetic Results: Inherited mutations related to cancer name: Return of Genetic Results: Inherited mutations related to other medical issues measure: Participant knowledge of clinical genetic testing measure: Participant expectations of benefit measure: Participant personal utility measure: Participant anxiety measure: Participant satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Graham Colditz, M.D., DrPH, MPH role: CONTACT phone: 314-454-7939 email: colditzg@wustl.edu name: Bettina Drake, Ph.D., MPH role: CONTACT phone: 314-747-4534 email: drakeb@wustl.edu name: Graham Colditz, M.D., DrPH, MPH role: PRINCIPAL_INVESTIGATOR name: Li Ding, Ph.D. role: SUB_INVESTIGATOR name: Bettina Drake, Ph.D. role: SUB_INVESTIGATOR name: Ryan Fields, M.D. role: SUB_INVESTIGATOR name: Yin Cao, ScD, MPH role: SUB_INVESTIGATOR name: Feng Chen, Ph.D. role: SUB_INVESTIGATOR name: Kia Davis, ScD, MPH role: SUB_INVESTIGATOR name: Patricia Dickson, M.D. role: SUB_INVESTIGATOR name: Eric Duncavage, M.D. role: SUB_INVESTIGATOR name: Mark Fiala, MSW role: SUB_INVESTIGATOR name: Aimee James, Ph.D., MPH role: SUB_INVESTIGATOR name: Reyka Jayasinge, Ph.D. role: SUB_INVESTIGATOR name: Kian-Huat Lim, M.D., Ph.D. role: SUB_INVESTIGATOR name: Erin Linnenbringer, Ph.D., MS role: SUB_INVESTIGATOR name: Jessica Mozersky, Ph.D. role: SUB_INVESTIGATOR name: Mary Politi, Ph.D. role: SUB_INVESTIGATOR name: David Spencer, M.D., Ph.D. role: SUB_INVESTIGATOR name: Tunji Toriola, M.D., Ph.D., MPH role: SUB_INVESTIGATOR name: Ravi Vij, M.D., MBA role: SUB_INVESTIGATOR name: Mark Watson, M.D., Ph.D. role: SUB_INVESTIGATOR name: Fei Wan, Ph.D. role: SUB_INVESTIGATOR name: Mike Wendl, DSC, MS, PHS role: SUB_INVESTIGATOR name: Matthew Wyczalkowsi, Ph.D. role: SUB_INVESTIGATOR name: Stephanie Solomon Cargill, Ph.D., MSPH role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False

 nctId: NCT06340633 id: SPI-1005-261 briefTitle: SPI-1005 in Adults Receiving Cochlear Implant overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-12 date: 2025-12 date: 2024-04-01 date: 2024-04-01 name: Sound Pharmaceuticals, Incorporated class: INDUSTRY name: Med-El Corporation briefSummary: The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.

The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?

The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.

Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.

The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have. conditions: Hearing Loss conditions: Cochlear Trauma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ebselen name: Placebo measure: Number of Participants with Treatment Emergent Adverse Events (TEAE) measure: Effect of SPI-1005 on Residual Low Frequency Hearing measure: Effect of SPI-1005 on Word Recognition measure: Effect of SPI-1005 on Speech Discrimination measure: Effect of SPI-1005 on Tinnitus measure: Effect of SPI-1005 on Vertigo sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340620 id: 24.017.01 briefTitle: EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope overallStatus: RECRUITING date: 2024-03-25 date: 2026-12 date: 2027-12 date: 2024-04-01 date: 2024-04-01 name: Orlando Health, Inc. class: OTHER briefSummary: This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract. conditions: Pancreatic Disease conditions: Pancreatic Cancer conditions: Pancreatic Cyst conditions: Gastrointestinal Tumor conditions: Bile Duct Diseases conditions: Bile Duct Cancer conditions: Lymph Node Disease conditions: Submucosal Tumor of Gastrointestinal Tract conditions: Gastrointestinal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Endoscopic ultrasound examination measure: Rate of successful completion of the requisite EUS examination measure: Ease of maneuverability of the device measure: Quality of EUS imaging measure: Ease of performing tissue acquisition measure: Diagnostic adequacy of procured specimen on onsite evaluation measure: Diagnostic adequacy of procured specimen in cell block measure: Diagnostic accuracy of procured specimen measure: Procedure duration measure: Rate of procedure-related adverse events measure: Procedure costs sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orlando Health status: RECRUITING city: Orlando state: Florida zip: 32806 country: United States name: Ji Young Bang, MD MPH role: CONTACT phone: 321-841-2431 email: jiyoung.bang@orlandohealth.com name: Barbara Broome role: CONTACT phone: 321-841-4356 email: barbara.broome@orlandohealth.com lat: 28.53834 lon: -81.37924 hasResults: False

 nctId: NCT06340607 id: 2023-0561 briefTitle: Neohepatic Albumin-Bilirubin Scores on Renal Outcomes in Living-donor Liver Transplantation Recipients overallStatus: COMPLETED date: 2012-01-05 date: 2020-01-05 date: 2022-12-31 date: 2024-04-01 date: 2024-04-01 name: Asan Medical Center class: OTHER briefSummary: This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients. conditions: Acute Kidney Injury conditions: Chronic Kidney Diseases conditions: Graft Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3422 type: ACTUAL measure: acute kidney injury measure: chronic kidney injury measure: graft failure sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center city: Seoul state: Song-pa Gu zip: 05500 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06340594 id: RF-2-2024 briefTitle: Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With? overallStatus: COMPLETED date: 2021-01-01 date: 2023-12-01 date: 2024-01-30 date: 2024-04-01 date: 2024-04-02 name: Assiut University class: OTHER briefSummary: Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches. conditions: Choledocholithiasis With Cholecystitis conditions: Biliary Stones studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 115 type: ACTUAL name: Laproscopic cholecystectomy (LC) name: Endoscopic Retrograde Cholangiopancreatography (ERCP) measure: Operative time operative time measure: CBD clearance rate measure: Length of hospital stay measure: Mortality rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine-Assiut University -Assiut-Egypt city: Assiut state: Asyut zip: 71515 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06340581 id: D5985C00009 id: 2023-509914-12 type: OTHER domain: EU CT briefTitle: A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C). overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2024-10-28 date: 2024-10-28 date: 2024-04-01 date: 2024-04-01 name: AstraZeneca class: INDUSTRY name: Parexel briefSummary: The purpose of this study is to assess the bioequivalence of the lung exposure of budesonide, glycopyrronium, and formoterol administered as budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with AeroChamber Plus Flow-Vu spacer compared with BGF MDI hydrofluoroalkane (HFA) with AeroChamber Plus Flow Vu spacer And BFG MDI HFO (Spacer vs No Spacer). conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Treatment A: BGF MDI HFA name: Treatment B: BGF MDI HFO name: Treatment C: BGF MDI HFO name: AeroChamber Plus Flow-Vu Spacer measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI measure: Maximum Observed Concentration (Cmax) of BGF MDI measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) measure: Maximum Observed Concentration (Cmax) measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) measure: Time to Reach Maximum Observed Concentration (tmax) measure: Terminal Rate Constant (λz) measure: Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz) measure: Mean Residence Time of the Unchanged Drug in the Systemic Circulation from Zero to Infinity (MRTinf) measure: Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Apparent Volume of Distribution at Steady State Following Extravascular Administration (Vz/F) measure: Number of Participants with Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06340568 id: BNT323-01 id: GOG-3105 type: OTHER domain: GOG foundation id: 2023-507525-42-00 type: OTHER domain: EU CT id: ENGOT- en25/NSGO-CTU type: OTHER domain: European Network for Gynaecological Oncological Trial groups (ENGOT) briefTitle: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-10 date: 2028-08 date: 2024-04-01 date: 2024-04-01 name: BioNTech SE class: INDUSTRY name: DualityBio Inc. briefSummary: The goal of this clinical study is to assess the efficacy of BNT323/DB-1303 compared with investigator's choice of chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the endometrial cancer population. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 468 type: ESTIMATED name: BNT323/DB-1303 name: Doxorubicin name: Paclitaxel measure: PFS by BICR in the endometrial cancer population measure: Overall survival (OS) in the endometrial cancer population measure: PFS assessed by the investigator in the endometrial cancer population measure: Objective response rate (ORR) in the endometrial cancer population measure: Duration of response (DoR) in the endometrial cancer population measure: Number of patients with occurrence of treatment-emergent adverse events (TEAEs) measure: Number of patients with occurrence of dose reduction, delay, and discontinuation of study treatments due to TEAEs sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340555 id: PIC-156-22 briefTitle: Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss acronym: Enzo overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-07-31 date: 2024-04-01 date: 2024-04-01 name: Fundació Sant Joan de Déu class: OTHER name: University of Barcelona name: University of Seville briefSummary: The goal of this clinical trial is to test impact of a multiprofessional intervention in mothers and partners who suffer a pregnancy loss. The main questions it aims to answer are:

* impact on mothers and partners mental heatlht status
* reasons why mothers do not consent to the intervention

Participants will:

* mothers and partners will complete 4 scales
* mothers and partners will participate in a interview

Researchers will compare with mothers with standard care to see if the multiprofessional intervention has an impact. conditions: Stillbirth and Fetal Death studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: GUIA ATENCION MULTIDISCIPLINAR SANT BOI name: USUAL CARE measure: Intensity of grief measure: Depressive symptoms measure: Anxiety symptoms measure: Perinatal postraumatic stress disorder sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Parc Sanitari Sant Joan de Deu city: Sant Boi De Llobregat state: Barcelona zip: 08830 country: Spain lat: 41.34357 lon: 2.03659 hasResults: False

 nctId: NCT06340542 id: UDhaka briefTitle: Comparison of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Upper Back Pain overallStatus: COMPLETED date: 2023-11-01 date: 2023-12-31 date: 2024-01-31 date: 2024-04-01 date: 2024-04-02 name: University of Dhaka class: OTHER briefSummary: Methodology: study aims to evaluate the effectiveness of thoracic mobility exercise and manual release technique in terms of pain intensity, thoracic mobility, muscle strength and improving disability.

Study Design: Study was conducted in Service unit of Department of Physiotherapy at university of peradeniya. Undergraduates who are currently having upper back pain for more than seven days was selected as sample. It is a randomized Controlled trail, Double blinded study. Participants allowed randomly to both groups which are experimental group which will receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment. Total sample size was 60. conditions: Upper Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a Randomized Control Trial, Double- Blinded study. Participants and accessors was blinded. Participants were allocated randomly in to two groups which are experimental group which will receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment by using lottery method. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants' allocation was concealed by using lottery method whether there are in exercise group or manual therapy group. Accessors was blinded which means they were not aware about the treatment or therapy which was obtained by the participants whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 57 type: ACTUAL name: Thoracic Mobility exercises name: Manual Release technique measure: Pain Intensity measure: Range of Motion measure: Muscle strength measure: Disability level - self perception sex: ALL minimumAge: 20 Years maximumAge: 26 Years stdAges: ADULT facility: Vithursha Sivakumar city: Jaffna state: Northern zip: 40001 country: Sri Lanka lat: 9.66845 lon: 80.00742 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2023-10-09 uploadDate: 2024-03-25T22:35 filename: Prot_SAP_ICF_000.pdf size: 1324441 hasResults: False

 nctId: NCT06340529 id: CLS_SIMULATION briefTitle: Comparison of the Perception of Non-technical Skills overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-31 date: 2024-06-30 date: 2024-04-01 date: 2024-04-03 name: University of Valencia class: OTHER briefSummary: Clinical simulation has recently acquired great importance in the health sciences. It is a pedagogical methodology that is increasingly used in health science degrees, since it is very useful for the acquisition of both technical and non-technical skills (leadership, teamwork and effective communication, among others).

However, if the investigators focus on physical therapy, the use of clinical simulation is a novel field and therefore requires a great deal of research. Researchers in this field do not yet have the consistency and experience as in other health branches such as medicine or nursing, where the participants have been using high-fidelity simulators for years for the learning of all their students.

Clinical simulation allows students to achieve these competencies without the need to practice on real patients. For all these reasons, and because of the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely suppressed, the need for our research is justified. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: Clinical Simulation measure: Ottawa Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340516 id: HER2BNP briefTitle: NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity overallStatus: RECRUITING date: 2024-03-14 date: 2029-03-14 date: 2029-03-14 date: 2024-04-01 date: 2024-04-01 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: Trastuzumab-induced cardiotoxicity (TIC) will be monitored in patients with HER2+ breast cancer undergoing trastuzumab treatment before and after breast cancer surgery. At baseline before start of trastuzumab treatment, echocardiography (ECHO)/multigated Acquisition Scan (MUGA) and measurement of plasma NT-proBNP will be performed. NT-proBNP will be measured again at 6 months and at 12 months of trastuzumab treatment. If elevations in NT-proBNP at 6 months and 12 months occur patients will be referred for ECHO/MUGA. The aim is to assess the sensitivity and specificity to detect TIC with NT-proBNP and whether ECHO/MUGA can be safely replaced by assessment of plasma NT-proBNP levels. conditions: Cardiotoxicity conditions: Breast Cancer conditions: Treatment Side Effects studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a national multicentre phase II trial investigating the sensitivity and specificity of NT-proBNP for the diagnose of cardiac toxicity during primary anti-HER2 blockade. NT-proBNP is compared with the todays´ standard (ECHO/MUGA). primaryPurpose: DIAGNOSTIC masking: NONE count: 700 type: ESTIMATED name: Plasma NT-proBNP measure: Sensitivity and specificity of NT-proBNP to detect trastuzumab-induced cardiotoxicity measure: Prevalence of trastuzumab-induced cardiotoxicity measure: Anthracycline-induced change in NT-proBNP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jubileumskliniken, Sahlgrenska University Hospital status: RECRUITING city: Gothenburg zip: 432 45 country: Sweden name: Daniel Giglio, Assoc Prof role: CONTACT phone: +46(0)31-342 16 06 email: daniel.giglio@pharm.gu.se lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06340503 id: IRB00111331 id: WFBCCC 01123 type: OTHER domain: Atrium Health Wake Forest Baptist Comprehensive Cancer Center id: P30CA012197 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA012197 briefTitle: Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-07 date: 2025-08 date: 2024-04-01 date: 2024-04-01 name: Wake Forest University Health Sciences class: OTHER name: National Cancer Institute (NCI) briefSummary: The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer. conditions: Breast Cancer conditions: Colon Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Research-grade accelerometer name: National Comprehensive Cancer Network (NCCN) Education Materials name: Garmin Vivofit activity tracker name: Exercise Consultation Calls name: Interview name: Physical Activity Index Assessment (Intervention Arm) name: Physical Activity Index Assessment (Control Arm) name: Health Surveys measure: Number of Eligible Participants - Participation Rate measure: Percentage of Participants to Complete Exercise Sessions - Adherence measure: Number of Participants Who Complete Study Questionnaires - Retention sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Principal Investigator role: CONTACT name: Shirley Bluethmann, PhD role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06340490 id: RJMty19-AID002 briefTitle: A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE) overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-12-31 date: 2027-12-31 date: 2024-04-01 date: 2024-04-01 name: Guangdong Ruishun Biotech Co., Ltd class: INDUSTRY name: RenJi Hospital name: Peking University People's Hospital name: Changhai Hospital name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School briefSummary: This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: RJMty19 (CD19-CAR-DNT cells) measure: Dose-Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Incidence of abnormalities measure: Pharmacokinetics (PK) indicator (Cmax) measure: Pharmacokinetics (PK) indicator (AUC) measure: Pharmacokinetics (PK) indicator (CAR copy numbers) measure: Remission rate of SLE based on DORIS criteria measure: Remission rate of SLE based on LLDAS criteria sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100044 country: China name: Zhanguo Li, MD, PHD role: CONTACT phone: +086-13910713924 email: li99@bjmu.edu.cn name: Chun Li, MD, PHD role: CONTACT phone: +086-13811190098 email: 13811190098@163.com lat: 39.9075 lon: 116.39723 facility: Nanjing Drum Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China name: Lingyun Sun, MD, PhD role: CONTACT phone: +086-025-83105555 email: lingyunsun2012@163.com lat: 32.06167 lon: 118.77778 facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai zip: 200001 country: China name: Shuang Ye, MD, PHD role: CONTACT phone: +086-13817615871 email: ye_shuang2000@163.com name: Qiong Fu, MD, PHD role: CONTACT phone: +086-13585603288 email: fuqiong@renji.com lat: 31.22222 lon: 121.45806 facility: Changhai Hospital city: Shanghai state: Shanghai zip: 200433 country: China name: Dongbao Zhao, MD, PhD role: CONTACT phone: +86-15921061314 email: dongbaozhao@163.com name: Jie Gao, MD, PhD role: CONTACT phone: +086-13585561861 email: gaojif@tom.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06340477 id: Mahnoor Arif/ REC -01802 briefTitle: Effect of Thoracic SNAGS on Vitals Among Individuals With Forward Head Posture overallStatus: RECRUITING date: 2024-03-01 date: 2024-06 date: 2024-07 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: To determine how vitals (heart rate, blood pressure, respiratory rate, oxygen saturation) and craniovertebral angle will be affected by thoracic SNAGs in individuals with forward head posture. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Thoracic SNAGs with conventional therapy name: conventional therapy measure: Aneroid sphygmomanometer measure: Pulse oximeter measure: Respiratory rate measure: NPRS (Numeric Pain Rating Scale) measure: Inclinometer measure: Photogrammetric method for craniovertebral angle sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Pakistan Railway Hospital status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Maria Khalid, MSOMPT role: CONTACT phone: 03315369768 email: maria.khalid@riphah.edu.pk name: Mahnoor arif, MSOMPT* role: CONTACT name: mahnoor arif, MSOMPT* role: PRINCIPAL_INVESTIGATOR lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06340464 id: REC.67-018-8-1 briefTitle: Preoperative Nutritional Status Scores to Predict PPC in Elderly With Cardiac Surgery overallStatus: RECRUITING date: 2024-03-21 date: 2025-12-31 date: 2026-11-30 date: 2024-04-01 date: 2024-04-01 name: Prince of Songkla University class: OTHER briefSummary: This prospective study investigate prognostic values and compare the role of nutritional status by using GNRI, MNA, and PNI in predicting post-operative pulmonary complication among elderly patients with cardiac surgery. conditions: Cardiac Surgery conditions: Elderly Patient conditions: Postoperative Pulmonary Complication conditions: Nutrition Scoring System studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 229 type: ESTIMATED name: GNRI, PNI, MNA measure: Postoperative pulmonary complication sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University status: RECRUITING city: Hat Yai state: Songkhla zip: 90110 country: Thailand name: Panalee Kittisopaporn role: CONTACT phone: 66832422540 lat: 7.00836 lon: 100.47668 hasResults: False

 nctId: NCT06340451 id: IOV-301 briefTitle: Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity overallStatus: RECRUITING date: 2024-04-16 date: 2025-04 date: 2025-04 date: 2024-04-01 date: 2024-04-23 name: Pacira Pharmaceuticals, Inc class: INDUSTRY briefSummary: This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment). conditions: Spasticity, Cerebral or Spinal Condition studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 132 type: ESTIMATED name: iovera° system name: sham iovera° system treatment measure: Change from baseline in the Modified Ashworth Scale score for elbow measured (0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity) measure: Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured measure: Change from baseline in the Modified Tardieu Scales for elbow (0 to 5, where lower score represents no resistance, and higher score represents joint immobility; Increase in angle from baseline [R1, and R2] represents improvement) measure: Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction) measure: Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff (-2 to +2, where lower score represents less expected outcomes, and higher scores represent greater expected outcomes) measure: Change from baseline in the Modified Ashworth Scale score for elbow measured immediately (within 3 hours) measure: Change from baseline in the Modified Ashworth Scale score for shoulder (shoulder abduction) measured immediately (within 3 hours) measure: Change from baseline in the Modified Ashworth Scale score for shoulder (forward flexion, external rotation) measured immediately (within 3 hours) measure: Change from baseline in the Modified Ashworth Scale score over 13 weeks post-treatment measured by area under the curve (AUC) for elbow (elbow extension) measure: Change from baseline in the Modified Ashworth Scale score over 13 weeks post-treatment measured by AUC for shoulder (shoulder abduction, shoulder forward flexion, external rotation) measure: Change from baseline in the Modified Tardieu Scales for elbow measured immediately (within 3 hours) measure: Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction) measured immediately (within 3 hours) measure: Change from baseline in the Modified Tardieu Scales for shoulder (forward flexion, external rotation) measured immediately (within 3 hours) measure: Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shepherd Center status: RECRUITING city: Atlanta state: Georgia zip: 30309 country: United States name: Michelle Tidwell role: CONTACT phone: 404-367-1317 email: michelle.tidwell@shepherd.org lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06340438 id: N-20240004 3rd subproject briefTitle: Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals overallStatus: NOT_YET_RECRUITING date: 2024-04-27 date: 2025-12-31 date: 2026-12-31 date: 2024-04-01 date: 2024-04-29 name: Aalborg University class: OTHER briefSummary: This project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities in an experimental setting. conditions: Histamine conditions: Cowhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The participants will randomly receive applications of cowhage and histamine. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participant will be blinded about application of pruritogens. whoMasked: PARTICIPANT count: 46 type: ESTIMATED name: Histamine name: Cowhage measure: Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ). measure: The Pittsburg Sleep Quality Index (PSQI) measure: Depression, Anxiety, Stress Scale (DASS-21) measure: Positive And Negative Affect Schedule (PANAS) measure: Pain Catastrophizing Scale (PCS). measure: Itch Catastrophizing Scale (ICS). measure: Learned Helplessness Scale (LHS) measure: Positive And Negative Affect Schedule (PANAS) measure: Depression, Anxiety, Stress Scale (DASS-21) measure: Positive And Negative Affect Schedule (PANAS) measure: Pain Catastrophizing Scale (PCS). measure: Itch Catastrophizing Scale (ICS). measure: Learned Helplessness Scale (LHS) measure: Positive And Negative Affect Schedule (PANAS) measure: Assessment of itch measure: Assessment of pain sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06340425 id: s68727 briefTitle: The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy: a Retrospective Study overallStatus: COMPLETED date: 2018-06-26 date: 2023-12-31 date: 2023-12-31 date: 2024-04-01 date: 2024-04-01 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Selective dorsal rhizotomy (SDR) is applied in children with spastic CP as a non-reversible tone reduction procedure. Better understanding of the effects of SDR on a multidimensional outcome set in one CP-cohort and on macroscopic muscle morphology can improve insights and clinical decision making. conditions: Cerebral Palsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 15 type: ACTUAL measure: Overall changes in spasticity measure: Overall change in muscle volume of the medial gastrocnemius measure: Overall changes in muscle length of the medial gastrocnemius measure: Overall changes in muscle cross-sectional area at 50% of muscle belly length measure: Overall changes in gait measure: Overall change in gross-motor function measure: Overall change of spasticity in the plantar flexors measure: Overall change of selectivity in the plantar flexors measure: Overall change of passive range of motion in the ankle and knee joint measure: Overall change of muscle strength in the plantar flexors measure: Scatter plots of muscle morphology data (same parameters as for the primary endpoints) sex: ALL minimumAge: 5 Years maximumAge: 16 Years stdAges: CHILD facility: UZ Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06340412 id: MFGM-FOR-HEALTH briefTitle: Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals overallStatus: RECRUITING date: 2024-03-11 date: 2024-10-01 date: 2024-10-01 date: 2024-04-01 date: 2024-04-01 name: University of Aarhus class: OTHER name: Arla Foods briefSummary: The aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans.

The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal. conditions: Postprandial Lipid Metabolism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A randomized, double-blinded, controlled, crossover trial primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch. name: Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch. name: Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch. measure: Difference in postprandial triglycerides measured as area under the curve (AUC). measure: Difference in concentration of GLP-1 measure: Difference in concentration of Ghrelin measure: Difference in concentration of LEAP2 measure: Difference in concentration of FFA measure: Difference in concentration of Insulin measure: Difference in concentration of glucagon measure: Difference in concentration of cholesterol (total, LDL and HDL) measure: Difference in concentration of GIP measure: Difference in concentration of CCK measure: Difference in concentration concentration of Gastrin measure: Difference in concentration concentration of GDF15 measure: Difference in concentration of LPS-BP (Lipopolysaccharide Binding Protein) measure: Difference in concentration concentration of Cytokines measure: Difference in concentration of apoB48 measure: Difference in concentration of apoB100 measure: Difference in glucose concentration measure: Difference in appetite sensation measure: Difference in gastric emptying rate measure: Ad libitum meal test measure: Metabolic rate measure: Substrate metabolism sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Steno Diabetes Center Aarhus, Aarhus University Hospital status: RECRUITING city: Aarhus zip: 8200 country: Denmark name: Jens H Voigt, MD role: CONTACT phone: +4526395294 email: Jens.voigt@clin.au.dk name: Esben H Søndergaard, MD, PhD role: CONTACT phone: +4528730943 email: Esben.sondergaard@clin.au.dk lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06340399 id: 202312117RINE briefTitle: BCAA in Patients Undergoing Gastric Cancer Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-28 date: 2029-12-31 date: 2030-12-31 date: 2024-04-01 date: 2024-04-01 name: National Taiwan University Hospital class: OTHER briefSummary: Older patients undergoing gastric cancer resection, at higher risk due to insufficient preoperative muscle mass, are more susceptible to SRML under surgical stress. This not only affects limb muscles but also impacts swallowing muscles, contributing to increased postoperative complications and mortality rates. Enhanced Recovery After Surgery (ERAS) has emerged as a multidisciplinary approach to facilitate postoperative recovery. This study aims to optimize oral nutrition under the ERAS model to observe its impact on SRML. BCAA is essential for skeletal muscles. However, there is limited research on the oral BCAA, whether before or after surgery, concerning SRML and its associated complications. The study entails an 18-month randomized controlled trial with 200 participants. One hundred individuals will take BCAA daily 5 to 14 days before surgery. After surgery, they can progress to a clear liquid diet around postoperative day five while continuing BCAA until 30 days postoperatively. The other one hundred participants will not receive BCAA. The study aims to investigate whether oral BCAA can reduce SRML, muscle loss, and decrease swallowing muscle strength, with observations on postoperative complications and outcomes within one year. conditions: Perioeprative Muscle Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: patients receiving BCAA primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: this is a open label use study whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: BCAA name: patient not administered BCAA measure: the occurrence of surgical related muscle loss sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340386 id: IEO 1365 briefTitle: Italian Validation of a Tool for Assessing Sexual Function After Breast Cancer, FSFI-BC overallStatus: RECRUITING date: 2020-10-19 date: 2024-12-31 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: European Institute of Oncology class: OTHER briefSummary: This is a validation study of the italian language for the Female Sexual Function Index-Breast Cancer questionnaire.

The validation of the instrument in Italian will allow the identification of possible issues related to sexual health and enable the provision of adequate medical and psychosexual counseling to these patients, both in clinical practice and in research studies. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Validation of the italian translation of Female Sexual Function Index-Breast Cancer questionnaire sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06340373 id: NICVD/ 2023/ 32 id: NICVD /Ethical/ 2023/ 32 type: OTHER domain: National Institute of Cardiovascular Diseases(NICVD) briefTitle: Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-06-30 date: 2024-04-01 date: 2024-04-03 name: National Institute of Cardiovascular Diseases, Bangladesh class: OTHER briefSummary: The progression of cardiac revascularization techniques, starting with standard balloon angioplasty (POBA) and progressing to the creation of drug-coated balloons (DCB) and drug-eluting stents (DES). The study's justification is presented, with a focus on the significance of comprehending the clinical and angiographic outcomes of DCB angioplasty, especially when considering the Bangladeshi population.

This study's main goal is to observe the clinical and angiographic outcomes of drug-coated balloon angioplasty after native coronary lesions that have been successfully revascularized. A few specific goals are to evaluate angiographic results (like percentage diameter stenosis, vascular remodelling, restenosis, and thrombosis) after DCB angioplasty and to assess clinical outcomes (like worsening angina, target vessel MI, ischemia-driven TLR, and cardiac mortality).

This observational study will take place from January to December 2024 at the Department of Cardiology, National Institute of Cardiovascular Diseases. The study population will be individuals who had successful revascularization of native coronary lesions with DCB angioplasty six months before. The study includes non-randomized purposive sampling, and the sample size will be determined by drawing on previous studies.

Every patient will receive a thorough clinical assessment that includes a history, physical examination, electrocardiogram, and biochemical testing. The data will be analysed in accordance with the assessment of angiographic outcomes by follow-up angiography.

The purpose of this study is to give useful insights into the clinical and angiographic results of DCB angioplasty in Bangladeshi patients with native coronary lesions, including the growing body of knowledge on the efficacy and safety of this therapeutic strategy in specific populations. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 303 type: ESTIMATED name: DCB Angioplasty measure: CCS (Canadian Cardiovascular Society) Class of Worsening angina of each participant measure: Number of participants with target vessel Myocardial infarction measure: Ischemia-driven Target lesion revascularization (TLR) each participant measure: Occurrence of Cardiac death in the participants measure: Site of the lesion measure: Lesion Length measure: % of Stenosis measure: Thrombolysis in Myocardial Infarction (TIMI) Flow measure: Pre dilatation - Balloon Type sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of CardioVascular Diseases status: RECRUITING city: Dhaka zip: 1207 country: Bangladesh name: Sayeedur Rahman Khan, MD role: CONTACT phone: +8801711850078 email: dr.rumibd@gmail.com name: Md Zahid Hasan, MD role: CONTACT phone: +8801723-218955 email: zhasan390@gmail.com name: Prof. Mohsin Ahmed, MD role: PRINCIPAL_INVESTIGATOR name: Dr. Sayeedur Rahman Khan, MD role: SUB_INVESTIGATOR name: Dr. Md Zahid Hasan, MD role: SUB_INVESTIGATOR name: Dr. Shariful Islam, MD role: SUB_INVESTIGATOR name: Dr. CM Kudrat E Khuda, MD role: SUB_INVESTIGATOR name: Dr. Mohammad Arifur Rahman, MD role: SUB_INVESTIGATOR name: Dr. Md Matiur Rahman, MD role: SUB_INVESTIGATOR name: Dr. SA Shiblee, MPH role: SUB_INVESTIGATOR name: Md. Habibur Rahman, M.Sc role: SUB_INVESTIGATOR lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06340360 id: 23-358-06 id: 2023-509981-39 type: EUDRACT_NUMBER briefTitle: A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) overallStatus: RECRUITING date: 2024-03-27 date: 2025-08-31 date: 2026-02 date: 2024-04-01 date: 2024-04-03 name: Nektar Therapeutics class: INDUSTRY briefSummary: This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata.

The estimated duration includes a screening period of up to 35 days, a 36-week treatment period, and a 24-week follow-up period. The maximum study duration is approximately 65 weeks for all participants. conditions: Alopecia Areata studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized to 1 of 3 groups (low dose, high dose, or placebo). primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Rezpegaldesleukin name: Placebo measure: Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36 measure: Percent change from baseline in SALT score measure: Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90% measure: Proportion of patients achieving an absolute SALT score ≤ 10/20/30 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Austin Institute for Clinical Research status: RECRUITING city: Pflugerville state: Texas zip: 786660 country: United States lat: 30.43937 lon: -97.62 hasResults: False

 nctId: NCT06340347 id: C5351010 briefTitle: A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2026-02-05 date: 2026-02-05 date: 2024-04-01 date: 2024-04-01 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function.

This study is seeking participants that are:

* stable loss of liver function with mild or moderate severity
* none of underlying conditions possibly affecting the study medicine being absorbed by the body

All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe.

Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic. conditions: Liver Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An open label, single dose, parallel cohort study primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: Osivelotor measure: Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor measure: Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor measure: Maximum observed whole blood and plasma concentration (Cmax) of osivelotor measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) measure: Number of Participants With Clinically Significant Laboratory Abnormalities measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings measure: Number of Participants With Clinically Significant With Clinically Significant Vital Signs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340334 id: KY20240123-05 briefTitle: Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12-31 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. pylori infection were compared in a multi-center clinical joint study in Jiangsu Province. conditions: Helicobacter Pylori Infection conditions: Tegoprazan conditions: Furazolidone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Tegoprazan-amoxicillin dual therapy measure: Helicobacter pylori eradication rate measure: Security observations measure: Patient compliance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340321 id: PBRC 2023-081 briefTitle: Impact of Metabolic Flexibility on Changes in Metabolic Health acronym: METPROS overallStatus: ENROLLING_BY_INVITATION date: 2024-06 date: 2025-01 date: 2025-01 date: 2024-04-01 date: 2024-04-03 name: Pennington Biomedical Research Center class: OTHER briefSummary: Metabolic flexibility is the capacity to adapt fuel oxidation to fuel availability so that ATP synthesis can match its cellular demands. Thus, for example, increases in glucose availability after a meal would increase glucose oxidation, while increases in lipid availability during fasting would increase lipid oxidation. Enhanced metabolic flexibility has been proposed to protect humans from metabolic diseases. Nevertheless, most studies examining associations between metabolic flexibility and metabolic health outcomes have used cross-sectional designs. Whether impaired metabolic flexibility causes or results from metabolic health impairment is thus unclear.

In this study, the investigators will use the data from a study conducted approximately 16 years ago in healthy participants without obesity. Using the data already collected in that study, the metabolic flexibility of each participant will be calculated. To test the association between metabolic flexibility and the change in metabolic health, the investigators will call back all the participants for a single follow-up visit to reassess several metabolic health outcomes. Thus, the main aim of the study is to test the association between metabolic flexibility and the change in metabolic health outcomes after 16 years in humans. conditions: Obesity conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 88 type: ESTIMATED name: Metabolic flexibility in the fasted state name: Metabolic flexibility in euglycemic-hyperinsulinemic clamp name: Metabolic flexibility in the metabolic chamber measure: Glucose measure: Total cholesterol measure: HDL cholesterol measure: LDL cholesterol measure: Triglycerides measure: HOMA-IR measure: Blood pressure measure: Waist circumference measure: Body mass index measure: Body fat percentage sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pennington Biomedical Research Center city: Baton Rouge state: Louisiana zip: 70808 country: United States lat: 30.45075 lon: -91.15455 hasResults: False

 nctId: NCT06340308 id: PARAF 986117570 briefTitle: Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol acronym: PARAF overallStatus: RECRUITING date: 2023-06-07 date: 2024-03 date: 2024-05 date: 2024-04-01 date: 2024-04-01 name: University of Pavia class: OTHER name: Foundation IRCCS San Matteo Hospital briefSummary: To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol on lipid profile conditions: Dyslipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol name: Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol measure: Variations of lipid profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Policlinico S. Matteo Foundation status: RECRUITING city: Pavia zip: 27100 country: Italy name: Giuseppe Derosa, MD, PhD role: CONTACT email: giuseppe.derosa@unipv.it name: Pamela Maffioli, MD role: CONTACT email: p.maffioli@smatteo.pv.it name: Giuseppe Derosa, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Pamela Maffioli, MD role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06340295 id: 2023313 briefTitle: A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population overallStatus: RECRUITING date: 2023-09-01 date: 2026-05-31 date: 2026-05-31 date: 2024-04-01 date: 2024-04-01 name: Peking University First Hospital class: OTHER name: Shanxi Bethune Hospital name: First Affiliated Hospital Xi'an Jiaotong University name: Tianjin Medical University General Hospital name: The First Hospital of Qinhuangdao name: Shandong Provincial Hospital name: Second Hospital of Jilin University name: People's Hospital of Xinjiang Uygur Autonomous Region name: MinDong Hospital of Ningde City briefSummary: Chronic obstructive pulmonary disease (COPD) is the most common chronic tract disease and the third leading cause of death worldwide. The treatment effect of COPD is poor, and the disease is progressive, resulting in a serious disease burden. The key reason is that early recognition is difficult and the early pathophysiological mechanism is unclear, which leads to the difficulty of early intervention.PRISm is likely to be the precursor stage of COPD, which may provide an important research object for the study of pathophysiological characteristics, inflammation and immunomodulatory mechanisms of early COPD, and may also become a new entry point for early intervention of COPD. This study attempts to establish a PRISm prospective cohort，and collects blood, EBC and urine for analysis of inflammatory factors, metabolomics, proteomics and microbiome, and performs chest HRCT to obtain imaging indicators, and conducts 3-year dynamic follow-up observation to study the evolution characteristics of pulmonary function and the incidence of COPD in the PRISm cohort. To compare the differences in imaging, inflammatory factors, metabolomics, proteomics and microbiome among the three PRISm groups, and establish a risk prediction model for progression to COPD through PRISm. It lays a foundation for understanding the characteristics of COPD at an earlier stage and exploring new early warning indicators. conditions: COPD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: The number and proportion of newly diagnosed COPD measure: The number and proportion of continuous PRISm population measure: The number and proportion of PRISm to normal population measure: Emerging diseases measure: Death and cause of death sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Jiping Liao, MD. role: CONTACT phone: 13521714181 email: colorfulwing01@163.com name: Chunbo Zhang role: CONTACT phone: 13086645758 email: 2399637945@qq.com name: Jiping Liao, MD. role: PRINCIPAL_INVESTIGATOR name: Guangfa Wang, MD. role: SUB_INVESTIGATOR name: Zhe Jin, MD. role: SUB_INVESTIGATOR name: Meng Zhang role: SUB_INVESTIGATOR name: Yan Hu, MD. role: SUB_INVESTIGATOR name: Chunbo Zhang role: SUB_INVESTIGATOR name: Xueying Li role: SUB_INVESTIGATOR name: Jian Chen role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Guangfa Wang, MD role: CONTACT phone: 13810644029 email: wangguangfa@hotmail.com name: Jiping Liao, MD role: CONTACT phone: 13521714181 email: colorfulwing01@163.com name: Yunxia Wang, PhD role: SUB_INVESTIGATOR name: Yijue Zhong, PhD role: SUB_INVESTIGATOR name: Chao Sun, PhD role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: The First Hospital of Qinhuangdao status: RECRUITING city: Qinhuangdao state: Hebei country: China name: Hua Qiao, MD role: CONTACT phone: 13780358298 email: qh1202@163.com lat: 39.93167 lon: 119.58833 facility: Tianjin Medical University General Hospital status: RECRUITING city: Tianjin state: Tianjin country: China name: Lixia Dong, MD role: CONTACT phone: 13001385918 email: luckydonglixia@163.com lat: 39.14222 lon: 117.17667 facility: Shandong Provincial Hospital Affiliated to Shandong University status: RECRUITING city: Jing'an country: China name: Jian Sun, MD role: CONTACT email: docbenjaminsun@163.com facility: Shanxi Bethune Hospital status: RECRUITING city: Taiyuan country: China name: Ruiying Wang, MD role: CONTACT phone: +86 13903436432 email: wry0526@163.com lat: 37.86944 lon: 112.56028 hasResults: False

 nctId: NCT06340282 id: MOTOMED briefTitle: Immersive Virtual Reality and Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients acronym: MOTOMED overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-01 date: 2024-04-03 name: Fundacion Miguel Servet class: OTHER briefSummary: This study will be conducted in a hospital in Spain to investigate how a special intervention using immersive virtual reality technology can benefit hospitalized older adults with difficulties in their daily functionality.

The main objective of this study is to evaluate whether a cognitive stimulation intervention through immersive virtual reality, along with specific physical exercises, can improve the cognitive and physical function of hospitalized older patients. It is expected that this innovative intervention will have a positive impact on the quality of life of these patients.

Participants eligible for the study must be over 75 years old, have severe functional dependency upon hospital admission, and be willing to participate. Those with severe dementia or other terminal illnesses will be excluded.

Participants will be randomly assigned to one of four study groups: a control group without intervention and three intervention groups, including viewing Spanish landscapes through virtual reality, performing specific physical exercises, or a combination of both interventions.

At the end of the study, various aspects such as cognitive and physical function, mood, quality of life, muscle strength, and acceptance of virtual reality technology by patients will be evaluated.

This study aims to provide new insights into the care of hospitalized older adults and explore innovative ways to improve their well-being during their hospital stay conditions: Disability Physical conditions: Cognition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This clinical randomized controlled trial will be conducted in the Acute Geriatric Unit of a tertiary hospital in Spain. A total of 212 acute patients will be enrolled according to the following criteria: age \> 75, Barthel Index \< 60, able to collaborate, expected length of stay \> 5 days, absence of clinical instability and severe dementia (GDS 7) or other end-stage disease. Patients will be randomly assigned to a control group (CG) or any of the three intervention groups (IG): IVR, ME, or IVR + ME. The IVR group will watch ad-hoc videos showing Spanish regional landscapes and villages, approximately 4 minutes per day for three consecutive days. The ME group will undergo aerobic and strength exercise for progressive training of the upper and lower limbs. The IVR + ME group will do both cognitive and physical intervention. The primary outcomes will be cognitive and physical measures at discharge. Mood, quality of life, isometric strength, and acceptance of IVR will be also assessed. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 212 type: ESTIMATED name: Virtual reality name: multicomponent exercise measure: Mini-Mental State Examination (MMSE) measure: Isometric handgrip strength sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06340269 id: PJ2308-0025 briefTitle: Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF acronym: MexACLF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-01 date: 2024-04-03 name: Mexbrain class: INDUSTRY briefSummary: The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are:

* Is the device safe when used according to the instructions for use?
* Does the device work as expected by removing the excess of free copper from the blood?

Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week. conditions: Acute on Chronic Liver Failure conditions: Multiple Organ Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, national, monocentric, single-arm, open label, feasibility pilot clinical trial. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: MEX-CD1 Dialysis measure: SADE for Safety purpose measure: SAE for Safety purpose measure: Performance of MEX-CD1 measure: Change in Acute on Chronic Liver Failure (ACLF) Grade measure: Change in CLIF-C ACLF score measure: Improvement in individual organ function measure: Development of secondary infection measure: Status of ICU measure: hospital discharge measure: Mortality sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie city: Lyon state: Rhône-Alpes zip: 69317 country: France name: Céline GUICHON, MD role: CONTACT phone: +33426109351 email: celine.guichon@chu-lyon.fr name: Céline Guichon, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06340256 id: IRB0000871253 briefTitle: Continuous Spinal Anesthesia Versus Epidural Anesthesia in Geriatric overallStatus: COMPLETED date: 2021-09-18 date: 2023-08-02 date: 2023-08-15 date: 2024-04-01 date: 2024-04-01 name: Assiut University class: OTHER briefSummary: 60 patients aged older than 60 years, American Society of Anesthesiologists (ASA) class II or III and scheduled for major hip surgery will be randomized, in to two groups anesthetized using continuous spinal anesthesia or using continuous epidural anesthesia. conditions: Epidural Catheter studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Continuous spinal anesthesia name: Continuous epidural anesthesia measure: Hemodynamic changes measure: Patient satisfaction sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Al-Azhar Faculty of Medicine city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06340243 id: HODGKIN briefTitle: Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-04-01 date: 2024-04-01 name: Assiut University class: OTHER briefSummary: determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome conditions: Pediatric Hodgkin Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: radiotherapy measure: assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06340230 id: BC-NEO-IIT-SHR-A1811-SHR1316 briefTitle: SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in ER Positive/HER2 Low Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-02-28 date: 2031-02-28 date: 2024-04-01 date: 2024-04-01 name: Shengjing Hospital class: OTHER name: Jiangsu HengRui Medicine Co., Ltd. briefSummary: This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III ER Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles. conditions: ER Positive/HER2 Low Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 93 type: ESTIMATED name: SHR-A1811 Injection + Adebrelimab Injection name: SHR-A1811 Injection + Adebrelimab Injection name: SHR-A1811 Injection measure: Total pathological complete response (tpCR: ypT0-is/ypN0) measure: Breast pathological complete response (bpCR：ypT0-is) measure: Residual cancer burden (RCB) measure: Best overall response rate (BORR) measure: Overall survival (OS) measure: Disease-free survival (DFS) measure: Event-free survival (EFS) measure: Health-related quality of life (HRQOL) (EORTC QLQ-C30) measure: Health-related quality of life (HRQOL) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shengjing Hospital affiliated to China Medical University city: Shenyang state: Liaoning zip: 110004 country: China name: Nan Niu, MD role: CONTACT phone: +8618940256668 email: niunannancy@163.com name: Caigang Liu, MD role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06340217 id: WMT-GDP-RCT briefTitle: Washed Microbiota Transplantation for Diabetic Gastroparesis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-01 date: 2029-07 date: 2024-04-01 date: 2024-04-17 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients. conditions: Diabetic Gastroparesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: washed microbiota transplantation name: placebo measure: The proportion of DGP with symptom relief after the procedure. measure: The extent of change observed in GCSI of participants; measure: The extent of change observed in Gastroparesis Core Symptom Daily Diary (GCS-DD) of participants; measure: The extent of change observed in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) of participants; measure: The extent of change observed in Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL) of participants; measure: The extent of change observed in electrogastrogram (EGG) of participants; measure: The extent of change observed in electrogastrogram (EGG) of participants; measure: The extent of change observed in gastrointestinal ultrasound (GIUS) of participants; measure: The incidence rate of adverse events; measure: The changes in gut microbiota composition and metabolites before and after treatment. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06340204 id: PKUPH-EWS-03 briefTitle: Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma overallStatus: RECRUITING date: 2024-03-25 date: 2026-03-25 date: 2026-12-25 date: 2024-04-01 date: 2024-04-03 name: Peking University People's Hospital class: OTHER name: Peking University Shougang Hospital name: Shandong Cancer Hospital and Institute briefSummary: The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma. conditions: Ewing Sarcoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Irinotecan Hydrochloride Liposome Injection measure: maximum tolerated dose (MTD) measure: Objective Response Rate (ORR) measure: Progression Free Survival (PFS) sex: ALL minimumAge: 8 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Shandong Cancer Hospital and Institute status: NOT_YET_RECRUITING city: Jina state: Shandong zip: 250117 country: China name: Dongyuan Zhu, M.D. role: CONTACT email: 405683898@qq.com facility: Peking University Shougang Hospital status: NOT_YET_RECRUITING city: Beijing zip: 100043 country: China name: Jin GU, M.D. role: CONTACT email: jingu_1999@yahoo.com lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital status: RECRUITING city: Beijin zip: 100034 country: China name: Jie Xu, M.D. role: CONTACT phone: +86 15901040835 email: xujie@pkuph.edu.cn name: Xiaodong Tang, M.D. role: PRINCIPAL_INVESTIGATOR name: Lu Xie, M.D. role: SUB_INVESTIGATOR hasResults: False

 nctId: NCT06340191 id: UJAPIlates1 briefTitle: Cueing and Pilates in Low Back Pain acronym: PIlatesuja overallStatus: COMPLETED date: 2023-05-02 date: 2024-02-20 date: 2024-02-26 date: 2024-04-01 date: 2024-04-01 name: University of Jaén class: OTHER briefSummary: The intervention involved two groups participating in supervised Pilates sessions, twice a week for 8 weeks, featuring a mix of mat and props-based exercises. Group 1 received additional cueing training to enhance alignment, muscle engagement, and movement technique, while Group 2 underwent the same Pilates regimen without this cueing component. conditions: Low Back Pain conditions: Pilates Exercise conditions: Pilates, Core Stability conditions: Mind-body Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 67 type: ACTUAL name: Pilates with cueing name: Pilates without cueing measure: Low back pain measure: Pain report measure: Fear of movement measure: Perceived Stress Scale measure: Pain self-efficacy measure: Patient Impression of Change measure: Body Awareness sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Jaen city: Jaen zip: 23071 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False

 nctId: NCT06340178 id: 2024-00246 briefTitle: CT-guided Lung Biopsy Risk Optimization Method acronym: BROM-I overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-01 date: 2024-04-01 name: Insel Gruppe AG, University Hospital Bern class: OTHER briefSummary: The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung. conditions: Pneumothorax conditions: Biopsy, Needle conditions: Risk Factors conditions: Radiology, Interventional studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 198 type: ESTIMATED name: Fluid application during ct-guided lung biopsy measure: Number of patients with pneumothorax measure: Number of patients with bleeding measure: Number of patients with chest tube placement measure: Number of patients with air embolism sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10 city: Bern zip: 3010 country: Switzerland lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06340165 id: 2023-KS-151 briefTitle: A Real-world Efficacy and Safety Study of Amlotinib for HER2-negative Advanced Breast Cancer overallStatus: RECRUITING date: 2024-02-04 date: 2025-06 date: 2025-06 date: 2024-04-01 date: 2024-04-01 name: The First Hospital of Jilin University class: OTHER briefSummary: This study analyses the efficacy and safety of amlotinib as a study drug in the treatment of HER-2 negative advanced breast cancer in the real world, including the number of treatment lines, monotherapy, combination therapy, and different molecular subtypes of breast cancer. Evidence-based medicine evidence for clinicians. Although the clinical application of amlotinib in breast cancer treatment is a supra-indication drug, in view of its high safety and possible good efficacy for advanced breast cancer, some patients have been clinically adopted to try the treatment after communicating with their families. This study provides evidence for the further use of amlotinib in breast cancer treatment by analysing the efficacy and safety of amlotinib in real-world applications. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 153 type: ESTIMATED name: Anlotinib measure: PFS sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin zip: 130021 country: China name: xu sun role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 hasResults: False

 nctId: NCT06340152 id: 808385 id: U01HG013189-01 type: NIH link: https://reporter.nih.gov/quickSearch/U01HG013189-01 briefTitle: Multi-Omics for Maternal Health After Preeclampsia acronym: MOM-Health overallStatus: RECRUITING date: 2023-12-20 date: 2028-12 date: 2028-12 date: 2024-04-01 date: 2024-04-01 name: University of California, San Diego class: OTHER name: National Human Genome Research Institute (NHGRI) name: Vanderbilt University Medical Center briefSummary: To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies. conditions: Pre-Eclampsia conditions: Pregnancy Induced Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1100 type: ESTIMATED measure: Preeclampsia measure: Gestational hypertension measure: Postpartum hypertension measure: Postpartum cardiovascular disease measure: Other cardiovascular disease sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of California, San Diego status: RECRUITING city: San Diego state: California zip: 92037 country: United States name: Samantha La Belle role: CONTACT phone: 858-249-5985 email: slabelle@health.ucsd.edu name: Louise Laurent, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Marni Jacobs, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06340139 id: Riphah/RCRAHS-ISB/REC/01742 briefTitle: Vestibulo-Ocular Reflex for Balance and Stimming in Autism Spectrum Disorder overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-20 date: 2024-08-20 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: Autism spectrum disorder is a neurodevelopmental disorder that encompasses a number of disorders specifically affecting social skills, Communication and present with Rapid repetitive behaviors. Autism spectrum disorder also presents with inability of body to process sensory information which can causes symptoms such as balance deficits, sensitivity to certain sounds or an exaggerated reaction to a normal stimulus. Autism spectrum disorder can affect the quality of life of an individual to a severe extent. This disorder due to sensory processing deficits also shows difficulty in motor planning, coordination and execution of tasks which can make performing activities of daily living highly difficult to perform. It is called a developmental disorder because it affects the growth. Milestones are often delayed in individuals with autism. Due to these deficits individual with autism if not provided with therapies at the right age can stay dependent on caretaker for their whole life. Rapid repetitive behaviors also known as self-stimulatory behaviors are a way to compensate with anxiety, difficulty in processing sensory information and are often used to stimulate themselves to feel calm. Though not a diagnostic symptom autism often still presents with vestibular dysfunction which affects the balance. Several individuals with autism have showed abnormal vestibular ocular reflexes; abnormally long latency of saccades. Rehabilitation protocol of Autism often includes symptomatic treatment and several therapy protocols such as physical therapy, occupational therapy, applied behavior analysis therapy and play therapy. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: conventional treatment name: experimental treatment measure: Aberrant behavior checklist measure: Berg Balance Scale (BBS) measure: Repetitive Behavior Scale - Revised measure: Functional Reach Test sex: ALL minimumAge: 13 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: zamam autism Centre status: RECRUITING city: Islamabad country: Pakistan name: Rahim Hussain role: CONTACT lat: 33.72148 lon: 73.04329 hasResults: False

 nctId: NCT06340126 id: REC/RCR & AHS/23/0567 briefTitle: Effects of Active Tissue Release Techniques on Groin Pain in 2nd Trimester of Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-20 date: 2024-10-05 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: The study will focus on the effects of active tissue release techniques on groin pain, hip range of motion, and functional disability in 2nd trimester of pregnancy. This will be a randomized controlled trial conducted on 30 participants from Prime Care Hospital. Pregnant women in the second trimester aged between 25 to 35 years, who have groin or round ligament pain will be included in this study. A sample of 30 will be divided into 2 groups. Group A will undergo treatment of active release techniques for 10 minutes thrice a week with no home plan of home relaxation exercises. In contrast, Group B will combine treatment of active release technology with home relaxation exercises. Treatment will be given for 4 weeks and pain will be assessed before and after the treatment through (NPRS) scale. Functional disability will be measured before and after the treatment through Quebec scale and Force Disability Scale Questionnaire in both groups. conditions: Groin Strain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Active release techniques name: Relaxation exercises measure: Numeric Pain Rating Scale measure: The Quebec questionnaire: measure: Goniometer: To measure range of motion: sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT facility: Prime Care Hospital city: Faisalābad state: Punjab zip: 38000 country: Pakistan name: Ghulam Fatima, PhD* role: CONTACT phone: 03034073057 email: ghulam.fatima@riphah.edu.pk lat: 31.41554 lon: 73.08969 hasResults: False

 nctId: NCT06340113 id: REC/RCR & AHS/23/0108 NASHIA briefTitle: Mulligan and Mckenzie Exercises Alongwith Stabilization Exercises in Patients With Chronic Neck Pain overallStatus: RECRUITING date: 2023-11-20 date: 2024-06-01 date: 2024-06-01 date: 2024-04-01 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: The goal of this \[type of study: Randomized control trial\] is to \[ compare the effectiveness of Mulligan and McKenzie Exercises along with stabilization exercises on pain, range of motion and disability \] in \[ in patients with chronic neck pain\].The main question it aims to answer is:

* Wether Mulligan is more effective or Mckenzie exercises along with stabilization exercises in the treatment of patients with chronic neck pain Group 1 will recieve Mulligan and stabilization exercises Group 2 will recieve Mckenzie and stabilization exercises conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: MCKENZIE AND STABILIZATION EXERCISES name: MULLIGAN AND STABILIZATION EXERCISES measure: Numeric pain rating scale measure: Neck Disability Index (NDI) measure: Goniometer sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Riphah international university status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Muhammad Sanaullah, MS role: CONTACT phone: 03224819253 email: muhammad.sanaullah@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06340100 id: REC/MS-PT/01832 briefTitle: Association of History of Concussion With Vestibular Impairment and Cognitive Function in Sports Athletes overallStatus: RECRUITING date: 2024-03-23 date: 2024-04-23 date: 2024-06-02 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: This study investigates the potential relationship between prior concussions and their impact on both vestibular function and cognitive abilities in athletes participating in sports. conditions: Concussion, Mild conditions: Vestibular Impairment conditions: Cognitive Impairment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 115 type: ESTIMATED name: find association between vestibular impairment , cognitive fiunction with concussin measure: CANTU measure: Sports concussion office assesment tool 6 sex: ALL minimumAge: 18 Years maximumAge: 36 Years stdAges: ADULT facility: HAYATABAD Sports complex status: RECRUITING city: Peshawar state: Khyber Pakhtun Khawan zip: 24730 country: Pakistan name: Nadia Ishtiaq, MSOMPT role: CONTACT phone: +922486977541 email: Nadia.Ishtiaq@riphah.edu.pk name: MAHEEN GUL, MSSPT* role: CONTACT phone: +923319533510 name: Maheen Gul, MS*SPT role: PRINCIPAL_INVESTIGATOR lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06340087 id: 706014-3 briefTitle: Impact Hesperetin in Combination With Sucrose on Blood Glucose Regulation overallStatus: RECRUITING date: 2024-03-31 date: 2024-08-31 date: 2025-03-31 date: 2024-04-01 date: 2024-04-23 name: University of Vienna class: OTHER briefSummary: The aim of this cross-over intervention study is to investigate the influence of hesperetin applied in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution and an isocaloric sucrose-only solution on markers of energy metabolism conditions: Blood Glucose Fluctuations conditions: Hunger studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: 10% Sucrose name: Sucrose+ Hesperetin name: 7% Sucrose measure: Change in blood glucose concentration measure: Change in appetite score measure: Change in food intake measure: Change in regulating hormones sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Christian Doppler Laboratory for Taste Research status: RECRUITING city: Vienna zip: 1090 country: Austria name: Barbara Lieder, PhD role: CONTACT phone: +431427770611 email: Barbara.Lieder@univie.ac.at lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06340074 id: STUDY00010282 briefTitle: Helping Educational Leadership Mobilize Evidence acronym: HELM overallStatus: COMPLETED date: 2022-08-28 date: 2023-06-01 date: 2023-06-07 date: 2024-04-01 date: 2024-04-01 name: University of Washington class: OTHER briefSummary: Many universal, evidence-based prevention practices (EBPPs) have been developed to prevent SEB problems, typically in elementary schools, but progress toward widespread implementation has been slow and few efforts have been made to develop and test interventions to enhance EBPP implementation in schools. Schools leaders (e.g., principals) are key to decision making and implementation of EBPPs, and their leadership has been shown to be consistently linked to student outcomes through their intentional efforts to support teacher adoption and use of innovative programs. Helping Educational Leaders Mobilize (HELM) Evidence is a pragmatic, multifaceted, organizationally-focused implementation strategy targeting the implementation leadership and implementation climate of school buildings (through principals) to enhance the adoption and delivery of EBPPs in elementary schools. This pilot study, part of the larger HELM project to adapt and test the strategy based on an existing leadership intervention, Leadership and Organizational Change for Implementation (LOCI), will be implemented in the context of Positive Greetings at the Door (PGD), a universal school-based EBPP previously demonstrated to reduce disruptive behavior and increase academic engagement. conditions: Behavior, Child studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 333 type: ACTUAL name: HELM name: Implementation Attention Control (IAC) measure: Proximal Outcome: Strategic Implementation Leadership measure: Proximal Outcome: Strategic Implementation Climate measure: Proximal Outcome: Implementation Citizenship Behavior measure: Proximal Outcome: Implementation Initiative Stability measure: Implementation Outcome: Fidelity and Sustainment - Observed measure: Implementation Outcome: Fidelity and Sustainment - Self Report measure: Implementation Outcome: Reach measure: Implementation Outcome: Facilitators and Barriers to Implementation measure: Implementation Outcome: Implementation Cost measure: Student Educational Outcomes measure: Student Behavioral Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington School Mental Health Assessment, Research, and Training (SMART) Center city: Seattle state: Washington zip: 98115-8160 country: United States lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06340061 id: Qianyu Wu briefTitle: The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters. overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: Henan Provincial People's Hospital class: OTHER briefSummary: The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma conditions: Glaucoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Observational study measure: IOP measure: bIOP measure: ACD measure: ACW measure: SSI measure: VF sex: ALL minimumAge: 22 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Provincial People's Hospital city: Zhengzhou state: Henan zip: 450003 country: China lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06340048 id: XC Liu briefTitle: Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure overallStatus: RECRUITING date: 2023-09-05 date: 2024-09-05 date: 2025-03-05 date: 2024-04-01 date: 2024-04-01 name: Help Therapeutics class: INDUSTRY name: TEDA International Cardiovascular Hospital briefSummary: The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure. conditions: Heart Failure studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: HiCM-188 therapy measure: The incidence of major Serious Adverse Events (SAE) measure: Grade 4 or above arrhythmias measure: The incidence of tumor measure: Left ventricular geometry as assessed by cardiac magnetic resonance imaging (MRI) measure: Size of myocardial infarction as assessed by MRI measure: Ventricular wall motion as assessed by MRI measure: Left ventricular ejection fraction as assessed by MRI measure: Cardiac Volumes as assessed by MRI measure: Cardiac output (CO) as assessed by MRI measure: 10.End-diastolic myocardial mass as assessed by MRI measure: Left ventricular ejection fraction (LVEF) as assessed by Echocardiography measure: Fractional shortening (FS) as assessed by Echocardiography measure: Left ventricular dimensions as assessed by Echocardiography measure: Cardiac Volumes as assessed by Echocardiography measure: Mitral valve inflow spectrum(E/A) as assessed by Echocardiography measure: Longitudinal strain as assessed by Echocardiography measure: Myocardial viability as assessed by SPECT measure: Myocardial blood flow as assessed by SPECT measure: NT-proBNP Levels measure: 6-minute walking distance measure: New York Heart Association (NYHA) functional classification measure: Changes of Quality of Life (QoL) as assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ) measure: Changes of Quality of Life(QOL) as assessed by 36-Item Short Form Survey (SF-36) sex: ALL minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TEDA International Cardiovascular Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300457 country: China name: Xiaocheng Liu role: CONTACT phone: +86-022-65208030 name: Xiaocheng Liu role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06340035 id: 20230901 briefTitle: Percutaneous Peripheral Nerve Stimulation of Gluteus Nerves to Improve Hip Strength and Power overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-04 date: 2024-06 date: 2024-04-01 date: 2024-04-01 name: Hospital Clinic of Barcelona class: OTHER briefSummary: The goal of this pilot clinical trial is to evaluate whether the ultrasound-guided percutaneous peripheral nerve stimulation through a needle results in greater gains in strength and power compared to the administration of current through surface electrodes in patients undergoing strength and power assessments. The main questions it aims to answer are:

Does percutaneous stimulation of the superior and inferior gluteal nerves using ultrasound-guided needles enhance strength and power more effectively than transcutaneous stimulation through electrodes?

Is the effectiveness of current delivery significantly different between percutaneous and transcutaneous methods when assessed with a linear encoder in a standarized hip extension exercise?

Participants will:

Be randomized into two groups: one undergoing ultrasound-guided percutaneous stimulation of the gluteal nerves (experimental group) and the other undergoing transcutaneous stimulation through electrodes (control group).

The same stimulation protocol at 10 Hz frequency with the maximum muscle contraction evoked without pain will be performed in both groups. Then, the participants will undergo strength and power assessment before and after therapy administration using a linear encoder in a hip extension exercise.

Researchers will compare the experimental group to the control group to see if the method of current delivery (percutaneous vs. transcutaneous) has a significant impact on the gains in strength and power. This comparison is based on the hypothesis that percutaneous delivery of current, guided by ultrasound, is more effective than simply positioning a surface electrode for transcutaneous stimulation. The evaluation of strength and power will be performed through a linear encoder that measures peak strength and concentric power in each repetition, conducted by a blind operator unaware of the patients' group allocations. conditions: Chronic Pain conditions: Chronic Knee Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This pilot study utilizes a randomized parallel-group design, focusing on procedure feasibility for future clinical trials, in line with extended CONSORT guidelines for pilot studies. Participants, selected through a convenience sampling method due to their chronic knee pain, received pre- and post-treatment evaluations to assess the effect on gluteal muscle function. Post-informed consent, participants were allocated to either TENS or ultrasound-guided percutaneous nerve stimulation via a computer-generated randomization process executed with GraphPad Software (San Diego, CA, USA), ensuring a balanced 1:1 ratio. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In the study, blinding will be implemented to minimize bias. The evaluating clinician will be blinded to participant group assignments, ensuring assessments are unbiased. Similarly, the data analyst will also be blinded, analyzing data without knowledge of group allocations to maintain impartiality. Data will be handled objectively, with statistical methods applied blindly to compare treatment groups. Despite challenges in completely blinding participants due to the distinct nature of interventions, every effort will be made to minimize potential bias. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ACTUAL name: TENS name: Percutaneous Peripheral Nerve Stimulation measure: Hip Extension Concentric Peak Power (Watts) measure: Hip Extension Concentric Peak Strength (Newtons) measure: Concentric Phase Velocity (m/s) measure: Maximum Strength (1RM in kgs) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Barcelona city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06340022 id: 2022-31 briefTitle: Pain and Anxiety Levels of Sleeperone Electronic Anesthesia System in Pediatric Patients overallStatus: COMPLETED date: 2023-03-13 date: 2023-10-02 date: 2023-11-15 date: 2024-04-01 date: 2024-04-01 name: Eskisehir Osmangazi University class: OTHER briefSummary: The conventional method used for dental anesthesia in children is the administration of a local anesthetic solution by injection. Although this process successfully eliminates pain during the procedure, it continues to be a problem for many children in terms of dental anxiety before and during anesthesia administration.

The aim of this study is to compare intraosseous anesthesia with SleeperOne® 5, a computer-assisted local anesthesia system, with conventional local anesthesia techniques in terms of pain and anxiety. conditions: Dental Anxiety conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study was a single-center randomized controlled trial using a split mouth design with a 1:1 split ratio. primaryPurpose: OTHER masking: NONE count: 32 type: ACTUAL name: Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale name: Face Image Scale (FIS) scoring system name: Visual Analogue Scale (VAS) name: pulse rate measure: The pulse rate measurements before and after the anesthesia techniques measure: Determine the anxiety level before the procedures measure: The anxiety measurements before and after the anesthesia techniques measure: The pain measurements during the anesthesia techniques sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Eskisehir Osmangazi University Faculty of Dentistry, Department of Pediatric Dentistry city: Eskişehir country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False

 nctId: NCT06340009 id: REC/01743 briefTitle: MIME THERAPY vs MOTOR IMAGERY TECHNIQUE in Bell's Palsy overallStatus: RECRUITING date: 2024-03-22 date: 2024-08-22 date: 2024-08-25 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: Bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. It was first identified by scientist Sir Charles Bell, and its sudden onset can lead to social, psychological, and emotional distress. Left untreated, Bell's palsy can have long-lasting effects on a patient's quality of life, including loss of facial muscle control, emotional stress, and communication difficulties. Rehabilitation protocols encompass various physical therapy techniques, among which Mime therapy and Motor imagery technique have shown promise. conditions: Bell Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: mime therapy name: motor imagery measure: House-Brackmann Scale (HBS) measure: Facial Disability Index (FDI) measure: Sunnybrook Facial Grading System measure: Synkinesis Assessment Questionnaire (SAQ) sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Muzaffar Hospital status: RECRUITING city: Sargodha country: Pakistan name: Mulazam Imran, MS-NMPT* role: CONTACT lat: 32.08361 lon: 72.67111 hasResults: False

 nctId: NCT06339996 id: KSVGH24-CT1-10 briefTitle: Male Supplements for Sperm Quality and Aging overallStatus: RECRUITING date: 2024-03-26 date: 2024-03-30 date: 2024-09-30 date: 2024-04-01 date: 2024-04-02 name: Kaohsiung Veterans General Hospital. class: OTHER briefSummary: This study investigates the effects of a new supplement on sperm quality in men with poor sperm quality. Fifty patients will receive the supplement for three months, followed by semen analysis and assessment of sperm aging and mitochondrial function. Changes in sexual function and aging symptoms will also be evaluated. conditions: Unrecognized Condition studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Male supplement measure: Semen analysis measure: oxygen consumption of mitochondria measure: mitochondrial function measure: sexual function measure: aging symptoms sex: MALE minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Kaohsiung Veterans General Hospital status: RECRUITING city: Kaohsiung country: Taiwan name: Li-Te Lin role: CONTACT phone: +88673464027 email: litelin1982@gmail.com name: Kuan-Hao Tsui role: CONTACT lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06339983 id: REC/RCR & AHS/23/0566 briefTitle: Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-20 date: 2024-10-05 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: Study focuses on comparing the effects of manual scar mobilization and myofascial cupping techniques on the outcomes of pain, physical characteristics, and appearance of cesarean scars. The study aims to contribute valuable insights into tailored interventions for improving cesarean scars. The randomized clinical trial will involve 52 participants, primigravida women aged 20 to 40 with completely healed but painful cesarean scars. Excluding those with previous scar therapy or infectious scars, the participants will be divided into two groups, with Group A receiving manual scar mobilization therapy and Group B receiving myofascial cupping therapy, both administered twice a week for four weeks. Pain assessment will be conducted using a numeric pain rating scale (NPRS), while physical characteristics and appearance will be evaluated using the Manchester Scar Scale for cesarean scars (MSS). The data collected will be analyzed using SPSS version 29. conditions: Cesarean Section; Complications, Wound, Hematoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Manual Scar Mobilization Therapy: name: Myofascial Cupping Therapy: measure: Numeric Pain Rating Scale measure: Manchester Scar Scale (MSS) sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Kulsoom Shoukat Medical Complex city: Faisalābad state: Punjab zip: 3800 country: Pakistan name: Ghulam Fatima, PhD* role: CONTACT phone: 03034073057 email: ghulam.fatima@riphah.edu.pk lat: 31.41554 lon: 73.08969 hasResults: False

 nctId: NCT06339970 id: REC/RCR & AHS/23/0199 iram briefTitle: Effects of Slider Versus Tensioners Nerve Gliding in Cervical Radiculopathy. overallStatus: RECRUITING date: 2023-11-23 date: 2024-06-01 date: 2024-06-01 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: This study will be a randomized clinical trial in which Slider versus Tensioners Nerve Gliding Technique along with Mulligan Spinal Mobilization will be applied on the individuals with cerviculorediculopathy and changes will be recorded using different methods and tools. Convenient sampling technique will be used to collect the data. The sample size of 40 patients will be recruited. Patients will be randomly allocated into two different groups through sealed envelope method.20 patients will be allocated in each group A will be treated with Slider Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique; Group B will be treated with Tensioners Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique .Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI) and goniometer will be used as Data collecting tools. After data collection from defined study setting, data will be entered and analyzed. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 42 type: ESTIMATED name: Slider Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique name: Tensioners Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique measure: Numeric Pain Rating Scale measure: Neck disability index measure: Goniometer sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Sehat Medical Compolex status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Iram Dalawar, DPT role: CONTACT phone: 03056087141 email: driramdalawar68@gmail.com name: Iram Dalawar role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06339957 id: STUDY00006394 briefTitle: Rheumatology Diet Study overallStatus: RECRUITING date: 2024-03-01 date: 2024-07-01 date: 2024-07-01 date: 2024-04-01 date: 2024-04-01 name: University of Central Florida class: OTHER briefSummary: This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information. conditions: Diet Habit conditions: Rheumatologic Disease conditions: Autoimmune Diseases conditions: Rheumatoid Arthritis conditions: Psoriatic Arthritis conditions: Ankylosing Spondylitis conditions: Dermatomyositis/Polymyositis conditions: Sjogren's Syndrome conditions: Systemic Lupus Erythematous conditions: Scleroderma conditions: Fibromyalgia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED measure: To determine how diet habits and activity affects autoimmune diseases using the proper statistical tests for the data set such as t-test and ANOVA. measure: To identify if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCF Health Clinics status: RECRUITING city: Orlando state: Florida zip: 32827 country: United States lat: 28.53834 lon: -81.37924 hasResults: False

 nctId: NCT06339944 id: REC/RCR& AHS/23/0198RubabTalib briefTitle: Effects of Sensory Motor Training and Kinesthetic Exercises in Knee Osteoarthritis. overallStatus: RECRUITING date: 2023-11-23 date: 2024-06-01 date: 2024-06-01 date: 2024-04-01 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: In this study i will see the effects of kinesthetic exercises and sensory motor training on pain and range of motion in patients with knee OA. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: sensory motor training name: kinesthetic exercises measure: VAS measure: goniometer measure: WOMAC questionaire measure: joint position sense test sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Tariq Hospital status: RECRUITING city: Sheikhupura state: Punjab zip: 39350 country: Pakistan name: Rubab Talib, MS role: CONTACT phone: 03040442101 email: rubabtalib111@gmail.com lat: 31.71306 lon: 73.97833 hasResults: False

 nctId: NCT06339931 id: REC/RCR &AHS/23/0181 briefTitle: Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy. overallStatus: RECRUITING date: 2023-11-23 date: 2024-06-01 date: 2024-06-01 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: Lumber radiculopathy, also known as sciatica, is a condition that causes pain in the lower back and legs due to irritation or compression of the spinal nerves. group between 20 and 50 years old. This study will explore the effects of lumbar spine mobilization with leg movement and spinal traction with and without belt in patients with pain and functional limitations due to lumbar radiculopathy. A randomized control trial will be conducted at Atta Jaspal Hospital and Trauma Center through convenient sampling technique on 44 patients, which will be allocated through simple random sampling through sealed opaque envelopes into groups A and B. Group A will be treated with SMWLM, conventional electrotherapy, and traction without a belt, and Group B will be treated with SMWL, conventional electrotherapy, and lumbar traction with a belt. A pretreatment baseline will be set for pain, ROM, and disability at the lumbar spine by using the NPRS, inclinometer, and ODI questioner. Follow-up will be conducted after 4 weeks of post-treatment sessions. The intensity of pain, range of motion, and disability index will be evaluated using the NPRS, inclinometer, and ODI questionnaire. The data will be analyzed using SPSS software version 26. The conclusion of the study will be based on either accepting or rejecting the null and alternate hypotheses. conditions: Lumbar Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 44 type: ESTIMATED name: SMWLM combined Spinal traction with belt name: SMWLM combined spinal traction without belt measure: Numeric pain rating scale measure: Inclinometer measure: Oswestry Disability Index sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Atta Jaspal Hospital and ortho trauma center status: RECRUITING city: Bhalwal state: Punjab zip: 40410 country: Pakistan name: Azka Ijaz, DPT role: CONTACT phone: 03171742917 email: azkijaz786@gmail.com name: Azka Ijaz, DPT role: PRINCIPAL_INVESTIGATOR lat: 32.26576 lon: 72.89809 hasResults: False

 nctId: NCT06339918 id: REC/RCR & AHS/23/0570 briefTitle: Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique in Primary Dysmenorrhea overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-20 date: 2024-10-05 date: 2024-04-01 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: A randomized clinical trial will be conducted at Riphah International University QIE Campus in Lahore, using non-probability convenience sampling with 28 participants. Criteria include women aged 14-26, nulliparous, experiencing primary dysmenorrhea, with normal menstrual cycles and the ability to exercise independently. Group A will receive kegel exercises and 4-7-8 breathing techniques over 8 weeks, while Group B will only receive the breathing technique. Assessments will be done on menstrual cycle days, with follow-ups at weeks 4 and 8 using specific scales. Data will be analyzed using SPSS version 27. conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: KegelExercise name: 4-7-8 breathing technique measure: Numeric Pain Rating Scale measure: WALIDD Primary Dysmenorrhea Intensity Scale measure: Pain Self-Efficacy Questionnaire (PSEQ) sex: FEMALE minimumAge: 14 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT facility: Riphah International University Clinic city: Lahore state: Punjab zip: 54700 country: Pakistan name: Ghulam Fatima role: CONTACT phone: +923034073057 email: ghulam.fatima@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06339905 id: 10840098-772.02-5564 briefTitle: The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success overallStatus: COMPLETED date: 2022-01-01 date: 2022-08-31 date: 2023-08-31 date: 2024-04-01 date: 2024-04-01 name: Istanbul Medipol University Hospital class: OTHER briefSummary: This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation. conditions: Periapical Periodontitis conditions: Root Canal Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 140 type: ACTUAL name: Sonic Activation with EndoActivator name: Control Needle Irrigation measure: change from baseline postoperative pain at 1 week measure: change from baseline periapical index at 1 year sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Istanbul Medipol University, Faculty of Dentistry city: Istanbul state: Esenler country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06339892 id: 2022-3.11/451 briefTitle: HCMV Breakthrough Infections During Letermovir Prophylaxis acronym: CMVbreak overallStatus: RECRUITING date: 2023-01-09 date: 2025-06 date: 2026-03 date: 2024-04-01 date: 2024-04-01 name: Foundation IRCCS San Matteo Hospital class: OTHER name: Ministero della Salute, Italy briefSummary: The goal of this clinical trial is to compare two strategies to monitor human cytomegalovirus (HCMV) infections in transplanted patients receiving letermovir (LTV) as anti-HCMV prophylaxis.

HCMV infection after transplantation is diagnosed by detection of HCMV DNA in blood. However, due to the peculiar mechanism of action of LTV, most episodes of HCMV DNA detection are caused by release in the blood stream of non-infectious HCMV DNA.

In true episodes of productive infection, HCMV DNA in blood is present inside the virion and therefore is resistant to DNAse digestion. Conversely, when non-infectious free-floating HCMV DNA is released in the bloodstream, it will be degraded after treatment of plasma with DNAse and will not be detectable by real-time PCR assays.

Researchers will compare determination of HCMV DNA in blood with or without previous digestion of non-infectious free-floating DNA with DNAse.

In patients of the Control group HCMV DNA will be tested without DNAse digestion. If HCMV DNA is positive, patients will stop LTV prophylaxis and receive antiviral therapy with another drug.

In patients of the Study group HCMV DNA will be tested after DNAse digestion. Only if HCMV DNA is positive after DNAse digestion, patients will stop LTV prophylaxis and receive antiviral therapy with another drug.

The main aim of the study is to demonstrate that, by avoiding inappropriate antiviral therapy during LTV prophylaxis, transplant patients will suffer of lower antiviral-drug-related toxicity. A monitoring strategy able to identify true episodes of HCMV productive infection during LTV prophylaxis will lead to a lower rate of inappropriate antiviral therapy and drug-related toxicity without an increased risk of HCMV disease. conditions: Cytomegalovirus Infections conditions: Cytomegalovirus Viremia conditions: Hematopoietic Stem Cell Transplantation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 140 type: ESTIMATED name: Determination of HCMV DNA in plasma after DNAse digestion. name: Determination of HCMV DNA in blood or plasma. measure: - Proportion of patients with positive HCMV DNAemia developing antiviral drug-related toxicity. measure: Proportion of patients developing HCMV DNAemia during LTV prophylaxis. measure: Proportion of patients developing HCMV disease within day 100 and between day 100 and 360 from transplant (key secondary endpoint) measure: Proportion of patients stopping LTV prophylaxis and shifting to GCV/VGCV/FOS therapy. measure: Proportion of patients requiring GCV/VGCV/FOS therapy between day 100 and 360. measure: Proportion of patients with persisting HCMV DNAemia. measure: Proportion of patients developing neutropenia between day 100 and 360. measure: Proportion of patients developing HCMV-specific T-cell response at day 100, 180, and 360. measure: Proportion of patients developing LTV-resistant HCMV strains. measure: Cumulative incidence of acute or chronic GvHD. measure: Transplant related mortality (TRM), underlying disease relapse, and 1-year survival. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST-Spedali Civili status: RECRUITING city: Brescia state: BS country: Italy name: Michele Malagola, MD role: CONTACT lat: 45.53558 lon: 10.21472 facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia state: PV zip: 27100 country: Italy name: Daniele Lilleri, MD role: CONTACT phone: +39 0382 502420 email: d.lilleri@smatteo.pv.it name: Irene Cassaniti, PhD role: CONTACT phone: +39 0382 502420 email: i.cassaniti@smatteo.pv.it lat: 45.19205 lon: 9.15917 facility: ASST-Ospedale Papa Giovanni XXIII status: NOT_YET_RECRUITING city: Bergamo country: Italy name: Alessandra Algarotti, MD role: CONTACT lat: 45.69601 lon: 9.66721 facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna status: NOT_YET_RECRUITING city: Bologna country: Italy name: Francesca Bonifazi, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: ASST Grande Ospedale Metropolitano Niguarda status: NOT_YET_RECRUITING city: Milano country: Italy name: Arianna Pani, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" status: NOT_YET_RECRUITING city: Reggio Calabria country: Italy name: Barbara Loteta, MD role: CONTACT lat: 38.11047 lon: 15.66129 facility: AOU Policlinico Umberto I status: NOT_YET_RECRUITING city: Roma country: Italy name: Corrado Girmenia, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Policlinico Universitario Agostino Gemelli status: NOT_YET_RECRUITING city: Roma country: Italy name: Patrizia Chiusolo, MD role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06339879 id: IRB-2023-1071 briefTitle: Health Effects of Grain Foods in Adults overallStatus: RECRUITING date: 2024-01-18 date: 2026-06-30 date: 2026-12-31 date: 2024-04-01 date: 2024-04-04 name: Purdue University class: OTHER name: Grain Food Foundation briefSummary: This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar. It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics, appetite, food/energy intake, body weight, blood pressure, acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars, saturated fats and sodium. conditions: High Whole Grain and Low Sugar conditions: Medium Whole Grain and Low Sugar conditions: Low Whole Grain and Low Sugar conditions: Low Whole Grain and High Sugar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel assignment primaryPurpose: BASIC_SCIENCE masking: NONE count: 120 type: ESTIMATED name: High Whole Grain, Low Sugar name: Low Whole Grain, Low Sugar name: High Whole Grain, High Sugar name: Low Whole Grain, High Sugar measure: Glycemia measure: Appetite measure: Taste Hedonics measure: Energy Intake measure: Body Weight measure: Systolic and Diastolic Blood Pressure measure: Lipemia sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT facility: Purdue University status: RECRUITING city: West Lafayette state: Indiana zip: 17907 country: United States name: Richard D Mattes, PhD role: CONTACT phone: 765-494-0662 email: mattes@purdue.edu name: Richard D Mattes, PhD, RD, MPH role: PRINCIPAL_INVESTIGATOR lat: 40.42587 lon: -86.90807 hasResults: False

 nctId: NCT06339866 id: E16734702 briefTitle: The Effect of Two Different Video Showings on Pain and Anxiety in Children Undergoing Adenotonsillectomy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-25 date: 2024-06-25 date: 2024-06-25 date: 2024-04-01 date: 2024-04-02 name: Zonguldak Bulent Ecevit University class: OTHER briefSummary: Purpose of the Research: The purpose of the research is to examine the effect of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.

Type of Research It is planned as a randomized controlled interventional type study to examine the effects of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy. conditions: Pain After Adenotonsillectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The population of the research will be all patients who had adenotonsillectomy surgery between the ages of 6-12 in the Ear Nose and Throat Service of Zonguldak Bülent Ecevit University Hospital, and the sample will be all patients who had adenotonsillectomy surgery between the specified dates and who meet the inclusion criteria. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ACTUAL name: The Effect of Two Different Video Interventions on Pain and Anxiety in Children with Adenotonsillectomy: A Randomized Controlled Study measure: After the intervention, the mean score of the children in the postoperative animation and cartoon group on the Wong Baker Pain Rating Scale will be lower than those in the control group. measure: After the intervention, the mean score of the Children's Anxiety Scale-Stability score of the children in the postoperative animation and cartoon group will be less than those in the control group. sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Mihriye city: Zonguldak zip: 67600 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False

 nctId: NCT06339853 id: 1-2023-0023 briefTitle: Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia overallStatus: COMPLETED date: 2023-09-07 date: 2024-02-29 date: 2024-02-29 date: 2024-04-01 date: 2024-04-01 name: Yonsei University class: OTHER briefSummary: The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: WELT-IP with wearable devices (Apple/galaxy watch. Oura ring) measure: Change from baseline to week 9 (post-treatment) of ISI measure: Secondary Outcome - Changes from baseline to week 9 of SE measure: Changes from baseline to week 9 of SOL. measure: Changes from baseline to week 9 of WASO. measure: Changes from baseline to week 9 of PHQ-9. measure: Changes from baseline to week 9 of GAD-7. measure: Changes from baseline to week 9 of compliance. sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Psychiatry, Severance Hospital city: Seoul, zip: 120-752 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06339840 id: 2024-036-01 briefTitle: The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2027-03-31 date: 2024-04-01 date: 2024-04-01 name: Third Affiliated Hospital of Zhengzhou University class: OTHER briefSummary: Obesity, defined by WHO standards as having a body mass index (BMI) equal to or greater than 30 kg/m², affects approximately 800 million people worldwide. It is evident that obesity has become a serious public health issue, resulting in significant health burdens.

Previous systematic reviews have indicated an association between obesity and male factor infertility. In populations undergoing assisted reproductive technology (ART), some studies have shown a correlation between increased male BMI and adverse ART outcomes. Furthermore, the negative effects of obesity may also be transmitted to offspring through genetic and epigenetic changes in reproductive cell DNA, increasing their risk of obesity, metabolic diseases, or other chronic conditions.

Currently, there is a lack of data on the impact of weight loss in obese men on fertility, and it is unclear which nutritional pattern in lifestyle interventions can more effectively control weight, improve semen quality, and address related endocrine issues in obese men, thereby improving reproductive treatment outcomes.

Based on previous literature, we hypothesize that lifestyle interventions, particularly strict low-carbohydrate diets combined with lifestyle guidance, may offer greater health benefits for obese men. These benefits include effective weight loss, improvement in semen parameters, reproductive metabolic health, quality of life related to reproductive health, and the impact on reproductive treatment outcomes. This provides a basis for non-pharmacological intervention strategies and methods for the health of obese men. conditions: Obesity conditions: Weight Loss conditions: Male Fertility conditions: Artificial Insemination conditions: IVF-ET studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Based on the design of this clinical trial, blinding is not implement ed for participants and care providers. Blinding is only applied to outcome assessors and investigators. Outcome assessors are clinical staff members who are unaware of the group assignments, and data is collected directly from the medical records system by EDC data entry personnel for management (double-checking). Data analysts will directly extract information and data from the EDC database for statistical analysis. Blinding will be revealed upon completion of result analysis. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ESTIMATED name: Low-carbohydrate diet group name: Health Education Group measure: Weight measure: Semen parameter- Sperm concentration measure: Semen parameter- Sperm motility measure: Semen parameter- Sperm morphology measure: Semen parameter- Sperm DNA fragmentation index (DFI) measure: Semen parameter- Sperm progressive motility (PR) measure: Semen parameter- Non-progressive motility (NP) measure: Semen parameter- Immotility (IM) measure: body mass index (BMI) measure: Waist circumference measure: Hip circumference measure: Lean mass measure: Fat mass measure: Abdominal fat measure: Visceral fat measure: Blood pressure measure: Heart rate measure: Lipid profile-triglycerides measure: Lipid profile-LDL measure: Lipid profile-HDL measure: Lipid profile-VLDL measure: Lipid profile-total cholesterol measure: Glucose metabolism-fasting glucose measure: Glucose metabolism-OGTT measure: Glucose metabolism-insulin measure: Glucose metabolism-C-peptide measure: Glucose metabolism-HbA1c measure: Sex hormones measure: Adult background measure: Questionnaire - Adult physical activity measure: Questionnaire - Quality of life measure: Questionnaire - Psychological condition measure: Questionnaire - Sleep measure: Spouse's reproductive outcome - Methods of Fertilization measure: Spouse's reproductive outcome - Time to pregnancy measure: Spouse's reproductive outcome - Length of gestational age measure: Spouse's reproductive outcome - Medication use measure: Spouse's reproductive outcome - Delivery mode measure: Spouse's reproductive outcome - Pregnancy complications measure: Spouse's reproductive outcome - Obstetrics complications measure: Fetal and offspring - Apgar score measure: Fetal and offspring - body weight measure: Fetal and offspring - Neonatal fat mass measure: Fetal and offspring - Birth defects/abnormalities measure: Fetal and offspring - length measure: Fetal and offspring - abdominal circumference measure: Fetal and offspring - crown circumference measure: Fetal and offspring - Glucose metabolism measure: Fetal and offspring - Lipid profile measure: Fetal and offspring - Offspring growth factors and hormones measure: Fetal and offspring - Cognitive development of offspring measure: Labs - Semen epigenetics marks measure: Labs - Adult Epigenetics measure: Labs - Cord blood - epigenetics measure: Labs - Cord tissue measure: Labs - Placenta measure: Labs - Placenta - biopsies measure: Labs - Offspring urine measure: Labs - Offspring feces sex: MALE minimumAge: 22 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06339827 id: 2023-102 briefTitle: ASk Questions in GYnecologic Oncology (ASQ-GYO) acronym: ASQ-GYO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2026-02 date: 2024-04-01 date: 2024-04-01 name: Ira Winer class: OTHER briefSummary: The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients. conditions: Ovarian Cancer conditions: Endometrial Cancer conditions: Cervical Cancer conditions: Vulvar Cancer conditions: Vaginal Cancer conditions: Gestational Trophoblastic Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 70 type: ESTIMATED name: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List measure: Change in pre- and post-visit self-efficacy scores and compared by trial group measure: Change in pre- and post-visit National Comprehensive Cancer Network (NCCN) Distress Thermometer scores compared by trial group measure: Change in pre- and post-visit Trust in a Physician scores compared by trial group measure: Knowledge Screen measure: Patient perceptions of the Question Prompt List sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barbara Ann Karmanos Cancer Institute city: Detroit state: Michigan zip: 48201 country: United States name: Ira Winer, M.D. PhD role: CONTACT phone: 313-576-9194 email: iwiner@med.wayne.edu name: Elizabeth Johns role: CONTACT email: hr3132@wayne.edu name: Susan Eggly, PhD role: SUB_INVESTIGATOR name: Elizabeth Johns, MD MS role: SUB_INVESTIGATOR name: Larrissa Mattei, MD role: SUB_INVESTIGATOR name: Anna Gotschlich, PhD role: SUB_INVESTIGATOR name: Wei Chen, PhD role: SUB_INVESTIGATOR name: Sam Robinson, PhD role: SUB_INVESTIGATOR name: Ira Winer, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 hasResults: False

 nctId: NCT06339814 id: 05/23-CE briefTitle: Eye Movement Desensitization and Reprocessing Group Treatment for Caregivers of Pediatric Brain Tumor Patients overallStatus: RECRUITING date: 2023-03-10 date: 2024-10 date: 2024-11-30 date: 2024-04-01 date: 2024-04-01 name: IRCCS Eugenio Medea class: OTHER briefSummary: Caregivers of pediatric brain tumor survivors may develop high levels of psychological distress, mostly depression and anxiety, with effects comparable to those of a traumatic event. Several studies suggest that Eye Movement Desensitization and Reprocessing could be a promising treatment in similar clinical populations (i.e. adults with brain tumor), but it has never been used for caregivers of pediatric brain tumor. The aims of the present study will be to test the feasibility of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for caregivers of pediatric brain tumor survivors in a clinical setting and to evaluate its effectiveness in decreasing the psychological distress in this population. The study will be monocentric, and with two parallel branches: the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol group, who will receive a 4-session treatment, versus the Treatment as Usual condition, who will receive standard support. Emotional distress will be measured before the treatment, immediately after the end of it, and two months later (follow-up), by means of several clinical scales. Twenty-four subjects will be recruited for each group (caregivers and controls). Statistical analysis will be performed to test the effect of the intervention. If a positive outcome occurs, it could offer preliminary results about the validity of the Eye Movement Desensitization and Reprocessing in treating this population's difficulties. conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be with two parallel branches, thus conforming to a Randomized Group Treatment Trial: Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol (those who will receive Eye Movement Desensitization and Reprocessing treatment plus the standard support) versus Treatment As Usual condition (those who will receive only standard support). The assessment will be performed at the moment of recruitment (T0), after the intervention for the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol group and after 1 month for the Treatment As Usual condition (T1), and for both 2 months after T1 (T2). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 48 type: ESTIMATED name: Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol name: Treatment As Usual measure: Impact of Event Scale-Revised-Total score measure: Impact of Event Scale-Revised-Intrusion score measure: Impact of Event Scale-Revised-Avoidance score measure: Impact of Event Scale-Revised-Hyperarousal score measure: Subjective Units of Distress-Total Score measure: State-Trait Anxiety Inventory-State anxiety score measure: State-Trait Anxiety Inventory-Trait anxiety score measure: Beck Depression Inventory-Total score measure: Parenting Stress Index-Total score measure: Parenting Stress Index-Parental stress score measure: Parenting Stress Index-Dysfunctional interaction score measure: Parenting Stress Index-Hard child score measure: Stress Index for Parents of Adolescents-Total stress score measure: Stress Index for Parents of Adolescents-Life restrictions score measure: Stress Index for Parents of Adolescents-Relationship with spouse/partner score measure: Stress Index for Parents of Adolescents-Social alienation score measure: Stress Index for Parents of Adolescents-Incompetence/guilt score measure: Caregiver Burden Inventory-Time-dependence burden score measure: Caregiver Burden Inventory-Developmental burden score measure: Caregiver Burden Inventory-Physical burden score measure: Caregiver Burden Inventory-Social burden score measure: Caregiver Burden Inventory-Emotional burden score measure: Family Assessment Device 3-Problem Solving score measure: Family Assessment Device 3-Communication score measure: Family Assessment Device 3-Roles score measure: Family Assessment Device 3-Affective Responsiveness score measure: Family Assessment Device 3-Affective Involvement score measure: Family Assessment Device 3-Behavior Control score measure: Family Assessment Device 3-General Functioning score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCSEMedea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06339801 id: HCJSM-24-193 briefTitle: Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-08-01 date: 2024-04-01 date: 2024-04-01 name: Hospital de Clinicas José de San Martín class: OTHER briefSummary: Existing current tests for diagnosing GERD are suboptimal because they lack adequate sensitivity or specificity. Upper gastrointestinal endoscopy is highly specific for diagnosing GERD, particularly when erosive esophagitis is present (Los Angeles Classification B, C, or D). Nevertheless, its sensitivity is limited, as this scenario is only present in 30% of cases. Most patients will exhibit normal endoscopic findings, indicating Non-Erosive Reflux Disease (NERD). The 24-hour impedance-pH monitoring (MII) is currently considered the gold standard. However, its main limitation is that it can only measure reflux activity over a 24-hour period, in addition to the discomfort caused by the catheter. 6-8 It is noteworthy that 50% of patients with NERD will have pathological reflux, and the other 50% will have a sensory disorder. The importance of making an accurate diagnosis lies in the treatment, which varies in each case.11 Recently, a minimally invasive device was developed and validated in the USA to assess changes in esophageal mucosal impedance. This serves as a tool for evaluating tissue changes associated with chronic reflux. However, this device has recently undergone improvements. This new technology has not been tested yet for GERD diagnosis. The primary benefit would be the ability to diagnose GERD in symptomatic patients with NERD during the initial endoscopy conducted under sedation.

Objectives

The Main objectives of this study are to:

1. Evaluate the diagnostic performance of mucosal impedance measurement.
2. Investigate the mucosal impedance pattern in patients with and without GERD.

Secondary objectives:

1. Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement
2. Evaluate the best probability score to distinguish between GERD and non-GERD Design Prospective, cross-sectional, and analytical study Study Design and Procedures The study will be conducted in the Gastroenterology Department of the Hospital de Clínicas José de San Martin, University of Buenos Aires, Argentina. Following a 4-week screening period during which a proton pump inhibitor (PPI) washout will be performed, and baseline measurements will be taken, all patients will undergo upper gastrointestinal endoscopy with mucosal impedance measurement and 24-hour impedance/pH monitoring. conditions: Gastroesophageal Reflux studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: MiVu measure: diagnostic performance measure: mucosal impedance pattern measure: Correlations measure: Probability score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339788 id: HD-MP-106 briefTitle: Pharmacokinetics of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-11 date: 2024-04-01 date: 2024-04-02 name: Handok Inc. class: INDUSTRY briefSummary: The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: HD-P023 name: Teneligliptin name: Empagliflozin measure: Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin measure: Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin measure: Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin measure: Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin measure: Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin measure: Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin measure: Clearance (CL/F) of Teneligliptin and Empagliflozin sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339775 id: 2024318 briefTitle: Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation overallStatus: RECRUITING date: 2023-09-01 date: 2026-12-31 date: 2027-06-30 date: 2024-04-01 date: 2024-04-01 name: Suping ZHANG class: OTHER briefSummary: B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab.

Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI.

Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.

(MNC infusion is about 5×10\^7/kg\~1×10\^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10\^7/kg\~1×10\^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital. conditions: Acute B-cell Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Blinatumomab measure: Overall survival measure: Disease-free survival measure: incidence of cytokine release syndrome （CRS） measure: Incidence of acute/chronic graft-versus-host disease （GVHD） measure: hematological adverse reactions Incidence rate sex: ALL maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhenzhou state: Henan zip: 450000 country: China name: Suping ZHANG role: CONTACT phone: +8613523510641 email: zsp198612@163.com name: Zhilei BIAN role: CONTACT phone: 037166862272 lat: 32.28034 lon: 119.16999 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-15 uploadDate: 2024-03-27T23:22 filename: Prot_000.pdf size: 167222 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-15 uploadDate: 2024-03-19T23:43 filename: ICF_001.pdf size: 140825 hasResults: False

 nctId: NCT06339762 id: 2024/03-19 briefTitle: Self-Compassion Training Given to Relatives of Patients in Palliative Care overallStatus: RECRUITING date: 2024-02-13 date: 2024-03-13 date: 2024-04-13 date: 2024-04-01 date: 2024-04-01 name: Firat University class: OTHER briefSummary: The concept of self-compassion is a concept that has been frequently the subject of research lately and has gained importance along with positive psychology. It is also referred to as self-understanding and self-compassion in the literature. The concept of self-compassion used in our study represents the concept of self-compassion in its original form as used in foreign sources. Compassion is classified according to the source to which it is directed or received. It is suggested that there are three different flows: the feeling of compassion that the individual directs from himself to others, the feeling of compassion he receives from others, and the feeling of compassion that he directs directly to his own self. It means showing oneself the same compassion and understanding one does to others, accepting and being open to one's own pain, and being accepting of oneself without being judgmental. Individuals with self-compassion believe that the difficulties, flaws and shortcomings they experience are normal. At the same time, they are aware that being human has characteristics and that everyone can experience these situations. Individuals may be less compassionate towards themselves than they are towards others. Individuals with self-compassion are as understanding, forgiving and loving towards themselves as they are towards other people. conditions: Self-Compassion Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Self-Compassion Training measure: Self-Compassion Scale: measure: Care Burden Scale: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fırat university status: RECRUITING city: Elazığ state: Center zip: 25240 country: Turkey name: Gülcan Bahçecioğlu Turan role: CONTACT phone: 506 557 60 86 lat: 38.67431 lon: 39.22321 hasResults: False

 nctId: NCT06339749 id: [2024] Ethics Review NO.040 briefTitle: Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-06-30 date: 2026-02-27 date: 2024-04-01 date: 2024-04-01 name: FANG HE class: OTHER briefSummary: In 2017, the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines built on evidence that elevated blood pressure increases cardiovascular mortality in the general population, Reclassification of BP; however, these diagnostic definitions do not include pregnant women, and whether newly diagnosed stage 1 hypertension affects pregnancy complications remains unclear. In this study, the combination of maternal factors, MAP and PLGF was used to comprehensively analyze the risk factors of preeclampsia through the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). According to the guidelines and consensus, the pregnant women were considered to be at high risk when the calculated risk was higher than 1% of the population. To compare the pregnancy outcomes of women with normal blood pressure in the first trimester and stage 1 hypertension in different risk groups, and to find out whether screening for preeclampsia can be omitted for women with normal blood pressure in the first trimester, while screening for preeclampsia should still be performed for women with stage 1 hypertension as an independent moderate risk factor, and finally to optimize the screening strategy for preeclampsia. conditions: stage1 Hypertension conditions: Preeclampsia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 626 type: ESTIMATED name: blood pressure name: Clinical protocols for preeclampsia risk screening measure: preeclampsia measure: premature delivery measure: fetal intrauterine growth restriction measure: Severe complications of preeclampsia sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: FANG HE city: Guangzhou state: Guangdong zip: 510150 country: China name: Fang He, M.D role: CONTACT phone: +86 13724831279 email: hefangjnu@126.com name: Yafei Wang, Master role: CONTACT phone: +86 18716442633 email: 542114919@qq.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06339736 id: 23815 briefTitle: Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders overallStatus: RECRUITING date: 2022-01-10 date: 2025-01 date: 2025-12 date: 2024-04-01 date: 2024-04-01 name: University of Pisa class: OTHER briefSummary: The aim of the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Patients with a clinical diagnosis of M-TMDs and a control group of healthy subjects were enrolled. At baseline, OHIP-14, PHQ-9 and GAD-7 were administered. PPT was registered at the level of masseter and temporalis muscles. The patients were then treated with oral splints and physio-kinesiotherapy following a standardized treatment protocol. At 6-months follow-up, PPT was registered, and the questionnaires were re-administered to compare treatment outcomes. conditions: TMD conditions: TMD/Orofacial Pain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Questionnaires administered to all study participants measure: Evaluation of the impact of muscular pain on oral health measure: Evaluation of the impact of muscular pain on anxiety measure: Evaluation of the impact of muscular pain on depression measure: Changes in muscular pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pisa status: RECRUITING city: Pisa zip: 56126 country: Italy name: Rossana Izzetti role: CONTACT phone: +39050993037 email: rossana.izzetti@unipi.it name: Rossana Izzetti role: PRINCIPAL_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06339723 id: 2024/03-17 briefTitle: Pecha Kuka Method About Percutaneous Endoscopic Gastrostomy for Caregivers Who Care for Palliative Care Patients overallStatus: RECRUITING date: 2024-02-13 date: 2024-03-13 date: 2024-04-13 date: 2024-04-01 date: 2024-04-01 name: Firat University class: OTHER briefSummary: Palliative care; It was started by Dame Cicely Saunders in the 1960s as a hospice for community-based provision. Today, palliative care is defined as care that begins with the patient's diagnosis, symptom management is carried out effectively, and a comprehensive, supportive, humanistic approach is based on the individual and his family. When the literature was examined, no study was found that evaluated the effectiveness of the training given by the Pecha Kuka method to caregivers caring for palliative care patients about percutaneous endoscopic gastrostomy. In addition, it is thought that the results of this research will shed light on identifying problems related to feeding practices in patients fed with PEG tubes and identifying misinformation and practices of caregivers. Determining the knowledge level and initiatives of caregivers regarding percutaneous endoscopic gastrostomy tube feeding practices will contribute to the development of educational activities and effective strategies. Study results may provide important data regarding improving the quality of care given to patients and caregivers after discharge and controlling complication rates. conditions: Pecha Kuka conditions: Palliative Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Pecha Kucha measure: Evaluation Form for Feeding Practices with Percutaneous Endoscopic Gastrostomy Tube: measure: Visual Analog Scale -Anxiety: sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fırat university status: RECRUITING city: Elazığ state: Center zip: 25240 country: Turkey name: Gülcan Bahçecioğlu Turan role: CONTACT phone: 506 557 60 86 lat: 38.67431 lon: 39.22321 hasResults: False

 nctId: NCT06339710 id: U1111-1288-5508 briefTitle: Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients acronym: Benlatino overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-01-30 date: 2026-10-30 date: 2024-04-01 date: 2024-04-01 name: Evandro Chagas Institute of Clinical Research class: OTHER briefSummary: Multicentric study on Chagas disease that seeks to evaluate a new treatment regimen using the drug benznidazole. Currently, existing treatment regimens are long and have frequent side effects, which leads to a high dropout rate among patients. The research proposes testing two shorter benznidazole regimens to see if they are as effective as standard treatment, but with fewer side effects.

The study will have 672 participants and will be carried out in four locations, Bolivia and Colombia. The objective is to analyze the efficacy and safety of new treatment regimens, evaluating the parasitological response in comparison with standard treatment. In addition, an economic assessment will be carried out to analyze direct and indirect costs, including procedures associated with the management of adverse events. conditions: Chronic Chagas Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 672 type: ESTIMATED name: benznidazole 300 mg daily 8 weeks measure: Proportion of participants with sustained negative Polymerase Chain Reaction (PCR) during the 24 months of follow-up after treatment. measure: Incidence of Adverse Events (AE) leading to treatment discontinuation during treatment period measure: Proportion of participants with positive PCR at different time points measure: Incidence and severity of clinically relevant events attributed to Chagas disease measure: To measure the quality of life (QoL) of participants measure: To measure the quality of life (QoL) of participants sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Israel Molina city: Minas Gerais state: Belo Horizonte country: Brazil name: CARLA Renata TREVIA role: CONTACT phone: 21996670525 email: renatasantos@cuidachagas.org name: Monique MG Gurgel, Master role: CONTACT phone: +55 21 997248094 email: moniquegurgel@cuiachagas.org name: Andrea Silvestre De Sousa, PHD role: PRINCIPAL_INVESTIGATOR lat: -8.96667 lon: -72.78333 facility: Carla Renata Ferreira Dos Santos Trevia city: Rio De Janeiro state: RJ zip: 22631390 country: Brazil name: Israel IM Molina, PHD role: CONTACT phone: +34 679337605 email: israel.molina@fiocruz.gov name: Monique MG Gurgel, Master role: CONTACT phone: +55 21 997248094 email: moniquegurgel@uidachagas.gov lat: -22.90278 lon: -43.2075 facility: Carla Renata Ferreira dos Santos Trevia city: Rio de Janeiro state: RJ zip: 22790-790 country: Brazil name: Israel IM Molina, PHd role: CONTACT phone: +34 679 33 76 05 email: israel.molina@fiocruz.gov name: Monique MG Gurgel, Master role: CONTACT phone: +55 21 name: Israel IM Molina, PHD role: PRINCIPAL_INVESTIGATOR name: Ana Gabriela AH Herrera, PHD role: PRINCIPAL_INVESTIGATOR name: Maria Ximena MX Escalante Lazcano, PHD role: PRINCIPAL_INVESTIGATOR name: Mario MO Mario Oliveira role: PRINCIPAL_INVESTIGATOR name: Juan JV Carlos Villar role: PRINCIPAL_INVESTIGATOR lat: -22.90278 lon: -43.2075 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-02-14 uploadDate: 2024-03-19T19:03 filename: Prot_000.pdf size: 1319333 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-02-14 uploadDate: 2024-03-19T18:18 filename: ICF_001.pdf size: 392791 hasResults: False

 nctId: NCT06339697 id: 2022-KY-233 briefTitle: Short-term Effects of Bowel Preparation on Gut Microbiome in Patients Undergoing Endoscopic Colon Polypectomy overallStatus: COMPLETED date: 2022-12-01 date: 2023-06-30 date: 2023-06-30 date: 2024-04-01 date: 2024-04-01 name: Zhang Yanli class: OTHER briefSummary: To investigate the role of different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) on the composition, evolution and recovery of the gut microbiome of patients with colonic polyps undergoing bowel preparation. conditions: Colon Polyp conditions: Cathartic Colon studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 194 type: ACTUAL name: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) measure: gut microbiome-taxonomy measure: gut microbiome-heatmap measure: gut microbiome-Alpha Diversity measure: gut microbiome-Beta Diversity measure: gut microbiome-Functional predictions measure: Age measure: Gender measure: Height measure: Weight measure: BMI measure: Whether the enrollee is a smoker measure: Whether the enrollee is a drinker measure: Evaluation of the effectiveness of intestinal cleansing Evaluation of the effectiveness of intestinal cleansing measure: Gastrointestinal Symptom Score measure: adverse event sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-12-01 uploadDate: 2024-03-20T22:22 filename: Prot_SAP_000.pdf size: 135642 hasResults: False

 nctId: NCT06339684 id: 2021 0075257 briefTitle: HPV Immunological Markers of Cervical Persistent Infection and Oncogenesis acronym: HPVImmuno overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-08 date: 2026-03-08 date: 2026-03-08 date: 2024-04-01 date: 2024-04-03 name: Foundation IRCCS San Matteo Hospital class: OTHER briefSummary: The aim of this observational study is to build an immunological assay to quantify an immunoscore system for clinical practice, which could identify HPV lesions with a risk of persistent cervical infection, which represents the main predictive factor of neoplastic evolution. A pattern of host immunological factors and HPV-related parameters, in order to identify an algorithm of risk stratification and tailoring treatment will be identified. Finally, in patients with HPV infection, a virus specific immunity after vaccination will be quantified, in order to highlight those patients who have the most significant risk of infection persistence. conditions: HPV-Related Cervical Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ACTUAL measure: Analysis plan for primary end-point measure: Analysis plan for secondary end-points sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Policlinico San Matteo city: Pavia country: Italy lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06339671 id: PASSAGE briefTitle: Post-operative Complications and Smoking Habits in Colorectal Surgery acronym: PASSAGE overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-09-25 date: 2025-09-25 date: 2024-04-01 date: 2024-04-09 name: IRCCS Ospedale San Raffaele class: OTHER name: Ospedale San Paolo name: Ospedali Riuniti Marche Nord pesaro briefSummary: PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled. conditions: Colorectal Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1527 type: ESTIMATED measure: Incidence and severity of postoperative complications surgery in three groups measure: Incidence and severity of postoperative complications surgery in NF (non-smokers) group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prof. Pierpaolo Sileri city: Milan country: Italy name: Pierpaolo Sileri role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06339658 id: TAD-ICG briefTitle: ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy overallStatus: RECRUITING date: 2021-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-04-01 date: 2024-04-15 name: Hospital Universitari de Bellvitge class: OTHER briefSummary: To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy. conditions: Breast Cancer conditions: Axillary Metastases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 43 type: ESTIMATED name: Targeted axillary dissection (TAD) by ICG name: Targeted axillary dissection (TAD) by Blue patent measure: Detection rate of sentinel lymph node measure: Detection rate of sentinel lymph node measure: Adverse effects sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de Bellvitge status: RECRUITING city: Hospitalet de Llobregat state: Barcelona zip: 08907 country: Spain name: Amparo Garcia-Tejedor, MDPhD role: CONTACT phone: 0034-660223417 email: agarciat@bellvitgehospital.cat lat: 41.35967 lon: 2.10028 hasResults: False

 nctId: NCT06339645 id: P00003121 briefTitle: Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder-A Retrospective Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-22 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: Hualien Tzu Chi General Hospital class: OTHER briefSummary: The correlation of safety and effectiveness between intravesical platelet-rich plasma injection in patients with interstitial cystitis/bladder-A retrospective study to evaluate the correlation of safety and effectiveness between intravesical platelet-rich plasma injection of IC/BPS, with age of at least 20-84 years old in Taiwan of either sex with IC/BPS symptoms and proven of IC by cystoscopic hydrodistention. Patients who meet all eligibility requirements for entry into the study of intravesical PRP injection. conditions: Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 658 type: ESTIMATED name: PRP measure: Global response assessment (GRA) sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wan Ru Yu city: Hualien City state: Outside U.S./Taiwan zip: 970 country: Taiwan name: Wan Ru Yu role: CONTACT phone: 0925051013 email: wanzu666@gmail.com lat: 23.97694 lon: 121.60444 hasResults: False

 nctId: NCT06339632 id: AVAP-NG 3363 briefTitle: Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-03-01 date: 2024-04-01 date: 2024-04-18 name: Hospital Sirio-Libanes class: OTHER name: Hospital Israelita Albert Einstein briefSummary: Transcutaneous electrical phrenic nerve stimulation (TEPNS) and transcutaneous electrical diaphragm stimulation (TEDS) are modalities that use surface electrodes placed on the patients' skin to generate action potentials and contractions of the muscle fibers of the diaphragm. The primary objective will be to evaluate the efficacy of TEPNS and TEDS in healthy adult individuals. Secondary objectives will be to assess the feasibility, safety, and level of discomfort reported by the individual resulting from the application of TEPNS and TEDS. conditions: Diaphragm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The researchers responsible for assessing diaphragm muscle through ultrasound will perform image recordings and captures during the "TEPNS" and "TEDS" intervention moments. Subsequently, the images will be analyzed by a blinded evaluator for the adopted intervention. The analyses will follow the methods described in the "diaphragm muscle mobility" and "diaphragm muscle thickness and thickening fraction" sections. Study participants will also be instructed not to disclose information regarding their experience and sensations during the intervention period, ensuring study blinding. whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: Transcutaneous electrical phrenic nerve stimulation (TEPNS) name: Transcutaneous electrical diaphragm stimulation (TEDS) measure: Diaphragm mobility measure: Diaphragm thickness measure: Thickening fraction measure: Evaluation of sensory discomfort measure: Safety of TEPNS and TEDS application sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hospital Sírio Libanês status: RECRUITING city: São Paulo zip: 01308-050 country: Brazil name: Renato F RIGHETTI, PhD role: CONTACT phone: 5511987496664 email: refragar@gmail.com name: Renato F Righetti, PhD role: PRINCIPAL_INVESTIGATOR name: Wellington P Yamaguti, PhD role: SUB_INVESTIGATOR name: Ricardo K Nawa, PhD role: SUB_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06339619 id: SYSKY-2023-1262-02 briefTitle: Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-03-11 date: 2026-03-01 date: 2026-09-01 date: 2024-04-01 date: 2024-04-01 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy. conditions: Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Adebrelimab name: Apatinib name: Tegafur measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: ≥Grade 3 AEs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510030 country: China name: Minghui Wang, Dr. role: CONTACT phone: 13826276828 email: wmingh@mail.sysu.edu.cn name: Minghui Wang, Dr. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06339606 id: 4316 briefTitle: Pregnancy Repository acronym: PR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2031-04-30 date: 2024-04-01 date: 2024-04-24 name: Sunnybrook Health Sciences Centre class: OTHER briefSummary: An essential part of clinical research is the availability and accessibility of human biospecimens for the identification of biomarkers, new treatments and measurement of response to therapy. Proteins, RNA and DNA can be extracted and studied as well. This is a critical first step in performing many fundamental molecular biology experiments. A variety of biospecimens are utilized for research including but not limited to normal and malignant tissues, blood, and other body fluids.

In order to obtain high-quality biospecimens, they must be acquired serially, stored according to current standards, and matched with clinical information for maximum value. As such, the investigators would like to create a repository of biospecimens collected from pregnant patients who are seen at Mount Sinai Hospital and other research hospitals in Toronto. Mount Sinai provides personnel and infrastructure to serve the largest (7500 births/year) and highest complex Maternity program in Ontario. Of the 7500 patients a year, at least 2500 are considered high risk pregnancies, where there's a possibility of preeclampsia, placenta accreta and a host of other complications. For this study, biological specimens - blood, cervical and placental samples - will be collected from these high-risk groups in order to better understand the causes of the underlying conditions. conditions: Pregnancy Related conditions: Fetal Growth Retardation conditions: Placental Insufficiency conditions: Preeclampsia conditions: Cervix; Pregnancy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 7000 type: ESTIMATED name: Biospecimen collection measure: Biomarker levels measure: Pathology sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06339593 id: 2023-0391 briefTitle: Regional Monitoring of CF Lung Disease overallStatus: RECRUITING date: 2024-01-05 date: 2028-01 date: 2028-01 date: 2024-04-01 date: 2024-04-01 name: Children's Hospital Medical Center, Cincinnati class: OTHER briefSummary: The main reason for this research study is to learn more about some new tests that are being developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can affect these tests. These new tests include using a breathable gas called Xenon (Xe) with MRI (magnetic resonance imaging) to improve the pictures of changes in the lungs. The Xenon (Xe) gas that has been treated to have a larger MRI signal (also called hyperpolarized). The other new test is called LCI (Lung Clearance Index) that can measure how well the lungs are working. The MRI machine used in this study has been approved by the U.S. Food and Drug Administration (FDA) and is commercially available for sale in the USA. Hyperpolarized Xe gas is an FDA-approved, inhaled contrast agent for lung ventilation MRI. The new Xe MRI techniques that are being developed and used for this research study are investigational, meaning these new Xe MRI techniques are not FDA approved, but they are similar to FDA-approved techniques that are used clinically at Cincinnati Children's Hospital Medical Center (CCHMC). Xe gas and the new MRI techniques used in this research study have been used for many years in research, including in many research studies conducted at CCHMC like this one. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Hyperpolarized Xe129 measure: Assessing structural and functional lung abnormalities via Xenon MRI measure: Assessing patients who have self-withdrawn airway clearance treatment to determine ventilation abnormalities. measure: Change in Xenon Ventilation Defect Process (VDP) sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Cincinnati Children's Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45229 country: United States name: Carrie Stevens, BS role: CONTACT phone: 513-636-9973 email: carrie.stevens@cchmc.org lat: 39.12713 lon: -84.51435 hasResults: False

 nctId: NCT06339580 id: 324456 briefTitle: Assessment of Volume-targeted Ventilation in Patients With Neuromuscular Disease acronym: VT-NMD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-04 date: 2024-04-01 date: 2024-04-25 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER briefSummary: Assessment of safety and efficacy of volume-targeted ventilation in patients with neuromuscular disease. conditions: Neuromuscular Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Volume-targeted non-invasive ventilation measure: Mean overnight transcutaneous carbon dioxide measure: Maximum overnight transcutaneous carbon dioxide measure: Overnight desaturation index measure: Visual analogue scale of sleep comfort measure: Health-related quality of life measure: Adherence to ventilation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guy's and St. Thomas NHS Foundation Trust city: London zip: SE1 7EH country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Guy's & St Thomas' NHS Foundation Trust city: London zip: SE1 9RT country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06339567 id: 671_Hemo-PCOS briefTitle: Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study acronym: Hemo-PCOS overallStatus: RECRUITING date: 2024-02-08 date: 2026-02-07 date: 2029-02-07 date: 2024-04-01 date: 2024-04-01 name: Fondation Hôpital Saint-Joseph class: OTHER briefSummary: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and insulin resistance appear to be important factors in the development of cardiovascular cardiovascular disease. In addition, patients frequently use anti-androgenic and/or contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the use of which is associated with an increased cardiovascular and thrombo and venous thrombosis (VTE). A meta-analysis published in 2020 by Gariani et al.

based on three large studies, estimated the risk of VTE in women with PCOS after adjustment for obesity and hormone therapy. This risk was significantly higher compared with women without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated the risk of VTE according to different PCOS phenotypes. Such data would be very useful in clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the differences PCOS phenotypes is limited by the large sample size required. required. VTE is a rare event in women of childbearing age, and the number of PCOS phenotypes is high.

PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers are thrombin generation tests (notably ETP) and their sensitivity to activated protein C (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG). conditions: Polycystic Ovary Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 320 type: ESTIMATED name: Thrombotic profile measure: biological procoagulant profile measure: Insuline resistance and weight measure: comparison of procoagulant profile depending on insulin resistance measure: comparison of procoagulant profile depending on hyperangrogenism measure: comparison of procoagulant profile depending on PCOS phenotype measure: comparison of procoagulant profile depending on AMH Rate measure: comparison of QoL score depending on PCOS phenotype sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Hôpital Paris Saint Joseph status: RECRUITING city: Paris country: France name: Juliette COURTIADE MAHLER role: CONTACT email: jcourtiade@ghpsj.fr name: Hélène Beaussier, pharmaD role: CONTACT email: hbeaussier@ghpsj.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06339554 id: 4806 briefTitle: Alectinib-induced Endocrine Toxicity acronym: TOSS-ALK overallStatus: COMPLETED date: 2018-10-12 date: 2023-10-30 date: 2023-10-30 date: 2024-04-01 date: 2024-04-01 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The experimental Cohort A (male ALK+ ANSCLC patients receiving alectinib), the control Cohort B (female ALK+ ANSCLC patients receiving alectinib) and control Cohort C (male NON-ALK ANSCLC patients) were prospectively evaluated for full hormone assessment of androgen deficiency, AT 8 weeks after treatment start and in case of reported suspected symptoms. Patients with major sexual dysfunctions were referred to endocrinologist. conditions: NSCLC Stage IV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 98 type: ACTUAL name: Alectinib 150 MG [Alecensa] measure: Incidence of endocrine toxicity in overall ALK-positive measure: Incidence of symptomatic hypogonadism in male ANSCLC patients sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Gemelli IRCCS city: Rome zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06339541 id: 029-FPO23 briefTitle: The ACC Preclinical Research Platform for Precision Oncology acronym: ACC Platform overallStatus: RECRUITING date: 2023-06-05 date: 2024-06-01 date: 2024-12-01 date: 2024-04-01 date: 2024-04-01 name: Fondazione del Piemonte per l'Oncologia class: OTHER name: Alleanza Contro il Cancro briefSummary: The ACC Preclinical Research Platform for Precision Oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of PDCM (Patient Derived Cancer Models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments. conditions: Solid Tumor conditions: Hematologic Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 250 type: ESTIMATED measure: number of PDCM (patient derived cancer models) measure: number of Whole Exome Sequencing (WES) e RNA-seq performed measure: number of PDCM shared within the network sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo status: RECRUITING city: Candiolo state: Turin zip: 10060 country: Italy name: Marco Asioli, BSc role: CONTACT phone: +390119933463 email: marco.asioli@ircc.it name: Enzo Medico, MD role: PRINCIPAL_INVESTIGATOR lat: 44.95858 lon: 7.59812 hasResults: False

 nctId: NCT06339528 id: EK-VPl421012021 briefTitle: Potential of Vojta's Reflex Locomotion as a Pre/Induction Method for Uterine Activity: a Pilot Study overallStatus: COMPLETED date: 2021-06-23 date: 2024-01-01 date: 2024-03-01 date: 2024-04-01 date: 2024-04-08 name: Faculty Hospital Kralovske Vinohrady class: OTHER_GOV briefSummary: The Vojta's method is neurophysiological rehabilitation method used to support and induce reflex responses of locomotor and vegetative system. It uses involuntary motor reaction of the body during pressure stimulation of so-called trigger zones. Pregnancy is currently considered a contraindication for using Vojta's therapy to potential risks of inducing regular uterine activity and risk of delivery. The aim of the study is to evaluate changes in uterine activity and also explore the possibility of using this method as a new approach for pre/induction of delivery. conditions: Induced Vaginal Delivery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 40 pregnant patients between 40+0 to 41+0 weeks of gestational age were randomly selected for this study. Stimulation of trigger zones according to Vojta's therapy was applied to 20 of them by a team of licensed physiotherapists while a control group received a sham stimulation carried out by physicians. Cardiotocographic (CTG) recordings were conducted right before and immediately after stimulation. CTG recordings were subsequently blindly evaluated by 2 independent obstetricians. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Stimulation of trigger zones according to Vojta's therapy was applied to 20 of them by a team of licensed physiotherapists while a control group received a sham stimulation carried out by physicians. Cardiotocographic (CTG) recordings were conducted right before and immediately after stimulation. CTG recordings were subsequently blindly evaluated by 2 independent obstetricians. Patients did not know if clinician have skills to stimulate properly according to the Vojta's Reflex Locomotion. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Vojta's Reflex Locomotion name: Sham stimulation measure: Cardiotocographic (CTG) recordings - measure: subjective perception during stimulation sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty Hospital Kralovske Vinohrady city: Praha zip: 11000 country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06339515 id: DuzceU-SBF-NYS-02 briefTitle: Teaching School Health Nursing Course With Universal Design Model overallStatus: NOT_YET_RECRUITING date: 2024-03-21 date: 2024-06-06 date: 2025-12-01 date: 2024-04-01 date: 2024-04-01 name: Duzce University class: OTHER briefSummary: The aim of this study is to design, implement and evaluate the School Health Nursing course in the undergraduate nursing program using the universal design model. conditions: Nursing Education studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Universal Design Model for Learning primaryPurpose: OTHER masking: NONE count: 27 type: ESTIMATED name: Universal Design Model measure: Critical Thinking Disposition Scale measure: Communication Skills Scale measure: Healthy Living Awareness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nuriye Yıldırım city: Düzce state: Duzce zip: 81620 country: Turkey name: Atiye Erbaş, PhD role: CONTACT phone: +90380 542 11 41 phoneExt: 3533 email: atiyeerbas@duzce.edu.tr name: PhD role: CONTACT name: Nuriye Yıldırım Şişman, PhD role: SUB_INVESTIGATOR name: Fahriye Hayırsever, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.83889 lon: 31.16389 hasResults: False

 nctId: NCT06339502 id: Duzce-U-merve0002 briefTitle: The Effect of the Use of Jigsaw Technique on Nursing Students' Critical Article Reviews and Students' Opinions overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2024-04-22 date: 2024-05-24 date: 2024-04-01 date: 2024-04-01 name: Duzce University class: OTHER briefSummary: Studies have proven that the Jigsaw learning method, one of the innovative learning methods, is an effective educational learning tool for nursing students. For nursing education to be sufficient to provide students with the modern roles required by the profession, students must actively learn instead of a memorized undergraduate education. -Training programs should enable them to participate in the teaching process. One of these programs is cooperative learning methods. The jigsaw learning technique creates a contemporary learning model by creating a positive learning environment, individualizing students and developing a sense of responsibility. No scientific literature has been found regarding the effect of the Jigsaw learning method on teaching critical article reading skills in nursing research courses in nursing education. It is assumed that the data obtained in this study will contribute to the effect of critical article reading training given using the Jigsaw technique, one of the cooperative learning techniques in nursing education, on students' critical article reviews and opinions about the technique. conditions: Education, Distance conditions: Students, Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Jigsaw Technique measure: Critical Thinking Disposition Scale measure: The Kolb Learning Style Inventory-III measure: Self Directed Learning Skills Scale sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Duzce University city: Duzce zip: 81100 country: Turkey name: Atiye Erbaş, PhD role: CONTACT email: atiyeerbas@duzce.edu.tr lat: 40.83889 lon: 31.16389 facility: Düzce University city: Duzce zip: 81100 country: Turkey lat: 40.83889 lon: 31.16389 hasResults: False

 nctId: NCT06339489 id: 2022DZMEC-PG-34 briefTitle: The Bone Metabolism Characteristics of Premature Ovarian Insufficiency acronym: POI overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-02-01 date: 2024-04-01 date: 2024-04-02 name: Shi Yun class: OTHER briefSummary: Explore the bone metabolism characteristics of premature ovarian insufficiency. conditions: Premature Ovarian Insufficiency conditions: Bone Diseases, Metabolic conditions: Bone Mineral Density studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Testing the serum levels of bone metabolic markers measure: tartrate resistant acid phosphatase-5b, TRACP-5b measure: bone specific alkaline phosphatase, BALP measure: bone mineral density, BMD sex: FEMALE minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Dongzhimen Hospital, Beijing University of Chinese Medicine city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06339476 id: Dilara ÜLGER ÖZBEK briefTitle: Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers overallStatus: COMPLETED date: 2023-06-01 date: 2024-03-10 date: 2024-03-24 date: 2024-04-01 date: 2024-04-03 name: Cumhuriyet University class: OTHER briefSummary: A cross-sectional study design was employed, involving 56 premenopausal participants with ages ranging from 20 to 49 years. Serum samples were collected during the early follicular phase, and levels of some biochemicals parameters analyzed. conditions: Menstrual Irregularity conditions: Menstrual Cycle Abnormal studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the overall study population of 56 subjects recruited from, Sivas Cumhuriyet University Faculty of Medicine Research and Practice Hospital, Gynecology and Obstetrics Clinic, divided into two groups: irregular menstrual cycle (n=28) and regular menstrual cycle control group (n=28). While those who met the criteria for menstrual irregularity were included, those with another gynecological disease (PCOS, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.) were excluded from the study. All participants provided written informed consent before participating in the study. Participants were asked to report the average length of their menstrual cycle over the past six months, as well as the consistency of cycle length. Menstrual regularity was assessed by self-report using a standardized questionnaire. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 56 type: ACTUAL name: Serum ADMA, MDA and M30 levels mesurment measure: ADMA, M30 and MDA levels mesurment in the blood serum to compare between patient and control. sex: FEMALE minimumAge: 20 Years maximumAge: 49 Years stdAges: ADULT facility: Sivas Cumhuriyet University Hospital city: Sivas state: Centre zip: 58050 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False

 nctId: NCT06339463 id: AAAU7985 briefTitle: Self-Distancing for Pediatric Anxiety and OCD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-01 date: 2024-04-01 name: Columbia University class: OTHER briefSummary: Self-Distancing is a cognitive technique that involves shifting perspective away from first person to promote an adaptive, self-reflective stance in emotionally charged situations. This trial aims to help learn how self-distancing may increase approach during exposure and thereby improve treatment response. To find out if self-distancing works by helping children approach fear inducing stimuli, the study will look at behaviors related to approach as well as symptom severity, before, after and during treatment.

The study hypothesizes that Self-Distancing will produce greater increases in approach behaviors and greater decreases in anxiety severity than in the Classic Exposure. conditions: Anxiety Disorders conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Youth will be randomized 10 weekly exposure therapy sessions with or without self-distancing. These conditions will run in parallel. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The rater will be blinded to which condition, self-distancing or classic exposure, child participants receive. whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: Self-Distancing (EXSD) name: Classic Exposure (EXC) measure: Treatment Engagement and Adherence Ratings (TEARS) measure: Anxiety Disorders Interview Schedule for DSM-5 (ADIS) Clinical Severity Rating (CSR) measure: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) measure: Screen for Child Anxiety Related Disorders (SCARED)- Parent and Child measure: Obsessive-Compulsive Inventory - Child Version (OCI- CV) measure: Toronto Obsessive Compulsive Scale, Parent version (TOCS) measure: Clinical Global Impression of Severity (CGI-S) Scale measure: Clinical Global Impression of Improvement (CGI-I) Scale sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: Columbia University Irving Medical Center city: New York state: New York zip: 10019 country: United States name: Sherry Chen role: CONTACT phone: 734-276-0443 email: yc4415@cumc.columbia.edu name: Rebecca Grossman, Ph.D. role: CONTACT phone: 734-276-0443 email: rg3347@cumc.columbia.edu name: Kate Fitzgerald, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06339450 id: ExpoCF briefTitle: Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects acronym: ExpoCF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-07-01 date: 2027-12-31 date: 2024-04-01 date: 2024-04-01 name: Centre Hospitalier Intercommunal Creteil class: OTHER briefSummary: Cystic fibrosis (CF) is the most common autosomal recessive disease that leads to early mortality in Caucasians and affects around 7500 patients in France. Progression of the disease depends on pulmonary exacerbations defined as acute deterioration of respiratory symptoms which ultimately impair lung function and quality of life. Most frequently caused by lung bacterial infections, exacerbations' effects include increased cough, increased sputum production, increased use of antibiotics, dyspnea and decreased lung function. The phenotypic variability of CF suggests the implication of other contributors especially to the CF airway disease. Beside genetic and epigenetic alterations, environmental factors - e.g tobacco smoke, air pollution, temperature changes, food intake - appear as relevant candidates. A previous review has discussed current knowledge on the effects of air pollution on the course of CF disease. Although scarce, the existing epidemiological andexperimental literature suggests a link between exposure to air pollutants and adverse health effects.Although scarce, the existing epidemiological and experimental literature suggests a link between exposure to air pollutants and adverse health effects. The EU sponsored REMEDIA project (Impact of exposome on the course of lung diseases, Grant agreement ID 874753) contributes to the understanding of the influence of the exposome on chronic obstructive pulmonary disease (COPD) and CF. Objective of work package 3 within the REMEDIA project is the development of a mobile environmental sensor toolbox that is capable to assess the external exposome. The biomarkertoolbox was developed and tested in a proof-of-concept study carried out in healthy volunteers. The next step is to validate the collectionof exhaled breath condensate (EBC) in a real-life study. In this aim, the objective of the present study will be to assess the feasibility of EBC collection in CF patients and healthy individuals conditions: Cystic Fibrosis, Pulmonary conditions: Environmental Exposure conditions: Exhaled Breath Condansate studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: walk tours measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Dysfunction or misused, failure, of EBC and sensor device measure: Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients. measure: Describe differences in CF subjects vs. healthy controls measure: Impact of environment exposome on health status and lung function measure: Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients. measure: Describe differences in CF subjects vs. healthy controls sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339437 id: Adeel3 briefTitle: Enhanced Recovery After Cholecystectomy overallStatus: COMPLETED date: 2023-04-01 date: 2023-10-30 date: 2023-11-01 date: 2024-04-01 date: 2024-04-12 name: Children Hospital and Institute of Child Health, Lahore class: OTHER briefSummary: this study will be conducted involving patients of all genders between the ages of 20 and 60 years who will undergo elective laparoscopic cholecystectomy for uncomplicated symptomatic gallstone disease. The study will be conducted in Department of West Surgical Ward, Mayo Hospital, Lahore, after receiving approval from the hospital's Ethical Committee. Patients having other co-morbid conditions, pregnant patients, and those undergoing laparoscopic cholecystectomy converted to open surgery will be excluded from the study. LFTs and other baseline investigations will be done routinely of every patient. Written informed consent will be obtained from all the patient. Patients will be divided into two groups with 30 patients in each group. Group A will consist of patient in whom ERAS protocol will be implemented and Group B in whom ERAS protocol will not be implemented. conditions: Cholelithiases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: ERAS protocols applied primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: outcomeassessor was not told about group allocation whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: ERAS Protocol measure: PONV measure: Visual Analogue Scale score sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: The Children Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06339424 id: 202400156A3 briefTitle: Atezolizumab and Bevacizumab With Photon Radiotherapy for Unresectable Hepatocellular Carcinoma acronym: PhotonAB overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2029-03-30 date: 2031-03-30 date: 2024-04-01 date: 2024-04-01 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) in conjunction with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) has become the established standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Despite an improved objective response rate (ORR) of 27%, the majority of patients face HCC progression and liver failure \[Finn et al., N Engl J Med 2020\]. Developing a new combined treatment strategy to overcome resistance to anti-PD-L1 and anti-VEGF is essential to improve patient outcomes.

Radiation treatment (RT) is highly efficacious in controlling localized solid tumors and has become an integral component of the treatment algorithm for unresectable HCC. Importantly, a recent retrospective cohort described that RT combined with atezolizumab plus bevacizumab was associated with favorable median overall survival of 16.1 months (Manzar et al, Cancers 2022). Our preclinical study (Hsieh et al., Science Immunology 2022) revealed that RT combined with PD-L1/PD-1 blockade induces immunogenic cell death and tumor antigen cross-presentation in antigen-presenting cells, thereby potentiating the systemic antitumor T cell responses in murine tumor models. However, whether the combinatorial therapy with RT, atezolizumab, and bevacizumab can trigger synergistic antitumor effects and systemic immune mobilization has not yet been validated in clinical trials for unresectable HCC.

Both atezolizumab/bevacizumab and X-ray RT are approved treatment methods for unresectable HCC by the U.S. and Taiwan Food and Drug Administration (FDA). The present phase II non-randomized trial aims to prospectively document the therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with atezolizumab/bevacizumab combined with conventional photon radiotherapy. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Atezolizumab name: Bevacizumab name: Photon radiotherapy measure: Progression free survival (PFS) measure: Local control (LC) measure: Time to progression (TTP) measure: Overall Response Rate (ORR) measure: Overall survival (OS) measure: Incidence and severity of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung Memorial Hospital at Linkou city: Taoyuan City zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06339411 id: 202302239A3 briefTitle: Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2027-07-31 date: 2024-04-01 date: 2024-04-02 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Background:

Stroke is a leading cause of mortality and disability globally, with acute ischemic strokes(AIS) due to Large Vessel Occlusion (LVO) presenting significant treatment challenges. Mechanical thrombectomy (MT) has emerged as an effective intervention for AIS within an 8-hour window from symptom onset. However, the potential to extend this window up to 24 hours for select patients could revolutionize outcomes for those arriving late at comprehensive stroke centers. This study investigates the efficacy and safety of Cerebrolysin as an adjunct therapy to MT in extended time window and improving patient recovery.

Methods:

We conducted a multi-center, prospective, randomized study within the Chang Gung Memorial Hospital system in Taiwan, targeting 100 AIS patients eligible for MT beyond the traditional 8-hour window. Participants were randomized to receive either standard care or Cerebrolysin post-MT, initiated within 24 hours of stroke onset and continued for 14 days. The study assessed neurological, neuropsychological, and biomarker outcomes at multiple time points post-stroke to evaluate the effects of Cerebrolysin on recovery.

Results:

The primary outcome will measure the proportion of patients achieving favorable functional outcomes (modified Rankin Scale 0-2) at 90 days. Secondary outcomes include the impact of Cerebrolysin on secondary hemorrhagic transformation, brain edema, mortality rates, and quality of life. The study aims to provide comprehensive data on the benefits of adding Cerebrolysin to the standard post-MT care, focusing on its potential to protect against reperfusion injuries and maintain blood-brain barrier integrity.

Conclusion:

By evaluating the role of Cerebrolysin in conjunction with MT, this study aims to extend the therapeutic window for AIS treatment, offering hope for improved outcomes for patients who would otherwise be ineligible for current reperfusion therapies. The findings may pave the way for new guidelines in stroke management, emphasizing the importance of integrated care approaches in enhancing patient recovery. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Cerebrolysin measure: Functional Recovery and Complication Rates Post-Thrombectomy measure: Imaging and High cortical Functional Assessment Endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339398 id: 002-2023 briefTitle: To Evaluate the Dose-response Effects of a Defined Volume of Physical Exercise on the Change of Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study acronym: METEX-PD overallStatus: ENROLLING_BY_INVITATION date: 2024-05 date: 2025-12-31 date: 2028-05-31 date: 2024-04-01 date: 2024-04-01 name: Casa di Cura San Raffaele Cassino class: NETWORK name: IRCCS San Raffaele Roma name: San Raffaele Telematic University name: University of Rome Tor Vergata name: University of Urbino "Carlo Bo" briefSummary: This is a prospective, observational, cohort pilot study of standardize volume of aerobic exercise on changes in BDNF concentration at 4-weeks of exercise training among Parkinson disease patients.

Thirty (N=30) participants will be consecutively enrolled and assigned to 2 groups: 1) Extensive Rehabilitation Group (exercise volume: 180 METs-min/week) or 2) Intensive Rehabilitation Group (exercise volume: 1350 METs-min/week).

The primary objective is to evaluate the dose-response effects of two different rehabilitation settings, characterized by different workload (measured as energy expenditure), on blood BDNF levels. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Aerobic exercise measure: Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) measure: Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) measure: Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) measure: Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1) measure: Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1) measure: Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1) measure: Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin measure: Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin measure: Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin measure: Change in peripheral biomarker of inflammation measure: Change in peripheral biomarker of inflammation measure: Change in peripheral biomarker of inflammation measure: Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples measure: Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples measure: Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples measure: Change in blood lactate levels assessed using finger-stick capillary blood samples measure: Change in gut microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene measure: Change in motor symptoms - MDS-UPDRS part II measure: Change in motor symptoms - MDS-UPDRS part II measure: Change in motor symptoms - MDS-UPDRS part II measure: Change in motor symptoms - MDS-UPDRS part III measure: Change in motor symptoms - MDS-UPDRS part III measure: Change in motor symptoms - MDS-UPDRS part III measure: Change in motor symptoms - MDS-UPDRS part IV measure: Change in motor symptoms - MDS-UPDRS part IV measure: Change in motor symptoms - MDS-UPDRS part IV measure: Change in movement analysis - stride length measure: Change in movement analysis - stride length measure: Change in movement analysis - stride length measure: Change in movement analysis - cadence measure: Change in movement analysis - cadence measure: Change in movement analysis - cadence measure: Change in movement analysis - propulsion measure: Change in movement analysis - propulsion measure: Change in movement analysis - propulsion measure: Change in movement analysis - Time Up and Go (TUG) measure: Change in movement analysis - Time Up and Go (TUG) measure: Change in movement analysis - Time Up and Go (TUG) measure: Change in walking capacity measure: Change in walking capacity measure: Change in walking capacity measure: Change in postural instability measure: Change in postural instability measure: Change in postural instability measure: Change in cognitive function - Montreal Cognitive Assessment (MoCA) measure: Change in cognitive function - Montreal Cognitive Assessment (MoCA) measure: Change in cognitive function - Montreal Cognitive Assessment (MoCA) measure: Change in cognitive function - Mini-Mental Examination (MMSE) measure: Change in cognitive function measure: Change in cognitive function measure: Change in cognitive function - Frontal Assessment Battery (FAB) measure: Change in cognitive function - Frontal Assessment Battery (FAB) measure: Change in cognitive function - Frontal Assessment Battery (FAB) measure: Change in severity of depressive symptomatology measure: Change in severity of depressive symptomatology measure: Change in severity of depressive symptomatology measure: Change in non-motor symptoms measure: Change in non-motor symptoms measure: Change in non-motor symptoms measure: Change in motor fluctuations measure: Change in motor fluctuations measure: Change in motor fluctuations measure: Change in quality of life measure: Change in quality of life measure: Change in quality of life measure: Change in cortical activity measure: Change in cortical activity measure: Change in Brain Connectivity measure: Change in Brain Connectivity sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Raffaele Cassino city: Cassino state: Frosinone zip: 03043 country: Italy lat: 41.48581 lon: 13.82835 hasResults: False

 nctId: NCT06339385 id: KY 2020-153-02 briefTitle: Management of PADIS in Emergency Intensive Care Unit overallStatus: COMPLETED date: 2021-06-13 date: 2021-08-12 date: 2021-08-12 date: 2024-04-01 date: 2024-04-02 name: Capital Medical University class: OTHER name: Beijing Tiantan Hospital name: The First Affiliated Hospital of Anhui Medical University name: The First Affiliated Hospital of Dalian Medical University name: Fudan University name: Affiliated hospital of Guilin medical university,China name: The Second Affiliated Hospital of Hainan Medical University name: The First Hospital of Hebei Medical University name: The First Hospital of Jilin University name: Southwest Hospital, China name: General hospital of shenyang military command name: Beijing Anzhen Hospital name: Mianyang Central Hospital name: Tianjin Medical University General Hospital name: The First Affiliated Hospital of Zhengzhou University name: The Jiangxi Provincial People's Hospital briefSummary: Investigate the prevalence of PADIS in EICU, as well as the awareness and clinical implementation status of medical staff towards PADIS.

The investigators conducted a multicenter cross-sectional survey in mainland China, including a one-day point prevalence investigation and a questionnaire survey. The inclusion criteria encompassed all adult patients admitted to the participating emergency department intensive care units (EDICUs) during the on-site screening, while exclusion criteria comprised patients aged less than 18 years, EDICU stays duration less than 24 hours before the screening, and participation in other concurrent trials. Hospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium. Physicians and nurses on duty 24 hours before the patients\&#39; enrollment was invited to complete the questionnaire survey regarding the ICU profiles, professional expertise, assessment and treatment of PAD, early mobilization, and sleep improvement practices. conditions: Pain conditions: Agitation, Emergence conditions: Delirium conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 162 type: ACTUAL name: PADIS assessment measure: PADIS assessment rate measure: Rates of analgesic and sedative administration measure: Rate of accidental removal of the catheter during the EICU stay measure: EDICU length of stay measure: The hospital length of stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan hospital city: Beijing state: Beijing zip: 100070 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06339372 id: AP1912-30102 briefTitle: Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours overallStatus: COMPLETED date: 2023-02-01 date: 2023-08-01 date: 2023-08-01 date: 2024-04-01 date: 2024-04-02 name: Cairo University class: OTHER briefSummary: The aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (UTI) and pneumonia. conditions: Immunonutrition conditions: Surgical Outcome conditions: Pain conditions: Oral Cavity conditions: Mandibular Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 176 type: ACTUAL name: Standard feeding name: Omega 3 and dipeptiven measure: The incidence of wound infection measure: Fistula formation measure: Length of hospital stay measure: Total dose of intraoperative opioids measure: Total dose of postoperative opioids measure: Degree of pain measure: The incidence of mortality measure: The incidence of complications sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo University city: Cairo zip: 11796 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06339359 id: 2024-02-014 briefTitle: A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-31 date: 2025-03-31 date: 2024-04-01 date: 2024-04-01 name: Bundang CHA Hospital class: OTHER briefSummary: This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis. conditions: ASD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessments measure: K-BSID-Ⅲ measure: ADI-R measure: M-CHAT measure: ADOS-2 measure: K-WPPSI-Ⅳ measure: K-CARS-2 measure: CBCL measure: SCQ measure: GMFM measure: HFT measure: BOT-2 measure: VMI-6 measure: SP measure: Eye Tracking measure: Motion Analysis sex: ALL maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: CHA Bundang Medical Center, CHA University status: RECRUITING city: Seongnam-si state: Gyeonggi-do zip: 463-712 country: Korea, Republic of name: Minyoung Kim, M.D., Ph.D. role: CONTACT phone: 82-31-780-1872 email: kmin@cha.ac.kr lat: 37.43861 lon: 127.13778 hasResults: False

 nctId: NCT06339346 id: 29BRC24.0028 - PROMOT1 briefTitle: Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection: a Retrospective Population-based Study (PROMOT1) acronym: PROMOT1 overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-01 date: 2024-04-30 date: 2024-04-30 date: 2024-04-01 date: 2024-04-01 name: University Hospital, Brest class: OTHER briefSummary: Colorectal cancers (CRC) extending beyond the muscularis mucosae and invading the submucosa without extending beyond it are classified as pT1.

Among these, a number of lesions presenting pejorative criteria, notably histopathological, have a significant risk of lymph node invasion, and are therefore candidates for partial colectomy with lymph node dissection. Tumors deemed to be at low risk of lymph node involvement can be treated by endoscopy alone.

It should be noted that further surgical intervention is not without comorbid consequences, and that a significant proportion of post-surgical surgical specimens are free of cancerous lesions.

The aim of this study is therefore to analyze the current histopathological criteria predictive of lymph node invasion, in order to more accurately select candidates for surgical management. conditions: Colorectal Cancer conditions: Colorectal Adenocarcinoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED measure: Analysis of lymph node invasion rates as a function of tumor characteristics measure: Population demographics measure: lesion characteristics measure: management measure: recurrence measure: survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Brest city: Brest zip: 29609 country: France lat: 48.3903 lon: -4.48628 hasResults: False

 nctId: NCT06339333 id: RRECB0523EC briefTitle: Evaluation of ACT Now GAIN Later overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-01 date: 2024-04-01 name: University College Dublin class: OTHER briefSummary: The goal of this Randomised Control Trial is to evaluate a Psychologist Guided Self Help Video Parenting Programme based on principles of Acceptance and Commitment Therapy (ACT)

The main questions it aims to answer are:

Primary Objectives

1. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in increasing parental psychological flexibility (measured by Psy-Flex, tool which measures psychological flexibility)? Please find attached.
2. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in decreasing child challenging behaviour (measured by the Eyberg Child Behavior Inventory)? Please find attached.

Secondary Objectives

1. Is ACT Now GAIN Later: an ACT based Parenting Programme, effective in improving parent-child relationships (measured by the Child-Parent Relationship Scale)? Please find attached.
2. Does ACT Now GAIN Later increase parental well-being as measured by (Depression Anxiety Stress Scale, Parenting Stress Index and Goal Based Outcome Tool)? Please find attached.
3. Does ACT Now GAIN Later increase parental self-efficacy (TOPSE and Parental Sense of Competence scale)? Please find attached.

Participants will complete a 7 week psychologist guided parenting intervention. Researchers will compare waitlist groups to see if there are differences in psychological flexibility, child behaviour, parent-child relationships, parental well-being or parental self-efficacy. conditions: Psychological Flexibility conditions: Child Behavior conditions: Relationship, Parent Child conditions: Well-Being, Psychological conditions: Self-efficacy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This quantitative study will be a two arm randomised control trial with an intervention group and waitlist group. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: ACT Now GAIN Later name: Control Group measure: Parental Psychological Flexibility measure: Child Behaviour measure: Parent-Child Relationships measure: Parental Well-Being measure: Parental Self-Efficacy measure: Parental Self-Efficacy sex: ALL minimumAge: 3 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06339320 id: PRO00037835 briefTitle: Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity overallStatus: RECRUITING date: 2024-02-28 date: 2033-10 date: 2033-10 date: 2024-04-01 date: 2024-04-01 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS). conditions: Endoscopic Sleeve Gastroplasty conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Retrospective Registry Study primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Endoscopic Sleeve Gastroplasty (ESG) name: Apollo OverStitch endoscopic suturing device measure: Number of participants with technically successful completion of the ESG procedure measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 measure: Change in body mass index (BMI) measured by kg/m2 measure: Change in hemoglobin A1C (%) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Houston Methodist Hospital status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Thomas R McCarty, MD, MPH role: CONTACT phone: 713-363-7436 email: tommccarty3@houstonmethodist.org lat: 29.76328 lon: -95.36327 facility: Houston Methodist Hospital - Sugarland status: RECRUITING city: Sugar Land state: Texas zip: 77479 country: United States name: Thomas R McCarty, MD, MPH role: CONTACT phone: 713-363-7436 email: tommccarty3@houstonmethodist.org lat: 29.61968 lon: -95.63495 hasResults: False

 nctId: NCT06339307 id: DJY004 briefTitle: A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for LNM in GC Patients overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-30 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: In our prior research, a risk scoring model for the occurrence of lymph node metastasis in patients who underwent radical gastrectomy for gastric cancer was established. To further validate this scoring model, a prospective study has been designed with the aim of prospectively assessing the model's clinical applicability. conditions: Predictive Cancer Model conditions: Gastric Cancer conditions: Lymph Node Metastasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: lymph node metastasis sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital of Tianjin Medical University status: RECRUITING city: Tianjin state: Tianjin country: China name: Jingyu Deng, M.D. role: CONTACT phone: +86-22-23340123 email: dengery@126.com lat: 39.14222 lon: 117.17667 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-07-01 uploadDate: 2024-03-17T10:10 filename: Prot_000.pdf size: 131262 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-07-01 uploadDate: 2024-03-17T10:11 filename: SAP_001.pdf size: 158196 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-07-01 uploadDate: 2024-03-17T10:11 filename: ICF_002.pdf size: 151390 hasResults: False

 nctId: NCT06339294 id: ZShabbir briefTitle: Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment overallStatus: COMPLETED date: 2023-06-16 date: 2023-12-15 date: 2023-12-31 date: 2024-04-01 date: 2024-04-01 name: Rawalpindi Medical College class: OTHER briefSummary: Background and Objectives To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment.

Subjects and Methods This randomized controlled trial will include 90 patients presenting to ENT OPD with complaints of earache, watery ear discharge, pruritis, and ear blockage and will be clinically diagnosed as a case of otomycosis on otoscopy. The external auditory canal of the patient will be cleared of fungal debris via suction before treatment In Group A ear canal will be filled with 1% clotrimazole ointment by using an IV catheter and syringe and in Group B pyodine-soaked gel foam will be placed in the external auditory canal. The patients will be followed up on post-treatment days 7 and 14. conditions: Otomycosis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 90 type: ACTUAL name: Clotrimazole Cream name: Povidone-Iodine measure: Treatment Response Based on Otoscopy measure: Condition of External Auditory Canal sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Benazir Bhutto Hospital city: Rawalpindi state: Punjab/46000 zip: 46000 country: Pakistan lat: 33.6007 lon: 73.0679 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-16 uploadDate: 2024-03-24T05:10 filename: Prot_SAP_000.pdf size: 557916 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-06-16 uploadDate: 2024-03-24T05:13 filename: ICF_001.pdf size: 1206939 hasResults: False

 nctId: NCT06339281 id: 2023YJZ87 briefTitle: A Multicenter Clinical Study of Apatinib Mesylate Combined With Doctor's Choice for Advanced Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06 date: 2026-12 date: 2024-04-01 date: 2024-04-19 name: Li Huiping class: OTHER briefSummary: Previous studies have found good efficacy of (investigator's choice of chemotherapy, or endocrine drug) in combination with apatinib mesylate in the treatment of her-2 negative, chest wall metastatic advanced breast cancer, and the present study proposes to further explore the efficacy of apatinib mesylate in her-2 negative, HR-positive advanced breast cancer. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 68 type: ESTIMATED name: apatinib mesylate+Capecitabine Tablets name: apatinib mesylate+Fulvestrant injection measure: Progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339268 id: MMABelgrade briefTitle: Cognitive and Physical Optimization in Prevention of Postoperative Cognitive Deficit in Elderly With Lung Resection acronym: COGNITION overallStatus: RECRUITING date: 2023-11-01 date: 2025-11-01 date: 2026-03-01 date: 2024-04-01 date: 2024-04-01 name: Military Medical Academy, Belgrade, Serbia class: OTHER briefSummary: Postoperative cognitive deficit and its connection with surgery and general anesthesia were first mentioned in the literature in 1955 by Bradford. Cognitive disorders in the postoperative period are postoperative delirium (POD) and postoperative cognitive dysfunction (POCD). POD is an acute dysfunction in cognition, which did not exist preoperatively. Attention deficit disorder is the main symptom of POD and refers to the inability to direct, focus, maintain, or shift attention. Memory impairment, disorientation, or perceptual disturbances may also be present. Cognitive capacity changes in POD patients develop and fluctuate in the first few days after surgery. Unlike POD, there is no formal definition for POCD. Based on data from the existing literature, it is defined as newly diagnosed cognitive deterioration that occurs after surgery. The diagnosis of POCD should be based on pre- and postoperative screening with appropriate psychometric tests. Risk factors for the development of POCD include those related to the surgical procedure, anesthesia, or the patient himself. Compared to less invasive and shorter operations, there is a higher risk of developing POCD after major, invasive, and long-term operations. Additional risk factors are intraoperative (intraoperative bleeding, perioperative transfusion treatment, hypotension) and postoperative complications (respiratory insufficiency, pneumonia, atelectasis, bronchospasm, bronchopleural fistula, and pulmonary edema). Presurgical optimization (Prehabilitation) is a widespread concept that aims to improve the general condition of the patient or optimize comorbidities before major surgery. Prehabilitation is primarily focused on improving physical ability and nutritional status, but it is developing in the direction of a multimodal approach that includes measures to reduce stress and anxiety. Psychological factors are increasingly recognized as an essential element of prehabilitation and are often added to prehabilitation programs.

Older patients, who meet the diagnostic criteria for frailty and are at risk of developing postoperative complications such as cognitive function disorders are increasingly

undergoing lung resection. These complications can affect the outcome and speed of postoperative recovery. conditions: Prehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After setting the indication for operative treatment, patients who meet the criteria for inclusion in the study, after signing the informed consent, will be randomized into two groups:

1. The first group (intervention) where the patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.
2. The second group (control) where patients receive standard treatment. primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Cognitive training, CogniFit App measure: Postoperative cognitive dysfunction measure: Perioperative depression and anxiety measure: Postoperative delirium measure: Functional status and postoperative recovery measure: Functional status and postoperative recovery measure: Postoperative recovery measure: Functional status and postoperative recovery measure: Overall outcome: Complication rate measure: Overall outcome: Morbidity measure: Overall outcome: Mortality sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Military Medical Academy status: RECRUITING city: Belgrade zip: 11000 country: Serbia name: Vojislava Neskovic, PhD role: CONTACT phone: +381 64 1775 320 email: vojkan43@gmail.com name: Marija Markovic, MD role: CONTACT phone: +381 62 666653 email: markovicmarija@hotmail.com lat: 44.80401 lon: 20.46513 hasResults: False

 nctId: NCT06339255 id: INT 180/19 briefTitle: Italian Observational Study on CAR-T Therapy for Lymphoma acronym: CART-SIE overallStatus: RECRUITING date: 2019-10-30 date: 2028-12-31 date: 2029-12-31 date: 2024-04-01 date: 2024-04-01 name: Paolo Corradini class: OTHER name: Annalisa Chiappella name: Cristiana Carniti name: Anna Dodero briefSummary: The goal of this observational study on chimeric antigen receptor T-cell therapy is to monitor the feasibility, efficacy, toxicity and biomarkers in a real life setting.

Partecipants will be asked to agree to their clinical data collection and to partecipate to the optional biological study that aims to evaluate biomarkers of toxicity and response (clinical characteristics, cytokine profile, cellcomposition and type of the CAR-T cell product, lymphoma genomics). The study will evaluate even the disease response according to lugano criteria by PET and CT in routine clinical activity. conditions: Diffuse Low Grade B-Cell Lymphoma conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL) conditions: Mantle Cell Lymphoma conditions: Follicular Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5300 type: ESTIMATED measure: Feasibility of the CAR-T cells treatment in lymphomas in the italian real life practice measure: Efficacy of the CAR-T cells treatment in lymphomas in the italian real life practice measure: Evaluation of Outcome: Overall Response rate (ORR), according to Lugano criteria. measure: Evaluation of Outcome: Overall survival (OS), according to Lugano criteria. measure: Evaluation of Outcome: Progression free survival (PFS) measure: Evaluation of Outcome: duration of response (DoR) measure: Evaluation of Outcome: Overall Response rate (ORR) measure: Evaluation of Outcome: Overall survival (OS) measure: Evaluation of Outcome: non-relapse mortality (NRM) measure: Evaluation of safety (CRS, neurotoxicity, infections, cytopenias, B cell aplasia, second malignancies) with particular attention to the safety in the new indications measure: Evaluation of bridging therapy: safety measure: Evaluation of bridging therapy: efficay measure: Evaluation of salvage therapy after CAR-T failure measure: Evaluation of salvage therapy after CAR-T failure measure: Comparison of the different CAR T-cell products (time from patient screening to infusion, disease response and safety) measure: Comparison of the different histotypes (PMBCL, DLBCL, MCL FL) according to CAR-T cell products measure: Characterization of biomarkers of early response (circulating tumor cell free DNA versus PET and CT scans) measure: Characterization of toxicity biomarkers measure: Analysis of the immune reconstitution measure: Analysis of the CAR-T expression measure: Influence of PET quantitative parameters: tMTV changes between baseline and +30 and +90 after CAR T-cell infusion (ΔSUV max) related to outcome measure: Influence of PET quantitative parameters: Distance max measure: Influence of PET quantitative parameters: Distance max bulky sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale Tumori status: RECRUITING city: Milan zip: 20133 country: Italy name: Paolo Corradini, Professor role: CONTACT phone: +39 02 2390 2950 email: paolo.corradini@istitutotumori.mi.it name: Anisa Bermema, PhD role: CONTACT phone: +39 02 2390 3145 email: anisa.bermema@istitutotumori.mi.it name: Annalisa Chiappella, MD role: SUB_INVESTIGATOR name: Anna Dodero, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06339242 id: 2024-01-NSCLC briefTitle: A Study of Furmonertinib Combined With Chemotherapy in the Treatment of NSCLC With Leptomeningeal Metastasis overallStatus: RECRUITING date: 2024-01-01 date: 2025-07-01 date: 2026-01-31 date: 2024-04-01 date: 2024-04-01 name: Jiangsu Province Nanjing Brain Hospital class: OTHER briefSummary: Leptomeningeal metastasis is a fatal complication of advanced lung cancer. There is no standard treatment for leptomeningeal metastasis after third-generation EGFR-TKIs. The Furmonertinib prototype persists longer in brain tissue, and its metabolites can also penetrate the blood-brain barrier. Ommaya cystlateral ventricle chemotherapy can quickly control the progression of intracranial lesions. The aim of this study is to evaluate the LM progression-free survival (LM-PFS) of Furmonertinib combined with lateral ventricular chemotherapy in the treatment of leptomeningeal metastatic NSCLC after third-generation EGFR-TKIs resistance. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Furmonertinib measure: LM-PFS（progression-free survival） measure: LM-ORR（Objective response rate） measure: LM-OS measure: Incidence of Treatment-Emergent Adverse Events measure: PFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Brain Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: fang S Cun role: CONTACT phone: 83728558 phoneExt: 025 email: fang1984@aliyun.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06339229 id: FSYYY-2024-12 briefTitle: Postoperative New-onset Proteinuria and Adverse Outcomes. overallStatus: COMPLETED date: 2000-01-01 date: 2022-12-31 date: 2023-11-01 date: 2024-04-01 date: 2024-04-01 name: Yaozhong Kong class: OTHER briefSummary: We aimed to assess the association between postoperative new-onset proteinuria, all-cause mortality, and decline in kidney function in Chinese people who underwent surgery. The exposure variable was the dipstick proteinuria values from the initial postoperative urinalysis within 30 days after surgery, categorized as negative, trace, 1+, and ≥2+. The primary outcome was 30-day mortality. The secondary outcomes included 1-year mortality and composite kidney outcome assessed using the postoperative estimated glomerular filtration rate. conditions: Surgery conditions: Proteinuria conditions: Mortality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2983899 type: ACTUAL name: proteinuria measure: mortality sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339216 id: OBU-BJ-GC-II-011 briefTitle: A Clinical Study of Adebrelimab Combined With Apatinib and Paclitaxel in Patients With Advanced Gastric Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-12-30 date: 2026-11-30 date: 2024-04-01 date: 2024-04-01 name: Chinese PLA General Hospital class: OTHER briefSummary: Phase II Clinical Study of Adebrelimab Combined with Apatinib and Paclitaxel for Injection(Albumin Bound) as Second-line Therapy in Patients with Advanced Gastric Cancer Previously Treated with Immunotherapy conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Adebrelimab+Apatinib+Paclitaxel for Injection(Albumin Bound) measure: ORR measure: PFS measure: DCR measure: OS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339203 id: 5240002 briefTitle: Intraoperative Wound Irrigation in Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-04-01 date: 2024-04-01 name: Loma Linda University class: OTHER name: Irrimax Corporation briefSummary: This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery. conditions: Cesarean Section Complications conditions: Cesarean Section; Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: Irrisept name: Normal Saline measure: Composite wound evaluation after caesarean delivery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Loma Linda University city: Loma Linda state: California zip: 92354 country: United States name: Nikia Gray Hutto, AS role: CONTACT phone: 909-558-4000 phoneExt: 44428 email: nhutto@llu.edu lat: 34.04835 lon: -117.26115 hasResults: False

 nctId: NCT06339190 id: E21-006-72840 briefTitle: Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis acronym: NAVAIDD overallStatus: RECRUITING date: 2021-08-01 date: 2025-12 date: 2027-12 date: 2024-04-01 date: 2024-04-01 name: Monash University class: OTHER name: Eastern Health name: University of Melbourne name: Wake Forest University name: Deakin University name: The Florey Institute of Neuroscience and Mental Health name: Invitae Corporation name: Redenlab briefSummary: This cohort study aims to determine if a blood test can aid with diagnosing dementia in anyone presenting with cognitive complaints to a single healthcare network. The investigators will measure levels of a brain protein, Neurofilament light chain (Nfl), and assess changes in language using speech tests.

Participants will have a single blood test and speech test, and will be followed up at 12-months to complete questionnaires and cognitive scales over the phone. The speech test will also be completed again at 12-months.

Individuals at risk of a Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample. conditions: Neurodegenerative Diseases conditions: Dementia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Venepuncture measure: Nfl correlation with neurodegeneration measure: Change in speech processing measure: Change in language processing measure: Change in Direct Magnitude Estimation measure: Modified Rankin Scale measure: Montreal Cognitive Assessment score measure: Hospital Anxiety and Depression Scale score measure: Clinical Global Impression score measure: WHO Disability Assessment 12-item telephone interview score measure: WHO Disability Assessment 36-item self report score measure: DNA sample for testing known pathogenic dementia mutations sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Box Hill Hospital status: RECRUITING city: Box Hill state: Victoria zip: 3128 country: Australia name: Svetlana Ivanic role: CONTACT email: svetlana.ivanic@monash.edu lat: -37.81887 lon: 145.12545 facility: Wantirna Health status: RECRUITING city: Wantirna state: Victoria zip: 3152 country: Australia name: Sarah Shue role: CONTACT lat: -37.85 lon: 145.21667 hasResults: False

 nctId: NCT06339177 id: 10001899 id: 001899-I briefTitle: Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study overallStatus: RECRUITING date: 2024-05-01 date: 2030-10-01 date: 2031-04-01 date: 2024-04-01 date: 2024-04-26 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: Background:

Hemophagocytic lymphohistiocytosis (HLH) is a disease caused by disrupted immune function. People with HLH are prone to fevers and illnesses, which can be fatal. Some people develop a genetic form of this disease (pHLH), but researchers do not understand why some other people develop a nongenetic form (sHLH). They also do not have good ways to diagnose and treat sHLH.

Objective:

To learn about sHLH and why some people get it and others do not.

Eligibility:

Adults aged 18 years and older with sHLH.

Design:

Participants will be admitted to the study based on a review of their medical records. Those who join will have at least 3 clinical evaluations over 9 to 12 months. These may occur during an inpatient hospitalization if they require medical care or in the outpatient clinic.

Participants will also have a physical exam at each visit. Up to half a cup of blood will be drawn at each visit. Participants may also have their blood drawn by their own doctors, who will send the samples to the researchers. Researchers may also contact these participants by telephone or video calls.

The blood will be used for clinical tests as well as research. No new treatments will be administered as part of this study; however, standard medications and treatments may be recommended.

Participants may opt to continue their visits once a year for 3 more years. Participants may also opt for an extra clinial evaluation 1 week after starting a new treatment.... conditions: Lymphohistiocytosis, Hemophagocytic conditions: Secondary Hemophagocytic Lymphohistiocytosis conditions: Macrophage Activation Syndrome conditions: Hyperinflammatory Syndromes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Identify immunologic mechanisms involved in the pathogenesis of sHLH from a variety of predisposing conditions. measure: Prospectively define acute and longitudinal clinical profiles that predict key clinical outcomes. measure: Compare clinical and immune profiles between the classically defined HLH subgroups. measure: Improve the understanding of the pathogenesis of sHLH. measure: Characterize risk factors to identify populations at risk for developing sHLH. sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center status: RECRUITING city: Bethesda state: Maryland zip: 20892 country: United States name: NIH Clinical Center Office of Patient Recruitment (OPR) role: CONTACT phone: 800-411-1222 phoneExt: TTY dial 711 email: ccopr@nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06339164 id: ObGynEASC006 briefTitle: Breech Delivery Skills. Resident Learning Program acronym: Breech overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-15 date: 2024-06-30 date: 2024-04-01 date: 2024-04-01 name: G. d'Annunzio University class: OTHER briefSummary: Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology. Formal frontal lecture and digital learning represent nowadays the two typical learning methods. A bedside evaluation it's not feasible due to rarity of such emergency, due to the common senior physicians involvement when it occurs, and due to medico-legal risks. Mannequin scenario represents the best way of skill evaluation conditions: Breech Presentation; Before Labor studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED name: skills and learning quality in breech delivery measure: Skills capacities measure: Skills capacities measure: learning qualities sex: ALL minimumAge: 24 Years maximumAge: 38 Years stdAges: ADULT facility: Claudio Celentano city: Pescara state: PE zip: 65100 country: Italy lat: 42.4584 lon: 14.20283 hasResults: False

 nctId: NCT06339151 id: TUH multiple dexamethasone TKA briefTitle: Comparing Single Dose and Multiple Dose of Dexamethasone Post TKA overallStatus: RECRUITING date: 2024-03-23 date: 2025-10-31 date: 2025-10-31 date: 2024-04-01 date: 2024-04-01 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this clinical trial is to investigate the efficacy of single dose and double dose of dexamethasone after primary total knee replacement.

The main question\[s\] it aims to answer \[is/are\]:

Does 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours interval of double dose of dexamethasone after primary total joint replacement?

Researchers will compare double dose of dexamethasone group to see if \[insert effects\].

Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\]. conditions: Osteo Arthritis Knee conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Dexamethasone before surgery name: Dexamethasone before and 12 hours after surgery name: Dexamethasone before and 24 hours after surgery measure: Pain at rest and motion measure: Nausea and vomiting measure: Morphine consumption measure: Blood sugar level measure: CRP level measure: Range of motion measure: Length of hospital stay measure: Complication sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University Hospital status: RECRUITING city: Khlong Luang state: Pathum Thani zip: 12120 country: Thailand name: Yot Tanariyakul, M.D. role: CONTACT phone: 6683930257 email: y.tanariyakul@gmail.com name: Yot Tanariyakul, M.D. role: PRINCIPAL_INVESTIGATOR name: Piya Pinsornsak, M.D. role: PRINCIPAL_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False

 nctId: NCT06339138 id: 17-010944 id: NCI-2024-00971 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 17-010944 type: OTHER domain: Mayo Clinic in Rochester briefTitle: Identification of Novel High Quality Methylated DNA Markers in Renal Tumors: Whole Methylome Discovery, Tissue Validation, and Feasibility Testing In Blood and Urine, The INQUIRE Study overallStatus: RECRUITING date: 2018-02-20 date: 2027-01-31 date: 2027-01-31 date: 2024-04-01 date: 2024-04-01 name: Mayo Clinic class: OTHER briefSummary: This study is being done to collect blood, tissue and urine samples to identify a novel high quality methylated DNA marker in patients with renal tumors. conditions: Chromophobe Renal Cell Carcinoma conditions: Clear Cell Papillary Renal Tumor conditions: Clear Cell Renal Cell Carcinoma conditions: Kidney Oncocytoma conditions: Papillary Renal Cell Carcinoma conditions: Urothelial Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 874 type: ESTIMATED name: Non-Interventional Study measure: Identify novel methylated DNA markers in tissue for malignant renal and urothelial tumors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: John C. Cheville, M.D. role: PRINCIPAL_INVESTIGATOR name: John B. Kisiel, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06339125 id: 2023p003637 briefTitle: Predictive Analytics and Computer Visualization Enhances Patient Safety to Prevent Falls overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-07 date: 2024-04-01 date: 2024-04-01 name: Massachusetts General Hospital class: OTHER name: Crico name: Inspiren Inc name: RGI Informatics LLC briefSummary: Annually, in the United States there are 700,000 - 1,000,000 inpatient falls reported, and one-third of patients sustain an injury. The average estimated cost per fall is $6,694, resulting in over $1.4 -1.9 billion dollars in losses each year (AHRQ, 2017). This study aims to compare the impact of different fall prevention strategies on the rate of occurrence of falls and falls with injury in an academic medical center on three adult medical units. While maintaining the usual standard of care for fall prevention, each unit will add one of the following: (1) use of a fall risk alert to nurses using an algorithm based on electronic health record data or (2) computerized camera visualization or (3) a combination of both. conditions: Falls and Falls With Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An observational cohort, mixed-methods study design will be conducted to determine the impact and effectiveness of usual care and three different fall prevention strategies that exceed the standard of care on three inpatient units at MGH over one year. Unit 1 will employ streaming analytics and the MGH algorithm only, Unit 2 will employee Inspiren's AUGI computer visualization only and Unit 3 will employ the combined streaming analytic/MGH algorithm and Inspiren's AUGI device. Unit 4, the control unit, will serve as an internal comparison group from the same institution. In addition to the study interventions all four units will continue to maintain usual MGH evidence-based practice, standards of care for fall prevention. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 4500 type: ESTIMATED name: Fall prevention algorithm name: Inspiren camera visualization measure: Falls measure: Falls with injury measure: Nurse perceptions measure: Nurse perceptions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339112 id: 2024/10 briefTitle: The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety on Children overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-01 date: 2024-12-01 date: 2024-04-01 date: 2024-04-01 name: Tarsus University class: OTHER briefSummary: This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G\*Power 3.1 program, in line with the literature (Durak 2019; Özsamuri 2020). While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data. conditions: Fear conditions: Anxiety conditions: Inhalant Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled experimental study primaryPurpose: OTHER masking: NONE count: 114 type: ESTIMATED name: Playing with toy nebulizer name: Cartoon measure: fear measure: anxiety sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: Tarsus State Hospital city: Mersin country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06339099 id: P.T.REC/012/002489 briefTitle: Loaded Gait Training on Gross Motor Function in Cerebral Palsy overallStatus: COMPLETED date: 2023-02-26 date: 2023-10-15 date: 2024-03-15 date: 2024-04-01 date: 2024-04-01 name: Cairo University class: OTHER briefSummary: A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy. Children were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training. Gross motor functions and knee extensor strength were measured. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Children were randomly assigned into two equal groups. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blinding. Parents were also blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 52 type: ACTUAL name: Conventional physical therapy program name: Loaded gait training measure: Gross motor function measure: knee extensor strength sex: ALL minimumAge: 5 Years maximumAge: 7 Years stdAges: CHILD facility: Faculty of Physical Therapy, Cairo University city: Giza state: Cairo zip: 12613 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06339086 id: BPR-201-I-III-01 briefTitle: Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08-30 date: 2025-12-30 date: 2024-04-01 date: 2024-04-01 name: Chengdu Brilliant Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment.

Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks.

Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 478 type: ESTIMATED name: Semaglutide Injection name: Semaglutide Injection(Ozempic®) name: Metformin measure: Change in HbA1c measure: Change in HbA1c measure: Change in FPG measure: Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% measure: Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% with no hypoglycemic event measure: Change in Body Weight measure: Proportion of participants with Weight Loss≥5%, ≥10% and ≥15% measure: Change in Diastolic and Systolic Blood Pressure measure: Changes in Blood Lipids measure: Incidence and severity of Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339073 id: 2021NZKY-045-01 briefTitle: CT-based Model for Predicting Prolonged Weaning in Patients With Abdominal Trauma overallStatus: COMPLETED date: 2023-10-01 date: 2023-12-15 date: 2024-02-05 date: 2024-04-01 date: 2024-04-01 name: Jinling Hospital, China class: OTHER briefSummary: Critically ill patients often require tracheal intubation for mechanical ventilation, and timely weaning is crucial for airway management and reducing complications. However, there is currently a lack of an effective tool to predict weaning time in critically ill patients. This retrospective study established an effective nomogram model for predicting the time of weaning from mechanical ventilation in abdominal trauma patients by considering multiple perspectives. The model has been validated and demonstrated good performance in terms of discrimination, calibration, and clinical utility. Moreover, the model can effectively predict the prognosis of critically ill patients. The findings of this study have important implications for guiding respiratory management in clinically critically ill patients, particularly trauma patients. conditions: Wounds and Injuries conditions: Ventilation Therapy; Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1023 type: ACTUAL name: mechanical ventilation measure: Prolonged mechanical ventilation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the General Surgical Department of Jinling Hospital city: Nanjing state: Jiangsu zip: 210002 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06339060 id: RTS-022 briefTitle: An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3). acronym: PALACE3 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-03-01 date: 2028-03-01 date: 2024-04-01 date: 2024-04-01 name: Ruijin Hospital class: OTHER briefSummary: Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to receive neoadjuvant chemo-radiotherapy combined with immunotherapy post organ preservation strategy (experimental group) or neoadjuvant chemo-radiotherapy followed by surgery (control group).

The 3-year overall survival rate is the primary outcome. conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomize patients who meet the inclusion criteria Grouping, randomly assigned to the experimental group in a 1:1 ratio (organ preservation strategy after neoadjuvant chemotherapy combined with immunotherapy) And the control group (limited time for esophageal cancer radical surgery after neoadjuvant radiotherapy and chemotherapy) count: 356 type: ESTIMATED name: Experimental: Arm 1 Organ preservation name: Active Comparator: Arm 2 Surgery measure: 3-year overall survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06339047 id: 2024/09 briefTitle: The Effect of Projector Kaleidoscope and Cartoons on Anxiety, Fear, and Pain in Children overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-01 date: 2024-12-01 date: 2024-04-01 date: 2024-04-01 name: Tarsus University class: OTHER briefSummary: The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.

The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery service of Tarsus State Hospital and will undergo outpatient surgical intervention.

In collecting research data; the Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Wong-Baker Pain Scale and Vital Signs Follow-up Form will be used. conditions: Anxiety and Fear conditions: Pain conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled experimental study primaryPurpose: OTHER masking: NONE count: 90 type: ESTIMATED name: Projector Kaleidoscope name: Cartoon measure: Anxiety measure: Fear measure: Pain after surgery sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Tarsus State Hospital city: Mersin country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06339034 id: STUDY briefTitle: Repurposing Lithium for Parkinson's Disease: a RCT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-08 date: 2025-10 date: 2024-04-01 date: 2024-04-01 name: State University of New York at Buffalo class: OTHER name: The Cure Parkinson's Trust briefSummary: This study will examine the effects of lithium 20mg/day compared to placebo on MRI and blood-based biomarkers among 20 early-stage Parkinson's disease patients. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, placebo-controlled primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Lithium name: Placebo measure: MRI-derived free water (FW) levels. measure: Peripheral blood mononuclear cell (PBMC) nuclear receptor-related 1 protein (Nurr1) mRNA expression measure: Serum neurofilament light chain (NfL) measure: PBMC superoxide dismutase type-1 (SOD-1) mRNA expression measure: PBMC pS9/total glycogen synthase kinase-3B (GSK-3B) ratio measure: PBMC pThr308 and pS473/total protein kinase B (Akt) ratios measure: Serum interleukin-6 measure: Serum glial fibrillary acidic protein (GFAP) measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) measure: Montreal Cognitive Assessment (MoCA) measure: Parkinson's Anxiety Scale measure: Geriatric Depression Scale-15 measure: Fatigue Severity Scale measure: Insomnia Severity Index measure: Parkinson's Disease Questionnaire-8 measure: Levodopa equivalent daily dose (LEDD) measure: Adverse events sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UBMD Neurology city: Williamsville state: New York zip: 14221 country: United States name: Thomas Guttuso, MD role: CONTACT phone: 716-932-6080 email: tguttuso@buffalo.edu name: Amelia Cheney role: CONTACT email: acheney4@buffalo.edu name: Thomas Guttuso, MD role: PRINCIPAL_INVESTIGATOR lat: 42.96395 lon: -78.73781 hasResults: False

 nctId: NCT06339021 id: DAPT-OCT briefTitle: OCT or Angiography Guided De-escalation of DAPT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-01 date: 2024-04-01 name: Shenyang Northern Hospital class: OTHER briefSummary: Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality to accurately assess vessel and lumen geometry and identify the hallmark of a culprit lesion including plaque disruption and thrombus. In addition, the incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized OCT-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Regarding the antithrombotic therapy after revascularization, the 2023 ESC guidelines recommend the P2Y12 receptor inhibitor de-escalation (i.e. switching from ticagrelor to clopidogrel) in ACS patients may be considered as an alternative strategy to the default treatment regimen in order to reduce the risk of bleeding events.

Based on the above conclusions, we designed a single-center, prospective, randomized controlled, exploratory study trial to evaluate whether the utility of OCT for guiding PCI with DES followed by antiplatelet de-escalation therapy could further reduce the stent-induced intimal hyperplasia of STEMI patients after stent implantation. conditions: Optical Coherence Tomography conditions: Dual Antiplatelet Therapy conditions: Antiplatelet De-escalation conditions: Neointimal Coverage conditions: ST Elevation Myocardial Infarction studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: OCT-guided PCI name: Conventional angiography-based PCI name: DAPT de-escalation name: default DAPT regimen measure: Neointimal thickness after DES implantation measure: Major adverse cardiovascular and cerebrovascular events (MACCE) measure: BARC types 2-5 bleeding measure: In-stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Hospital city: Shenyang state: Liaoning country: China name: Yaling Han, Dr role: CONTACT phone: +86-24-28897313 email: cardiology@163.com name: Yaling Han, MD role: PRINCIPAL_INVESTIGATOR name: Yang Li, MD role: SUB_INVESTIGATOR name: Yi Li, MD role: SUB_INVESTIGATOR lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06339008 id: 18789 id: J2T-MC-KGBT type: OTHER domain: Eli Lilly and Company id: 2023-508817-18-00 type: OTHER domain: EU Clinical Trial Number briefTitle: A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1) overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2025-05-30 date: 2026-05-01 date: 2024-04-01 date: 2024-04-15 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months conditions: Perennial Allergic Rhinitis (PAR) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 450 type: ESTIMATED name: LY3650150 name: Placebo name: Standard therapy for INCS measure: Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16 measure: Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at week 16 measure: Mean CFBL in RQLQ(S) at week 56 measure: Mean CFBL in TNSS at Week 4 measure: Mean CFBL in TNSS at Week 56 measure: Mean CFBL in Postnasal drip score at Week 16 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southern California Research city: California City state: California zip: 92691 country: United States role: CONTACT phone: 949-276-4917 name: Warner Carr role: PRINCIPAL_INVESTIGATOR lat: 35.1258 lon: -117.9859 facility: 310 Clinical Research city: Inglewood state: California zip: 90301 country: United States role: CONTACT phone: 310-878-2636 name: Soheil Hekmat role: PRINCIPAL_INVESTIGATOR lat: 33.96168 lon: -118.35313 facility: Allergy and Asthma city: San Diego state: California zip: 92123 country: United States role: CONTACT phone: 858-268-2368 phoneExt: 143 name: Bob Geng role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: Asthma and Allergy Associates, PC city: Colorado Springs state: Colorado zip: 80907-6231 country: United States role: CONTACT phone: 719-473-8330 x5 name: Luke Webb role: PRINCIPAL_INVESTIGATOR lat: 38.83388 lon: -104.82136 facility: Florida Center For Allergy & Asthma Care Aventura city: Aventura state: Florida zip: 33180 country: United States role: CONTACT phone: 305-931-7583 name: Jaime Landman role: PRINCIPAL_INVESTIGATOR lat: 25.95648 lon: -80.13921 facility: Bluegrass Allergy Research city: Lexington state: Kentucky zip: 40509 country: United States role: CONTACT phone: 859-303-7191 name: William Greisner role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: Allergy, Asthma & Sinus Center city: Greenfield state: Massachusetts zip: 53228 country: United States role: CONTACT phone: 414-529-8519 name: Gary Steven role: PRINCIPAL_INVESTIGATOR lat: 42.58759 lon: -72.59953 facility: Respiratory Medicine Research Institute of Michigan, PLC city: Ypsilanti state: Michigan zip: 48197 country: United States role: CONTACT phone: 734-528-0477 name: Jeffrey Leflein role: PRINCIPAL_INVESTIGATOR lat: 42.24115 lon: -83.61299 facility: Clinical Research Institute city: Minneapolis state: Minnesota zip: 55402 country: United States role: CONTACT phone: 612-333-2200 phoneExt: 378 name: Gary Berman role: PRINCIPAL_INVESTIGATOR lat: 44.97997 lon: -93.26384 facility: Allergy and Asthma Consultants city: Saint Louis state: Missouri zip: 63141 country: United States role: CONTACT phone: 314-991-5117 name: Robert Onder role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Dr. Patrick Perin city: Teaneck state: New Jersey zip: 07666 country: United States name: Patrick Perin role: PRINCIPAL_INVESTIGATOR lat: 40.8976 lon: -74.01597 facility: Bernstein Clinical Research Center, LLC city: Cincinnati state: Ohio zip: 45236 country: United States role: CONTACT phone: 314-991-5117 name: David Bernstein role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Northwest Research Center city: Portland state: Oregon zip: 97202 country: United States role: CONTACT phone: 503-238-6233 name: Anthony Montanaro role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Allergy and Clinical Immunology Associates city: Pittsburgh state: Pennsylvania zip: 15241 country: United States role: CONTACT phone: 412-833-4051 phoneExt: 116 name: Michael Palumbo role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: Kerrville Allergy and Asthma Associates city: Kerrville state: Texas zip: 78028 country: United States role: CONTACT phone: 830-896-1433 name: Dale Mohar role: PRINCIPAL_INVESTIGATOR lat: 30.04743 lon: -99.14032 facility: Allergy Asthma Research Institute city: Waco state: Texas zip: 76712 country: United States role: CONTACT phone: 254-741-8151 name: Niran Amar role: PRINCIPAL_INVESTIGATOR lat: 31.54933 lon: -97.14667 hasResults: False

 nctId: NCT06338995 id: 18790 id: J2T-MC-KGBU type: OTHER domain: Eli Lilly and Company id: 2023-508760-29-00 type: OTHER domain: EU CT Number briefTitle: A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP) overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-11-22 date: 2026-10-25 date: 2024-04-01 date: 2024-04-01 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months. conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, parallel group, placebo controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 510 type: ESTIMATED name: LY3650150 name: Placebo name: Standard therapy for INCS measure: Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity measure: Mean CFBL in Endoscopic Nasal Polyp Score (NPS) measure: Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) measure: Mean change in Forced Expiratory Volume in 1 Second (FEV1) measure: Mean CFBL in Severity of Loss of Smell measure: Mean CFBL in Postnasal Drip sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS city: Mandeville state: Louisiana zip: 70448 country: United States name: James Connolly role: PRINCIPAL_INVESTIGATOR lat: 30.35825 lon: -90.06563 facility: Ear Nose and Throat Associates of Texas PA city: McKinney state: Texas zip: 75070-5735 country: United States name: Dale Ehmer, Jr. role: PRINCIPAL_INVESTIGATOR lat: 33.19762 lon: -96.61527 facility: Alamo ENT Associates city: San Antonio state: Texas zip: 78258-3227 country: United States role: CONTACT phone: 210-545-0404 name: Jeffrey Rosenbloom role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: Richmond Ear Nose and Throat city: Richmond state: Virginia zip: 23235 country: United States role: CONTACT phone: 804-622-3768 name: Michael Armstrong role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06338982 id: N-20230059 briefTitle: Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2029-10-31 date: 2030-10-31 date: 2024-04-01 date: 2024-04-01 name: Kimie Bols Østergaard class: OTHER briefSummary: The goal of this clinical trial is to investigate the hypothesis that there are none difference in the treatment result of orthognathic surgery on the lower jaw, with interoperative wisdom tooth removal rather than preoperative wisdom tooth removal. In patients with severe dental malocclusion combined with a dentofacial deformity. The main question it aims to answer are:

• Is there a difference in the degree of complication and the patient's perception, with inter-operative wisdom tooth removal rather than pre-operative wisdom tooth removal.

Participants will be will be divided into two groups, with one group having their wisdom teeth removed 6 months before their jaw moving surgery and the other group having their wisdom teeth removed in connection with their jaw moving surgery. conditions: Impacted Third Molar Tooth conditions: Osteotomy conditions: Orthognathic Surgery conditions: Mandibular Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial with a test group and a control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: Interoperative wisdom tooth removal in conjunction with BSSO measure: Fracture pattern following BSSO with or without impacted third molars measure: Condylar segment position following BSSO with or without impacted third molars measure: Oral Health Impact Profile-14 (OHIP-14) measure: The Modified Dental Anxiety Scale (MDAS) measure: Short Form-36 (SF-36) measure: PROMs measure: Length of the surgical procedure measure: Intraoperative bleeding measure: Frequency of intra- and postoperative complications sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aalborg universitets hospital city: Aalborg zip: 9000 country: Denmark lat: 57.048 lon: 9.9187 hasResults: False

 nctId: NCT06338969 id: PostBariKetosis briefTitle: The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis overallStatus: RECRUITING date: 2024-03-25 date: 2025-04-01 date: 2025-08-01 date: 2024-04-01 date: 2024-04-03 name: The Society of Bariatric and Metabolic Surgeons of Kazakhstan class: OTHER briefSummary: Background:

Ketosis after bariatric surgery is a metabolic process that occurs when the body breaks down fat for energy because of not getting enough carbohydrates.

Insufficient production of ketone bodies reduces the rate of weight loss, and excessive amounts of ketones can lead to ketoacidosis or liver failure in patients with nonalcoholic steatohepatitis (NASH).

The investigators hypothesize that weight loss is directly related to calorie intake, and a significant reduction in carbohydrate content leads to increased ketosis and the risk of ketoacidosis.

Objectives:

The study aimed to compare the incidence of ketoacidosis and liver failure in patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass. In addition, the investigators want to find out how carbohydrate restriction will affect weight loss for up to 1 year. conditions: Obesity, Morbid conditions: NASH conditions: Ketosis conditions: Keto Acidosis conditions: Carbohydrate Metabolism Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Carbohydrate Restriction after a Gastric Bypass measure: Cases of ketosis and incidence of ketoacidosis measure: Cases of liver failure measure: Change in body mass index (Δ BMI) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Oral Ospanov status: RECRUITING city: Astana state: Aqmola zip: 010000 country: Kazakhstan name: Oral Ospanov, PhD role: CONTACT phone: 7015287734 phoneExt: +7 email: bariatric.kz@gmail.com lat: 51.1801 lon: 71.44598 hasResults: False

 nctId: NCT06338956 id: Lipid-PCI briefTitle: Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI acronym: Lipid-PCI overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-01 date: 2024-04-01 name: Samsung Medical Center class: OTHER briefSummary: For the management of low-density lipoprotein-cholesterol (LDL-C), some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in LDL-C levels. High-intensity or maximally tolerated intensity can be maintained without a target goal. However, the European guideline recommends less than 55 mg/dL of LDL-C after PCI. conditions: Coronary Artery Disease conditions: Hyperlipidemias studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 94189 type: ESTIMATED name: LDL reduction therapy measure: MACCE measure: Cardiovascular death measure: Spontaneous myocardial infarction measure: Repeat revascularization measure: Ischemic stroke sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Ki Hong Choi, MD role: CONTACT phone: 82-2-3410-3419 email: cardiokh@gmail.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06338943 id: 02-02/24 briefTitle: Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction acronym: MAPO-HF overallStatus: RECRUITING date: 2024-03-18 date: 2025-01 date: 2025-01 date: 2024-04-01 date: 2024-04-01 name: National Medical Research Center for Therapy and Preventive Medicine class: OTHER_GOV briefSummary: Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. Nowadays, the relationship of adverse pregnancy factors with the development of long-term cardiac pathology, in particular, HFpEF, has not been completely established. One of the most significant issue is studying the younger phenotype of women.

The goal of this observational analytical cross-sectional study is to study the relationship of heart failure with a preserved ejection fraction in middle-aged women with adverse pregnancy outcomes in the history of pregnancy.

Research question: is there an association between adverse pregnancy factors and the development of HF in middle-aged women?

Objectives

1. To assess the frequency of detection of APOs in the history of pregnancy in middle-aged women, depending on the presence or absence of HFpEF.
2. To compare clinical and anamnestic data, morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF.
3. To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women.
4. To identify mediators between the presence of APOs and the development of HFpEF in middle-aged women.

Study population - 45-60 year-old women with the history of pregnancy (\>20 weeks) in the absence of low left ventricle ejection fraction (\<50%)

Primary endpoint: The prevalence of HFpEF in patients with the history of APOs. conditions: Heart Failure Preserved Ejection Fraction conditions: Pregnancy Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Echocardiography name: Questionnaire measure: HFpEF incidence measure: APOs incidence sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: National Medical Research Center for Therapy and Preventive Medicine status: RECRUITING city: Moscow country: Russian Federation name: Olga Dzhioeva, MD, PhD role: CONTACT phone: +79166141821 email: odzhioeva@gnicpm.ru name: Max Shperling, MD role: PRINCIPAL_INVESTIGATOR name: Alexandr Mols role: SUB_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06338930 id: ROADMAP briefTitle: Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy acronym: ROADMAP overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-03-02 date: 2027-03-30 date: 2024-04-01 date: 2024-04-01 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Routine follow-up of patients with inflammatory bowel disease (IBD) under stable doses of maintenance therapy or no IBD-related therapy at all, consists of intensive monitoring with prescheduled outpatient visits every six or twelve months. However, many of these patients do not require additional interventions from the IBD specialist during these visits. In addition, patients in long-term remission, often request a less frequent follow-up in the hospital and in consequence a less frequent absence from school or work. In conclusion, these routinely follow-up visits might put unnecessary burden on both healthcare providers and IBD patients, as well as on healthcare resources.

Until now, no clear standard was set for how to organize a remote monitoring programme that is feasible and safe in a large patient population. Despite the possible added value of remote monitoring for IBD patients on stable or no therapy and who are in remission, they are seldomly the targeted population in clinical trials analysing the effects of remote monitoring in IBD. Secondly, a significant reduction in outpatient clinic visits, is often not actively included in the programme, but more an outcome result. Finally, to compose a safe remote monitoring programme, subjective and objective parameters of disease activity should be collected.

With the ROADMAP study, the main objective is to evaluate the safety and feasibility of remote monitoring in IBD patients that are stable on their current therapy or receive no IBD-related therapy. Secondly, a health economic evaluation will be conducted. Patients will be randomised to either the remote monitoring group or control group. The remote monitoring group will visit the outpatient clinic after two years. During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin measures. An IBD nurse will evaluate all incoming data and act in case of red flags. conditions: Crohn Disease conditions: Colitis, Ulcerative conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 456 type: ESTIMATED name: Remote monitoring measure: Patient safety measured as the number of patients not requiring unplanned IBD related hospital visits (outpatient clinic, emergency department, hospitalization, or surgery) or rescue therapy with steroids within two years. measure: Costs and cost savings for hospital, RIZIV, employer, patient, … in the intervention group versus the control group. measure: Time saving for patients in the intervention group versus the control group will be measured using a "timing questionnaire". measure: Number of telephone/email contacts with the IBD team within one year and within two years. measure: Number of contacts with the general practitioner for IBD related reasons within one year and within two years. measure: Absence at work or school within one year and within two years in the intervention group versus the control group will be measured using the WPAI IBD questionnaire. measure: Quality of life in the intervention group versus the control group will be measured using the European Quality of Live Five Dimension Five Level Scale. measure: Number of patients refusing to participate in this trial and the reason why. measure: Reasons to stop remote monitoring. measure: Patient's compliance, measured via missing data in the intervention versus the control group measure: Satisfaction with the program in the intervention group. measure: System usability in the intervention group. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338917 id: File 2022 DI 61 briefTitle: Mental Health and Vigorous-intensity Physical Activity acronym: +MoveMENT overallStatus: ENROLLING_BY_INVITATION date: 2023-09-10 date: 2026-01-31 date: 2026-01-31 date: 2024-04-01 date: 2024-04-01 name: University of Vic - Central University of Catalonia class: OTHER name: IRIS-CC name: AGAUR briefSummary: People with severe mental illness have unhealthy lifestyles and habits, such as sedentary behavior and physical inactivity. Which are associated with a higher prevalence of premature mortality and chronic comorbidities.

The aim of this study is to evaluate the efficacy of a physical activity program, which pretends to increase the number of vigorous-intensity physical activity bouts in their daily life, as a habit, combining High Intensity Interval Training (HIIT) and Vigorous Intensity Life-Style Physical Activity (VILPA). Secondary aims are to evaluate the efficacy of the program on fitness, physical activity and sedentary behavior level and patron; depressive, mania and psychotic symptomatology, functionality and cognitive functioning; quality of life and mood. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE maskingDescription: Participants in both groups are not aware of the existence of the other group. The health provider in the control group is aware of the existence of the intervention group but does not know which intervention is being carried out. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Vigorous-intensity physical activity program measure: Psychotic symptomatology measure: Depression symptomatology measure: Depression severity measure: Mania symptomatology measure: Mania severity measure: Disability measure: Quality of life measure: Cognitive functioning measure: Mood measure: Subjective physical activity patron measure: Subjective sedentary behaviour patron measure: Perception of physical fitness measure: Objective physical activity patron measure: Objective sedentary behavior patron measure: Cardiorespiratory endurance measure: Velocity measure: Agility measure: Lower limb strength measure: Subjective perception of joy measure: Subjective perception of calm measure: Subjective perception of energy measure: Subjective perception of time spent measure: Subjective perception of the received information measure: Subjective perception of respect received sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vic city: Vic state: Barcelona zip: 08500 country: Spain lat: 41.93012 lon: 2.25486 hasResults: False

 nctId: NCT06338904 id: PID2022-141225OB-I00 briefTitle: Brief Problem-solving Intervention in Different Formats for the Prevention of Suicide in Adults Over 50 acronym: SOLPROSU50+ overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2026-05-31 date: 2026-05-31 date: 2024-04-01 date: 2024-04-01 name: University of Santiago de Compostela class: OTHER name: Ministry of science and innovation of Spain briefSummary: Suicide represents a personal tragedy and an enormous global public health problem. One of the most vulnerable groups is adults 50 years and older. Despite this stage of life is particularly amenable to the implementation of targeted suicide prevention strategies, we have few studies of the efficacy of psychological interventions, those that do exist have methodological limitations, and none were implemented in formats other than face-to-face, which limits their accessibility. There is a need for brief psychological interventions that can be administered in both face-to-face and remote formats, do not require long training periods, and are effective in different contexts: for example, problem-solving therapy. The main objective of this project is to evaluate the efficacy of a brief problem-solving psychological intervention for targeted suicide prevention in people aged 50 years and older, administered in face-to-face, conference call, and smartphone app formats. A randomized controlled trial will be performed. Participants will be recruited through healthcare centers in the Autonomous Community of Galicia (Spain). To be included, participants must: (a) be at least 50 years old, (b) reside in Galicia, and (c) present suicidal ideation. Subjects will be excluded if they: (a) present serious mental health or medical disorders; (b) have begun receiving psychological or psychopharmacological treatment in the previous two months or are participating in other suicide prevention research; (c) do not have an appropriate mobile device or sufficient fluency to communicate in Spanish, or have problems that make it impossible to participate; or (d) plan to move in the next 18 months. At pre-intervention information will be collected on sociodemographic, family, personal history, current suicide risk and other clinical variables. 212 participants will be randomly assigned to (1) a problem-solving-based psychological intervention delivered face-to-face (PSPI-FF; experimental group 1); (2) a problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC; experimental group 2); (3) a problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A; experimental group 3); or (4) a usual care control group (UCCG). Participants in the experimental groups will complete the six sessions/modules of the interventions. Finally, subjects in all groups will be evaluated at post-intervention and 3, 6 and 12-month follow-ups. conditions: Suicide studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 212 type: ACTUAL name: Problem-solving-based psychological intervention measure: Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months. measure: Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months. measure: Change from baseline hopelessness to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline anxiety and depressive symptoms to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline reasons for living to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline impulsivity to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline problem-solving skills to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline social support to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Change from baseline syndrome of clinical anger to post-treatment (7 weeks), and follow-ups at 6 and 12 months measure: Treatment adherence measure: Satisfaction with the service received measure: Sociodemographic, familial, personal history, and current suicide risk variables sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Group on Mental Health and Psychopatology city: Santiago de Compostela state: A Coruña zip: 15782 country: Spain lat: 42.88052 lon: -8.54569 hasResults: False

 nctId: NCT06338891 id: ACPM34 briefTitle: Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks overallStatus: RECRUITING date: 2024-05-01 date: 2024-08-30 date: 2025-05-01 date: 2024-04-01 date: 2024-04-01 name: University of Palermo class: OTHER briefSummary: Familial Mediterranean Fever (FMF) is a chronic hereditary autoinflammatory disease caused by mutations in the MEditerranean FeVer (MEFV) gene which codes for pyrin. Dysfunction of this protein determines an inappropriate response to inflammatory stimuli. The clinical course of the disease is characterized by recurrent episodes of fever and inflammation of the serous membranes, which manifest with chest, abdominal and joint pain. Several studies suggest a possible association between acute FMF attacks and dietary triggers, including wheat. However, it is still unclear to what extent wheat is responsible for the reactivation of FMF and if, between one acute attack and another, patients with FMF experience other symptoms, both gastrointestinal and extraintestinal, characteristic of gluten/wheat sensitivity not linked to celiac disease or immunoglobulin E (IgE)-mediated wheat allergy (i.e. Non-Celiac Wheat Gluten/Sensitivity, NCGS/NCWS).

Therefore, this study aims to evaluate the appearance of symptoms compatible with an acute attack of FMF following the ingestion of wheat or other foods, and the prevalence of self-perceived gluten/wheat sensitivity in patients with FMF. conditions: Familial Mediterranean Fever conditions: Non-celiac Gluten Sensitivity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Main questionnaire name: Secondary questionnaire measure: Prevalence of the self-perception of wheat as a potential trigger of acute attack in patients with familial Mediterranean fever (FMF) measure: Prevalence of the self-perception of other foods, other than wheat, as potential triggers of an acute attack in patients with FMF measure: Prevalence of self-reported NCGS/NCWS in patients with FMF measure: Genetic differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Genetic differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Genetic differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Ethnic group differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Ethnic group differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Ethnic group differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Education level differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Education level differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Education level differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Working activity differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Working activity differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Working activity differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Gastrointestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Extraintestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Extraintestinal symptoms duration between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Gastrointestinal symptoms duration differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: FMF specific drugs intake differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: FMF specific drugs intake differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: FMF specific drugs intake differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in number/year of FMF attacks between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in FMF specific drugs intake adherence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in marital status between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in marital status between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in marital status between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in age at FMF diagnosis between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. measure: Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. measure: Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. measure: Differences in age at FMF symptom's onset between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. sex: ALL minimumAge: 6 Months maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Palermo status: RECRUITING city: Palermo state: Sicily zip: 90127 country: Italy name: Pasquale Mansueto role: CONTACT phone: 00390916554815 email: pasquale.mansueto@unipa.it name: Pasquale Mansueto role: PRINCIPAL_INVESTIGATOR name: Antonio Carroccio role: SUB_INVESTIGATOR name: Aurelio Seidita role: SUB_INVESTIGATOR lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06338878 id: 2023PI087 briefTitle: PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes acronym: PATHWAY-HF overallStatus: RECRUITING date: 2024-03-01 date: 2027-01 date: 2029-01 date: 2024-04-01 date: 2024-04-01 name: Pr. Nicolas GIRERD class: OTHER briefSummary: This is a monocentric cohort study conducted in the cardiology department of Nancy hospital. The main purpose of the study is to document the global management strategy of patients hospitalized for heart failure and evaluate the association between patient's care and post-hospitalization outcome. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: All-cause post-hospitalization mortality measure: Rehospitalization for heart failure measure: Percentage of maximum dose of each cardiotropic treatment indicated in heart failure according to ESC recommendations measure: Influenza and pneumococcal vaccination status measure: Evolution of renal function measure: All-cause Rehospitalization measure: All-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU de Nancy status: RECRUITING city: Nancy country: France name: Laura FILIPPETTI role: CONTACT email: l.filippetti@chru-nancy.fr lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06338865 id: Study00003146 briefTitle: Short Title: Standard vs. Lower Pressure Pneumoperitoneum overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-01 date: 2024-04-01 name: Cedars-Sinai Medical Center class: OTHER briefSummary: This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. conditions: Laparoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Patients and post-anesthesia care unit nurses will be masked. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 294 type: ESTIMATED name: Carbon dioxide name: Bupivacaine name: Oxycodone measure: Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10) measure: First reported pain score in PACU (numerical rating scale, 0-10) measure: Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10) measure: Inpatient morphine milligram equivalents measure: Total number of 5mg oxycodone pills taken in the 2 weeks following discharge measure: Need for insufflation pressure increase intra-operatively due to inadequate visualization measure: Operative time measure: Estimated blood loss measure: Intraoperative complications measure: Conversion to laparotomy measure: Postoperative length of stay measure: Surgeon-reported adequacy of assigned insufflation pressure measure: Need for adjustment of insufflation pressure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338852 id: 4347 briefTitle: Awareness of Gynaecologists About Role of Physical Therapy in Genital Prolapse overallStatus: COMPLETED date: 2023-03-03 date: 2023-06-03 date: 2023-07-03 date: 2024-04-01 date: 2024-04-01 name: Cairo University class: OTHER briefSummary: The aim of this study will be to detect if there is awareness of gynecologists about the role of physical therapy in genital prolapse.

Physical therapy plays an important role in assessment, prevention and treatment of pelvic floor dysfunction and genital prolapse, it helps to stimulate and strength pelvic floor muscle.

Physical therapy treatments for the pelvic floor may include bladder training, pelvic floor muscles training with or without biofeedback, vaginal cones, electro stimulation or other adjuncts to training. conditions: Genital Prolapse studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 370 type: ACTUAL name: Socio demographic and evaluation questionnaires measure: Socio demographic and evaluation questionnaires sex: ALL minimumAge: 29 Years maximumAge: 44 Years stdAges: ADULT facility: Faculty of physical therapy cairo university city: Cairo zip: 37617692 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06338839 id: D8450R00006 briefTitle: Transthyretin Amyloidosis Cardiomyopathy in Patients With HFpEF in Russia acronym: TETRAMER overallStatus: RECRUITING date: 2023-12-28 date: 2024-11-30 date: 2024-11-30 date: 2024-04-01 date: 2024-04-01 name: AstraZeneca class: INDUSTRY briefSummary: A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice.

The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participating/participated in the PRIORITY-CHF study and have HFpEF. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The prospective phase will consist of three visits, during which a routine comprehensive cardiologic evaluation in order to confirm or exclude ATTR-CM diagnosis will be performed. In patients with confirmed ATTR-CM the material for genetic testing will be collected in order to specify the type of ATTR-amyloidosis conditions: Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 6000 type: ESTIMATED measure: Prevalence of ATTR-CM in patients with HFpEF in routine clinical practice in the Russian Federation measure: demographic and clinical characteristics, and test results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Akhtubinsk country: Russian Federation lat: 48.27955 lon: 46.17217 facility: Research Site status: RECRUITING city: Astrakhan country: Russian Federation lat: 46.34968 lon: 48.04076 facility: Research Site status: RECRUITING city: Beslan country: Russian Federation lat: 43.19217 lon: 44.54313 facility: Research Site status: RECRUITING city: Izhevsk country: Russian Federation lat: 56.84976 lon: 53.20448 facility: Research Site status: RECRUITING city: Kaluga country: Russian Federation lat: 54.5293 lon: 36.27542 facility: Research Site status: RECRUITING city: Krasnodar country: Russian Federation lat: 45.04484 lon: 38.97603 facility: Research Site status: RECRUITING city: Rostov-on-Don country: Russian Federation lat: 47.23135 lon: 39.72328 facility: Research Site status: RECRUITING city: Smolensk country: Russian Federation lat: 54.7818 lon: 32.0401 facility: Research Site status: RECRUITING city: Vladimir country: Russian Federation lat: 56.13655 lon: 40.39658 facility: Research Site status: RECRUITING city: Vladivostok country: Russian Federation lat: 43.10562 lon: 131.87353 facility: Research Site status: RECRUITING city: Volgograd country: Russian Federation lat: 48.71939 lon: 44.50183 facility: Research Site status: RECRUITING city: Yaroslavl country: Russian Federation lat: 57.62987 lon: 39.87368 hasResults: False

 nctId: NCT06338826 id: ANRS0250s-BI-LIGHT briefTitle: Study Evaluating the Safety, in Terms of HBV Virological Control at 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected With the HIV-1 and HBV Viruses acronym: BI-LIGHT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02-28 date: 2027-02-28 date: 2024-04-01 date: 2024-04-01 name: ANRS, Emerging Infectious Diseases class: OTHER_GOV briefSummary: The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy conditions: HIV Infections conditions: HBV Coinfection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Interventional, sequential, Phase IIA equivalent, multicenter, open-label, randomized, non-comparative study evaluating, for 96 weeks, the safety in terms of HBV virological control of 2 antiviral therapy relief strategies, in HIV-1 and HBV co-infected patients with prolonged virological success (undetectable HIV-1 and HBV viral loads for ≥ 2 years) and on unmodified antiviral therapy for ≥ 1 year.

Participants will be randomized 1:2:2 into 3 parallel arms:

* Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF
* Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days
* Arm 3 (B7): Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR). The choice of dual therapy is left to the discretion of the investigator. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 140 type: ESTIMATED name: TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI name: Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR) measure: The proportion of participants with HBV virological failure at 96 weeks. measure: • HBV virological success rate at 48 weeks measure: • HIV virological success rate at 48 and 96 weeks measure: • Time to virological failure (rebound HBV and/or HIV viral load) measure: • The rate of participants with at least one HBV viral load blip until W48 and until W96 measure: • Selection of HBV resistance mutations at the time of virological failure measure: • Incidence of grade 3 or higher adverse events of grade 3 or higher, incidence of adverse events and incidence of strategy discontinuation of the strategy at W48 and W96 measure: • Evolution of CD4 from W0 to W48 and W96 measure: • Evolution of total cholesterol from W0 to W48 and W96 measure: • Evaluation of the adherence by self-reported questionnaire measure: • Evaluation of quality of life using the Pro-Qol self-questionnaire measure: Evolution of CD8 T lymphocytes from W0 to W48 and W96 measure: Evolution of the CD4/CD8 ratio from W0 to W48 and W96 measure: Evolution of LDL-c from W0 to W48 and W96 measure: Evolution of HDL-c from W0 to W48 and W96 measure: Evolution of triglycerides from W0 to W48 and W96 measure: Evolution of fasting blood sugar from W0 to W48 and W96 measure: HBV virological success rate at 96 weeks between arms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338813 id: Merve Unutmaz briefTitle: Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus overallStatus: COMPLETED date: 2022-10-30 date: 2023-02-22 date: 2023-03-01 date: 2024-04-01 date: 2024-04-01 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Although many measurement techniques have been tried for intra-abdominal pressure, the Kron technique is currently the gold standard method. However, the search for other methods continues due to its long application time, the need for more equipment, and impracticality. Consequently, the investigators sought to investigate a quicker and more accessible method suitable for successful intra-abdominal pressure measurement in the emergency department. This study aimed to compare intra-abdominal pressure measurements in patients diagnosed with ileus using a digital manometer and the Kron Technique. conditions: Ileus studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SCREENING masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Digital Manometry measure: Digital manometer measuring for Intraabdominal Pressure sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06338800 id: PSY-2324-S-0134 briefTitle: One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-12 date: 2024-04-01 date: 2024-04-01 name: Accare class: OTHER briefSummary: The goal of this study is to evaluate one session with exposure with Virtual Reality (VR) in in children and adolescents, aged 8-18 years with an anxiety disorder. The main questions it aims to answer are:

1. What are the expectations of children and adolescents and therapists with VR exposure?
2. What is the acceptability of the VR session (positive and negative effects)?
3. What are possible working mechanisms of VR exposure? During ongoing treatment, participants will receive a session of exposure with VR. conditions: Anxiety Disorders conditions: Exposure conditions: Social Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: During ongoing treatment for their anxiety disorder 30 children and adolescents (8-18 years) with an anxiety disorder will receive a session of exposure with VR. Before the session expectations of VR exposure will be assessed. Before and after the session willingness to participate in exposure in vivo will be measured. During the session anxiety, idiosyncratic expectations, and self-efficacy are measured. After the session, positive effects, experiences, and negative side effects will be asked for. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: One session exposure with Virtual Reality measure: Willingness to participate in exposure in vivo measure: Idiosyncratic expectations measure: Anxiety measure: Expectations of Virtual Reality measure: Acceptability sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06338787 id: 23-0826.2 briefTitle: A Novel Iron-Based Supplement for Athletes Aged 14-17 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-12 date: 2024-04-01 date: 2024-04-01 name: University of Calgary class: OTHER name: Mitacs name: Natural Sciences and Engineering Research Council, Canada briefSummary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females. conditions: Iron Deficiencies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: FeSC measure: Iron Status measure: Hemoglobin measure: Lower Gut microbiome measure: Exercise Capacity measure: Gastrointestinal Symptoms 1 measure: Gastrointestinal Symptoms 2 measure: Sleepiness measure: Stress and Recovery sex: FEMALE minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06338774 id: 202310129 id: R33AG078041 type: NIH link: https://reporter.nih.gov/quickSearch/R33AG078041 briefTitle: Cognitive Control to Boost Physical Activity Adherence acronym: BOOST overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-11-30 date: 2024-04-01 date: 2024-04-02 name: University of Iowa class: OTHER name: Northeastern University name: National Institute on Aging (NIA) briefSummary: This trial is designed to develop and test the efficacy of cognitive training strategies to improve self-regulatory capacities for middle-aged adults to adopt and sustain a physically active lifestyle. The main questions it aims to answer are:

* Can cognitive training designed to improve cognitive control improve physical activity adherence?
* What are the psychological, physiological, cognitive, and sociodemographic factors that affect the impact of cognitive control on physical activity adherence?

Participants will

* Complete a 6-week home-based, computerized cognitive training program
* Complete a 6-week home-based, aerobic exercise training program with supervision of a health coach and trainer
* Complete a 6-week home-based, aerobic exercise training program prescribed by a health coach and trainer
* Visit the laboratory before and after cognitive training, and before and after physical training, to complete assessments of cognition and aerobic fitness conditions: Physical Inactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Six week parallel group intervention, followed by a 12 week exercise program. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: Cognitive training name: Exercise measure: Physical Activity Adherence sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Psychological and Brain Sciences Building city: Iowa City state: Iowa zip: 52242 country: United States name: Michelle W Voss, PhD role: CONTACT phone: 319-335-2057 email: michelle-voss@uiowa.edu name: Ruthina Malone role: CONTACT phone: 319-335-2407 email: ruthina-malone@uiowa.edu name: Michelle Voss, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.66113 lon: -91.53017 facility: Center for Cognitive and Brain Health city: Boston state: Massachusetts zip: 02115 country: United States name: Charles Hillman, PhD role: CONTACT phone: 617-373-8342 email: c.hillman@northeastern.edu name: Virginia Davis role: CONTACT phone: 617-373-3448 email: vi.davis@northeastern.edu name: Charles Hillman, PhD role: PRINCIPAL_INVESTIGATOR name: Arthur F Kramer, PhD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06338761 id: E-cigarette PCI briefTitle: Switching to E-cigarette After PCI acronym: E-cig-PCI overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-01 date: 2024-04-01 name: Samsung Medical Center class: OTHER briefSummary: Despite the increasing popularity of electronic cigarettes (E-cigarettes), the prognostic impact of switching to E-cigarettes in smokers with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) remains uncertain. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 17442 type: ESTIMATED name: Smoking cessation name: Switching to E-cigarette measure: MACE measure: Cardiovascular death measure: All-cause death measure: Spontaneous myocardial infarction measure: Repeat revascularization sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Ki Hong Choi, MD role: CONTACT phone: 82-2-3410-3419 email: cardiokh@gmail.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06338748 id: 24-157 briefTitle: Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery acronym: DexcomG7 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-01 date: 2024-04-01 name: The Cleveland Clinic class: OTHER name: DexCom, Inc. briefSummary: This is a prospective longitudinal study to study the agreement between a continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the Cardiovascular Intensive Care Unit (CVICU), and by Point of Care (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems, as well as errors, will be calculated. conditions: Continuous Glucose Monitoring studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients undergoing heart surgery at the Cleveland Clinic (main campus) who would normally be tested for high sugar levels by poking a finger and using a test strip. primaryPurpose: OTHER masking: NONE maskingDescription: The study will involve using blinded Dexcom G7 continuous glucose monitoring (CGM) devices count: 28 type: ESTIMATED name: Continuous glucose monitor (CGM) Dexcom G7 used in blinded mode measure: Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from arterial blood gas (ABG) or peripheral/central venous catheter or fingerstick point of care (POC) while patients are in the CVICU measure: Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Foundation city: Cleveland state: Ohio zip: 44195 country: United States name: Kimberly Jenkins role: CONTACT phone: 216-445-4791 email: jenkink@ccf.org name: Kimberly Jenkins role: CONTACT phone: (216) 445-4791 email: jenkink@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06338735 id: 14540 briefTitle: Ultra-High Frequency Ultrasonography in Sjögren's Syndrome acronym: UltraSjögren overallStatus: RECRUITING date: 2016-01-11 date: 2026-12-31 date: 2030-12 date: 2024-04-01 date: 2024-04-01 name: University of Pisa class: OTHER briefSummary: Patients diagnosed with a diagnosis of Sjogren's syndrome performed according to the ACR/EULAR criteria will be included in the study. Sjogren's syndrome diagnosis will be performed following a complete diagnostic work-up involving rheumatologic assessment, glandular functional tests, and blood testing for anti-Ro(SSA) antibodies. Conventional ultrasonography of major salivary glands and ultra-high frequency ultrasonography (70 MHz) of minor salivary glands will be performed, and the scans assessed using the Outcome Measures in Rheumatology (OMERACT) scoring system (Score 0 normal glandular tissue, Score 1 mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis. Focus Score will be assessed following biopsy of minor salivary glands. conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 800 type: ESTIMATED name: Ultra-High Frequency Ultrasound scan of minor salivary glands measure: OMERACT score measure: Correspondence between ultrasonography and histology sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pisa status: RECRUITING city: Pisa zip: 56126 country: Italy name: Rossana Izzetti role: CONTACT phone: +39050993037 email: rossana.izzetti@unipi.it name: Rossana Izzetti role: PRINCIPAL_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06338722 id: 23-397 briefTitle: Making it Work Program for Systemic Sclerosis overallStatus: RECRUITING date: 2023-12-08 date: 2024-07-31 date: 2024-09-30 date: 2024-04-01 date: 2024-04-01 name: University of New Mexico class: OTHER briefSummary: The purpose of this clinical trial is to see if an online intervention program for people with Systemic Sclerosis (scleroderma) helps keep people in the workforce and increase self-confidence in dealing with challenges at work. The program is called Making it Work Systemic Sclerosis.

Researchers will compare a group who gets the program to a group who will get the program at a later point in time (wait list control group) to see if self-confidence in dealing with work challenge gets better.

People in the Making it Work group will complete questionnaires and attend one 2 hour meetings each week for 5 weeks and meet with an occupational therapist and vocational counselor. People in the wait list control group will complete the questionnaires and participate in the program at a later point in time. conditions: Scleroderma, Systemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention receives the Making it work program Wait list Control receives usual care but will be offered the program after the intervention groups finish primaryPurpose: TREATMENT masking: NONE maskingDescription: People will know what group they are in when they are invited to attend the intervention sessions count: 50 type: ESTIMATED name: Making it Work Systemic Sclerosis measure: Job Related Self-efficacy Scale measure: Job Self-Efficacy Scale measure: Work Productivity and Activity Impairment Questionnaire Specific Health Problem Subscale measure: The Work Instability Scale sex: ALL minimumAge: 18 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of New Mexico status: RECRUITING city: Albuquerque state: New Mexico zip: 87131-0001 country: United States name: Janet L Poole, PhD role: CONTACT phone: 505-272-8276 email: jpoole@salud.unm.edu lat: 35.08449 lon: -106.65114 hasResults: False

 nctId: NCT06338709 id: 11-002 briefTitle: Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP® overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-08 date: 2026-08 date: 2024-04-01 date: 2024-04-01 name: Advanced Bariatric Technology class: INDUSTRY name: NAMSA briefSummary: Overweight and obesity are at epidemic proportions in the world population as well as in the United States, where nearly 42% of the adult population(1) is considered to meet the definition of obesity, namely a body mass index ("BMI") ≥ 30 kg/m2. Well-established links between obesity and increased morbidities and mortality make treatment of the utmost importance; however, there continues to be a significant unmet need for more effective treatments for obesity. Bariatric surgery is recognized as an effective treatment for obese patients, particularly in more severe cases where surgical restriction of the stomach's capacity and outlet size are considered necessary. The BariClip® is a laparoscopically implanted device for treatment of obesity and serves as an alternative to current existing technology for use in bariatric surgery. The BariClip® is a medical device, non-adjustable, resembling a clip that is placed parallel to the greater curvature of the stomach, causing restriction of the gastric lumen in a vertical fashion. This multi-center, randomized, moderate-lifestyle (program of diet and exercise) controlled pivotal study of the BariClip® device is intended to gather data to objectively support its safety and effectiveness for the treatment of obesity in adults and to ultimately support marketing authorization of this device as a viable alternative to existing bariatric surgical procedures. Specifically, this study aims to look at efficacy of the BariClip® device with regards to weight loss metrics and secondary health metrics and safety of the BariClip® device with regards to serious adverse events. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 165 type: ESTIMATED name: BariClip® Device Treatment measure: Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects measure: Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group measure: Weight and Height will be combined to report BMI in kg/m^2 measure: Blood Pressure (BP) in mmHg, both systolic and diastolic measure: Diagnosis and/or Change in Severity of Diabetes Mellitus (DM) measure: Weight in kilograms measure: Height in meters measure: Waist Circumference in centimeters measure: Incidence of Serious Adverse Events (SAEs) sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338696 id: COA-CREC070/2023 briefTitle: Thailand ATTR-CM Registry overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-06-01 date: 2030-06-30 date: 2024-04-01 date: 2024-04-01 name: Mahidol University class: OTHER name: Pfizer briefSummary: The investigators of this registry aim to study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with ATTR amyloidosis in Thailand longitudinally. This will enable the investigators to study this disease in depth. With a better understanding, the investigators can aim to develop early screening programs for at-risk patients, raising awareness among non-cardiologists. As amyloid-specific therapies have now become available in Thailand, the findings of this registry can be helpful for epidemiological studies in Thailand. conditions: Transthyretin Amyloid Cardiomyopathy (ATTR-CM) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: No intervention measure: Rate of death measure: Rate of heart failure hospitalization measure: Transthyretin (ATTR) amyloidosis medication sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine at Chulalongkorn University city: Bangkok country: Thailand name: Sarinya Puwanant, MD role: CONTACT name: Sarinya Puwanant, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 facility: Faculty of Medicine Ramathibodi hospital, Mahidol University city: Bangkok country: Thailand name: Teerapat Yingchoncharoen, MD role: CONTACT name: Teerapat Yingchoncharoen, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 facility: Faculty of Medicine Siriraj Hospital, Mahidol University city: Bangkok country: Thailand name: Kanchalaporn Jirataiporn, B.N.S role: CONTACT name: Srisakul Chirakarnjanakorn, MD role: PRINCIPAL_INVESTIGATOR name: Adisak Maneesai, MD role: SUB_INVESTIGATOR name: Porntera Sethalao, MD role: SUB_INVESTIGATOR lat: 13.75398 lon: 100.50144 facility: Phramongkutklao Hospital city: Bangkok country: Thailand name: Hutsaya Prasitdumrong, MD role: CONTACT name: Hutsaya Prasitdumrong, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 facility: Faculty of Medicine Chiang Mai University city: Chiang Mai country: Thailand lat: 18.79038 lon: 98.98468 facility: Queen Sirikit Heart Center of The Northeast city: Khon Kaen country: Thailand name: Vichai Senthong, MD role: CONTACT name: Vichai Senthong, MD role: PRINCIPAL_INVESTIGATOR lat: 16.44671 lon: 102.833 facility: Faculty of Medicine, Thammasat University city: Pathum Thani country: Thailand name: Adisai Buakhamsri, MD role: CONTACT name: Adisai Buakhamsri, MD role: PRINCIPAL_INVESTIGATOR lat: 14.01346 lon: 100.53049 facility: Prince of Songkla University city: Songkhla country: Thailand lat: 7.19882 lon: 100.5951 hasResults: False

 nctId: NCT06338683 id: QRCH-2024001 briefTitle: Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer overallStatus: RECRUITING date: 2024-03-20 date: 2027-03-20 date: 2028-03-20 date: 2024-03-29 date: 2024-03-29 name: Qinghai Red Cross Hospital class: OTHER briefSummary: This study aims to assess the impact of adding olanzapine to nutritional advice and standard anti-tumor therapy on the survival and safety of patients with locally advanced, unresectable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer, and lung cancer. Researchers seek to determine whether olanzapine can improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in advanced cancer patients who received standard anti-tumor therapy, and investigate the relationship between olanzapine-induced weight changes and patient survival. conditions: Advanced Cancer conditions: Olanzapine conditions: Progression Free Survival studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 230 type: ESTIMATED name: Olanzapine 2.5 MG name: Standard anti-tumor treatment name: Nutritional advice measure: Comparing the difference in Median PFS between the two groups measure: Comparing the difference in Median OS between the two groups measure: Comparing the difference in ORR between the two groups measure: Comparing the difference in the incidence of ≥3% weight loss between the two groups measure: Comparing the difference in BMI between the two groups measure: Comparing the difference in the improvement in other symptoms (appetite, nausea, fatigue, insomnia) between the two groups measure: Comparing the difference in Quality of life in the overall stage between the two groups measure: neutrophil-to-lymphocyte ratio measure: platelet-to-lymphocyte ratio measure: C-reactive protein (CRP) concentration measure: concentration of albumin measure: Level of interleukin (IL)-6 and IL-8 measure: Comparing the difference in the side effects of olanzapine treatment between the two groups sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qinghai Red Cross Hospital status: RECRUITING city: Xining state: Qinghai zip: 810000 country: China name: Qiuxia Dong, Dr role: CONTACT phone: 0971-8267613 email: 2816278916@qq.com lat: 36.62554 lon: 101.75739 hasResults: False

 nctId: NCT06338670 id: CLTD5839 briefTitle: Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users acronym: RECONNECT overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-11-22 date: 2024-11-22 date: 2024-03-29 date: 2024-03-29 name: Cochlear class: INDUSTRY name: Avania briefSummary: This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia implant. Participants will attend four study visits, where they will complete various hearing assessments using the Osia sound processors. conditions: Hearing Loss, Mixed Conductive-Sensorineural conditions: Hearing Loss, Conductive studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Within-subject primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Cochlear Osia 3 Sound Processor name: Cochlear™ Osia® 2 Sound Processor measure: Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL measure: Change (within subject) in word recognition score in quiet measured at 65 dB SPL measure: Change (within subject) in aided thresholds in sound field measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz measure: Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips measure: Percentage of participants who preferred Osia 3 over Osia 2 sound processor sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The HEARing CRC city: Melbourne state: Victoria zip: 3053 country: Australia name: Robert Cowan role: CONTACT phone: +61418780198 email: r.cowan@unimelb.edu.au lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06338657 id: 7H-23-5 id: NCI-2024-01367 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 7H-23-5 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2026-04-04 date: 2027-04-04 date: 2024-03-29 date: 2024-03-29 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with head and neck squamous cell carcinoma. The active drug in FID-007 is paclitaxel, an established chemotherapy drug that has been shown to kill cancer cells. FID-007 is a packaged form of paclitaxel using a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller. This study is being done to help identify future treatment options and better understand how to improve outcomes of patients with head and neck cancers after surgery. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Magnetic Resonance Imaging name: PEOX-based Polymer Encapsulated Paclitaxel FID-007 name: Tumor Resection measure: Evaluate the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007 measure: Incidence of adverse events (AEs) measure: Major pathologic response rate measure: Complete pathologic response rate measure: Rate of locoregional recurrence measure: Rate of distant metastasis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Los Angeles General Medical Center city: Los Angeles state: California zip: 90033 country: United States name: Sandy Tran, MS role: CONTACT phone: 323-865-0451 email: Sandy.tran@med.usc.edu name: Jacob S. Thomas, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: USC / Norris Comprehensive Cancer Center city: Los Angeles state: California zip: 90033 country: United States name: Sandy Tran, MS role: CONTACT phone: 323-865-0451 email: Sandy.tran@med.usc.edu name: Jacob S. Thomas, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06338644 id: HelwanUY briefTitle: Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients. acronym: Palbociclib overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-09-01 date: 2026-09-01 date: 2024-03-29 date: 2024-03-29 name: Helwan University class: OTHER briefSummary: Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies conditions: Hormone-receptor-positive Breast Cancer conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast conditions: Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Palbociclib measure: 1-year Progression free survival (PFS) measure: Neutropenia sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338631 id: 43C301 briefTitle: Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess" acronym: OB-KID overallStatus: RECRUITING date: 2023-08-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-29 date: 2024-03-29 name: Istituto Auxologico Italiano class: OTHER briefSummary: Overweight and obesity are increasingly prevalent worldwide. Weight excess increases the risk of in developing the metabolic syndrome, which is composed by a set of cardiometabolic risk factors such as abdominal adiposity, dyslipidemia, high blood pressure and elevated fasting glucose levels. Obesity and the metabolic syndrome are known to be risk factors for the development of chronic kidney disease. It is not clear however, whether they can be considered independent risk factors for impaired renal function and renal damage. Whereas obesity may represent an independent risk factor for renal damage, it is not clear yet if the contemporaneous presence of obesity and metabolic alterations is associated with an additional increase in the risk.

It may be important to understand the relationship between obesity, metabolic syndrome and renal health, as treatment strategies may be different for the two metabolic phenotypes of obesity, i.e., metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) patients.

The primary objective of this multicentre observational prospective study is to assess the relationship between metabolic phenotype and reduced renal function (glomerular filtration rate \<90 ml/min/1.73m2 or microalbuminuria 30-300 mg/24h) in a population of 1000 patients with overweight or obesity.

The secondary aim is to study the association between diet quality, consumption of ultra-processed foods and indicators of reduced renal function and renal damage. conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Diet measure: Glomerular filtration rate measure: Microalbuminuria measure: Glycemia measure: Body mass index sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Istituto Auxologico Italiano, Città Studi ICANS status: RECRUITING city: Milano zip: 20100 country: Italy name: Alberto Battezzati, Prof role: CONTACT phone: +390261911 email: a.battezzati@auxologico.it lat: 45.46427 lon: 9.18951 facility: Programma Infradipartimentale di Dietoterapia nel Trapianto e nell' Insufficienza Renale Cronica, DAI di Medicina Interna ad Indirizzo Specialistico, del Policlinico Federico II di Napoli status: RECRUITING city: Naples country: Italy name: Bruna Guida, Prof. role: CONTACT lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06338618 id: 1532-N-23 briefTitle: Manual Therapy in Metabolic Liver Disease acronym: OSTEO-EHMet overallStatus: RECRUITING date: 2024-04-03 date: 2024-06 date: 2024-08 date: 2024-03-29 date: 2024-04-05 name: University of Seville class: OTHER briefSummary: Hepatic steatosis is a disease that is becoming more common in our society; approximately 40% of the population suffers from non-alcoholic fatty liver. The beneficial effect of manual therapy for the treatment of viscera dysfunctions such as the stomach or colon is known. The objective of this study is to demonstrate the anti-inflammatory effects of visceral manual therapy in patients with metabolic liver disease associated with non-alcoholic fatty liver. conditions: NAFLD, Non-alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: liver treatment protocol measure: Hepatic steatosis index measure: FIB-4 index measure: NAFLD-fibrosis index measure: HOMA index measure: TyG index measure: Change from baseline in algometry measure: Visual analogue Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitary Hospital Juan Ramón Jiménez status: RECRUITING city: Huelva zip: 21005 country: Spain name: Javer Carrasco Sánchez, Dr role: CONTACT phone: 682289772 email: fjcarrascos@icloud.com lat: 37.26638 lon: -6.94004 hasResults: False

 nctId: NCT06338605 id: MEC-2023-0715 briefTitle: Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK4/6 Inhibitors Trough Cystatin C Analysis acronym: CYSTATINcDK4/6 overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-12 date: 2024-04-01 date: 2024-06-01 date: 2024-03-29 date: 2024-03-29 name: Erasmus Medical Center class: OTHER briefSummary: CDK4/6 inhibitors have led to an improvement of both progression free survival (PFS) and overall survival (OS) in patients with advanced estrogen positive (ER+)/HER2- breast cancer when applied in the first or second line of treatment. Despite the advantages of CDK4/6 inhibitors, these medications can lead to adverse effects. One of the adverse events observed across all types of CDK4/6 inhibitors is an elevation in creatinine levels. An elevation in plasma creatinine during treatment with abemaciclib is not always indicative of a reduction in renal function; it can also be attributed to the inhibition of active tubular secretion of creatinine. This phenomenon is known as pseudo acute kidney injury (pseudo-AKI).

The incidence of pseudo-AKI in patients using CDK4/6 inhibitors is currently unknown. A method to distinguish pseudo-AKI from AKI is measuring the level of an alternative filtration marker in blood, for example cystatin C. Cystatin C is also filtered at the glomerulus but not secreted intro the renal tubulus or reabsorbed into the bloodstream. Also, there is no affection by muscle mass or diet. In this study the investigators will explore the incidence of both AKI and pseudo-AKI in patients who are treated with CDK4/6 inhibitor treatment by assessing both creatinine and cystatin C in plasma. conditions: Advanced Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ESTIMATED name: no intervention, observational study of AKI under CDK4/6 inhibitor treatment measure: Pseudo-AKI in patients on CDK4/6 inhibitors measure: Pseudo-AKI in patients on CDK4/6 inhibitors per drug measure: AKI in patients measure: Influencing factors cystatin C levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Center city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06338592 id: UUtah_00153806 briefTitle: The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale acronym: MyLungHealth overallStatus: RECRUITING date: 2024-03-28 date: 2025-03-27 date: 2025-12-31 date: 2024-03-29 date: 2024-04-04 name: University of Utah class: OTHER briefSummary: Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centered intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision making. conditions: Lung Cancer conditions: Lung Neoplasms/Diagnosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a patient randomized trial that includes two sub-studies, with 2 arms each. primaryPurpose: SCREENING masking: NONE count: 42415 type: ESTIMATED name: MyLungHealth name: DecisionPrecision+ measure: Study 1 primary outcome: Percentage of participants identified as eligible for LCS. measure: Study 2 primary outcome: Percentage of participants for whom LDCT was ordered. measure: Study 1 secondary outcome: Percentage of participants for whom LDCT was ordered. measure: Study 1 secondary outcome: Percentage of participants for whom LDCT was completed. measure: Study 2 secondary outcome: Percentage of participants for whom LDCT was completed. measure: Study 2 secondary outcome: Percentage of participants for whom LCS care gap was closed. sex: ALL minimumAge: 50 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States name: Devin Mann, MD role: CONTACT email: devin.mann@nyulangone.org name: Devin Mann, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Utah Health status: RECRUITING city: Salt Lake City state: Utah zip: 84112 country: United States name: Kensaku Kawamoto, MD, PhD, MHS role: CONTACT email: kensaku.kawamoto@utah.edu name: Kensaku Kawamoto, MD, PhD, MHS role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06338579 id: 2023PPRC04 id: 2023-A01763-42 type: OTHER domain: IDRCB briefTitle: Overview of Self-medication Among French Navy Personnel acronym: AutoMMaN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-04 date: 2024-03-29 date: 2024-03-29 name: Direction Centrale du Service de Santé des Armées class: OTHER briefSummary: The goal of this cross-sectional descriptive observational study is to assess the extent of self-medication among the crews of surface ships at the Toulon naval base. This study could include healthy volunteers, or participants with well-controlled chronic pathologies enabling them to be fit for embarkation, who are currently being deployed for at least 4 weeks on a surface ship at the naval base.

Participants will tick and complete a questionnaire (between 15 and 30 minutes) after 4 consecutive weeks on the ship. conditions: Self Medication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Questionnaire measure: percentage of patients who have self-medication sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338566 id: 2021PPRC10 id: 2023-A01975-40 type: OTHER domain: IDRCB briefTitle: Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle acronym: PROCLOU overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-04 date: 2024-03-29 date: 2024-03-29 name: Direction Centrale du Service de Santé des Armées class: OTHER briefSummary: The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting.

Patients will be asked to complete a questionnaire during follow-up consultations. conditions: Ankle Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Follow-up measure: bony outcome of transcalcaneal nailing measure: functional result of the procedure sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338553 id: 231620 briefTitle: GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab acronym: GLP-TEP overallStatus: RECRUITING date: 2024-06 date: 2027-03 date: 2027-03 date: 2024-03-29 date: 2024-04-03 name: Vanderbilt University Medical Center class: OTHER briefSummary: The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment. This study involves giving participants a liquid meal under three different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The first meal test is pre-teplizumab, followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo. Each test involves blood draws before and during the meal test, GLP-1Ra or placebo administration, and an ultrasound to measure blood vessel function. The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In this study, participants with stage 2 T1DM undergoing Teplizumab (TZIELD®) treatment will be randomly assigned to receive single doses of either a GLP-1Ra or a placebo. Three separate MMTT tests will be conducted to assess the effects on blood sugar levels, insulin function, and vascular health. The first test will occur before TZIELD® treatment and participants will receive a placebo at this MMTT. The other two tests will take place 3-5 months after TZIELD® treatment. In these post-treatment tests, the study team will 'cross over', or switch, the order in which participants receive the GLP-1Ra or placebo, with a minimum one-week gap to avoid overlap of effects. For example, a participant may take the GLP-1Ra then placebo or the placebo then the GLP-1Ra. In some cases, the investigator may allow participants who have already received TZIELD® treatment prior to joining the study to skip the pre-treatment test and proceed directly to the post-treatment tests. primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: For applicable participants, a placebo will be given prior to a pre-TZIELD® meal test. For participants who have already received Teplizumab (TZIELD®) or those who are progressing to the 2 remaining study visits, a GLP-1Ra or placebo will be given in random orders at these two visits. The GLP-1Ra will only be given one time. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Placebo name: Semaglutide (Rybelsus®) measure: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study measure: Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study measure: Determine the impact of GLP-1Ra on endothelial function in a pilot study sex: ALL minimumAge: 12 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Vanderbilt University Medical Center status: RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Justin M Gregroy, MD, MSCI role: CONTACT phone: (615) 322- 7427 email: metabolism@vumc.org name: Tyler J Smith, DNP, APRN, FNP-C role: CONTACT email: metabolism@vumc.org name: Justin M Gregory, MD, MSCI role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-27 uploadDate: 2024-03-01T16:04 filename: Prot_000.pdf size: 567921 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-21 uploadDate: 2024-03-01T15:15 filename: ICF_001.pdf size: 2385304 hasResults: False

 nctId: NCT06338540 id: A26020822 briefTitle: Relation of Caries Color to Caries Severity and Its Microbial Load overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-01 date: 2024-01-01 date: 2024-07-01 date: 2024-03-29 date: 2024-03-29 name: Mansoura University class: OTHER briefSummary: This study is to find the relation of caries color to caries severity and its microbial load in primary molars. conditions: Relation of Caries Color studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1: Yellow caries color Group 2: dark brown caries color Group 3: light brown caries color Group 4: black caries color primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Black color of caries name: dark brown color of caries name: light brown color of caries name: yellow color of caries measure: Caries color related to history of pain measure: Caries color related to ICDAS measure: Caries color related to pulp exposed measure: Caries color related to microbial load sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: Mansoura university city: Mansoura state: Dakahlia zip: 35511 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06338527 id: 2024YX321 briefTitle: Effects of Aromatherapy on Patients Undergoing Chemotherapy for Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2024-06-01 date: 2024-06-15 date: 2024-03-29 date: 2024-03-29 name: Weifang Medical University class: OTHER briefSummary: The objective of this study was to investigate the effects of aromatherapy on sleep quality and anxiety in patients undergoing chemotherapy for breast cancer. conditions: Sleep Quality conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Aromatherapy name: No intervention measure: Sleep quality measure: Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weifang People's Hospital city: Weifang state: Shangdong zip: 261000 country: China name: Shirong Fang, M.D. role: CONTACT email: fsr0536@163.com lat: 36.71 lon: 119.10194 hasResults: False

 nctId: NCT06338514 id: KutahyaHSU-DRYNEEDLE-dorsalgia briefTitle: The Effectiveness of Dry Needling Treatment in Patients Diagnosed With Dorsal Myofascial Pain Syndrome. overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-25 date: 2024-06-25 date: 2024-03-29 date: 2024-03-29 name: Kutahya Health Sciences University class: OTHER briefSummary: Back pain is commonly seen in the working-age population, with the peak occurrence around the age of 40. Its frequency does not increase with age and is not associated with age-related degenerative changes in the spine. Especially when the underlying cause is conditions such as myofascial pain syndrome (MPS), where regional muscle sensitivity in the rhomboid and trapezius areas is prominent, dry needling treatment has become increasingly popular and the subject of numerous studies in recent years. In the diagnosis of MPS, two valuable findings include the detection of a taut band upon palpation and the presence of trigger points in muscle fibers with mild finger pressure. The study we are planning involves a double-blind efficacy trial where real and sham dry needling procedures will be performed under ultrasound guidance, ensuring that both the patient and the evaluator are blinded. This study design has the potential to make a significant contribution to the literature in this field. conditions: Myofascial Trigger Point Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-group, sham-controlled, double-blind, prospective, randomized controlled trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In the dry needling application, patients will be blinded to the groups they are randomized into. The evaluator will also be unaware of which group the patients belong to. The practitioner will perform the procedures in both groups using ultrasound guidance, targeting the standard trigger points in the painful dorsal trapezius and rhomboid muscles in the study group, and targeting subcutaneous fatty tissue in the same regions in the sham group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Real dry needling name: Sham dry needling measure: Visual Analog Scale measure: Patient-Specific Functional Scale measure: Pressure Pain Threshold Measurement measure: What does Oswestry stand for? The Oswestry Disability Index (ODI) measure: The 12-item Short-Form Health Survey version 2 (SF-12v2) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338501 id: 77325224.4.0000.5235 briefTitle: Assessment of Heart Rate Variability, Performance and Dehydration in Muay Thai Athletes overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-06-30 date: 2025-06-30 date: 2024-03-29 date: 2024-03-29 name: Centro Universitário Augusto Motta class: OTHER briefSummary: Known as "Thai boxing," Muay Thai utilizes a combination of upper limb strikes (such as punches and elbow strikes) as well as lower limb strikes (such as kicks and knee strikes), and is thus referred to as the "art of eight limbs." It is practiced worldwide and is a prominent discipline in many mixed martial arts (MMA) training camps. In this sport, training load control involves monitoring and adjusting the quantity and intensity of training according to each athlete's capacity. In the context of combat sports, such as Muay Thai, heart rate variability (HRV) and assessment of body composition by bioelectrical impedance analysis can be used as tools to evaluate training responses. Additionally, HRV can also serve as a tool for assessing recovery after training or competition. If HRV does not return to baseline after training or competition, it may be a sign that the athlete is not fully recovered and may need more time to recuperate before returning to training or competition. Due to the absence of studies in the literature that have assessed a possible association between HRV and dehydration and rehydration processes in amateur Muay Thai athletes, it becomes essential to evaluate this correlation. Given the growing interest in practicing Muay Thai in gyms, assessing the sympathetic-vagal balance, body composition, and performance of these athletes becomes of utmost importance. Therefore, the aim of this study is to investigate the relationship between dehydration indicators, HRV parameters, and performance in the frequency speed kick test (FSKT). Participants will be assessed before and after an eight-week training program, conducted three times a week. Assessments will include resting HRV measurement and FSKT; in addition, bioimpedance will be used to estimate the body composition of participants pre- and post-training. It is expected that the results will reveal changes in HRV, performance, and body composition of the athletes after training. conditions: Nervous System Diseases conditions: Dehydration studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Specifical Functional Training Exercises measure: HRV during specifical physical test measure: Correlation with BIA analysis, HRV and Specific Physical Test sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338488 id: KutahyaHSU-DRYNEEDLE-SHOULDER briefTitle: The Effectiveness of Dry Needling Treatment in Patients With Shoulder Myofascial Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-25 date: 2024-06-25 date: 2024-03-29 date: 2024-03-29 name: Kutahya Health Sciences University class: OTHER briefSummary: Myofascial pain can be diagnosed by the presence of one or more myofascial trigger points (MTrPs), defined as hyperirritable spots in taut bands of skeletal muscle fibers palpable by hand. The treatment of myofascial pain primarily relies on the inactivation of MTrPs, often through manual pressure techniques or dry needling. In manual pressure techniques, the physiotherapist applies increasing pressure directly to the MTrP. In dry needling, acupuncture-like filiform needles are applied to the same point. There are two types of dry needling: superficial dry needling, which penetrates only the skin and superficial muscle, and deep dry needling, which involves inserting a needle directly into the MTrP. The sole or adjunct effectiveness of dry needling treatment targeting the trapezius and infraspinatus muscles has been investigated, particularly in patients with shoulder myofascial pain syndrome. In the study we are planning, a double-blinded efficacy trial will be conducted in patients with shoulder myofascial pain syndrome, where real and sham dry needling applications will be performed under ultrasound guidance, with both the patient and the evaluator blinded. This study design has the potential to make a significant contribution to the literature in this field. conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective double-blind randomized sham-controlled study. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In the dry needling application, patients will be blinded to the groups they are randomized into. The evaluator will also be unaware of which group the patients belong to. The practitioner will perform the procedures in both groups using ultrasound guidance, targeting the standard trigger points in the painful shoulder's trapezius and infraspinatus muscles in the study group, and targeting subcutaneous fatty tissue in the same regions in the sham group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Real dry needling name: Sham dry needling measure: Visual Analog Scale measure: Patient-Specific Functional Scale measure: Pressure Pain Threshold Measurement measure: The Shoulder Pain and Disability Index (SPADI) measure: The Quick DASH Outcome Measure measure: The 12-item Short-Form Health Survey version 2 (SF-12v2) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338475 id: 20205703 briefTitle: A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06 date: 2026-06 date: 2024-03-29 date: 2024-03-29 name: University of California, Irvine class: OTHER briefSummary: Building upon the results of a single-arm trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), this trial is a randomized-controlled biobehavioral pilot trial of GET versus a time-and attention matched control (Instrumental Supportive Listening; ISL) in Latino/Hispanic young adult cancer survivors. Outcomes include improved distress symptoms, emotion regulation, goal navigation skills, and changes in stress-sensitive biomarkers.

Participants will be randomized to receive six sessions of GET or ISL delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary and secondary psychological outcomes prior to (T0), immediately after (T1), and twelve weeks after intervention (T2). Additionally, identified biomarkers will be measured at baseline and at T1, and T2. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Goal-Focused Emotion-Regulation Therapy (GET) name: Individual Supportive Listening (ISL) measure: Change in Hospital Anxiety and Depression Scale (HADS) measure: Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFαRII) measure: Change in Salivary Diurnal Cortisol Slope and Daily Output measure: Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) Subscale Score measure: Change in Career Thoughts Inventory (CTI) Global Score measure: Change in Emotion Regulation Questionnaire (ERQ) Scale Scores measure: Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score measure: Change in Emotional Approach Coping Questionnaire (EAC) Scale Scores sex: MALE minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT hasResults: False

 nctId: NCT06338462 id: 2000034128 id: R21AI174129 type: NIH link: https://reporter.nih.gov/quickSearch/R21AI174129 briefTitle: Cali Sin Tos Aim 2 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-03-29 date: 2024-03-29 name: Yale University class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: The overall objective of this Aim is to design and iteratively adapt a home-based, mHealth- and oral testing facilitated strategy for implementing tuberculosis (TB) contact tracing in Cali, Colombia. Investigators will employ an iterative, community-engaged, participatory co-design process to optimize the feasibility, acceptability, usability, and appropriateness of the mobile health (mHealth) and oral testing strategy, in preparation for a future, appropriately powered implementation-effectiveness trial.

This protocol includes the baseline contact tracing protocol and the procedures for determining adaptations to the mHealth strategy (i.e., nominal group technique). conditions: Tuberculosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: target sample size is an anticipated 120 index persons with TB enrolled over three design cycles primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Chatbot name: Oral testing measure: Implementation of the mHealth strategy to assess feasibility. measure: Oral specimen collection to assess feasibility. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM) city: Cali country: Colombia lat: 3.43722 lon: -76.5225 hasResults: False

 nctId: NCT06338449 id: XZMU-2022-ZK068 briefTitle: The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease overallStatus: COMPLETED date: 2022-10-13 date: 2022-12-20 date: 2022-12-31 date: 2024-03-29 date: 2024-04-02 name: Xuzhou Medical University class: OTHER briefSummary: The purpose of this clinical trial is to investigate which exercise regimen is more effective in improving non-alcoholic fatty liver disease (NAFLD) in a young population. The primary questions it aims to answer are:

Does aerobic training, resistance training, or a combination of both help improve liver function and glycemic and lipid parameters in NAFLD patients? Which of these three exercise regimens is more effective in improving the aforementioned parameters? Is the improvement in liver function related to bile acid metabolism?

Participants will:

Engage in physical exercise 4-5 times per week for two consecutive months, following a predefined exercise regimen.

Have blood samples collected to test for glucose, lipids, liver function, and other parameters before starting the exercise program and after two months of completing the regimen. conditions: Non-alcoholic Fatty Liver Disease NAFLD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The specific exercise plan and grouping are as follows:

Participants were randomly (Using an electronic random number generator) divided into four groups: control group (Control), aerobic training group (AT), resistance training group (RT), and combined aerobic and resistance training group (AT + RT), with each group consisting of 10 individuals, totaling 40 participants. All participants were young adults aged between 18 and 21 years old. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: After the data is obtained, the person analyzing the data will not know the specific grouping and participant information. The groups will be replaced by Group A, B, C, D, and the participants will be indicated by their IDs. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Aerobic training (AT) name: Resistance training (RT) name: Combined aerobic and resistance training (AT + RT) measure: Changes in body weight compared to baseline at 8 weeks measure: Changes in Body Mass Index compared to baseline at 8 weeks measure: Changes in total cholesterol compared to baseline at 8 weeks measure: Changes in triglycerides compared to baseline at 8 weeks measure: Changes in high-density lipoprotein compared to baseline at 8 weeks measure: Changes in low-density lipoprotein compared to baseline at 8 weeks measure: Changes in alanine aminotransferase compared to baseline at 8 weeks measure: Changes in aspartate aminotransferase compared to baseline at 8 weeks measure: Changes in alkaline phosphatase compared to baseline at 8 weeks measure: Changes in gamma-glutamyl transferase compared to baseline at 8 weeks measure: Changes in direct bilirubin compared to baseline at 8 weeks measure: Changes in total bile acids compared to baseline at 8 weeks measure: Changes in adenosine deaminase compared to baseline at 8 weeks measure: Changes in percentage of body fat compared to baseline at 8 weeks measure: Changes in waist-to-hip ratio compared to baseline at 8 weeks measure: Changes in blood glucose compared to baseline at 8 weeks measure: Changes in the level of insulin compared to baseline at 8 weeks measure: Changes in albumin compared to baseline at 8 weeks measure: Changes in C-reactive protein compared to baseline at 8 weeks measure: Changes in other subtypes of bile acids compared to baseline at 8 weeks sex: ALL minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT facility: Outdoor track and field facility of Xuzhou Medical University city: Xuzhou state: Jiangsu zip: 221000 country: China lat: 34.18045 lon: 117.15707 hasResults: False

 nctId: NCT06338436 id: VAR-2022-05 briefTitle: Varian ProBeam Proton Therapy System China Clinical Trial (Guangzhou) overallStatus: COMPLETED date: 2022-12-21 date: 2023-09-26 date: 2023-11-13 date: 2024-03-29 date: 2024-04-02 name: Varian, a Siemens Healthineers Company class: INDUSTRY briefSummary: This study is prospective, single-center, single-arm objective performance criteria.

This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration. conditions: Tumor, Solid studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: a clinical study of prospective, single-arm objective performance criteria primaryPurpose: TREATMENT masking: NONE count: 47 type: ACTUAL name: Proton Radiation Therapy System (ProBeam) measure: Effectiveness evaluation: Local tumor control rate 90 days after the proton radiation treatment completion measure: Safety evaluation: Incidence of Acute radiation injury measure: Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06338423 id: JagiellonianU-08 briefTitle: Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure overallStatus: COMPLETED date: 2015-01-01 date: 2022-12-31 date: 2022-12-31 date: 2024-03-29 date: 2024-03-29 name: Jagiellonian University class: OTHER briefSummary: This prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy (LSG) in the reduction of levels of rhabdomyolysis markers (myoglobin, creatine kinase, creatinine) and incidence of RML and AKI in the postoperative period.

Method Patients

A prospective clinical trial has been conducted between January 2015 and December 2022 in a tertiary referral University Hospital (Krakow, Poland). It is designed as a single-center, prospective trial with two intervention arms. During the study, we specified 3 periods:

* January 2015 - December 2016 - only standard mattresses were used
* January 2017 - December 2019 - both types of mattresses were used
* January 2020 - December 2022 - only vacuum mattresses were used

Participants Patients aged ≥18 were qualified for LSG due to obesity and divided The first group (Vacuum Mattress group) are those laid on vacuum mattresses during the surgery. The control group consisted of patients for whom a standard operating mattress was used during the surgery. Patients with preoperative chronic renal failure were excluded from the study. Other exclusion criteria were perioperative complications which required postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERABS) Protocol \< 85%.

Procedures and perioperative care All patients underwent LSG. Patients were operated in the beach chair position. In the study group, the patient was laid on vacuum mattresses during the surgery. In the case of control group patients, a standard operating mattress was used during the surgery. Perioperative care for all patients was in accordance with the ERABS protocol adopted in our center\[\]. Blood samples were collected on the first postoperative to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI, and other complications were monitored for 30 days after surgery.

End Point Criteria The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which required additional treatment.

Secondary endpoints is the concentrations of RML markers (myoglobin, creatine kinase, creatinine) on the first postoperative day conditions: Rhabdomyolysis conditions: Acute Kidney Injury conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1184 type: ACTUAL name: vacuum mattress name: Standard Mattress measure: Incidance of Rhabdomyolisis(RML) And/OR Acute Kidnay Injury (AKI) measure: Concentration of myoglobin marker measure: Concentration of creatine kinase marker measure: Concentration of creatinine marker sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University Mecical Collage city: Kraków state: Malopolskie zip: 31-501 country: Poland lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06338410 id: UHS/Education/126-24/131 briefTitle: Effect of Kangaroo Mother Care on Oxidative Stress and Bonding acronym: KMC overallStatus: COMPLETED date: 2023-08-01 date: 2024-03-20 date: 2024-03-20 date: 2024-03-29 date: 2024-04-01 name: University of Health Sciences Lahore class: OTHER name: Services Hospital, Lahore briefSummary: The goal of this clinical trial is to learn if Kangaroo Mother care can have effect on oxidative stress in premature neonates. It will also learn about the bonding between mother and her premature infant. The main questions it aims to answer are:

* Does Kangaroo mother care lower the biomarker of oxidative stress in premature neonates?
* Is Kangaroo mother care associated with mother-infant bonding? Researchers will compare Kangaroo mother care to Conventional incubator care to see if Kangaroo mother care works to have effect on oxidative stress.

Participants will be:

* given Kangaroo mother care on third day of life or standard incubator care for one hour
* Urine sample for oxidative stress biomarker will be collected via noninvasive method before and after Kangaroo mother care or conventional incubator care from premature neonates.
* Mother-infant bonding scale will be filled by mothers of enrolled premature infants before and after kangaroo mother care and conventional incubator care conditions: Kangaroo Mother Care conditions: Oxidative Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Kangaroo Mother Care measure: biomarker of Oxidative Stress (Allantoin) in urine sample of premature infants measure: Mother- Infant Bonding sex: ALL minimumAge: 3 Days maximumAge: 3 Days stdAges: CHILD facility: Services Hospital, Lahore city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06338397 id: 2023_0455 briefTitle: Social & Affective Cognition in Alzheimer's Disease & Associated Disorders acronym: SOCIALIZE overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2027-05-02 date: 2027-05-02 date: 2024-03-29 date: 2024-03-29 name: University Hospital, Lille class: OTHER name: France Alzheimer briefSummary: Recent studies have shown that individual neuropsychological scores of patients with Alzheimer's disease and Associated Disorders (ADAD) are only poorly correlated to their behavioral difficulties, such as disinhibition, apathy, social decision-making or vulnerability. Recently, social \& affective cognitive disorders have been highlighted as potential cause of social behavioral abnormalities. However, no previous studies have assessed the specific relationship between social \& affective cognition \& social behavior in ADAD. Our pilot study aims to explore the correlations between core and extended social \& affective cognitive processes and social behavior as observed during the neuropsychological examination, as well as to explore the common brain regions involved in those domains. conditions: Alzheimer's Disease conditions: Frontotemporal Degeneration (Semantic & Behavioral Variants) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 120 type: ESTIMATED name: SCANN measure: Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants. measure: Correlation coefficients between the mini Social cognition & Emotional Assessment - mini-SEA - sub scores and the neuropsychological assessment (as measured by the Social Behavior Observer Checklist - SBOC - score in all participants. measure: Correlation coefficient between the SBOC score with MRI markers in all participants measure: Correlation coefficient between mini-SEA sub scores & MRI markers in all participants. measure: Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups. measure: Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups. sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338384 id: 44735129 briefTitle: Examining Engagement Trends Among Participants in Peripheral Neuropathy Clinical Research overallStatus: NOT_YET_RECRUITING date: 2025-04 date: 2026-04 date: 2027-04 date: 2024-03-29 date: 2024-03-29 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: This trial aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in peripheral neuropathy clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.

Ultimately, this trial endeavors to deepen our understanding of the factors impacting peripheral neuropathy clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition. conditions: Peripheral Neuropathy studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Number of peripheral neuropathy patients who decide to enroll in a clinical research measure: Rate of peripheral neuropathy patients who remain in clinical trial to trial completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-22 uploadDate: 2024-03-22T09:04 filename: ICF_000.pdf size: 67357 hasResults: False

 nctId: NCT06338371 id: IZTU-TEKBAŞ-001 briefTitle: Effect of Pelvic Floor Muscle Exercise on Sexual Function overallStatus: COMPLETED date: 2021-11-01 date: 2022-04-06 date: 2022-05-06 date: 2024-03-29 date: 2024-03-29 name: Serap Tekbas class: OTHER briefSummary: The goal of this evaluate the effect of pelvic floor muscle exercises on sexual function in women of reproductive age. A randomized controlled trial was conducted in a sample of women of reproductive age, 77 women were randomly assigned to control (n=39) and training (n=38) groups. A form including questions regarding socio-demographic characteristics and the Female Sexual Function Index was applied to all women included in the study. Pelvic floor exercise training was given to the women in the training group and the Female Sexual Function Index was applied to both groups in the 1st, 2nd, and 3rd months. The differences between those who received and those who did not receive training and the effects of regular pelvic exercise on sexual function were evaluated by month.

Research Hypotheses H1: Sexual function scores of women of reproductive age who regularly perform pelvic floor muscle exercises are higher than those who do not exercise.

H2: Sexual function scores are higher for those who regularly exercise their pelvic floor muscles for at least two months conditions: Pelvic Floor Muscle Weakness conditions: Sexuality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 77 type: ACTUAL name: Pelvic Floor exercise training measure: Determining Number of Participants measure: Initial scale application measure: Distribution of participants into groups measure: Providing pelvic floor exercise for training group measure: Female Sexual Function Index measure: Female Sexual Function Index measure: Female Sexual Function Index sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Izmir Tinaztepe University city: İzmir state: Buca zip: 35400 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06338358 id: 44519568 briefTitle: Understanding Participation Habits Among Plaque Psoriasis Patients overallStatus: NOT_YET_RECRUITING date: 2025-04 date: 2026-04 date: 2027-04 date: 2024-03-29 date: 2024-03-29 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: The study intends to investigate the personal experiences of plaque psoriasis patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.

The data collected from this study will help improve future outcomes for all plaque psoriasis as well as those in under-represented demographic groups. conditions: Plaque Psoriasis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Rate of patients who decide to enroll in a plaque psoriasis clinical research. measure: Number of plaque psoriasis study participants who remain in clinical study until completion. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-22 uploadDate: 2024-03-22T09:21 filename: ICF_000.pdf size: 67831 hasResults: False

 nctId: NCT06338345 id: 38RC23.0222 briefTitle: Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients acronym: KAMELOT overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-09-01 date: 2028-09-01 date: 2024-03-29 date: 2024-03-29 name: University Hospital, Grenoble class: OTHER briefSummary: The use of antibiotic therapy is common in intensive care units and primarily involves beta-lactams. Its optimal implementation is made difficult by the pharmacokinetic changes inherent in critically ill patients.

Despite the current recommendations from the French Society of Anesthesiology and Intensive Care (SFAR) and the French Society of Pharmacology and Therapeutics (SFPT), there are no recommendations on prescription modalities for patients under veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The use of antibiotic therapy is common in VA-ECMO patients and their pharmacokinetic variability factors are then exacerbated.

We aim to conduct a prospective, multicenter, interventional study designed to identify predictive factors for failure to achieve therapeutic target circulating concentrations of beta-lactams in patients under VA-ECMO treated with one of the studied beta-lactams conditions: Cardiogenic Shock conditions: Post-cardiac Surgery conditions: Cardiac Arrest conditions: Extracorporeal Membrane Oxygenation Complication conditions: Infections studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 225 type: ESTIMATED name: Therapeutic drug monitoring of beta-lactam measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied city: Clermont-Ferrand zip: 63003 country: France lat: 45.77966 lon: 3.08628 facility: CHU Dijon-Bourgogne city: Dijon zip: 21000 country: France name: Pierre-Alain BAHR, MD role: CONTACT lat: 47.31667 lon: 5.01667 facility: Aphp Pitie Salpetriere city: Paris zip: 75013 country: France name: PAULINE DUREAU, MD role: CONTACT lat: 48.85341 lon: 2.3488 facility: CHU ROUEN - Hôpital Charles-Nicolle city: Rouen zip: 76031 country: France name: Emmanuel BESNIER, MD, PhD role: CONTACT lat: 49.44313 lon: 1.09932 facility: Hôpital Rangueil - CHU Toulouse city: Toulouse zip: 31059 country: France name: Stéphanie RUIZ, MD role: CONTACT name: Camille MANE, MD role: CONTACT lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06338332 id: AW23.050, W19.249 briefTitle: Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer acronym: OCCBRIGHT overallStatus: RECRUITING date: 2024-01-01 date: 2025-01 date: 2028-01 date: 2024-03-29 date: 2024-03-29 name: Amphia Hospital class: OTHER briefSummary: Rationale: Approximately 13% (range 10-28%) of all colorectal cancer patients (CRC) present with an acute obstruction. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. Different options can be considered in the management of obstructing right sided CRC: 1) primary resection, simultaneous treatment of obstruction and tumour resection, or 2) staged treatment of the obstruction with secondary resection of the tumour. Currently, in the Netherlands, an emergency resection has been judged to be inferior to postponing surgery. Patients who present with right sided obstructive colon cancer at one of the participating hospitals are subjected to a bridge to surgery (BTS) protocol.

Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer.

Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel.

Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient.

Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events. conditions: Colonic Neoplasms Malignant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED measure: Complication-free survival measure: Complications overall measure: Type of surgical intervention measure: Time till surgery measure: Resection measure: TNM measure: Hospital stay measure: One year stoma rate measure: One year survival rates measure: Disease free survival rates one year measure: Disease free survival rates three years measure: Three year survival rates measure: Tumour type (obstructing, not obstructing), measure: Metastasis preoperative measure: Pre-operative diagnostics measure: Type of bridge-to-surgery measure: Nutrition (TPN/extra nutrition) measure: Consultation of other specialist measure: Gender measure: Age at surgery measure: ASA measure: Bodyweight measure: Height measure: Concomitant and previous therapy measure: C-reactive protein measure: Haemoglobin measure: Laboratory values measure: Leukocytes measure: Prothrombin time measure: Sodium measure: Potassium measure: Glomerular filtration rate measure: Albumin measure: Bilirubin measure: ASAT measure: ALAT measure: LDH measure: ALP measure: Gamma-GT measure: Creatinkinase measure: Phosphate measure: Lactate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amphia Hospital status: RECRUITING city: Breda state: Noord-Brabant zip: 4818CK country: Netherlands name: Elze Lockhorst, Drs. role: CONTACT phone: +31 613723827 email: elockhorst@amphia.nl name: Jennifer Schreinemakers, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.58656 lon: 4.77596 hasResults: False

 nctId: NCT06338319 id: 23-048-E briefTitle: Book Sharing for Toddlers With Clefts acronym: BOOST overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-08 date: 2024-03-29 date: 2024-03-29 name: Seattle Children's Hospital class: OTHER name: University of Washington name: Nationwide Children's Hospital name: Children's Hospital Los Angeles name: Ohio State University briefSummary: Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups. conditions: Cleft Palate conditions: Cleft Lip and Palate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 320 type: ESTIMATED name: Book-Sharing for Toddlers with Clefts (BOOST) measure: Expressive One Word Picture Vocabulary Test-Fourth Edition measure: Receptive One Word Picture Vocabulary Test-Fourth Edition measure: Child Language Sample measure: MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test measure: Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants measure: Frequency of Shared Reading measure: Quality of Shared Reading measure: Child Language During Reading sex: ALL minimumAge: 24 Months maximumAge: 32 Months stdAges: CHILD hasResults: False

 nctId: NCT06338306 id: 08073421 briefTitle: Tacrolimus and Personalized Therapy to Prevent Acute Rejection Episodes overallStatus: RECRUITING date: 2022-01-07 date: 2022-06-30 date: 2025-06-30 date: 2024-03-29 date: 2024-04-09 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER briefSummary: Heart transplant is the only effective treatment for people with advanced heart failure.

Post-transplant pharmacological therapies are of fundamental importance for the survival of individuals after surgery: although considerable progress has been made for combined immunosuppressive therapies, acute cellular and especially non-cellular rejection still represents a great challenge for doctors.

To verify the absence of the first signs of acute rejection, the analysis of numerous cardiac biopsies (EMB endomyocardial biopsies) is necessary during the first 12 months following the transplant.

Thanks to these scheduled checks, doctors are able to identify the first symptoms of possible chronic rejection and reduce its episodes.

Since the analysis of biopsies is also based on subjective interpretations, cases of erroneous conclusions are frequent.

The researchers of this study aim not only to analyze the biopsies according to the current best clinical practice, but also to evaluate how much anti-rejection drug is actually contained within them.

This is an analysis that is still little used for this type of transplant, which could provide very useful information to doctors.

The researchers will focus their attention on one drug in particular, tacrolimus, abbreviated to "TAC".

The amount of drug measured in biopsies will be compared with that measured in whole blood samples and in particular blood cells (peripheral blood mononuclear cells: PBMC).

The genetic characteristics of each person play an important role in the success of treatment with the drug. To best interpret the results, all participants will be asked to take a blood sample to identify some characteristics of their DNA that could influence the outcome of tacrolimus therapy. conditions: Heart Transplant Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Tacrolimus（FK506） measure: Tacrolimus quantification in an unconventional matrix measure: Tacrolimus quantification in PBMCs measure: Tacrolimus quantification in whole blood measure: Genetic profile in heart transplant recipients sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia zip: 27100 country: Italy name: Ferrari Alessandra, PharmD role: CONTACT phone: +390382503689 email: alessandra.ferrari@smatteo.pv.it name: Simona De Gregori role: PRINCIPAL_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06338293 id: KY20240123-02 briefTitle: Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques acronym: EItoCVP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2025-05 date: 2024-03-29 date: 2024-03-29 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Inclisiran sodium name: Rosuvastatin measure: The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%) measure: The change rate of TAV and plaque load of the target vascular lesion; measure: The change rate of lipid composition of plaque: including the lipid volume , the maximum area and angle of lipid, the length of vulnerable plaque, etc. measure: The change rates of other components of plaque (fiber, calcification, crystal, macrophage) measure: The change rates of lesion OFR and target vessel OFR measure: The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338280 id: VDW002 briefTitle: Remotely Observed Methadone Evaluation II acronym: ROME II overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-05-01 date: 2024-03-29 date: 2024-04-02 name: Sonara Health class: INDUSTRY briefSummary: Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Sonara measure: Retention measure: Take homes received over time measure: Opioid cravings measure: Urine toxicology measure: Opioid withdrawal severity measure: Health-related quality of life measure: Drug Abuse Treatment Costs Analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338267 id: SENS-102-RSRT briefTitle: Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking acronym: VIBRANT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-03-29 date: 2024-03-29 name: Rett Syndrome Research Trust class: OTHER briefSummary: The VIBRANT study aims to validate biosensors to objectively and directly measure symptoms in Rett syndrome and create confidence in the use of these devices in clinical trials. VIBRANT will use several FDA-cleared wearable biosensors and a non-wearable device to collect symptom data from patients with Rett syndrome for up to 9 weeks. Symptoms of interest include heart rate, breathing, sleep, blood oxygen levels, and movement. Participants will use the biosensors intermittently at home, document device use and symptom status, and will come to the clinic for 1 overnight sleep study. A cohort of up to 10 participants receiving an intervention in a separate clinical trial may also enroll and participate on a custom device schedule for up to 1 year.

The study will provide information on the feasibility and ease of use for families at home, biosensor data will be compared to data collected at the same time from the overnight sleep study to demonstrate how well they work in individuals with Rett syndrome, and Emerald will be developed to include movement as a measurable symptom. conditions: Rett Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Assess breathing rate and apnea (breath holds) with RespiraSense measure: Assess heart rate variability with Vivalink VV330 ECG patch measure: Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring measure: Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSG measure: Validate ECG-derived breathing compared to in-lab PSG measure: Validate FDA-cleared RespiraSense breathing sensor in Rett syndrome compared to in-lab PSG measure: Validate FDA-cleared Viatom Kids O2 pediatric pulse oximeter ring in Rett syndrome compared to in-lab PSG and/or Nonin wristOx pulse oximeter measure: Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSG measure: Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator measure: Develop Emerald ability to measure daytime movement sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University city: Chicago state: Illinois zip: 60612 country: United States name: Study Coordinator role: CONTACT name: Pallavi Patawi, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Study Coordinator role: CONTACT name: David Lieberman, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Baylor College of Medicine city: Houston state: Texas zip: 77030 country: United States name: Study Coordinator role: CONTACT name: Bernhard Suter, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06338254 id: E-10840098-772.02-5416 briefTitle: Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women overallStatus: COMPLETED date: 2022-09-04 date: 2023-06-04 date: 2023-06-10 date: 2024-03-29 date: 2024-03-29 name: Istanbul Medipol University Hospital class: OTHER briefSummary: This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women. conditions: Pregnancy Complications conditions: Edema Leg conditions: Physiotherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The participants are blinded. whoMasked: PARTICIPANT count: 60 type: ACTUAL name: percussion massage therapy measure: The Visual Analog Scale (VAS) measure: Evaluation of edema measure: Fatigue Severity Scale (FSS) measure: Short Form-36 (SF-36) sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06338241 id: CPP2021-008391 briefTitle: Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model acronym: Galibone overallStatus: RECRUITING date: 2024-03-02 date: 2025-06-02 date: 2025-09-02 date: 2024-03-29 date: 2024-04-03 name: Mario Pérez Sayáns class: OTHER name: Universidad de Murcia briefSummary: The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars. conditions: Bone Loss conditions: Regenerative Inflammation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin name: Bovine Hydroxyapatite measure: Bone Regeneration_Reduction in radiolucent volume measure: Bone Regeneration_bone volume measure: Bone Regeneration_bone density measure: Bone Regeneration_Fractal dimension measure: Pain levels through visual analog scale measure: Clinical Inflammation evaluating by presence/absence measure: Healing measured by healing index measure: Post-surgical complications evaluated by presence or absense measure: Oral Health-related Quality of Life measured by OHIP-14 test sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry of Universidade de Santiago de Compostela status: RECRUITING city: Santiago De Compostela state: A Coruña zip: 15705 country: Spain name: MARIO PEREZ SAYANS GARCIA, PHD, PHD role: CONTACT email: mario.perez@usc.es lat: 42.88052 lon: -8.54569 facility: Faculty of Dentistry University of Murcia status: RECRUITING city: Murcia country: Spain name: FABIO CAMACHO ALONSO, PHD role: CONTACT email: fcamacho@um.es lat: 37.98704 lon: -1.13004 hasResults: False

 nctId: NCT06338228 id: 2023-A02458-37 briefTitle: A New Decisional Tree for the Management of Acetabular Fractures : Monocentric Observational Study acronym: FANAD overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-29 date: 2024-03-29 name: University Hospital, Grenoble class: OTHER briefSummary: Acetabular fractures are challenging fractures to treat. Many fracture patterns occur, in a deep anatomical area surrounded by numerous vascular and nervous elements, generally in a polytraumatic context . A reduction with less than 2 mm of incongruence is generally considered acceptable, limiting post-operative osteoarthritis that could rapidly require total hip arthroplasty. Due to the long learning curve, this surgery is limited to large reference centers

. In the last twenty years, the main series published in the literature are small series due to the rarity of the fractures and their trauma context (loss of follow-up, polytrauma patients...). The large variety of fracture patterns according to the Letournel classification creates a spread in patient distribution and decreases the power of statistical analysis. That is the reason why big series are rare and only a few of them allow significant conclusions . The other studies are meta-analyses with their limitations

The lack of consensus makes it difficult to interpret the results between series, so the investigators developed a decision tree to address this knowledge gap.

The aim of this study is to assess and compare the results of a decisional tree for acetabular fracture in a large cohort of patients from a well-known experimental trauma center. conditions: Management of Acetabular Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 250 type: ESTIMATED measure: The main objective of the study is to evaluate and compare the results of a decision tree for the management of acetabulum fractures (also called acetabulum) in a large cohort of patients from the trauma center at Grenoble University Hospital measure: Define the prognostic factors associated with poor clinical outcomes and total hip replacement surgery measure: Compare clinical and radiological findings with the literature measure: Compare clinical and radiological findings with the literature measure: Compare clinical and radiological findings with the literature measure: Compare clinical and radiological findings with the literature measure: Compare clinical and radiological findings with the literature measure: Propose a new assessment of the traumatic hip joint based on PROMs (Patient Reported Outcomes Measures) via a dedicated digital application (Orthense by Digikare) measure: Evaluation of Outcomes and Complications of Early Weight Bearing in Older Adults sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Grenoble Alpes University Hospital,La tronche status: RECRUITING city: Grenoble zip: 38700 country: France name: Sarah, Pharm D role: CONTACT phone: 0033 4 76 76 75 24 email: SUneisi@chu-grenoble.fr name: Mehdi BOUDISSA, Pr role: PRINCIPAL_INVESTIGATOR lat: 45.16667 lon: 5.71667 hasResults: False

 nctId: NCT06338215 id: UNATI_2024 id: 101097681 type: OTHER_GRANT domain: European Research Council briefTitle: Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality acronym: UNATI overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-06-30 date: 2029-06-30 date: 2024-03-29 date: 2024-03-29 name: Clinica Universidad de Navarra, Universidad de Navarra class: OTHER briefSummary: The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years).

The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes.

Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine.

Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases. conditions: All Cause Mortality conditions: Cardiovascular Diseases conditions: Invasive Cancer conditions: Liver Cirrhosis conditions: Type 2 Diabetes conditions: Depression conditions: Dementia conditions: Injury Traumatic conditions: Tuberculosis conditions: Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 10000 type: ESTIMATED name: Moderate Alcohol Drinking Pattern name: Abstention measure: Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases measure: Comparison between groups of the incidence of the most severe outcomes measure: Comparison between groups of invasive cancer incidence with extended follow-up sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Navarra city: Pamplona state: Navarra zip: 31008 country: Spain name: Estíbaliz Goñi, Nutritionist role: CONTACT phone: 34948425600 phoneExt: 80-6596 email: egonioch@unav.es name: Rafael Perez-Araluce, PharmD role: CONTACT phone: +34948425600 phoneExt: 80-6672 email: rperez.21@alumni.unav.es name: Miguel A Martinez-Gonzalez, MD, MPH, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.81687 lon: -1.64323 hasResults: False

 nctId: NCT06338202 id: CV027-1137 briefTitle: Real-World Effectiveness of Mavacamten in Canada acronym: MAVEN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-29 date: 2024-03-29 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada. conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Mavacamten measure: Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation measure: Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation measure: Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation measure: Age measure: Sex at birth measure: Ethnicity measure: Employment status measure: Body mass index (BMI) measure: Obstructive hypertrophic cardiomyopathy (oHCM) disease duration measure: Proportion of patients in each New York Heart Association (NYHA) functional class II and III measure: Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient measure: Left ventricular ejection fraction by 2D echocardiogram (LVEFb) measure: Mavacamten dose regimen measure: Proportion of patients who discontinued mavacamten measure: Duration of treatment prior to mavacamten discontinuation measure: Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation measure: Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation measure: Reason for discontinuing mavacamten treatment measure: Functional assessment schedule sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London Health Science Centre (LHSC) city: London state: Ontario zip: N6A 5A5 country: Canada lat: 42.98339 lon: -81.23304 hasResults: False

 nctId: NCT06338189 id: USuffolk briefTitle: The 5Ad Diet for Functional Bowel Disorders overallStatus: RECRUITING date: 2022-05-08 date: 2025-04-01 date: 2026-04-01 date: 2024-03-29 date: 2024-03-29 name: University of Suffolk class: OTHER briefSummary: The goal of this randomised controlled trial (RCT) is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo-, di-, monosaccharide and polyols (FODMAP) diet in reducing gastrointestinal symptoms associated with functional bowel disorders/food intolerances.

The primary aims of this RCT are to determine:

* Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances.
* Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue.

To achieve the above aims, an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm, in a cross-over design with a 7 days washout phase in between. Both dietary protocols will be followed by each participant for 7 days.

Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms (abdominal pain, bloating, flatulence, bowel urgency, straining and incomplete defecation), stool form and frequency of defecation. conditions: Functional Bowel Disorder conditions: Irritable Bowel Syndrome conditions: Food Intolerance conditions: Food Intolerance Syndromes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: The 5Ad Diet name: The Low FODMAP Diet measure: Abdominal Pain measure: Abdominal Bloating measure: Flatulence measure: Bowel Urgency measure: Straining measure: Incomplete Defecation measure: Stool Form measure: Frequency of defecation measure: Fatigue measure: Mental Fatigue measure: Physical Fatigue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Suffolk status: RECRUITING city: Ipswich state: Suffolk zip: IP4 1QJ country: United Kingdom name: Camilla Bunn role: CONTACT phone: +44 1473 338332 email: c.bunn2@uos.ac.uk name: Dr Fandi Ibrahim role: CONTACT phone: +44 1473 338623 email: f.ibrahim@uos.ac.uk name: Camilla Bunn role: PRINCIPAL_INVESTIGATOR name: Dr Fandi Ibrahim role: SUB_INVESTIGATOR name: Dr Federica Masieri role: SUB_INVESTIGATOR name: Martin Sinclair role: SUB_INVESTIGATOR lat: 52.05917 lon: 1.15545 hasResults: False

 nctId: NCT06338176 id: Pro00128904 briefTitle: Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-30 date: 2026-04-30 date: 2024-03-29 date: 2024-04-22 name: University of Alberta class: OTHER name: Alberta Health services briefSummary: Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.

Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.

The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system. conditions: Staph Aureus Bacteremia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1800 type: ESTIMATED name: OPTIMUS-SAB clinical care pathway measure: Adherence to quality-of-care indicators measure: Length of stay measure: Hospital re-admission rates measure: All-cause mortality measure: In hospital mortality measure: Costing evaluation measure: Implementation evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06338163 id: POSSIBLE 1.6 briefTitle: Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery acronym: POSSIBLE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06-30 date: 2025-09-30 date: 2024-03-29 date: 2024-04-04 name: Marco Catarci class: OTHER name: Associazione Chirurghi Ospedalieri Italiani briefSummary: This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, \& lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center. conditions: Surgical Site Infection conditions: Surgical Procedures, Operative studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled prospective multicenter primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Assessor of the primary outcome will be masked concerning arm allocation whoMasked: OUTCOMES_ASSESSOR count: 2000 type: ESTIMATED name: Polihexanide-based bundle name: Standard bundle measure: Surgical Site Infections rate measure: Incisional (superficial and deep) Surgical Site Infections rate measure: Infectious morbidity rates measure: Anastomotic leakage rates measure: Overall morbidity rates measure: Major morbidity rates measure: Comprehensive complication index measure: Overall length of postoperative hospital stay measure: Readmission rates measure: Patient-reported outcome measures sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OSpedale Santa Maria Annunziata city: Firenze state: FI zip: 50012 country: Italy name: Marco Scatizzi, MD role: CONTACT phone: 393474137246 email: marcoscatizzi@gmail.com lat: 43.77925 lon: 11.24626 facility: Ospedale Civile di Macerata city: Macerata state: MC zip: 62100 country: Italy name: Massimo Sartelli, MD role: CONTACT phone: +393405369701 email: massimosartelli@gmail.com lat: 43.29789 lon: 13.45293 facility: Ospedale Sandro Pertini city: Roma state: RM zip: 00157 country: Italy name: Marco Catarci, MD role: CONTACT phone: +393298610040 email: marco.catarci@aslroma2.it name: Michele Benedetti, MD role: SUB_INVESTIGATOR name: Paolo Ciano, MD role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06338150 id: STUDY-23-00503 id: GCO 19-0175 type: OTHER_GRANT domain: Icahn School of Medicine at Mount Sinai id: 5R01CA244899 type: NIH link: https://reporter.nih.gov/quickSearch/5R01CA244899 briefTitle: Precision Medicine Study overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-03-29 date: 2024-03-29 name: Icahn School of Medicine at Mount Sinai class: OTHER name: National Cancer Institute (NCI) briefSummary: This will be a 2 year study to evaluate and improve cancer sequencing as applied to the characterization of tumor molecular make-up and the identification of novel therapeutics (n=100). Participants who will undergo tumor biopsy for management of multiple myeloma (MM) will self-refer to the study or be referred by their treating physician. Participants will initially meet with a clinician to review study consents and provide medical, medication, and family history information. After informed consent, biospecimen samples from peripheral blood, cheek swab, and tumor samples from bone marrow (aspirate and biopsy), peripheral blood, or any mass/fluid containing tumor cells will be obtained (from procedures indicated as part of their standard oncology care) for cancer sequencing (CS) (whole exome sequencing of germline and tumor genomes, RNA sequencing of tumor transcriptome, single cell, and CyTOF analysis). CS data will be interpreted via somatic variation identification, network modeling, and cancer transcriptome profiling to facilitate mapping activity levels of genes to networks and for identifying genes activated or dysregulated in cancer cells. Sequencing and analysis will be performed at the Genomics Core Facility at the Icahn School of Medicine at Mount Sinai. In instances where internal sequencing capabilities do not allow for certain types of analysis, de-identified samples or data may be sent out to third parties for additional analysis. The study will be using GenPath, a division of BioReference® Health, LLC for this project which is a CLIA certified lab. All genetic tests will be performed in a CLIA certified lab and all tests will be FDA or NYS approved. The RNA Sequencing test will receive NYS Department of Health (Wadsworth Center) approval before results are provided to physicians and patients. Samples will be de-identified and processed by the Mount Sinai Human Immune Monitoring Core (HIMC) before being sent to an external CLIA-certified lab for sequencing and analysis. Interpretation will be performed by a multidisciplinary team that includes genomicists, pathologists, and clinicians familiar with the particular cancer diagnosed in the participant. Once results are available, they will be shared with the participant and treating physician during a follow-up results session and any findings obtained explained. This study is not intended to implement findings, only to report them. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Total number of somatic Single-nucleotide variants (SNVs) per patient measure: Total number of somatic insertions (INS) per patient measure: Total number of somatic deletions (DEL) per patient measure: Number of SNVs per megabase of the MM genome measure: Number of INS per megabase of the MM genome measure: Number of DEL per megabase of the MM genome measure: Number of mutations per megabase among MM subgroups measure: Number of mutations per megabase among genomic regions for all MM and mutational subgroups measure: Gene mutations identified measure: Chromosomal abnormalities identified measure: Molecular signatures identified measure: Established Prognostic markers identified measure: Somatic variants identified as targets of FDA-approved drugs (pharmacogenomics variant data) measure: Network-informed key driver variants identified measure: Transcriptome variations identified measure: Germline mutations identified in cancer predisposition genes measure: FDA approved drugs available that block enzymes produced in those pathways identified measure: Treatment recommended by computational pipeline based on patient's clinical and genetic measure: Germline whole exome sequencing profile measure: Tumor genome whole exome sequencing profile measure: Tumor transcriptome profile measure: Single-cell sequencing profile measure: Cytometric profile measure: Signaling Pathways associated measure: Enzymes associated with each signaling pathway identified measure: Improvement of cancer sequencing-guided treatment recommendations by machine learning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Health System city: New York state: New York zip: 10029 country: United States name: Cesar Rodriguez Valdes, MD, PhD role: CONTACT email: Cesar.Rodriguez@mssm.edu name: Katherine Vandris role: CONTACT email: Katherine.Vandris@mssm.edu name: Cesar Rodriguez Valdes role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06338137 id: 4-2024urol briefTitle: Comparison of High and Low Pulse Energy Dusting Protocols Using Holmium: YAG-laser in Flexible Ureteroscopy for Renal Stones Treatment overallStatus: COMPLETED date: 2022-08-25 date: 2023-08-25 date: 2024-01-01 date: 2024-03-29 date: 2024-04-04 name: Menoufia University class: OTHER briefSummary: Rcompare high-energy versus low-energy laser settings in renal stone lithotripsy using low power machines) Holmium YAG 30 watts, examining their respective advantages, limitations, and overall efficacy. conditions: Renal Stone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ACTUAL name: Holmium Yag laser measure: Stone free rates measure: Preoperative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hossam Kandeel city: Shibīn Al Kawm state: State Or Province zip: 32511 country: Egypt lat: 30.55258 lon: 31.00904 hasResults: False

 nctId: NCT06338124 id: David Ibrahim briefTitle: Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-15 date: 2025-04-01 date: 2024-03-29 date: 2024-03-29 name: Egymedicalpedia class: INDUSTRY briefSummary: Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .

Some of these markers as procalcitonin and CD14, are costly and not feasible options for low- and middle-income countries . While other biomarkers are feasible and accessible to be evaluated as Triglyceride\\glucose index (TyG) , Relative Distributive Width of red blood corpuscles to albumin ratio (RAR), C-reactive protein,Neutrophile \\Lympocyte ratio and serum lactate levels . conditions: Sepsis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Triglyceride glucose index measure: Mortality sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assuit University Hospital city: Assiut country: Egypt name: Dina Hamad, Assist.Prof role: CONTACT phone: +201063040703 email: dinaalihamad@yahoo.com lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06338111 id: 2461 briefTitle: Interventions Meant to Improve the Outcome of Critical Care Patients in the ED overallStatus: COMPLETED date: 2020-11-09 date: 2022-12-06 date: 2023-04-30 date: 2024-03-29 date: 2024-04-16 name: Iuliu Hatieganu University of Medicine and Pharmacy class: OTHER briefSummary: This study aims to identify the prognostic role of procalcitonin (PCT), soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1), the soluble form of the urokinase plasminogen activator receptor (suPAR), highly sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and azurocidin 1 (AZU1) in 28-day mortality for patients with sepsis in Emergency Department. conditions: Sepsis Syndrome conditions: Emergency Department conditions: Biomarker studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 67 type: ACTUAL name: ELISA Sepsis Biomarkers dosage measure: Can we better predict mortality in septic patients from the Emergency Department? sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cluj County Hospital Emergency Department city: Cluj-Napoca state: Cluj zip: 400006 country: Romania lat: 46.76667 lon: 23.6 hasResults: False

 nctId: NCT06338098 id: HFNVSH.001 briefTitle: Effect of an 8-week Heartfulness Meditation Program on Burnout and Stress at Veterinary Specialty Hospital overallStatus: COMPLETED date: 2023-02-28 date: 2023-10-02 date: 2023-10-02 date: 2024-03-29 date: 2024-04-02 name: Heartfulness Institute class: OTHER name: Angell Animal Medical Center briefSummary: This quantitative study assesses the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers. Assessments at baseline will include the Perceived Stress Scale (PSS) and Maslach Burnout Toolkit, and the same questionnaires were collected in Week 8 and Week 16. The Google form questionnaire will ask the participant for their email address. The form will also include a question eliciting interest in participation in the 8-weeks Heartfulness Meditation program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, and tools to cope with burnout. conditions: Stress conditions: Burnout, Professional studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 74 type: ACTUAL name: 8-week wellness and relaxation meditation program measure: Assess the current level of Anxiety measure: Changes level of Stress measure: Assess the current level of Burnout measure: Changes level of Burnout sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Angell Animal Medical Center, city: Boston state: Massachusetts zip: 02130 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06338085 id: meryemvrlshn00000000002 briefTitle: The Effect of Emotional Freedom Technique (EFT) on Depression in Postmenopausal Women overallStatus: RECRUITING date: 2024-03-11 date: 2024-05-04 date: 2024-05-20 date: 2024-03-29 date: 2024-04-05 name: Meryem Vural Şahin class: OTHER briefSummary: The aim of this study is to determine the effect of EFT (Emotional Freedom Technique), a nonpharmacological method, on menopausal symptoms and depression in postmenopausal women. By determining the effectiveness of the Emotional Freedom Technique, the applicability of non-pharmacological method treatment in women with depression and menopausal symptoms in postmenopausal period will be proven. As a result of the study, if a positive effect on menopausal symptoms and depression is found in women with EFT, it can be recommended as an evidence-based alternative method in midwifery and nursing care. conditions: Menopause studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: the groups with a conventional therapy control group primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: emotional liberation technique measure: Beck Depression Scale measure: Menopause Rating Scale (MRS) sex: FEMALE maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: family health center no. 1 in Çayyolu status: RECRUITING city: Ankara state: Çankaya country: Turkey name: MERYEM VURAL ŞAHİN role: CONTACT phone: 05535344779 email: meryemyasam@gmail.com name: Meltem UĞURLU role: PRINCIPAL_INVESTIGATOR name: Derya Yüksel KOÇAK role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06338072 id: DIABETEXX/1 briefTitle: Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1). acronym: DIABETEXX/1 overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-03 date: 2025-01-01 date: 2025-08-01 date: 2024-03-29 date: 2024-04-23 name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal class: OTHER name: Universitat Politècnica de València briefSummary: The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control. conditions: Type 1 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 119 type: ESTIMATED measure: Time in range measure: Time below range measure: Time above range measure: Caloric intake measure: Temperature measure: Photoplethysmography measure: Accelerometry sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Lía Nattero-Chávez city: Madrid zip: 28034 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06338059 id: Gulcanozturkchatipchousein briefTitle: Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-06-01 date: 2024-03-29 date: 2024-03-29 name: Fatih Sultan Mehmet Training and Research Hospital class: OTHER briefSummary: Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema. conditions: Vitamin D Deficiency conditions: B12 Deficiency Vitamin conditions: Lipedema studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ACTUAL name: Vitamin B12 Level measure: Vitamin B12 Level measure: 25 OH Vitamin D Level sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gulcan Ozturk city: Istanbul zip: 34752 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06338046 id: EAShi23M01 briefTitle: In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY acronym: Shitake overallStatus: COMPLETED date: 2023-10-01 date: 2023-11-15 date: 2023-12-22 date: 2024-03-29 date: 2024-03-29 name: Ritamaria Di Lorenzo class: OTHER briefSummary: This double-blind placebo-controlled study intends to confirm skin adaptogen and sebum balance efficacy of the investigational active ingredient NC65 - Vita D-Light, transmitted at 0.5% w/w in a topical cosmetic formulation, on a panel of healthy human subjects.

The study is performed by RD Cosmetics - University of Naples Federico II, from October to June 2024. The study involves female and male subjects, scheduled for eligibility screening at the study site. A total of 40 subjects were enrolled, and randomly divided into 2 groups: 20 subjects received the active treatment (cosmetic formulation with 0.5 %w/w NC65 - Vita D-Light) and 20 subjects the placebo one.

The cosmetic effectiveness of the products was instrumentally detected, using innovative, non-invasive and worldwide recognized devices for skin analysis, like:

* Corneometer CM 825 (C+K electronic GmbH) detects water's content of the stratum corneum.
* Tewameter® TM Hex (C+K electronic GmbH) detects the trans-epidermal water loss (TEWL).
* Sebumeter SM 815 accurately and reproducibly measures the level of sebum on the skin surface.
* Visia VISIA® (Canfield Scientific, Inc.) for skin surface assessment.

The monitored skin features parameters will be check after 1 hour (T1h) for the adaptogen test, and after 7, 14 and 28 days (T7 -T14-T28), for the detox test. Panelists will complete the self-assessment questionnaire at the end of the study period (T28). conditions: SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 parallel arm, double blind, randomized, placebo-controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: neither the patient nor the investigator knows who is getting which treatment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Corthellus Shiitake(Mushroom) Extract name: Placebo measure: Soothing Test measure: Detox and adaptogen Test sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II city: Naples zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06338033 id: 2024-03-23 briefTitle: Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction overallStatus: COMPLETED date: 2020-09-19 date: 2023-08-28 date: 2023-11-30 date: 2024-03-29 date: 2024-03-29 name: Chongqing Medical University class: OTHER briefSummary: Obesity and heart failure with preserved ejection fraction (HFpEF) have multiple pathologic associations that affect the prognosis of HFpEF. Chinese people are more prone to visceral obesity, resulting in varying degrees of true obesity in individuals with the same body mass index (BMI). There are no prognostic studies of VFA/BMI in the HFpEF population. conditions: Heart Failure With Preserved Ejection Fraction and Visceral Fat studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 298 type: ACTUAL measure: All-cause mortality measure: Rehospitalization for heart failure measure: Composite endpoints of all-cause mortality and rehospitalization for heart failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Chongqing Medical University city: Chongqing country: China lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06338020 id: RHPT/0022/0042 briefTitle: Adaptive Variable-Resistance Training in Pediatric Survivors of Acute Lymphoblastic Leukemia overallStatus: COMPLETED date: 2022-12-29 date: 2024-01-04 date: 2024-01-04 date: 2024-03-29 date: 2024-03-29 name: Cairo University class: OTHER briefSummary: This study was designed to investigate the effect of eight weeks of adaptive variable-resistance training (Adaptive-VRT) on chemotherapy-induced sarcopenia, fatigue, and functional restrictions in a convenience sample of pediatric survivors of acute lymphoblastic leukemia (ALL). Sixty-two pediatric survivors of ALL were randomly allocated to the experimental group (n = 31, received the adaptive variable-resistance training) or the Control group (n = 31, received standard physical therapy care). Both groups were assessed for muscle mass, strength, fatigue, and functional capacity before and after treatment. conditions: Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, dual-arm, randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment. whoMasked: OUTCOMES_ASSESSOR count: 62 type: ACTUAL name: Adaptive variable-resistance training name: Standard physical therapy measure: Thigh muscle thickness measure: Muscle strength measure: Fatigue measure: Six-minute walk test measure: 4x10 meter Shuttle Run test measure: Timed up and down stairs test sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ragab K. Elnaggar city: Al Kharj state: Riyadh country: Saudi Arabia lat: 24.15541 lon: 47.33457 hasResults: False

 nctId: NCT06338007 id: 2012-KAEK-15/2702 briefTitle: Relationship Between Hand Dynamometer Measurements, PFT, and mFI With Postoperative Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-01 date: 2025-01-01 date: 2024-03-29 date: 2024-04-17 name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital class: OTHER briefSummary: The study will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital and will include 100 patients over the age of 40 who are scheduled for lung malignancy surgery after 01 April 2024. Informed consent will be obtained from all patients, who will be assigned a number from 1 to 100.

For patients over 40 years of age who are scheduled to undergo lung malignancy resection surgery, demographic data including age, gender, height, weight, body mass index (BMI), diagnosis, comorbidities, and ASA (American Society of Anaesthesiologist) score will be recorded. In addition, hand grip strength measurement, pulmonary function test, and modified frailty index (a scoring system that includes 11 parameters) will be recorded prior to surgery. Intraoperative and postoperative complications will be documented. The duration of the patient's stay in the intensive care unit, chest tube removal, length of hospital stay, and postoperative complications will also be recorded. A follow-up call will be made to the patient by the responsible researcher 90 days after the operation to inquire about any complications that may have developed within that time frame.

The study aims to investigate the relationship between preoperative hand grip strength measurement, pulmonary function test analysis (PFT), and modified frailty index with the duration of intensive care unit stay, chest tube withdrawal time, hospital stay, and postoperative complications in patients undergoing lung resection due to malignancy. conditions: Complication,Postoperative conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Hand Dynamometer name: Pulmonary Function Test name: Modified Frailty Index measure: Complication sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Atatürk Sanatorium Training and Research Hospital city: Ankara state: Keçiören zip: 06290 country: Turkey name: Gülay ÜLGER, specialist role: CONTACT phone: 05059532122 phoneExt: +9 email: gulayulger@gmail.com name: Onur KÜÇÜK, specialist role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06337994 id: AUH-Neurol-TBI_2024 briefTitle: Memantine Hydrochloride for Treatment of Cognitive Dysfunction Due to Traumatic Brain Injury overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-01 date: 2024-12-30 date: 2024-03-29 date: 2024-03-29 name: Assiut University class: OTHER briefSummary: Posttraumatic consequences are common causes of disability and long-term morbidity. They include cognitive dysfunction, seizures, headache, dizziness, fatigue, sensory deficits, neurodegeneration and psychiatric disorders (e.g. posttraumatic stress disorder, depression, anxiety, etc). Diffuse axonal injury and disruption of normal neuronal function are the most common and important pathologic features of traumatic primary closed head injury. depression, anxiety, etc). Excitotoxicity and apoptosis caused by activation of N-methyl-D-aspartate (NMDA) glutamate receptors, are two main suggested mechanisms of traumatic neuronal cell death and posttraumtic neurologic adverse consequences. Experimental and clinical studies have demonstrated that memantine hydrochloride, NMDA-type glutamate receptor antagonist, could have beneficial effect in treatment of posttraumatic cognitive dysfunction. Memantine may contribute to cognitive improvements in TBI by decreasing the synaptic 'noise' resulting from excessive NMDA receptor activation, inhibition of β-amyloid mediated toxicity and readjustment of the balance between inhibition and excitation on neuronal networks in the central nervous system (CNS). conditions: Treatment of Posttraumatic Cognitive Dysfunction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Memantine Hydrochloride measure: The severity of traumatic brain injury (TBI) measure: The symptoms of depression measure: The symptoms of anxiety measure: The cognitive function measure: Quality of life measure: The cognitive function sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Assiut University, Faculty of Medicine, Hospital of Neurology, Psychiatry and Neurosurgery status: RECRUITING city: Assiut zip: 71516 country: Egypt name: Sherifa A Hamed, M.D. role: CONTACT phone: +201115324560 email: hamedsherifa@aun.edu.eg name: Sherifa A Hamed, MD role: PRINCIPAL_INVESTIGATOR lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06337981 id: 21DE20901 briefTitle: Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients overallStatus: COMPLETED date: 2021-11-22 date: 2022-06-14 date: 2022-11-28 date: 2024-03-29 date: 2024-04-29 name: AJU Pharm Co., Ltd. class: INDUSTRY name: GL Pharm Tech Corporation briefSummary: This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease. conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 99 type: ACTUAL name: (AJU-S56 5% and placebo) name: AJU-S56 5% name: Placebo(Vehicle) measure: Total corneal staining score (TCSS) measure: LGCSS measure: TFBUT sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AJU Pharm Co., Ltd. city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06337968 id: Circum-Psoas Block LN briefTitle: CPB for Arthroscopic Hip Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-05-31 date: 2024-03-29 date: 2024-04-19 name: The Second Hospital of Shandong University class: OTHER briefSummary: Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Postoperative pain reduces patient satisfaction and delay patient recovery and discharge. The efficacy of regional anesthesia techniques in postoperative pain management have been proved in various surgeries. However, it remains controversial whether or not peripheral nerve blocks can significantly improve postoperative analgesia after hip arthroscopy.

Several studies have shown that the fascia iliac block cannot improve postoperative analgesia for hip arthroscopy because it blocks only some branches of the lumbar plexus but not the sacral plexus. Circum-Psoas Block (CPB) which has been defined in recent years is able to block the lumbar plexus nerves as well as sacral plexus such as the sciatic, superior gluteal, and inferior gluteal nerves. Therefore, the investigators predict that it can provide effective postoperative analgesia for hip arthroscopy. In this study, the researchers aim to investigate the effectiveness of CPB in hip arthroscopy. conditions: Acute Pain conditions: Opioid Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Circum-psoas Block name: Sham block measure: pain severity at 6 hours postoperatively measure: Postoperative opioid consumption measure: Postoperative nausea and vomiting measure: neurologic evaluation measure: Patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06337955 id: 20170007596 briefTitle: Non Primary HCMV Infection: Natural History and Immune Response overallStatus: ACTIVE_NOT_RECRUITING date: 2017-06-06 date: 2024-09 date: 2024-12 date: 2024-03-29 date: 2024-04-01 name: Foundation IRCCS San Matteo Hospital class: OTHER name: Università degli Studi di Pavia name: Merck Sharp & Dohme LLC name: Fondazione Regionale per la Ricerca Biomedica (FRRB) - Regione Lombardia briefSummary: The goals of this observational study are: i) investigate the natural history of non-primary (i.e. reactivation and reinfection) HCMV infection in HCMV-seropositive Italian women and the relevant humoral and cell-mediated immune response; ii) reliably distinguish between reactivation and reinfection.

Prerequisite of the study is the availability of a maternal HCMV strain at baseline (original strain) to which subsequent strains detected during follow-up are compared in order to distinguish between reactivation (original strain) or reinfection (new strain).

To increase the likelihood of exposure to different HCMV strains, the study population is restricted to mothers of children attending day care centers. conditions: Cytomegalovirus Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 204 type: ACTUAL measure: HCMV non-primary infection (reinfection or reactivation). measure: HCMV-specific humoral and cell-mediated immune response during non-primary infection. measure: Maternal behaviours and occurrence of non-primary infection measure: Potential use of saliva swabs for antibody determination. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Policlinico San Matteo city: Pavia state: PV zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06337942 id: 23-001621 briefTitle: Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study overallStatus: RECRUITING date: 2024-04-01 date: 2025-04 date: 2027-04 date: 2024-03-29 date: 2024-03-29 name: University of California, Los Angeles class: OTHER briefSummary: The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant. The main questions it aims to answer are:

* Is human bladder transplantation feasible and safe?
* How will the new bladder function in terms of storage and emptying?

Participants will undergo a bladder-only or combined kidney and bladder transplantation. They will then be followed for two years to evaluate the efficacy, safety, and functionality of the bladder transplant. conditions: Bladder Disease conditions: Bladder, Neurogenic conditions: Bladder Cancer conditions: Kidney Failure studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Bladder Transplantation name: Combined Kidney and Bladder Transplantation measure: Demonstrating the technical success of bladder or combined kidney-bladder transplantation measure: Incidence of adverse events after bladder or combined kidney-bladder transplantation measure: Incidence of immune rejection after bladder or combined kidney-bladder transplantation measure: Evaluate the functionality of the transplanted bladder sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Magdalena Mendez-Smith role: CONTACT phone: 310-267-7727 email: mmendezsmith@mednet.ucla.edu name: Nima Nassiri, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06337929 id: Ethics Approval: n. 6.683.936 briefTitle: Effects of Capoeira on the Physical and Psychological Performance of Adults overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2024-07-15 date: 2024-12-13 date: 2024-03-29 date: 2024-03-29 name: Universidade Federal do vale do São Francisco class: OTHER briefSummary: Regular physical activity (PA) promotes benefits for both physical and mental health. Among the numerous PA\&#39;s with a collective nature that can add to the existing recommendations, combat sports training interventions are viable alternatives since they integrate benefits in different aspects for health. In this way, capoeira can be a strategy for the prescription of exercise, aiming to serve participants collectively and maintaining the adherence of this practitioner to the intervention. However, little is known about this issue. So, the aim of the present study is to verify the effect of 12 weeks of capoeira training on the physical performance and psychological aspects of previously physically inactive adults. conditions: Training conditions: Mental Health conditions: Physical Fitness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: CAPOEIRA TRAINING name: CONTROL GROUP measure: Change from baseline in aerobic fitness (maximal oxygen uptake and anaerobic threshold) at week 12 measure: Change from baseline in anaerobic fitness (Peak, average and minimum power in the Wingate test) at week 12 measure: Change from baseline in muscle strength (Horizontal Leg Press) at week 12 measure: Change from baseline in muscle power (Vertical Jump Tests from Squat Jump and Counter Movement Jump) on force platform at week 12 measure: Change from baseline in balance (Center of Pressure) on force platform at week 12 measure: Change from baseline in motor coordination (Test of Gross Motor Development) at week 12 measure: Change from baseline in Emotional Intelligence to sport (Likert-type scales with 26 items) at week 12 measure: Change from baseline in Motivation for Sport II (Likert-type scales with 18 items) at week 12 measure: Change from baseline in Quality of life measuring by Questionnaire of Word Health Organization (WHOQOL-bref) at week 12 sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: UNIVASF city: Petrolina state: Pernambuco zip: 56300000 country: Brazil lat: -9.39861 lon: -40.50083 hasResults: False

 nctId: NCT06337916 id: 2021/16-01 briefTitle: The Effect of Cervical Stabilization Exercises on the Cervical Proprioception in Patients With Chronic Neck Pain overallStatus: COMPLETED date: 2022-10-07 date: 2022-11-25 date: 2023-01-30 date: 2024-03-29 date: 2024-04-02 name: Şenay Özdolap class: OTHER name: Zonguldak Bulent Ecevit University briefSummary: Neck pain is one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Neck pain is categorized by duration as acute, subacute and chronic neck pain (acute, \<6 weeks; subacute, ≤3 months; chronic, \>3 months). Chronic neck pain is more common in women and its incidence increases with age. Cervical disc herniation, cervical spondylosis, cervical stenosis, myofascial pain syndrome, cervical instability, whiplash injury, Klippel feil syndrome, thoracic outlet syndrome, cervical sprain, cervical strain, tumors, rheumatic diseases, torticollis, inflammatory neck pain are the main causes.

Anterior tilt of the head is a common posture in neck pain. In this posture, the upper cervical vertebrae are extension, the lower cervical vertebrae are flexion and the cervical lordosis is decreased. With neck pain, inhibition occurs in the deep neck flexor (longus coli and capitis) and extensor (multifidus, rotator, semispinalis) muscles, increased fat infiltration, deterioration in type 1 and 2 fiber ratios, and muscle atrophy. The risk of micro and macro trauma increases and muscle support decreases. Thus, there is an increase in the activation response and fatigue of the neck superficial muscle group (trapeze, scalene, sternocleidomastoid muscles), and a decrease in neck joint movement and proprioception sense. As a result, it was determined that there are deficiencies in the sense of proprioception in patients with neck pain.

Studies have shown that many receptors related to the sense of position are on deep cervical flexor muscles such as Musculus Longus Capitis and Musculus Longus Colli. In cases where there are changes such as atrophy and fat infiltration in these muscles, there is a decrease in proprioceptive sensation.Conservative treatment is the first choice in the treatment of neck pain. The important components of this treatment are stretching, strengthening, posture, stabilization, proprioception, relaxation, joint movement exercises and aerobic exercises. The purpose of stabilization exercises, which have been used in the treatment of chronic neck pain recently; to support the vertebral column by activating the stabilizing muscles and to improve posture by increasing kinesthetic awareness.

This study will examine the relationship between the sense of cervical proprioception and cervical stabilization exercises in patients with chronic neck pain.

In this study, between 15 June 2022 and 30 January 2023; 72 volunteers, aged between 18-55 years, with neck pain for more than 3 months, with good cognitive function, who applied to the our Physical Medicine and Rehabilitation Clinic will be included. The patients will be randomized to two groups as cervical stabilization exercise group and conventional cervical exercise treatment group. The patients in group 1 will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks, and the patients in group 2 will perform cervical stabilization exercises for 6 weeks, 3 days a week, 1 session a day. conventional cervical exercises will be given. Patients of both groups will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.

Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.

Demographic information (address, telephone, age, occupation, height, weight, marital status, etc.) of the patients to be included in the study will be recorded and general musculoskeletal examinations will be performed. The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form-36 (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM). conditions: Neck Pain conditions: Chronic Neck Pain studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Cervical Stabilization Exercise name: Cervical Standard Exercise Group measure: assessment of cervical joint position sense measure: assessment of cervical range of motion measure: assessment of neck disability measure: assessment of pain measure: assessment of life quality sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Zonguldak Bülent Ecevit University city: Zonguldak zip: 67100 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False

 nctId: NCT06337903 id: Self-compassion for PwMS briefTitle: Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-04-30 date: 2024-03-29 date: 2024-04-01 name: Robert Simpson class: OTHER briefSummary: The goal of this clinical trial is to develop and investigate a compassion-based intervention (Mindful Self-Compassion course) in people with multiple sclerosis. The main objectives are:

1. Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up
2. Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
3. Determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion.

Participants will be asked to take part in an 8-week online Mindful Self-Compassion course and report changes in levels of stress, anxiety, depression, self-compassion, adjustment, emotion, and quality of life from pre- to post-intervention and at 3-month follow-up. Additionally, participants will be asked to take part in a semi-structured interview to explore their experiences with the course, perceived effects, and suggestions for improvement. conditions: Multiple Sclerosis conditions: Self-Compassion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 45 type: ESTIMATED name: Self-compassion intervention (the Mindful Self-Compassion course) measure: Recruitment measure: Retention measure: Adherence measure: Follow-up rates measure: Stress measure: Anxiety measure: Depression measure: Self-compassion measure: Emotion Regulation measure: Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29) measure: Participant Experiences and Perspectives measure: Adjustment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unity Health Toronto city: Toronto country: Canada name: Robert Simpson, PhD role: CONTACT lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06337890 id: FEZECO briefTitle: CO2 Automated Angiographies With Fusion Imaging for Zero- or Near Zero- Contrast FEVAR. overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-29 date: 2024-03-29 name: University of Bologna class: OTHER briefSummary: Fenestrated endovascular aneurysm repair (FEVAR) is an established technique used to treat complex aortic aneurysms (TAAAs), with satisfactory early and midterm results.

Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay, higher morbidity, and long-term mortality in the peri-operative period and during follow-up. One of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium (ICM).

Automated carbon dioxide (CO2) angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair (EVAR) in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function.

In adjunct, hybrid room and fusion imaging (FI) technologies are useful tools to reduce intraoperative contrast medium and fluoroscopy time.

In literature there are few reports regarding the use of CO2 for fenestrated endografting repair of complex aortic aneurysms.

The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms. conditions: Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Zero contrast FEVAR measure: Rate of technical success measure: Reintervention and mortality measure: Number of participants with perioperative renal function worsening measure: Rate of TVVs instability measure: Rate of survival measure: Rate of reintervention measure: Number of participants with renal function worsening sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bologna status: RECRUITING city: Bologna state: Emilia Romagna zip: 40138 country: Italy name: Enrico Gallitto, MD, PhD role: CONTACT phone: +390512143288 email: enrico.gallitto@gmail.com lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06337877 id: pEEG ARDS briefTitle: Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-04-17 date: 2024-04-24 date: 2024-03-29 date: 2024-03-29 name: Tepecik Training and Research Hospital class: OTHER briefSummary: "In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used." conditions: Sedation Complication conditions: Acute Respiratory Distress Syndrome Due to COVID-19 conditions: Anesthesia Awareness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 52 type: ACTUAL name: Depth of sedation monitoring measure: To determine the sedation levels of patients during paralysis measure: The prevalence of inadequate or excessive sedation, measure: Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS), sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aykut Saritaş city: İ̇zmi̇r zip: 35640 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06337864 id: H-24017055 briefTitle: Evaluating the Efficacy and Safety of Large Neutral Amino Acids in the Treatment of Classical Phenylketonuria overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-12 date: 2024-03-29 date: 2024-03-29 name: Rigshospitalet, Denmark class: OTHER briefSummary: This research investigates the effectiveness and safety of large neutral amino acid (LNAA) supplementation in patients with classical phenylketonuria (PKU). Advanced brain imaging techniques alongside comprehensive neuropsychological and functional assessments will be employed. Short-term and long-term follow-up of participants will be conducted. conditions: Brain Diseases conditions: Brain Diseases, Metabolic conditions: Brain Diseases, Metabolic, Inborn conditions: Genetic Diseases, Inborn conditions: Metabolism, Inborn Errors conditions: Amino Acid Metabolism, Inborn Errors conditions: Metabolic Disease conditions: Phenylketonurias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: To fully assess the effectiveness of LNAA, the following trials will be conducted:

1. A crossover study comparing LNAA supplementation to no treatment
2. A crossover study comparing LNAA supplementation to the Phe-free PKU diet
3. Open-label extension study to assess the long-term safety and efficacy of LNAA supplementation
4. Healthy control group primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: PreKUnil® LNAA Medical Food for PKU measure: Dynamic positron emission tomography (PET) imaging with the fluorine-18-labeled tracer [18F]-(E)-N-(3-iodoprop-2-enyl)-2β-carbofluoroethoxy-3β-(4'-methyl phenyl)nortropane ([18F]FE-PE2I) measure: Computerized neuropsychological testing (responses over study iPad) measure: Behaviour Rating Inventory of Executive Function - Adult version (BRIEF-A) measure: Behaviour Rating Inventory of Executive Function - Second edition (BRIEF-2) measure: Adult attention deficit hyperactivity disorder (ADHD) Self-Report Scale (ASRS v1.1) measure: Adolescent ADHD Self-Report Scale measure: PKU-QOL Questionnaire Adolescent or Adult version measure: Symptom Checklist-90-Revised (SCL-90-R) measure: Behavior Assessment System for Children, Third Edition (BASC-3) measure: Neuropsychological testing of flexibility and verbal fluency measure: Urine peripheral biomarkers of neurotransmitters measure: Incidence and severity of treatment-emergent adverse events (TEAEs) measure: Fasting plasma amino acids, dried blood spots (finger-prick method) measure: Brain perfusion measures measure: Adherence to dietary treatment measure: Brain Magnetic Resonance Imaging (MRI) measure: Wechsler Adult Intelligence Scale (WAIS) - IV sex: ALL minimumAge: 16 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Copenhagen University Hospital, Rigshospitalet city: Copenhagen country: Denmark name: Olivia Welle Fjellbirkeland, MD role: CONTACT email: olivia.welle.fjellbirkeland@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06337851 id: AtaturkTRH2003/9 briefTitle: Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma overallStatus: COMPLETED date: 2003-11 date: 2010-04 date: 2011-04 date: 2024-03-29 date: 2024-03-29 name: Ataturk Training and Research Hospital class: OTHER briefSummary: Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.

In previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any.

Inclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDH

Exclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgery

Randomization Simple randomization, without blocking, will be used to divide patients into two groups simultaneous burr hole craniostomy (Group-1) and consecutive burr hole craniostomy (Group-2).

Clinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used.

Radiological Evaluation Radiological evaluations will be made with CT and MR imaging.

Operation Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point. In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated.

Follow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours.

Only the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics.

In the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed.

This evaluation protocol will be executed immediately following the surgical procedure, after the removal of surgical drains (usually on the second postoperative day), and at designated intervals of the 1st, 3rd, 6th, and 12th months to monitor patient progress and recovery. conditions: Subdural Hematoma, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 43 type: ACTUAL name: Simultaneous burr hole craniostomy name: Consecutive burr hole craniostomy measure: The Primary Outcome: Mortality measure: The Primary Outcome: Early Postoperative Success Rate (Redo Surgery) measure: The secondary outcome: Follow-up assessment (Age) measure: The secondary outcome: Follow-up assessment (Sex) measure: The secondary outcome: Follow-up assessment (Trauma-Relation) measure: The secondary outcome: Follow-up assessment (Concomitant Pathologies) measure: The secondary outcome: Follow-up assessment (The Glasgow Coma Scale) measure: The secondary outcome: Follow-up assessment (The Markwalder Grading Scale) measure: The secondary outcome: Follow-up assessment (Neurological Examination - Motor) measure: The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi) measure: The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign) measure: The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift) measure: The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Izmir Ataturk Training and Research Hospital city: Izmir zip: 35360 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06337838 id: 2024.BRACKETS-Pilot briefTitle: Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial acronym: BRACKETS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-03 date: 2024-03-29 date: 2024-03-29 name: Population Health Research Institute class: OTHER briefSummary: The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo. conditions: Chronic Kidney Diseases conditions: Acute Kidney Injury conditions: Bleeding conditions: Surgery studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: 2x2 partial factorial design where patients are first randomized to receive prophylactic intravenous TXA versus placebo, and (when the study drug is available) to be randomized to receive prophylactic intravenous desmopressin versus placebo before noncardiac surgery. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Study drugs will be sourced locally and will be prepared by appropriately qualified center personnel who are independent of the study team to ensure blinding is maintained. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Desmopressin Injectable Solution name: Tranexamic Acid Injectable Product name: Placebo measure: Rate of recruitment measure: Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial measure: Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial measure: Completion of 30-day follow-up measure: Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS) measure: Reoperation for reasons of bleeding measure: Blood (red blood cells or whole blood) transfused measure: Blood (red blood cells or whole blood) transfused measure: Any blood transfusion (red blood cells or whole blood) measure: Any blood transfusion (red blood cells or whole blood) measure: Lowest measured hemoglobin concentration measure: Most recent hemoglobin concentration measure: Death measure: Major arterial and venous thrombosis measure: Myocardial Injury after Noncardiac Surgery (MINS) measure: Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction measure: MINS that is an isolated ischemic troponin elevation measure: Stroke measure: Non-hemorrhagic stroke measure: Hemorrhagic stroke measure: Peripheral arterial thrombosis measure: Thrombosis of arteriovenous fistula or graft measure: Symptomatic proximal venous thromboembolism measure: Symptomatic pulmonary embolism measure: Symptomatic proximal leg or arm deep venous thrombosis (DVT) measure: Non-fatal cardiac arrest measure: Coronary revascularization procedure measure: Clinically important atrial fibrillation or flutter measure: Acute heart failure measure: Acute kidney injury (for patients not receiving dialysis before surgery) measure: New start of dialysis measure: Seizure measure: Clinically significant intraoperative hypotension measure: Clinically significant postoperative hypotension measure: Sepsis measure: Duration of surgery measure: Receipt of platelets measure: Receipt of fibrinogen measure: Receipt of fresh frozen plasma measure: Receipt of cryoprecipitate measure: Receipt of recombinant Factor VIIa measure: Receipt of prothrombin complex concentrate measure: Prescribed erythropoiesis stimulating agent measure: Severe hyponatremia measure: Duration of hospital stay after surgery measure: Duration of critical care stay after surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06337825 id: 22-727 briefTitle: Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-19 date: 2024-03-12 date: 2024-06-29 date: 2024-03-29 date: 2024-04-15 name: The Cleveland Clinic class: OTHER briefSummary: Wearable electronic devices are becoming more prevalent in daily life, as they offer real time information on physiological parameters such as heart rate, activity level, oxygenation, and sleep patterns for their users. These wearable electronic devices are easy to install and offer no major risk or discomfort to the user. Implementation of these technologies into medicine has exponentially grown in the past decade with supporting evidence for their use in cardiovascular disease and sleep medicine. The investigators believe that these devices will be able to capture the changes associated with improvement in non-specific symptoms that have not been previously demonstrated. conditions: Primary Hyperparathyroidism conditions: Multinodular Goiter studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Activity Tracker (Fitbit) name: HbA1C name: The PROMPT Questionnaire measure: Change in resting heart rate over time among study participants as monitored by fitness tracker measure: Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker measure: Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker measure: Change in steps over time among study participants as monitored by fitness tracker measure: Change in total active minutes over time among study participants as monitored by fitness tracker measure: Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker measure: Change in glucose levels (HbA1C) measure: Correlation of Quality of Life surveys with the PROMPT survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Foundation city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06337812 id: HUM00240473 briefTitle: Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06 date: 2025-06 date: 2024-03-29 date: 2024-03-29 name: University of Michigan class: OTHER briefSummary: The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health. conditions: Type2diabetes conditions: Heart Failure With Preserved Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: Potato Starch measure: Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool measure: Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma measure: Changes in propionate levels - stool measure: Changes in propionate levels- plasma measure: Changes in acetate levels- stool measure: Changes in acetate levels- plasma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Hayley Billingsley, PhD role: CONTACT phone: 734-726-0308 email: hbilings@med.umich.edu name: Scott Hummel, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06337799 id: 202210411 briefTitle: Use of Allied-health Professionals to Improve Treatment of Disease overallStatus: NOT_YET_RECRUITING date: 2026-10 date: 2030-03 date: 2030-03 date: 2024-03-29 date: 2024-03-29 name: University of Iowa class: OTHER briefSummary: The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care.

Participants will:

Take their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months. conditions: Preeclampsia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Research Pharmacist measure: Number of Subjects at Risk for Hypertension measure: Number of Subjects Exposed to a Screening Clinic measure: Number of Subjects Screened at a Screening Clinic measure: Number of Subjects Followed-Up by the Research Pharmacist measure: Number of Subjects Diagnosed with Hypertension measure: Number of Subjects Treated for Hypertension, if Diagnosed sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06337786 id: MSK-2023-TSJ1 briefTitle: Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical Set-up in Patients With Rheumatoid Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-03-29 date: 2024-04-05 name: Henning Bliddal class: OTHER name: Eurostars name: DAMAN name: Medical University of Vienna briefSummary: Rheumatoid arthritis (RA) is one of the most frequently occurring autoimmune rheumatic diseases, affecting an estimated 1% of the global population (1). RA is a chronic inflammatory disease that leads to the development of synovial inflammation and effusion, ultimately followed by joint destruction and permanent disability.

There is a discrepancy in the understanding of what's of importance when living a life with a chronic disease.

The importance of patients' perspectives concerning disease- and treatment related impacts, is of crucial importance when involving patients in decisions about treatment, and to support the patients in optimal medication-taking behaviour to ensure patient health and reduce health care costs. There are still unmet needs that have a huge impact on quality of life (QoL) such as fatigue, pain, sleep and psychological issues, etc, which need to be taken seriously as these can have severe and debilitating consequences for the individual.

The aim of this study is to investigate and evaluate the effects of the digital app RheumaBuddy4.1 (RB4.1) and the ability to provide support and increase quality of life in patients with RA conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The trial is an open-label matched register controlled clinical trial with two parallel groups (intervention and matched controls from the DANBIO register).

The number of study participants is 40 in the intervention arm and up to 120 in the matched control arm. primaryPurpose: OTHER masking: NONE count: 160 type: ESTIMATED name: Digital app RB4.1 name: Control arm measure: Primary Outcome measure: Disease-activity Score28 using C-reactive protein (DAS28-CRP) measure: Self-Efficacy measure: Pain and Fatigue measure: Health related quality of life measure: Physical function/activity measure: Well-Being measure: Medication Adherence measure: Better alignment between patient and health care professionals sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Parker Institute, Bispebjerg and Frederiksberg Hospital city: Frederiksberg state: Copenhagen F zip: 2000 country: Denmark name: Tanja Schjødt Jørgensen role: CONTACT phone: +4538164173 email: tanja.schjoedt.joergensen@regionh.dk name: Lars Erik Kristensen role: CONTACT phone: +4538164157 email: lars.erik.kristensen@regionh.dk lat: 55.67938 lon: 12.53463 hasResults: False

 nctId: NCT06337773 id: B-BR-112-036 briefTitle: Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-09-30 date: 2026-12-25 date: 2024-03-29 date: 2024-03-29 name: Fooyin University class: OTHER briefSummary: This study is aimed to demonstrate the long-term effectiveness of 8-week precision nursing education program through the e-flipped classroom model for YCC survivors and provide a compliant strategy to improve quality of life and emotional status of these patients. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: 8-weeks's on-line precision nursing education program measure: The depression symptoms on young colorectal cancer survivors measure: Dispositional mindfulness status on young colorectal cancer survivors measure: General quality of life on young colorectal cancer survivors measure: Colorectal specific quality of life on young colorectal cancer survivors measure: Cancer threat appraisal on young colorectal cancer survivors sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06337760 id: IEO 1669 briefTitle: YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs. acronym: YOUNGSTER overallStatus: RECRUITING date: 2023-03-10 date: 2026-12-31 date: 2027-06-30 date: 2024-03-29 date: 2024-03-29 name: European Institute of Oncology class: OTHER briefSummary: The objective of the study is to create a common and unique platform for the acquisition of biological samples and, subsequently, the possible identification of predictive and prognostic biomarkers for young adults with gastrointestinal and neuroendocrine cancers.The definition "adolescent and young adults (AYA)" covers a broad group of patients ranging from the upper limit of the paediatric competence to the youngest patients usually considered and treated as adults. However, a well-defined and universally accepted age range is still not established. Young adults with cancer have distinct epidemiological, biological, and clinical characteristics, as well as special medical and psychosocial needs that are often unmet. In consideration of their poor representation in clinical studies, as well as the rarer, albeit increasing, frequency at an epidemiological level, knowledge of the risk factors associated with cancers in young adults is very poor. It is therefore of fundamental importance to focus attention on this specific cohort of patients, in order to describe in ever more detail any specific biomolecular aspects, and make full use of the pharmacological resources currently available. conditions: Neuroendocrine Neoplasm conditions: Adenocarcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 90 type: ESTIMATED measure: Numbers of partecipants with genetic alterations measure: Number of partecipants with survival outcomes measure: Number of partecipants toxicities sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Lorenzo Gervaso, MD role: CONTACT name: Chiara Alessandra Cella, MD role: SUB_INVESTIGATOR name: Luca Mazzarella, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06337747 id: 04-2023-PLLA briefTitle: Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs. Extended Temporal Fossa + Hairline overallStatus: RECRUITING date: 2023-05-19 date: 2024-04-30 date: 2024-06 date: 2024-03-29 date: 2024-03-29 name: Erevna Innovations Inc. class: OTHER briefSummary: The use of poly-L-Lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Furthermore, the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured. Therefore, this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A prospective, randomized-controlled trial primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Traditional technique name: Experimental technique measure: To access the efficacy of the tradition and experimental technique measure: To access the safety of the tradition and experimental technique sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erevna Innovations Inc status: RECRUITING city: Montreal state: Quebec zip: H3R 3A1 country: Canada name: Andreas Nikolis, MD role: CONTACT phone: 514-488-0163 email: research@vicpark.com lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06337734 id: 2 briefTitle: An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension overallStatus: COMPLETED date: 2021-11-01 date: 2023-08-01 date: 2023-08-01 date: 2024-03-29 date: 2024-04-01 name: University of California, San Diego class: OTHER briefSummary: This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 141 type: ACTUAL name: AI-Driven Lifestyle Coaching Program measure: Average change in systolic blood pressure (SBP) from baseline to 12 weeks measure: Average change in diastolic blood pressure (DBP) from baseline to 12 weeks measure: Average change in SBP from baseline to 24 weeks measure: Average change in DBP from baseline to 24 weeks measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks measure: Average weekly percentage of active participants measuring their BP measure: Average weekly percentage of active participants syncing their wearable measure: Average weekly percentage of active participants answering the mobile app questionnaire measure: Number of manual clinician outreaches based on the escalation rules set for the study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Diego city: La Jolla state: California zip: 92093 country: United States lat: 32.84727 lon: -117.2742 hasResults: False

 nctId: NCT06337721 id: R01AA030786 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA030786 briefTitle: Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-05 date: 2028-08 date: 2024-03-29 date: 2024-03-29 name: University of California, Riverside class: OTHER briefSummary: This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT). conditions: Alcohol Use Disorder conditions: Alcohol; Harmful Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Will conduct a randomized controlled trial of the SPEAR intervention vs. control group. primaryPurpose: PREVENTION masking: NONE count: 240 type: ESTIMATED name: SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) measure: Heavy Episodic Drinking (HED) Days measure: Alcohol Consumption sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: UC Riverside city: Riverside state: California zip: 91784 country: United States lat: 33.95335 lon: -117.39616 hasResults: False

 nctId: NCT06337708 id: STUDY00017286 id: R01HL168170 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL168170 briefTitle: Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women overallStatus: RECRUITING date: 2024-01-19 date: 2027-03-31 date: 2028-03-31 date: 2024-03-29 date: 2024-03-29 name: Arizona State University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women. conditions: Physical Activity conditions: Exercise conditions: Heart Diseases conditions: Diabetes Mellitus conditions: Physical Inactivity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Smart Walk name: Fitbit measure: Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months measure: Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months measure: Change in cardiorespiratory fitness from baseline to 4- and 12-months measure: Change in aortic pulse wave velocity from baseline to 4- and 12-months measure: Change in body weight from baseline to 4- and 12-months. measure: Change in body mass index from baseline to 4- and 12-months measure: Change in waste circumference from baseline to 4- and 12-months measure: Change in blood pressure (mmHG) from baseline to 4- and 12-months measure: Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months measure: Change in interleukin 6 (IL-6) from baseline to 4- and 12-months measure: Change in interleukin 10 (IL-10) from baseline to 4- and 12-months measure: Change in interleukin 15 (IL-15) from baseline to 4- and 12-months measure: Change in fasting blood glucose glucose from baseline to 4- and 12-months measure: Change in serum insulin from baseline to 4- and 12-months measure: Change in serum lipids (mg/DL) from baseline to 4- and 12-months measure: Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months measure: Change in exercise self-efficacy from baseline to 4- and 12-months measure: Change in self-regulation for physical activity from baseline to 4- and 12-months measure: Change in social support for physical activity from baseline to 4- and 12-months measure: Change in outcome expectations for physical activity from baseline to 4- and 12-months measure: Change in behavioral capability for physical activity from baseline to 4- and 12-months measure: Treatment acceptance measure: Protocol Adherence measure: Program costs measure: Participant costs measure: Cost-effectiveness measure: Objectively-measured home neighborhood characteristics measure: Subjectively-measured Neighborhood environment walkability measure: Race-related Stress measure: Perceived Structural Racism sex: FEMALE minimumAge: 24 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arizona State University status: RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: Carina Platte, PhD role: CONTACT phone: 602-543-2213 email: carina.platte@asu.edu name: Rodney Joseph, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 hasResults: False

 nctId: NCT06337695 id: HREBA.CC-23-0271 briefTitle: VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-11-01 date: 2026-12-01 date: 2024-03-29 date: 2024-04-02 name: University of Calgary class: OTHER briefSummary: The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICIs) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy conditions: Cancer conditions: Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized, Double-Blinded, Placebo Controlled Trial primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 298 type: ESTIMATED name: Vedolizumab name: Placebo measure: Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months measure: Proportion of patients with histologically confirmed colitis-free survival at 6 months measure: Proportion of patients with severe diarrhea or colitis at 6 months measure: Hazard Ratio of patients with diarrhea or colitis after 6 months measure: Total average dose of checkpoint inhibitor therapy received within 6 and 12 months measure: Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs) measure: Proportion of participants who require permanent ICI discontinuation due to irAEs measure: Proportion of patients requiring rescue corticosteroids for ICI related diarrhea/colitis measure: Total average prednisone equivalent dose of rescue corticosteroids required measure: Proportion of participants requiring all-cause hospitalization by Day +180 and Day +365 measure: Proportion of participants requiring ICI-related diarrhea/colitis-specific hospitalization by Day +180 and Day +365 measure: Mean change in the EuroQol EQ-5D instrument at Day +180 and Day +365 compared to baseline measure: Overall survival (measured as death) at +180 and Day +365 compared to baseline measure: Progression-free survival at 6- and 12-months, defined using the Response Evaluation Criteria in Solid Tumors (RECIST), v1.176 measure: Proportion of participants experiencing any adverse events (AEs) measure: Proportion of participants experiencing serious AEs measure: Proportion of participants experiencing other irAEs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06337682 id: CB_CY_P09_23_11 briefTitle: Blood Pressure Management in the Care Home Population acronym: BPITCH overallStatus: ACTIVE_NOT_RECRUITING date: 2016-01 date: 2020-01 date: 2024-06 date: 2024-03-29 date: 2024-03-29 name: University of Leeds class: OTHER name: Bradford Teaching Hospitals NHS Foundation Trust briefSummary: The UK care home population is projected to increase significantly over the coming decades. A high proportion of individuals in a care home have multiple long-term conditions and take large amounts of prescribed medication. This means they are routinely excluded from research studies and so there is little evidence on which to base treatment of long-term conditions such as high blood pressure. Furthermore, given that 1 in 4 people admitted into a care home die within 1 year, the benefit of treating high blood pressure to reduce the risk of heart attack or stroke must be balanced with the need to optimise quality of life. The aim of this study is to describe the health and social characteristics of the UK care home population with a particular focus on the management of blood pressure in the population. It is hoped that the findings of this study will help inform future research into the management of chronic conditions in care home residents. conditions: Aging conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED measure: Frequency of blood pressure measurements measure: change in antihypertensive medication measure: Injurious falls measure: Prevalence of hypertension measure: Antihypertensive medication measure: Blood pressure treatment measure: change in systolic pressure following care home admission sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Academic Unit for Ageing and Stroke Research city: Bradford state: West Yorkshire zip: BD9 6RJ country: United Kingdom lat: 53.79391 lon: -1.75206 hasResults: False

 nctId: NCT06337669 id: OSRSCP-GUP21006 briefTitle: Characterization of DupEx2 Duchenne Muscular Dystrophy acronym: DMDDup2 overallStatus: RECRUITING date: 2022-01-31 date: 2025-01-31 date: 2025-01-31 date: 2024-03-29 date: 2024-03-29 name: IRCCS San Raffaele class: OTHER briefSummary: To characterize the clinical phenotype and possible predictive/prognostic factors of patients with Duchenne muscular dystrophy (DMD) due to duplication of exon 2 (Dup2). Specifically, we aim 1) to describe the progression of motor, respiratory and cardiac function; 2) to enquire if the phenotypic spectrum of Dup2 is milder than classic DMD, 3) to perform whole genome sequencing (WGS) to characterize DNA breakpoints to correlate with the phenotype; 4) to collect material for future proteomic/transcriptomic studies.

Background/Rationale DMD is caused by mutations in the DMD gene and in 11% of cases is due to duplications. The most promising therapeutic approaches include mutation-specific therapies. Notably, there is increasing evidence that specific groups of mutations may underlie different disease trajectories compared to the "average" DMD population. It is thus mandatory to have more information on genotype-phenotype correlations and patterns of progression related to different genotypes.

Dup2 is the most common DMD duplication and the only one for which a AAV-mediated exon skipping study is ongoing. Despite most case series and databases ascribe Dup2 to severe phenotype, our preliminary findings sustain that these patients have collectively a milder progression of the disease and in 1/3 of cases a significantly milder phenotype. Moreover, our attempts to reveal mechanism involved in attenuating the phenotype would confute the hypothesis of alternative spicing transcripts as previously described for DMD with deletion of exon 2.

Research design and methods Clinical information regarding a cohort of 26 Italian Dup2 patients will be collected. Differences in time to loss of ambulation compared to a DMD control group will be achieved. Finally, we will retrieve DNA for correlative WGS studies.

Anticipated output We expect that Dup2 patients present a milder DMD phenotype , which might be predicted by genomic studies. conditions: Muscular Dystrophy, Duchenne studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 26 type: ESTIMATED measure: Age at loss of ambulation measure: Time test for motor function measure: Respiratory function sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Dept. of Neurology, IRCCS Ospedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Stefano C Previtali, MD role: CONTACT phone: 00390226433036 email: neuromuscolare@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06337656 id: VITAL_0 briefTitle: Vibration Training Approach in Liver Cirrhosis acronym: VITAL overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2026-04-01 date: 2024-03-29 date: 2024-04-01 name: University Hospital of Cologne class: OTHER briefSummary: * Comprehensive Investigation of the Impact of Side-Alternating Whole-Body Vibration Training on Muscle Mass and Muscle Strength in Patients with Liver Cirrhosis and Sarcopenia
* Simultaneous Characterization and Evaluation of Dynamic Changes in Health-Related Quality of Life in our Patient Cohort with Liver Cirrhosis and Sarcopenia through Side-Alternating Whole-Body Vibration Training. conditions: Liver Cirrhosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Galileo WBV measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle mass measure: Evaluation of the Effectiveness on muscle thickness measure: Evaluation of the Effectiveness on mobility, in particular the risk of falling measure: Evaluation of the Effectiveness on physical function measure: Evaluation of Safety of the Training Method measure: Health-Related Quality of Life measure: Health-Related Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06337643 id: MVX01-01 briefTitle: A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-07 date: 2024-04-16 date: 2024-04-16 date: 2024-03-29 date: 2024-03-29 name: Matrivax Research and Development Corporation class: INDUSTRY briefSummary: The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels. conditions: Pneumococcal Vaccine studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Cohort 1 is open-label. Cohorts 2-5 include two open-label sentinel participants each and the remainder of the participants are randomized and double-blind to either MVX01 or MVX01 Placebo (Participant \& Site). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 75 type: ESTIMATED name: MVX01 name: MVX01 Placebo measure: Incidence of immediate reactogenicity adverse events measure: Incidence of solicited reactogenicity events measure: Incidence of adverse events (AEs) measure: Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI) measure: Changes in safety laboratory results compared to baseline measure: Changes in vital signs compared to baseline measure: Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity (Meridian) Clinical Research city: Savannah state: Georgia zip: 31406 country: United States lat: 32.08354 lon: -81.09983 facility: Alliance for Multispecialty Research (AMR) city: Knoxville state: Tennessee zip: 37909 country: United States lat: 35.96064 lon: -83.92074 hasResults: False

 nctId: NCT06337630 id: IC 2022-10 briefTitle: A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors acronym: POP-ART overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2025-06-15 date: 2029-02-15 date: 2024-03-29 date: 2024-03-29 name: Institut Curie class: OTHER name: ProLynx LLC name: Merck Sharp & Dohme LLC briefSummary: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types. primaryPurpose: TREATMENT masking: NONE count: 92 type: ESTIMATED name: PLX038 + Tuvusertib measure: Dose escalation step : Dose limiting toxicities (DLTs) measure: Expansion cohorts : Best tumor response measure: Expansion cohorts : Serious Adverse Events (SAEs) measure: Expansion cohorts : Adverse Events (AEs) measure: Dose escalation step : Pharmacokinetics effect of PLX038 and Tuvusertib measure: Dose escalation step : Pharmacodynamics effect of PLX038 and Tuvusertib measure: Dose escalation step : objective response rate (ORR) measure: Dose escalation step : Time to response (TTR) measure: Dose escalation step : Duration of Response (DoR) measure: Dose escalation step : Progression free survival (PFS) measure: Expansion cohorts : Time to response (TTR) measure: Expansion cohorts : Duration of Response (DoR) measure: Expansion cohorts : Progression free survival (PFS) measure: Expansion cohorts : Overall Survival (OS) measure: Expansion cohorts : Efficacy of PLX038 + Tuvusertib in pre-defined biomarker subgroups measure: Expansion cohorts : Pharmacokinetics effect of PLX038 and Tuvusertib measure: Expansion cohorts : Pharmacodynamics effect of PLX038 and Tuvusertib measure: Exploratory endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut Curie city: Paris zip: 75005 country: France name: François-Clément BIDARD role: CONTACT email: francois-clement.bidard@curie.fr name: François-Clément BIDARD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Institut Curie city: Saint-Cloud zip: 92210 country: France name: François-Clément BIDARD role: CONTACT email: francois-clement.bidard@curie.fr name: François-Clément BIDARD role: PRINCIPAL_INVESTIGATOR lat: 48.84598 lon: 2.20289 hasResults: False

 nctId: NCT06337617 id: CDRB436B2407 briefTitle: A Multi-center Retrospective Study With Secondary Use of Data of Tafinlar (Dabrafenib) Plus Mekinist (Trametinib) in Chinese Patients With BRAF V600 Mutation Positive Melanoma overallStatus: COMPLETED date: 2022-05-10 date: 2023-06-29 date: 2023-06-29 date: 2024-03-29 date: 2024-03-29 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This was a multi-center, observational, retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic BRAF V600 mutation positive melanoma, for mucosal melanoma patients (Cohort A) and non-mucosal melanoma patients (Cohort B, cutaneous and acral melanoma), separately. Study population was identified as patients initiating dabrafenib plus trametinib from 01 May 2020 to 31 July 2022 who fulfilled the inclusion/exclusion criteria. The follow-up period ended at the earliest of the following: end of study observation period (i.e., 31 December 2022), death, upon withdrawal of consent or the last available record. conditions: BRAF V600 Mutation Positive Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 90 type: ACTUAL measure: Real-world overall response rate (rwORR) measure: Mean Age measure: Percentage of patients per sex measure: Number of years of disease history at treatment initiation since initial melanoma diagnosis measure: Number and percentage of patients per anatomic sites of origin measure: Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis measure: Number and percentage of patients per tumor stage measure: Number and percentage of patients with occurrence of tumor metastasis measure: Number and percentage of patients per metastatic location measure: Number and percentage of patients per metastases measure: Lactate dehydrogenase (LDH) levels measure: Eastern Cooperative Oncology Group (ECOG) performance status measure: Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment measure: Number and percentage of patients per type of surgery measure: Number and percentage of patients per name of surgery measure: Number and percentage of patients per surgical and medical procedure measure: Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment measure: Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type measure: Number and percentage of patients per reason for immunotherapy discontinuation measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response measure: Number and percentage of patients per prior anti-neoplastic drug for melanoma measure: Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment intent measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment setting measure: Number and percentage of patients per radiation site measure: Mean total dosage for all radiotherapy measure: Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response measure: Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting measure: Number and percentage of patients per type of D+T treatment change measure: Number and percentage of patients per reason for D+T treatment change measure: Mean duration of D+T, if not ongoing to end of study follow-up measure: rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS) measure: Real-world disease control rate (rwDCR) of D+T (FAS) measure: Real-world duration of response (rwDOR) of dabrafenib plus trametinib measure: Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS) measure: Real-world overall survival (rwOS) since D+T initiation (FAS) measure: Time to treatment discontinuation (FAS) measure: Number and percentage of patients with adverse events of special interest (AESIs) (FAS) measure: Number and percentage of patients with serious adverse events (SAEs) (FAS) measure: rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use measure: rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use measure: rwOS since D+T initiation (MMS), by immunotherapy use measure: rwOS since D+T initiation (NMS), by immunotherapy use measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type measure: Number and percentage of patients per reason for immunotherapy discontinuation measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication measure: Number and percentage of patients per concomitant medication measure: Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS) measure: Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis city: Shanghai zip: 201203 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06337604 id: TNP-2092-04 briefTitle: The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets overallStatus: COMPLETED date: 2017-10-10 date: 2017-11-23 date: 2017-11-23 date: 2024-03-29 date: 2024-04-01 name: TenNor Therapeutics Inc. class: INDUSTRY briefSummary: A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with Helicobacter pylori infection conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ACTUAL name: TNP-2092 capsules name: TNP-2092 capsules placebo name: Rabeprazole sodium enteric-coated tablets measure: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) measure: Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t) measure: Maximum Observed Plasma Concentration (Cmax) of TNP-2092 measure: Percentage of Participants With Adverse Events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The First Hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False

 nctId: NCT06337591 id: INRCA_003_2024 briefTitle: Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location acronym: VI-RADS overallStatus: COMPLETED date: 2022-10-15 date: 2024-03-10 date: 2024-03-10 date: 2024-03-29 date: 2024-03-29 name: Istituto Nazionale di Ricovero e Cura per Anziani class: OTHER briefSummary: VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ACTUAL name: VI-RADS measure: Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Hospital city: Ancona country: Italy lat: 43.5942 lon: 13.50337 facility: IRCCS INRCA Hospital city: Ancona country: Italy lat: 43.5942 lon: 13.50337 facility: Carlo Urbani Hospital city: Jesi country: Italy lat: 43.52142 lon: 13.24368 hasResults: False

 nctId: NCT06337578 id: 23C308 briefTitle: Advances in Telephone-based Cognitive Screening Procedures acronym: TBCS overallStatus: RECRUITING date: 2023-10-25 date: 2026-10-25 date: 2026-10-25 date: 2024-03-29 date: 2024-03-29 name: Istituto Auxologico Italiano class: OTHER briefSummary: 1. Background

   Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Furthermore, in these populations, cognitive screening measures are often employed as outcomes in epidemiological settings, as well as endpoints in clinical trials. Therefore, cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific (i.e., specific to each language and culture).

   The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening (TBCS) procedures - which, until recently, have been mostly neglected in Italy, despite having the potential to bring clear benefits to clinical practice and research. In fact, TBCS techniques allow, through the use of a very widespread, accessible and easy-to-use telecommunication medium, to break down the geographical, logistical, socio-demographic and organizational barriers that make it difficult and/or prevent 1) access to these clinical services and 2) the continuity of their provision, as well as the creation and completion of 3) large-scale epidemiological studies and 4) decentralized clinical trials. However, although some TBCS tests have recently been developed and standardized in Italy, their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated. Furthermore, currently, the "paper-and-pencil" version of the international gold-standard for TBCS procedures . i.e. the Telephone Interview For Cognitive Status (TICS), which has been recently standardized in this country - is not available within the Italian scenario. In fact, although the feasibility of a de visu version of the TICS (i.e., In-Person TICS; IP-TICS) has been demonstrated in this country, an actual standardization of this test has not yet been implemented to date. Such a tool would, however, allow flexible use of screening assessments, regardless of the delivery method, both in clinical and experimental contexts.
2. Aims

   The present study primarily aims to provide exhaustive evidence regarding the psychometric, diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders. Secondly, this study aims to derive, in normotypical Italian subjects, 1) normative data for the IP-TICS and 2) the conversion algorithms between the latter (and other widely used "paper-and-pencil" screeners ) and the TICS.
3. Methods

The study is monocentric, observational, prospective. Over a period of 3 years, patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited: 1) amyotrophic lateral sclerosis (N≥88); 2) Alzheimer's disease (N≥66); 3) Lewy body dementia (N≥30); 4) frontotemporal dementia (N≥30); 5) chronic cerebrovascular disorders (N≥66). Furthermore, N≥287 normotypical subjects representative of the Italian population will be recruited. The following TBCS tests will be administered to patients: 1) TICS; 2) Telephone-based Frontal Assessment Battery; 3) Telephone Language Screener; 4) Telephone-based Verbal Fluency Battery; 5) ALS Cognitive Behavioral Screen-Phone Version. Additionally, patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes. Normal subjects will instead be administered: 1) TICS; 2) IP-TICS; 3) Mini-Mental State Examination (MMSE); 4) Montreal Cognitive Assessment (MoCA). In patients, telephone follow-ups are expected after 6, 12 and 18 months. Statistical analyses will be carried out aimed at 1) the detailed study, in patients, of the psychometrics, diagnostics and cross-sectional/longitudinal clinical usability of the aforementioned TBCS test, as well as at 2) the derivation, in normotypical subjects, of the normative data of the IP-TICS and MoCA Memory Index Score (MIS), as well as the conversion algorithms between TICS and IP-TICS/MMSE/MoCA. conditions: Amyotrophic Lateral Sclerosis conditions: Alzheimer's Disease conditions: Lewy Body Dementia conditions: Frontotemporal Degeneration conditions: Cerebrovascular Disorders studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 280 type: ESTIMATED name: Telephone-based neuropsychological assessment - ALS name: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD name: Telephone-based and in-person cognitive screening - NIs measure: ALS Cognitive Behavioral Screen-Phone Version in ALS patients measure: Telephone Interview for Cognitive Status in AD, LBD, FTD and CVD patients measure: Telephone-based Frontal Assessment Battery in ALS, AD, LBD, FTD and CVD patients measure: Telephone Language Screener in ALS, AD, LBD, FTD and CVD patients measure: Telephone-based Verbal Fluency Battery in ALS, AD, LBD, FTD and CVD patients measure: Mini-Mental State Examination in NI measure: Montreal Cognitive Assessment in NI sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milano zip: 20149 country: Italy name: Barbara Poletti, Ph.D. role: CONTACT phone: +390261911 phoneExt: 2609 email: b.poletti@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06337565 id: GIS-DUMBO 2-2024 briefTitle: Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2030-05-20 date: 2030-05-20 date: 2024-03-29 date: 2024-03-29 name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa class: OTHER briefSummary: This is an observational study where pregnant women treated with non-anti-TNF agents or targeted small molecules approved for IBD treatment will be included. Although it is a multicentre, nationwide study, the number of patients to be included is expected to be relatively low (in DUMBO 1, during 5 years of recruitment, 88 patients treated with ustekimunab, 34 treated with vedolizumab, and 2 exposed to tofacitinib were included); however, this registry involved over 60 Spanish centres and it is a paramount study providing with data on the safety of drugs during pregnancy, as patients with this condition are excluded from clinical trials. In this regard, no sample size estimation was made, as we plan to include all patients who meet the inclusion criteria and consent their enrolment. conditions: Drusgs for IBD studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: To assess the safety of new drugs (non-anti-TNF biologics and targeted small molecules) used for IBD treatment both for pregnancy and in offspring, mainly focused on the risk of serious infections (from birth and in the first 4 years of life). measure: To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with new drugs used for the treatment of IBD. measure: To assess the developmental status of children born from IBD mothers treated with new drugs during the first 4 years of life. measure: To compare the relative risk of serious adverse events in children born from mothers with IBD who have been exposed in utero to different new drugs to treat IBD with that of children who were not exposed to these agents. measure: To compare the prevalence of malformations in children exposed to new drugs to treat IBD in utero with that of children who were not exposed to these agents. measure: To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD. sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario de La Princesa city: Madrid zip: 28006 country: Spain name: Javier P. Gisbert, PhD, MD role: CONTACT phone: 913093911 email: javier.p.gisbert@gmail.com name: María G Donday, PhD role: CONTACT phone: 913093911 email: mariagdonday@gmail.com lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06337552 id: MCC-22709 briefTitle: High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial) overallStatus: RECRUITING date: 2024-02-19 date: 2027-03 date: 2027-03 date: 2024-03-29 date: 2024-03-29 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER briefSummary: The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiotherapy (CRT). conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Clincial response will be determined in clinic when patients undergo blinded tumor assessments by standard digital rectal exam, endoscopy, and rectal MRI at baseline and at the end of the intervention. whoMasked: CARE_PROVIDER count: 30 type: ESTIMATED name: FEED-FF name: Standard of Care (SUC) measure: Effects of the FEED-FF diet on clinical response to chemoradiation measure: Effects of FEED-FF diet on the gut microbiome measure: Effects of FEED-FF diet on local immune-related biomarkers measure: Effects of FEED-FF diet on quality of life measure: Efficacy of the FEED-FF intervention measure: Feasibility of the FEED-FF intervention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Stephanie Hogue role: CONTACT phone: 813-745-1891 email: Stephanie.Hogue@moffitt.org name: Doratha (Armen) Byrd, MPH, PhD role: PRINCIPAL_INVESTIGATOR name: Sylvia Crowder, PhD, RDN, LDN role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06337539 id: PI-23-185 briefTitle: Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants acronym: LYMPHODEP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-07-31 date: 2024-03-29 date: 2024-03-29 name: Germans Trias i Pujol Hospital class: OTHER briefSummary: Objectives: To identify in patients with major depression different peripheral markers of neuroinflammation in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and its relationship with the response to antidepressant treatment with selective serotonin reuptake inhibitors (SSRIs).

Methodology: This is a prospective observational cohort study in patients with major depression naturally subjected to treatment with SSRIs. For this, 30 patients with major depression attended in the Outpatient Psychiatry Consultations will be selected. All of them will be evaluated at baseline and after 3 months of treatment, collecting demographic and clinical variables, Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) psychiatric diagnoses, psychopathological scales and immunological and biochemical variables. The correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation with treatment, will be analyzed. A group of 20 healthy subjects will be used as a control group.

Subsequently, a bivariate comparative analysis will be carried out, where the statistically significant or marginally significant variables associated with psychopathological variables will be used to build a multivariate binary logistic regression model. conditions: Depression conditions: Inflammation conditions: Antidepressants conditions: Immunity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: SSRI measure: Treatment Response measure: Lymphocyte subpopulations measure: Biochemical variables measure: Single-cell CITEseq sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Germans Trias i Pujol city: Badalona state: Catalonia zip: 08916 country: Spain lat: 41.45004 lon: 2.24741 hasResults: False

 nctId: NCT06337526 id: IRB-71503 briefTitle: Predicting Pain Exacerbations in Children With Complex Regional Pain Syndrome (CRPS) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-03-29 date: 2024-04-10 name: Stanford University class: OTHER name: Medeloop.ai briefSummary: objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with CRPS. conditions: Complex Regional Pain Syndromes studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Apple Watch v8 measure: Change from baseline in pain score sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Pediatric Pain Clinic city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06337513 id: S-20230055 briefTitle: Spondyloarthritis Inception Cohort of Southern Denmark acronym: SPINCODE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-08 date: 2028-08 date: 2024-03-29 date: 2024-03-29 name: The Danish Center for Expertise in Rheumatology class: OTHER briefSummary: People with axial spondyloarthritis (axSpA) experience a diagnostic delay of 6.5 years in men and up to 8.8 years in women. One of the reasons for the diagnostic delay seems to be limited awareness of the disease characteristics in the referring health care professionals in primary care. By raising awareness about the disease, the study aims at reducing the diagnostic delay and improving early treatment. In addition to diagnostic and pharmacological treatment, physical exercise and rehabilitation are recommended in people with axSpA. In Denmark, people with axSpA are only offered free of charge physiotherapy when the disease has progressed to a stage with radiographic changes of the spine even though people in the early stage of axSpA report a similar disease burden.

The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark (SPINCODE) is to set up an axSpA inception cohort among individuals with low back pain ≥ 3 months who are considered to be at risk for axSpA. The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes, including novel imaging techniques and identify predictive outcomes. Moreover, the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA. conditions: Axial Spondyloarthritis conditions: Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In the rehabilitation feasibility study: pre-post design. In the rehabilitation RCT, participants are allocated to either the intervention or control group with standard care. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Blinding of the the health care professionals and patients is not possible in the rehabilitation intervention. The person analysing the data will be blinded to the group allocation. whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Rehabilitation intervention name: Usual care measure: Clinicians diagnosis of axSpA measure: Health related quality of life measure: axSpA disease activity measure: axSpA disease mobility measure: axSpA patient-reported physical function measure: Inflammatory back pain (IBP) symptoms measure: Physical examination I measure: Physical examination II measure: Symptomatic SpA features I measure: Symptomatic SpA features II measure: Symptomatic SpA features III measure: Symptomatic SpA features IV measure: Symptomatic SpA features V measure: Symptomatic SpA features VI measure: Physicians global assessment of disease activity measure: Magnetic resonance imaging of sacroiliac joints (SIJ) and spine measure: low dose computed tomography of SIJ and spine measure: dual energy computed tomography of SIJ measure: radiography SIJ measure: Work measure: Fatigue measure: Physical activity measure: Sleep measure: Self-efficacy measure: Objective physical function measure: Aerobic capacity measure: Patient global assessment measure: Acceptable state measure: Mental state sex: ALL minimumAge: 18 Years maximumAge: 48 Years stdAges: ADULT hasResults: False

 nctId: NCT06337500 id: 2023/764 briefTitle: Validation of a Making Decision Hybrid (Ecologic and Virtual) Task acronym: LABLife overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-02-01 date: 2025-06-01 date: 2024-03-29 date: 2024-03-29 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the "hybrid" task and the "virtual" task will be evaluated. conditions: Healthy Volunteers conditions: Behavior and Behavior Mechanisms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 180 type: ESTIMATED name: Neurophysiological measure (EEG) name: Survey measure: Validation of the homemade "Lab-Life" interface as a tool for simulating an ecological task with sufficient fidelity, while meeting the conditions required for recording high-quality brain activity using an EEG-HR. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06337487 id: 2022/716 briefTitle: Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients acronym: SOS-DETEQT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-08 date: 2024-03-29 date: 2024-03-29 name: Centre Hospitalier Universitaire de Besancon class: OTHER name: Direction Générale de l'Offre de Soins briefSummary: The aim of this study is to evaluate the value of the nurse's use of the Quality of Life (QoL) scores of the European Organisation for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire \[QLQ\] C30 as an aid in identifying the needs for supportive oncological care at the start of care, in patients followed up for locally advanced or metastatic cancer starting systemic antineoplastic treatment. The main questions it aims to answer are as follows:

* Comparison of the personalised oncology support care plans proposed by the nurse before and after the QoL results were obtained
* The nurse's assessment of the relevance of the information provided by the QOL scores.

During the Care Support Stage (CSS), the nurse will assess the patient's situation during the interview and will fill in directly on an electronic form the Oncological Support Care proposed to the patient, making up the Personalised Pre-QoL Oncological Support Care Plan (PPSOS pre-QoL). The nurse will then give the patient the tablet to fill in the QoL questionnaire. She will then look at the results of the QoL questionnaire and the alerts in the event of deterioration, and will reassess the PPSOS using a new computerised PPSOS post-QoL form. The nurse will assess the relevance of the information provided by the QoL scores concerning the urgency of care, the need to go into certain subjects in greater depth, the identification of problems not addressed before or the discussion of sensitive subjects not addressed before. The nurse will give the patient the tablet to fill in a satisfaction questionnaire. In an attempt to control the biases inherent in an assessment carried out by a single healthcare professional, the clinical records of the patients included will be presented to a group of professionals who will also propose a PPSOS, known as Experts. The group will be made up of a nurse, a medical oncologist and at least two healthcare professionals and professionals in a similar field (dietician, psychologist, APA teacher, social worker, etc.). This group will analyse all the patient files included in the two study centres at dedicated meetings. In order to characterise patient care following the CSS, the oncological support care performed, unscheduled hospitalisations, emergency room visits and calls to the on-call medical team will be collected for the two months following the CSS. conditions: Oncology studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients, nurses and health professionals and professionals assimilated to the health are recruited in 3 different groups but no comparison will be made between them. Recruitment of patients will be stopped once 79 analyzable patients will be enrolled. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 93 type: ESTIMATED name: QoL questionnaires name: Qualitative Interview (for one part of nurses only) name: ORIC questionnaire name: Professionals satisfaction survey name: Patients satisfaction survey measure: Change between pre and post QoL Questionnaires measure: The nurse's assessement of the relevance of the information provided by each patients's QoL scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Besançon city: Besançon zip: 25000 country: France name: Magalie Pagnot, Nurse role: CONTACT email: m1courgey@chu-besancon.fr lat: 47.24878 lon: 6.01815 facility: Groupement Hospitalier de Haute-Saône city: Vesoul country: France name: Cathy Pothier, Nurse role: CONTACT lat: 47.63333 lon: 6.16667 hasResults: False

 nctId: NCT06337474 id: [2023]YLJSA089 briefTitle: An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-03-30 date: 2026-03-30 date: 2024-03-29 date: 2024-03-29 name: Changzhou No.2 People's Hospital class: OTHER name: Rui Therapeutics Co., Ltd briefSummary: A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells (KN5501) in patients with refractory immune thrombocytopenia. 9 patients are planned to be enrolled in the dose-escalation trial (9×10\^9 cells, 13.5×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate evaluation of KN5501 for the treatment of refractory immune thrombocytopenia. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with refractory immune thrombocytopenia. conditions: Thrombocytopenia Alloimmune studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: anti-CD19 CAR NK cells (KN5501) measure: Incidence of Dose Limiting Toxicity (DLTs) measure: Treatment Emergent Adverse Events (TEAEs) measure: Objective Response Rate of subjects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06337461 id: CCM1930 briefTitle: Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography acronym: CONCERTO overallStatus: RECRUITING date: 2023-05-22 date: 2025-05-30 date: 2025-05-30 date: 2024-03-29 date: 2024-03-29 name: Centro Cardiologico Monzino class: OTHER name: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari name: Politecnico di Milano briefSummary: Detection of coronary stenosis is of utmost importance in identifying vulnerable patients. The combined use of coronary computed tomography angiography at rest (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) provides both anatomic and functional analysis of coronary artery disease (CAD) using a single imaging test. Stress-CTP evaluates myocardial perfusion by measuring myocardial blood flow (MBF) under pharmacologically induced stress conditions. The drawback is that stress-CTP requires additional scanning and administration of an intravenous stressor with an increase in radiation exposure and potential stressor-related side effects. The investigators recently patented a computational model that can reproduce MBF under stress conditions (Italian patent n. 102021000031475 Metodo implementato mediante computer per la simulazione del flusso sanguigno miocardico in condizioni di stress \[Computational method for simulating myocardial blood flow in stress conditions\], half owned by Centro Cardiologico Monzino, half by Politecnico di Milano).

On top of this, CCTA can characterize plaque type and identify adverse plaque characteristics. Moreover, biomechanics analysis allows the study of luminal stenosis and stress within the plaque. Finally, radiomics, extracting quantitative features from medical images to create big data and identify novel imaging biomarkers, can be applied to improve the diagnostic accuracy of coronary plaques. conditions: Chronic Coronary Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 400 type: ESTIMATED measure: Development of a computational model to predict MBF avoiding CT stress protocol measure: Improvement of CAD risk assesment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Cardiologico Monzino status: RECRUITING city: Milan zip: 20131 country: Italy name: Chiara Centenaro role: CONTACT phone: 0258002031 phoneExt: +39 email: chiara.centenaro@cardiologicomonzino.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06337448 id: 74090923.9.0000.5544 briefTitle: Light Emitting Diode in the Treatment of Vulvodynia overallStatus: RECRUITING date: 2024-01-16 date: 2026-01 date: 2026-12 date: 2024-03-29 date: 2024-03-29 name: Centro de Atenção ao Assoalho Pélvico class: OTHER briefSummary: Vulvar pain can be related to a specific cause (inflammation, cancer, trauma, infection) or can be classified as vulvodynia, when vulvar pain is idiopathic and lasts for at least three months. The main symptoms reported are pain, burning, erythema, increased sensitivity, itching and burning, which affect the quality of life, psycho-emotional well-being, relationships and sexual function of these women. Photobiomodulation has been described in the literature as an alternative to treat pain. Our group has studied blue LED for some vulvovaginal dysfunctions and, due to the positive sensory effects observed in patients with vaginal stenosis and genitourinary syndrome of menopause, it is hypothesized that this technique could also bring beneficial effects for women with vulvodynia. A pilot study will be carried out, with descriptive data, with 10 women with vulvodynia. Participants will be evaluated with a basic anamnestic questionnaire and sociodemographic data. The following questionnaires will be used: Female Sexual Function Index (FSFI), Sexual Quotient - Female Version, Vulvar Pain Assessment Questionnaire. After answering the questionnaires, the volunteer will undergo a perineal physical assessment by an experienced physiotherapist, which includes a) inspection of the genital region, reflex tests, assessment of the functions of the pelvic floor muscles, b) the cotton swab test to evaluate painful sensitivity in the vestibule, c) the tampon test to evaluate painful sensitivity in the introitus and vaginal canal. Pain assessments will be quantified by the visual analogue pain scale (VAS), which ranges from 0 (no pain) to 10 (maximum pain). At the end of the treatment, the participant will answer the questionnaires again, undergo reassessment of pain sensitivity in vulva, introitus and vaginal canal, of the function of the pelvic floor muscles and will be asked "What is your perception of improvement" and "What is your level of satisfaction with the treatment?". The answers will be giving according to a Likert Scale of five points. The LED application protocol will be carried out with external use equipment model Antares, from the company IBRAMED (Amparo, São Paulo, Brazil), with a cluster G2 applicator. The power will be 450mW/cm2 and dose 5J/cm2 for 2 minutes and 13 seconds (automatic programming) in 450nm waves (blue wavelength). The treatment consists of eight sessions, carried out daily, except on weekends. conditions: Vulvodynia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Blue LED measure: Number of participants with treatment-related adverse events as assessed by Visual Analogue Scale. measure: Tolerability of participants to the treatment assessed by Likert Scale. measure: Evaluate the clinical response assessed by the Visual Analogue Scale. measure: Evaluate the clinical response assessed by a questionnaire. measure: Evaluate the sexual function of women with vulvodynia by Female Sexual Function Index (FSFI). measure: Evaluate the sexual function of women with vulvodynia by Sexual Quotient - Female Version (SQ-FV). sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Atenção ao assoalho pélvico status: RECRUITING city: Salvador state: Bahia zip: 40290000 country: Brazil name: Patricia Lordelo, post doc role: CONTACT phone: +5571988592400 email: pvslordelo@hotmail.com lat: -12.97111 lon: -38.51083 hasResults: False

 nctId: NCT06337435 id: 8223 briefTitle: Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding overallStatus: COMPLETED date: 2022-12-15 date: 2023-07-10 date: 2024-01-18 date: 2024-03-29 date: 2024-03-29 name: Cairo University class: OTHER briefSummary: this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding conditions: Crowding of Anterior Mandibular Teeth studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 12 type: ACTUAL name: multi-looped wire measure: The improvement of lower incisors irregularity using Little Irregularity Index. measure: The stability of lower incisor positioning after ending treatment sex: ALL minimumAge: 16 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: faculty of dentistry Cairo university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06337422 id: BE21-023 briefTitle: Bioequivalence Study of Generic Celecoxib 200 mg Capsules overallStatus: NOT_YET_RECRUITING date: 2024-09-23 date: 2024-09-27 date: 2024-10-04 date: 2024-03-29 date: 2024-04-02 name: International Bio service class: NETWORK briefSummary: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Celecoxib 200 mg capsule measure: Bioequivalence based on Cmax period measure: Bioequivalence based on AUC parameters sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06337409 id: BE24-004 briefTitle: Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-07-05 date: 2024-07-13 date: 2024-03-29 date: 2024-04-02 name: International Bio service class: NETWORK briefSummary: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Generic empagliflozin 25 mg film-coated tablets measure: Bioequivalence based on Cmax period measure: Bioequivalence based on AUC parameters sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06337396 id: 1001 briefTitle: Omic Approaches to Neurodevelopmental Disabilities overallStatus: COMPLETED date: 2021-05-05 date: 2023-07-28 date: 2023-12-31 date: 2024-03-29 date: 2024-03-29 name: IRCCS Eugenio Medea class: OTHER briefSummary: to bridge the gap between the molecular structure of CNV and the effect on the phenotype, considering NDDs as complex diseases, as they are a consequence of the imbalance in several dosage-sensitive genes, we might try to approach them through different --omics investigations (genomics, epigenomics, transcriptomics) according to the emerging field of network medicine. This holistic can provide valuable insight into understanding peculiar molecular mechanisms and unsuspected molecular interactions that contribute to the pathogenesis of the condition and possibly pave the way for uncovering new drug strategies that even if they do not heal the patient may improve his performance and the social interaction conditions: Neurodevelopmental Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 22 type: ACTUAL name: WGS and transcriptome analysis measure: Number of likely pathogenic structural variants measure: Number of patients for whom a genotype-phenotype correlation is found sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Scientific Institute IRCCS Eugenio Medea city: Bosisio Parini state: LC zip: 23842 country: Italy lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06337383 id: 12.2021 ANGELMAN briefTitle: Study of the Prevalence of Autistic Traits in Angelman Syndrome overallStatus: RECRUITING date: 2022-03-15 date: 2024-06 date: 2024-06 date: 2024-03-29 date: 2024-04-18 name: IRCCS Eugenio Medea class: OTHER briefSummary: The goal of this observational cross-sectional study is to establish the prevalence of autism spectrum disorder in children and adolescents with Angelman syndrome. The main questions it aims to answer are:

* which clinical variables differentiate AS patients with and without Autism Spectrum Disorder between genetics, epilepsy, pharmacotherapy, behavioural problems, parenting style and parents' perceived stress.
* which clinical variables differentiate parenting styles and levels of perceived stress.

Data from neuropsychological, speech therapy and physiotherapeutic assessments are collected during regular clinical follow-ups, regarding: cognitive development ("Bayely Scales of Infant Development-III", Cognitive Scale) and adaptive behaviour; Autism and Autism Spectrum Disorder ("Autism Diagnostic Observational Schedule-2"); parental stress and parenting styles; social-communicative skills; motor development. conditions: Angelman Syndrome studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 46 type: ESTIMATED measure: Total score of the Autism Diagnostic Observation Schedule -2 (ADOS-2), Module 1, measure: Age-equivalent score at the Cognitive Scale of the Bayley Scales of Infant Development - 3rd version (Bayley-III) measure: Total Stress score at the Parent Stress Index - 4th edition (PSI-4) questionnaire measure: Global score at the Aberrant Behaviour Checklist (ABC) measure: Total Raw score at the Social Communication Questionnaire - Current version(SCQ) sex: ALL minimumAge: 4 Years maximumAge: 14 Years stdAges: CHILD facility: I.R.C.C.S. "E.Medea" status: RECRUITING city: Conegliano state: Treviso zip: 31015 country: Italy name: Martina Baggio role: CONTACT phone: +39 340 802 1282 email: martina.baggio@lanostrafamiglia.it lat: 45.88805 lon: 12.30201 hasResults: False

 nctId: NCT06337370 id: 61284 briefTitle: Self-management Nursing Intervention for Women With Rheumatoid Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-10 date: 2024-09-10 date: 2024-03-29 date: 2024-03-29 name: Universidad Nacional de Colombia class: OTHER briefSummary: Introduction. Chronic autoimmune diseases are catalogued as catastrophic conditions that generate a negative impact on the health and well-being of the affected person. In this particular case, rheumatoid arthritis is its main representative, which is a predominant disease in women, affecting not only the musculoskeletal system but in general, all dimensions of the human being and generating great costs for health systems. Adaptation to living with the disease requires the individual to develop capacities for a positive management of the condition, and in this sense, the development of self-management behaviors becomes a crucial element. Method. The investigators propose a two-arm pragmatic randomized clinical trial with pre- and post-intervention measures, to evaluate the effect of the Chronic Disease Selfmanagement Program (CDSMP) on the increase in the levels of self-efficacy, self-management and health-related quality of life of women with RA who are attended by outpatient rheumatology consultation in a health institution in Bogota compared to usual care. Results. A description will be made of the sociodemographic and clinical variables present in you together with the measurement of the variables of health-related quality of life through the QOLRA-II; self-efficacy with the specific scale of self-efficacy in arthritis; and self-management behaviors by means of the scale of self-management in the disease. The measurement for the intervention group will be performed before and after the implementation of the program and for the control group an initial measurement and another one after six weeks. Discussion. The implementation of the CDSMP could generate a positive effect on the variables of self-management, self-efficacy and health-related quality of life in women with RA who are attended by outpatient consultation in a health institution in Bogota compared to usual care. conditions: Arthritis, Rheumatoid studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: CDSMP is a group-based chronic disease self-management education intervention comprised of 2.5-hour sessions, including time for a break and snack. The maximum number of participants per session ranges from 12 to 16. In total the program consists of 6 sessions that take place once a week for a total duration of 6 weeks. The development of each of the sessions is standardized and scripted; two group leaders previously trained by a Master Trainer, who in turn was trained to train leaders with Stanford University, guide the sessions. In the case of the present study, the main researcher and a nursing professional with experience in health education will receive the training from a Master Trainer of the program. Participants receive the book "Taking Control of Your Health" at the beginning of the program. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: In order to guarantee the objectivity and impartiality of the research team, randomization will be accompanied by blinding. A single-blind trial is proposed in which the participants during the conduct of the study will be unaware of their assignment to the experimental or control groups; likewise, the research assistants who perform the pre and post measurement will be unaware of their assignment to the groups; there will be specific assistants for the pre measurement and specific assistants for the post measurement with each group. Candidates will be invited to participate in the study, explaining to them that it is a randomized study in which they may be assigned to a specific intervention group, that their assignment will only be random, that neither the research team nor the treating health team will be able to interfere with their assignment and that this will be revealed to them once the study is completed. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 55 type: ESTIMATED name: Chronic Disease Self Management Program name: Conventional Care Group measure: Self-management behaviors measure: Perceived Self-efficacy, measure: Health-related quality of life sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundación Santa Fe de Bogotá city: Bogotá country: Colombia name: Klaus Mieth Alviar, Dr. role: CONTACT phone: 601 6030303 phoneExt: 5402 email: comiteinvestigativo@fsfb.org.co lat: 4.60971 lon: -74.08175 hasResults: False

 nctId: NCT06337357 id: NatGerHos-Sarcopenia briefTitle: Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-12 date: 2024-03-29 date: 2024-04-12 name: National Geriatric Hospital class: OTHER_GOV briefSummary: A randomized controlled clinical trial that will test how progressive resistance training will impact outcomes of sarcopenia in older patients with type 2 diabetes who have been diagnosed as sarcopenia. The intervention will be 12 weeks in duration with approximately 24 sessions of resistance exercises. Outcome measures will be collected at baseline, 4, 8 weeks and 12 weeks. conditions: Sarcopenia conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Progressive Resistance Training measure: Physical performance 1 - Handgrip strength measure: Physical performance 2 - Gait speed measure: Physical performance 3 - Short Physical Performance Battery (SPPB) measure: Muscle mass measure: Nutritional status measure: Health-related Quality of Life measure: Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs) sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Geriatric Hospital city: Hanoi zip: 100000 country: Vietnam name: Huyen TT Vu, PhD role: CONTACT phone: +84913531579 email: vuthanhhuyen11@yahoo.com lat: 21.0245 lon: 105.84117 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-23 uploadDate: 2024-03-22T11:34 filename: ICF_000.pdf size: 212556 hasResults: False

 nctId: NCT06337344 id: HSEARS20230213007 briefTitle: Neurophysiological Effects of Mind-body Exercise in Healthy Adults overallStatus: RECRUITING date: 2024-02-01 date: 2024-04 date: 2024-04 date: 2024-03-29 date: 2024-03-29 name: The Hong Kong Polytechnic University class: OTHER briefSummary: There is some clinical evidence showing that Baduanjin (BDJ) practice, a type of mind-body based physical exercise, can improve executive function (EF). However, the neurophysiological changes associated with improved cognitive function remain elusive. Therefore, this study aims to carry out randomised controlled trial to explore how the single-session BDJ practice affect the function of prefrontal cortex(PFC) and also the EF of healthy adults, measure by fNIRS and verbal fluency test accordingly. A total of 60 healthy adults (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 18 to 40 year old, without any physical, neurological, and neuropsychiatric disorder, classified as right-handed by Edinburgh Handedness Inventory, also with normal intelligence as verified by the Test of Nonverbal Intelligence will be recruited and randomly assigned to treatment(i.e. BDJ), active control(i.e, exercise), and passive control(i.e. video viewing) group. The investigator anticipate that this single-session BDJ practice will result in - (1) enhancing executive functioning , and (2) changes in functional brain activation pattern in PFC in adults. The result will give a spotlight to neurophysiological treatment effect of single-session Baduanjin on healthy adults, in developing intervention for improving executive functioning of adults. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Baduanjin name: Exercise name: Video Viewing measure: Change in cognitive function as assessed by verbal fluency task (VFT) measure: Hemodynamic changes as assessed by fNIRS sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hung Hom state: Kowloon country: Hong Kong name: Yvonne Han, PhD role: CONTACT phone: +852 2766 7578 lat: 22.30715 lon: 114.18532 hasResults: False

 nctId: NCT06337331 id: NSH 1401 briefTitle: Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2026-08-31 date: 2027-08-31 date: 2024-03-29 date: 2024-04-02 name: Northside Hospital, Inc. class: OTHER briefSummary: Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter. conditions: Acute Myeloid Leukemia conditions: Myelodysplastic Syndromes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: Venetoclax name: Decitabine name: Fludarabine name: Busulfan name: Total Body Irradiation measure: Incidence of relapse/progression by conducting blood and bone marrow biopsy evaluations at one-year post-transplant measure: Number of patients alive at one-year post transplant measure: Number of patients alive without recurrence of disease at one-year post transplant by conducting blood and bone marrow biopsy procedures measure: Number of patients who died one year post-transplant not related to recurrence of disease measure: Number of patients who fully engrafted (blood counts fully recovered) by conducting chimerism studies at 30-, 60-, 90-, 180-, and 365-days post transplant measure: Number of patients who developed acute graft-versus-host disease by recording signs and symptoms of acute GVHD according to MAGIC standards at one-year post-transplant measure: Number of patients who developed chronic graft-versus-host disease by recording signs and symptoms of chronic GVHD according to NIH standards at one-year post-transplant measure: Number of patients who are alive at one-year post transplant who also did not develop GVHD measure: Number of patients with treatment-related adverse events to venetoclax as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Caitlin Guzowski city: Atlanta state: Georgia zip: 30342 country: United States lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06337318 id: NCI-2024-02361 id: NCI-2024-02361 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: S2308 type: OTHER domain: SWOG id: S2308 type: OTHER domain: CTEP id: U10CA180888 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180888 briefTitle: Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2032-03-31 date: 2032-03-31 date: 2024-03-29 date: 2024-04-05 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden. conditions: Classic Follicular Lymphoma conditions: Follicular Lymphoma With Unusual Cytological Features studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Mosunetuzumab name: Positron Emission Tomography name: Rituximab name: Rituximab and Hyaluronidase Human measure: 3-year milestone progression free survival (PFS) measure: PFS measure: Overall survival measure: Overall response rate measure: Event free survival (EFS) measure: Incidence of adverse events measure: Restricted chance of longer PFS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06337305 id: STUDY00146138 briefTitle: Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer overallStatus: COMPLETED date: 2020-08-19 date: 2022-08-19 date: 2023-08-19 date: 2024-03-29 date: 2024-03-29 name: University of Kansas Medical Center class: OTHER briefSummary: This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 74 type: ACTUAL measure: Change in resiliency as measured by the Connor-Davidson Resilience Scale (CD-RISC-25). measure: Change in quality of life in patients undergoing radical cystectomy as measured by the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys). measure: Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29. measure: Identification of clinical and demographic factors in bladder cancer patients measure: Demographics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 hasResults: False

 nctId: NCT06337292 id: IRB00440042 briefTitle: Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial acronym: iVAC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-09-30 date: 2028-12-31 date: 2024-03-29 date: 2024-03-29 name: Major Extremity Trauma Research Consortium class: OTHER briefSummary: This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. The secondary outcomes will independently assess the components of the primary outcome. conditions: Fracture of Tibia conditions: Wound Heal conditions: Infected Wound conditions: Wound Complication conditions: Wound Dehiscence studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization into study treatment arms (incisional NPWT or non-suction standard of care) will occur in variable permuted blocks, stratified by clinical center, in a 1:1 ratio. Patients will be randomized electronically by an online Data Management System maintained by the Coordinating Center at Johns Hopkins School of Public Health. primaryPurpose: TREATMENT masking: NONE count: 352 type: ESTIMATED name: Incisional Negative Pressure Wound Therapy (NPWT) measure: Complication composite outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06337279 id: FMUUH-0322 briefTitle: Systemic Oxidative Stress Score as a Predictor of Gastric Cancer Survival and Recurrence Risk overallStatus: COMPLETED date: 2022-12-10 date: 2023-08-20 date: 2024-03-20 date: 2024-03-29 date: 2024-03-29 name: Fujian Medical University class: OTHER name: Fujian Medical University Union Hospital briefSummary: The Systemic Oxidative Stress Score (SOSS) , a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in GC patients. Nomograms based on SOSS provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3820 type: ACTUAL measure: 5-year OS measure: 5-year DFS sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union Hospital city: Fuzhou state: Fujian zip: 350000 country: China lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06337266 id: 2024KY246 briefTitle: A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma overallStatus: COMPLETED date: 2023-01-01 date: 2023-08-20 date: 2024-03-19 date: 2024-03-29 date: 2024-03-29 name: Fujian Medical University class: OTHER name: Fujian Medical University Union Hospital briefSummary: This study aimed to develop a novel Prognostic Oxidative Stress-Immune-Inflammatory Score (POSII Score) and introduce an innovative online calculator designed to predict long-term survival and assess the recurrence risk of gastric cancer (GC). conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3622 type: ACTUAL measure: 5-year OS measure: 5-year DFS sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union Hospital city: Fuzhou state: Fujian zip: 350000 country: China lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06337253 id: MOZ202401 briefTitle: Seasonal Malaria Chemoprevention Rapid Assessment Study Mozambique overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2024-05-26 date: 2024-11-26 date: 2024-03-29 date: 2024-03-29 name: Malaria Consortium class: OTHER briefSummary: Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections caused by Plasmodium falciparum in areas where the burden of malaria is high and malaria transmission is seasonal. SMC is commonly seen as a success story in the Sahel region, however, there are regions in east and southern Africa where malaria transmission is seasonal, and the burden is high. However, the same decision-making frameworks that was used in the Sahel are unlikely to be applicable to east and southern Africa due to higher pre-existing resistance to the drugs used, seasonality heterogeneity, contextual difference, and unknown cost-effectiveness, amongst others. This study aims to estimate the chemoprevention efficacy, potential upscale impact, acceptability, and feasibility of SMC with sulfadoxine-pyrimenthamine + amodiaquine (SP+AQ) medicines in Niassa Province in Mozambique.

The study is divided into two separate components with different objectives which outputs feed into each other: a non-randomized controlled trial to estimate the chemoprevention efficacy of SP+AQ; and a qualitative study that will evaluate the feasibility and acceptability of the intervention.

These will be the first studies analysing the chemoprevention efficacy, feasibility, acceptability, and potential scale-up impact of SMC in Niassa Province, Mozambique The outcomes of these studies aim to guide future policy changes at local, national, and international levels and potentially allow for a historically successful program to expand in a sustained and cost-effective way beyond the Sahel region. conditions: Malaria,Falciparum conditions: Chemoprevention studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The intervention in this study is the administration of one cycle of SPAQ medicines. SPAQ medicines procured by Malaria Consortium are from one of the 3 manufacturers with WHO prequalification, with whom Malaria Consortium has framework agreements: Tridem Pharma, S Kant Healthcare Ltd, or MacLeods Pharmaceuticals Ltd.

Each monthly SMC cycle consists of one dispersible tablet of SP and three daily dispersible tablets of AQ. There are two doses of SPAQ: a lower dose for children aged three to \<12 months, and a higher dose for children aged 12 to 59 months. For children aged 12 to 59 months, the dosage comprises a single dose of a full tablet of SP 500/25mg and three daily doses of a full tablet of AQ 153mg. Those aged three to \<12 months are administered half the dose given to those aged 12 to 59 months, given as full dispersible tablets. primaryPurpose: PREVENTION masking: NONE count: 1000 type: ESTIMATED name: Sulfadoxine/pyrimethamine plus amodiaquine measure: Chemoprevention failure measure: Uncomplicated malaria within 28 days sex: ALL minimumAge: 3 Months maximumAge: 59 Months stdAges: CHILD hasResults: False

 nctId: NCT06337240 id: pelvic floor exercise briefTitle: Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease overallStatus: RECRUITING date: 2024-03-29 date: 2024-07-02 date: 2024-07-02 date: 2024-03-29 date: 2024-03-29 name: Cairo University class: OTHER briefSummary: The aim of the study is To compare between the effect of both pelvic floor and Pilates exercises on urinary incontinences in COPD patients. conditions: Urinary Incontinence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Pelvic floor on COPD patients name: Pilates exercises on COPD patients measure: Urinary incontinence (1 Hour and 24- Hour pad test) measure: Incontinence severity index: measure: Urinary incontinence quality of life questionnaire (I-QOL) measure: Cough symptoms score measure: Cough symptoms questionnaire measure: The COPD Assessment Tool (CAT) sex: FEMALE minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Cairo country: Egypt name: Donia El masry, doctorate role: CONTACT phone: 01005587119 email: donia.elmasry@cu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06337227 id: 2/22 briefTitle: Potential Role of Sirtuins as Epigenetic Biomarkers of the Patient With Atherosclerosis or Calcific Aortic Stenosis overallStatus: RECRUITING date: 2023-10-19 date: 2024-10 date: 2026-10 date: 2024-03-29 date: 2024-04-02 name: IRCCS SYNLAB SDN class: OTHER name: Federico II University briefSummary: The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and epigenetic studies in human VSMC cells. conditions: Atherosclerosis and Calcific Aortic Stenosis With and Without Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3 type: ESTIMATED name: lncRNA signature analyses measure: To evaluate by analysis of data obtained from NGS techniques whether and which proteins belonging to the Sirtuin family may be deregulated in patients with atherosclerosis or calcific aortic stenosis measure: To evaluate the experimental results achieved in the clinical-diagnostic context sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs Synlab Sdn status: RECRUITING city: Naples zip: 80143 country: Italy name: Monica Franzese, PhD role: CONTACT phone: +393334041413 email: direzionescientifica.irccssdn@synlab.it lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06337214 id: TCHIRB-11301014-E briefTitle: TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy overallStatus: RECRUITING date: 2024-03-13 date: 2025-02-28 date: 2025-02-28 date: 2024-03-29 date: 2024-04-02 name: Taipei City Hospital class: OTHER_GOV briefSummary: The goal of this study is to evaluate the impact of the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. The main questions it aims to answer are:

Can the "Traditional Chinese Medicine Therapy Program" alleviate symptoms experienced by breast cancer patients? Does the program improve the quality of life for breast cancer patients receiving Western medical treatments? How does the program contribute to the management of side effects associated with Western oncological therapies?

Participants will:

Engage in the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" provided by the Taiwan Compassionate Cancer Care Association.

Receive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling.

This study seeks to integrate the concept of holistic healthcare, emphasizing coordinated care that encompasses physical, mental, and social aspects, into the treatment of breast cancer. conditions: Breast Cancer conditions: Neoplasm, Breast conditions: Patient Participation conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy measure: Questionnaire: Constitution in Chinese Medicine Questionnaire measure: Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4) measure: Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23) measure: Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy" sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei City Hospital status: RECRUITING city: Taipei zip: 10845 country: Taiwan name: Yu-Hsuan Tai, MD role: CONTACT phone: +886918130891 email: daidayangisele@gmail.com,dbb02@tpech.gov.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06337201 id: BTH-6.1.1-0138-2023 briefTitle: A Digital Life Story to Support Person-centred Care for Older Adults With Dementia Perspectives overallStatus: RECRUITING date: 2022-08-15 date: 2026-01 date: 2027-06 date: 2024-03-29 date: 2024-03-29 name: Blekinge Institute of Technology class: OTHER briefSummary: Person-centred care can be supported when healthcare professionals access and actively use the information recorded in a life story. Active use of the life story can create security for a person with dementia and their carers. The written life story describes the person and their life experiences, which can define the person's identity. National guidelines for care and nursing in dementia and Blekinge's regional guidelines emphasise the importance of care and nursing for people with dementia, which should be given with a person-centred approach, where the life story becomes a tool for healthcare professionals. Research shows that a life story can be designed in several ways. For example, in book form, as a brochure, collage, memory box or electronically. The life story is also intended as a tool for healthcare professionals to create security and facilitate communication with the individual. As more and more older adults are using computers and tablets as assistive devices, and it is also becoming more common for healthcare professionals to use, for example, tablets as assistive devices in nursing care, the life story could be shared in digital form as an application and become a living document.

Overall aim: To test an application for the life story with the intention of supporting person-centred care for older adults with dementia and to test whether the application can replace the written completion document. Study I: Exploring the research area of the life story in digital form. Study II: Focus group interviews with healthcare professionals. Study III: Test the application, Min Memoria. Study IV: Observations on the use of the application. conditions: Cognitive Impairment conditions: Dementia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 30 type: ESTIMATED name: Test of the application Min Memoria measure: Healthcare professionals' experiences using a written life story in the daily care of older adults with dementia measure: Data on the use of a digital life story tool. measure: Observation when using a digital life story sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Blekinge Institute of Technology status: RECRUITING city: Karlskrona state: Blekinge zip: 37179 country: Sweden name: Johan Sanmartin Berglund, MD, PhD role: CONTACT phone: +46455385471 email: johan.sanmartin.berglund@bth.se name: Peter Anderberg, PhD role: CONTACT phone: +46455385436 email: peter.anderberg@bth.se lat: 56.16156 lon: 15.58661 hasResults: False

 nctId: NCT06337188 id: AAC PhII briefTitle: Adaptive and Individualized AAC Phase II overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-29 date: 2024-03-29 name: Altec Inc. class: INDUSTRY name: University of Nebraska briefSummary: The overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a personalized, comprehensive keyboard interface for communication, not otherwise available to people in need of alternative communication. conditions: Communication Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Experimental AAC name: Generic AAC measure: Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT) measure: Information Transfer Rate measure: National Aeronautics and Space Administration (NASA) Task Load Index measure: Character-to-character Movement Time measure: Path Efficiency measure: Frequency of Selecting Word Completion Options measure: Number of Written Disfluencies sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06337175 id: 000000230988 briefTitle: Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction overallStatus: RECRUITING date: 2021-06-01 date: 2023-10-30 date: 2024-04-30 date: 2024-03-29 date: 2024-03-29 name: Kafrelsheikh University class: OTHER briefSummary: The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction. conditions: Ischemic Stroke conditions: Alteplase Adverse Reaction studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study consisted of two distinct groups. The first group comprised 464 patients who did not experience hemorrhagic infarction, while the second group comprised 152 patients who experienced hemorrhagic infarction. primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Alteplase name: Alteplase measure: predictors of the hemorrhagic infarction type 1 measure: predictors of the hemorrhagic infarction type 2 measure: predictors of the parenchymal hematoma type 1 measure: predictors of the parenchymal hematoma type 2 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33155 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: mohamed_gomaa@med.kfs.edu.eg name: sherihan R ahmed, MD role: CONTACT phone: 2001007481842 email: sherihanrezk2016@gmail.com lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06337162 id: UPCC 20223 id: IRB#855195 type: OTHER domain: University of Pennsylvania IRB briefTitle: Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC) acronym: HCC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-09-01 date: 2024-03-29 date: 2024-03-29 name: Abramson Cancer Center at Penn Medicine class: OTHER name: Incyte Corporation briefSummary: This is a pilot safety study of the oral PD-L1 inhibitor INCB099280 in patients with HCC awaiting liver transplant. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: INCB099280 measure: Acute Cellular Rejection of Liver Transplant Attributed to Study Therapy measure: Acute Cellular Rejection of Liver Transplant Within 3 Months measure: Acute Cellular Rejection of Liver Transplant Within 1 Year measure: Toxicity Rates by Category and Grade measure: Proportion of Patients Downstaged measure: Pathologic Complete Response Rate measure: Recurrence-Free Survival at 1 Year After Transplant measure: Overall Survival at 1 Year After Transplant sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abramson Cancer Center at University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Jennifer Walsh role: CONTACT phone: 215-615-5858 email: Jennifer.Walsh4@pennmedicine.upenn.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06337149 id: APHP230348 id: IDRCB: 2023-A00006-39 type: REGISTRY domain: IDRCB ANSM briefTitle: Relationship Between Breathing and Attention in Children With Ondine Syndrome acronym: OndineCo overallStatus: RECRUITING date: 2024-02-29 date: 2025-03-01 date: 2026-09-01 date: 2024-03-29 date: 2024-03-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Congenital central hypoventilation syndrome (CCHS) is a rare disorder of autonomic and respiratory regulation that alters oxygen delivery to the brain. CCHS patients are at risk for broad neurocognitive deficits. Patients retain ventilatory activity when awake through a respiratory-related cortical network but the need to mobilise cortical resources to breathe lead to breathing-cognition interferences during cognitive tasks. The purpose of this study is to assess the relationship between breathing pattern and attention in CCHS children conditions: Ondine Syndrome conditions: Congenital Central Hypoventilation Syndrome (CCHS) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: neuropsychological tests used usually in clinical practice (TEA-ch, NEPSY, BRIEF) and research (Conners 3, K-CPT II or CPT III, Flankers Task) measure: Wechsler scale measure: Nepsy II test sex: ALL minimumAge: 6 Years maximumAge: 16 Years stdAges: CHILD facility: Robert Debre Hospital status: RECRUITING city: Paris zip: 75019 country: France name: Christophe DELCLAUX, MD, PhD role: CONTACT phone: +331 40 03 41 90 email: christophe.delclaux@aphp.fr name: Benjamin DUDOIGNON, MD role: CONTACT phone: +331 40 03 41 90 email: benjamin.dudoignon@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06337136 id: 2022-A01837-36 briefTitle: neonAtal motoR paTtErn autoMatIc analySis acronym: AIMOTHERNeo overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-05 date: 2024-03-29 date: 2024-03-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: This project consists in developing a computerized clinical assessment system for newborns that takes into account the four major criteria of the various clinical scales: facial mimicry, cry, posture and movement. Classification of motor patterns according to gestational age at birth The aim of this work is the automated identification of pathological motor patterns related to anoxo-ischemic encephalopathy/brachial plexus paralysis/early neonatal bacterial infection/stroke/etc ... conditions: Automated Computer Analysis conditions: Neonatal Motor Pattern studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: comparison of the computer score with the clinical examination measure: Comparison of the evolution of neurological examination and posture based on the day of life for each patient and each group of patients sex: ALL minimumAge: 1 Day maximumAge: 15 Days stdAges: CHILD facility: Department of paediatric neurological care and intentive care unity (PICU), Raymond Poincaré hospital - APHP city: Garches zip: 92380 country: France lat: 48.84226 lon: 2.18232 hasResults: False

 nctId: NCT06337123 id: K-38 briefTitle: Physica TT Tibial Plate Follow up Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-12 date: 2027-12 date: 2024-03-29 date: 2024-03-29 name: Limacorporate S.p.a class: INDUSTRY briefSummary: This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications. conditions: Knee Arthropathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 130 type: ESTIMATED name: Device: Physica TT TIbial Plate and Physica Porous KR name: Device: Physica TT TIbial Plate and Physica Porous PS measure: Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery measure: Changes in Range of Motion over time up to 2 years after surgery measure: Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery. measure: Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery. measure: Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery. measure: Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery measure: Survival rate (Kaplan-Meier) at 2 years after surgery measure: Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Casa di Cura San Camillo Hopital city: Forte Dei Marmi state: Lucca zip: 55042 country: Italy name: Alessandro Tripodo role: CONTACT name: Alessandro Tripodo role: PRINCIPAL_INVESTIGATOR lat: 43.96388 lon: 10.17478 facility: Ospedale Privato Accreditato Sol et Salus city: Torre Pedrera state: Rimini zip: 47922 country: Italy name: Marco Fravisini role: CONTACT name: Marco Fravisini role: PRINCIPAL_INVESTIGATOR lat: 44.10694 lon: 12.51274 facility: Casa di Cura Carmona city: Messina zip: 98100 country: Italy name: Marcello La Bruna role: CONTACT name: Marcello La Bruna role: PRINCIPAL_INVESTIGATOR lat: 38.19394 lon: 15.55256 facility: Istituto Clinico Porta Sole city: Perugia zip: 06100 country: Italy lat: 43.1122 lon: 12.38878 hasResults: False

 nctId: NCT06337110 id: 20436A briefTitle: A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-05-25 date: 2024-05-25 date: 2024-03-29 date: 2024-03-29 name: H. Lundbeck A/S class: INDUSTRY briefSummary: The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Lu AF28996 measure: Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces) measure: AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity measure: Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material measure: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material measure: T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material measure: AUC0-infinity of Lu AF28996 measure: Cmax of Lu AF28996 measure: Tmax of Lu AF28996 measure: T½ of Lu AF28996 sex: MALE minimumAge: 35 Years maximumAge: 60 Years stdAges: ADULT facility: Fortrea Clinical Research Unit Ltd city: Holbeck state: Leeds zip: LS11 9EH country: United Kingdom lat: 53.25 lon: -1.18333 hasResults: False

 nctId: NCT06337097 id: 2023-1021 id: NCI-2024-02687 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy overallStatus: RECRUITING date: 2024-02-02 date: 2026-12-31 date: 2028-12-31 date: 2024-03-29 date: 2024-04-29 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects. conditions: Immune Checkpoint Therapy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 880 type: ESTIMATED name: Troponin surveillance name: Standard of care measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Nicolas Palaskas, MD role: CONTACT phone: 713-606-3957 email: nlpalaskas@mdanderson.org name: Nicolas Palaskas, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06337084 id: MNPR-101-D001 briefTitle: Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors overallStatus: RECRUITING date: 2024-04-10 date: 2025-04 date: 2025-06 date: 2024-03-29 date: 2024-04-11 name: Monopar Therapeutics class: INDUSTRY briefSummary: The goal of this study is to test a new PET imaging agent in patients with solid tumors. This tracer is made of a radioactively-labeled monoclonal antibody MNPR-101, and can show where tumors are present in the body using a PET-scan. The investigators will investigate if the new imaging agent correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain therapies.

Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 30 minutes. The PET-scans are on separate days within 10 days after injection of the tracer (e.g., 2 hours after injection plus 3-5 days and 7-10 days after injection). Furthermore, the investigators will take blood samples 6 times (5 mL each). Blood pharmacokinetics (PK) will be measured on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10.

The amount of radioactivity injected will range between 37-74 MBq (±10%). conditions: Solid Tumor, Adult conditions: Bladder Cancer conditions: Urothelial Carcinoma conditions: Triple-negative Breast Cancer conditions: Lung Cancer conditions: Colorectal Cancer conditions: Gastric Cancer conditions: Ovarian Cancer conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 12 type: ESTIMATED name: Diagnostic Test: MNPR-101-DFO*-89Zr PET Scan measure: assess dosimetry and biodistribution of product measure: assess tumor Standard Uptake Values (SUV) of product measure: assess pharmacokinetics (PK) levels of product measure: assess tumor uptake to background and tumor uptake to liver ratios of product sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Melbourne Theranostic Innovation Centre (MTIC) status: RECRUITING city: North Melbourne state: Victoria zip: 3051 country: Australia name: Referral Coordinator role: CONTACT phone: 03 9454 5800 lat: -37.80132 lon: 144.95822 hasResults: False

 nctId: NCT06337071 id: AM2023MCV4Ⅱ briefTitle: A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-06 date: 2025-06 date: 2024-03-29 date: 2024-03-29 name: Aimei Vacin BioPharm (Zhejiang) Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination. conditions: Meningococcal Meningitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1200 type: ESTIMATED name: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine name: ACYW135 Meningococcal Polysaccharide Vaccine measure: Immunogenicity 1 measure: Immunogenicity 2 measure: Immunogenicity 3 measure: Safety 1 measure: Immunogenicity 4 measure: Immunogenicity 5 measure: Immunogenicity 6 measure: Immunogenicity 7 measure: Immunogenicity 8 measure: Immune persistence 1 measure: Immune persistence 2 measure: Safety 2 measure: Safety 3 measure: Safety 4 sex: ALL minimumAge: 3 Months maximumAge: 15 Years stdAges: CHILD facility: Yunnan Center For Disease Control and Prevention city: Kunming state: Yunnan zip: 650022 country: China name: ZHENG Yan role: CONTACT phone: +8687163627796 email: yaqueer_zy@163.com lat: 25.03889 lon: 102.71833 hasResults: False

 nctId: NCT06337058 id: KSUHULYAKAMALAK001 briefTitle: Motivational Interviews With Women Experiencing Sexual Dysfunction During Menopause Period overallStatus: COMPLETED date: 2020-06-15 date: 2021-06-15 date: 2022-12-15 date: 2024-03-29 date: 2024-03-29 name: Hülya KAMALAK class: OTHER briefSummary: The aim of this study is to evaluate the effect of motivational interviews with women who experience sexual dysfunction during menopause on sexual quality of life and self-efficacy.The population of the study consisted of menopausal women who applied to the gynecology outpatient clinic of Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. It was calculated as 164 women (82 experimental, 82 control).In data collection, 'Personal Information Form (EK- )', 'Arizona Sexual Experiences Scale (ACYÖ) (EK- )', 'Sexual Quality of Life Scale-Female (SIQQ-F) (EK-)' and 'Sexual Self-Efficacy Scale' (Annex- )' was used. conditions: Sexual Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 164 type: ACTUAL name: Experimental group (motivational interview) measure: Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F) measure: Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F) measure: Sexual Quality of Life-Female Questionnaire (SQOL-F) measure: Sexual Quality of Life-Female Questionnaire (SQOL-F) measure: Sexual Self-Efficacy Scale (SSES) measure: Sexual Self-Efficacy Scale (SSES) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kahramanmaras Sutçu Imam University city: Kahramanmaraş country: Turkey lat: 37.5847 lon: 36.92641 hasResults: False

 nctId: NCT06337045 id: AF-rehab briefTitle: Atrial Fibrillation, Prevention and Rehabilitation overallStatus: COMPLETED date: 2019-02-01 date: 2020-06-30 date: 2020-06-30 date: 2024-03-29 date: 2024-03-29 name: Odense University Hospital class: OTHER name: Department of Cardiology, Odense University Hospital, Odense, Denmark. name: Health Center, Municipality of Svendborg, Svendborg, Denmark. name: Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark. name: The Danish Heart Association, Funen, and local committee in Svendborg, Denmark briefSummary: Evidence shows that people with atrial fibrillation (AF) can benefit from prevention and rehabilitation interventions related to quality of life, lowered anxiety, etc. In this study, a complex prevention and rehabilitation intervention for people with AF was carried out in a Health Center at a Danish municipality in cooperation with the cardiology department at Svendborg Hospital. The study was designed as a feasibility study, with data gathered systematically including focus group interviews and quantitative patient reported outcomes. People with AF were included at the hospital. Eligible participants were offered intervention in the Health Center. Interventions, in accordance with present international guidelines, consisted of physical exercise, patient education, psychosocial support and consultations with health professionals as well as risk factor management. Also, medicinal yoga (MediYoga) were chosen to be part of the intervention due to promising research results within AF. All interventions were optional and based on needs assessment and preferences.

The primary objective was to investigate the feasibility of delivering a complex prevention and rehabilitation intervention for people with AF in a municipal Health Center.

There were the following four secondary objectives:

1. To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention.
2. To explore the participant's needs and preferences of the interventions.
3. To explore changes in HRQoL, anxiety and depression.
4. To explore the feasibility of collecting patient reported outcome measures as part of the intervention.

The hypothesis was that the complex prevention and rehabilitation intervention was feasible in a municipality-based set-up, and was well received by people with AF and may contribute to better outcomes in terms of HRQoL, anxiety and depression. conditions: Atrial Fibrillation conditions: Prevention conditions: Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Eligible participants were diagnosed with AF at the hospital and had symptomatic AF rated by the modified European Heart Rhythm Association (mEHRA) score ≥2B. If the patient was eligible based on the mEHRA-score, at least one of the following risk factors had to be present: hypertension, diabetes, obesity, smoking, excessive alcohol consumption, physical inactivity, sleep apnoea, anxiety, depression, or mental vulnerability. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ACTUAL name: Complex prevention and rehabilitation intervention measure: HeartQoL measure: The hospital anxiety and depression scale (HADS) measure: Experience of participating, experiences needs and preferences of interventions measure: Feasibility of collecting patient reported outcomes (PROMs). The PROMs was the HeartQoL and the hospital anxiety and depression scale. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Cardiology, Odense University Hospital city: Odense state: Region Of Southern Denmark zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: Health Center, Municipality Svendborg city: Svendborg state: Region Of Southern Denmark zip: 5700 country: Denmark lat: 55.05982 lon: 10.60677 hasResults: False

 nctId: NCT06337032 id: GS-US-380-6684 briefTitle: A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2034-03 date: 2034-03 date: 2024-03-29 date: 2024-03-29 name: Gilead Sciences class: INDUSTRY briefSummary: The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.

The primary objectives of this study are as follows:

* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.
* To evaluate the safety of the study drug(s) in participants with HIV-1. conditions: HIV-1-infection studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 350 type: ESTIMATED name: F/TAF (High Dose Tablet) name: F/TAF (Low Dose Tablet) name: F/TAF (Lowest Dose Tablet) name: F/TAF (High Dose TOS) name: F/TAF (Low Dose TOS) name: F/TAF (Lowest Dose TOS) name: E/C/F/TAF name: E/C/F/TAF (Low Dose) name: Cobicistat (High Dose) name: Cobicistat (Low Dose) name: Cobicistat (TOS) name: B/F/TAF (High Dose) name: B/F/TAF (Low Dose) name: B/F/TAF (High Dose TOS) name: B/F/TAF (Low Dose TOS) name: B/F/TAF (Lowest Dose TOS) name: 3rd ARV Agent name: Nucleos(t)ide reverse transcriptase inhibitors (NRTI) name: ATV name: DRV name: Lopinavir Boosted with ritonavir (LPV/r) measure: Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06337019 id: IRMO briefTitle: The Italian Registry of Malnutrition in Oncology acronym: IRMO overallStatus: RECRUITING date: 2022-10-25 date: 2027-10 date: 2027-10 date: 2024-03-29 date: 2024-04-03 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER name: Istituto di Ricerche Farmacologiche Mario Negri IRCCS briefSummary: The aim of the Italian Registry of Malnutrition in Oncology (IRMO) is to set up a digital register of newly diagnosed or treated oncologic patients to monitor their nutritional status, early identify malnutrition and investigate the implications of nutritional support management. In particular, this project aims to establish a prospective cohort of cancer patients in order to investigate the effects of nutritional status and management on overall survival (OS) and progression free survival (PFS), and analyse the effects of the nutritional management and support on patients' symptoms and QoL. conditions: Cancer conditions: Cancer Metastatic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: Cohort observational measure: Overall survival measure: Progression-free survival measure: Treatment toxicity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Tumori Giovanni Paolo II, status: NOT_YET_RECRUITING city: Bari state: BA country: Italy name: Antonella Daniele role: CONTACT lat: 41.11148 lon: 16.8554 facility: IRCCS Saverio De Bellis status: RECRUITING city: Castellana Grotte state: BA country: Italy name: Giovanni de Pergola role: CONTACT name: Rosalisa Cici role: CONTACT lat: 40.88643 lon: 17.16549 facility: Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna state: BO country: Italy name: Alessandra Longhi role: CONTACT name: Toni Ibrahim role: CONTACT lat: 44.49381 lon: 11.33875 facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS status: RECRUITING city: Meldola state: FC country: Italy name: Patrizia Serra role: CONTACT lat: 44.12775 lon: 12.0626 facility: IRCCS Ospedale Policlinico San Martino status: NOT_YET_RECRUITING city: Genova state: GE country: Italy name: Samir Guseppe Sukkar role: CONTACT lat: 44.40478 lon: 8.94438 facility: IRCCS Ospedale San Raffaele, Milano status: RECRUITING city: Milano state: MI country: Italy name: Roberto Mele role: CONTACT lat: 45.46427 lon: 9.18951 facility: Centro di Riferimento Oncologico status: RECRUITING city: Aviano state: PN country: Italy name: Renato Cannizzaro role: CONTACT lat: 46.07056 lon: 12.59472 facility: IOV Istituto Oncologico Veneto status: RECRUITING city: Padova state: PV country: Italy name: Maria Teresa Nardi role: CONTACT name: Marco Tonello role: CONTACT lat: 45.40797 lon: 11.88586 facility: AUSL IRCCS Reggio-Emilia status: RECRUITING city: Reggio Emilia state: RE country: Italy name: Debora Pezzuolo role: CONTACT lat: 44.69825 lon: 10.63125 facility: IDI IRCCS - Istituto Dermopatico dell'Immacolata status: RECRUITING city: Roma state: RM country: Italy name: Cristina Fortes role: CONTACT lat: 41.89193 lon: 12.51133 facility: Istituto Nazionale Tumori Regina Elena status: RECRUITING city: Roma state: RM country: Italy name: Lupe Sanchez Mete role: CONTACT lat: 41.89193 lon: 12.51133 facility: Policlinico Universitario Agostino Gemelli status: RECRUITING city: Roma state: RM country: Italy name: Carmelo Pozzo role: CONTACT name: Maria Cristina Mele role: CONTACT lat: 41.89193 lon: 12.51133 facility: Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS status: RECRUITING city: Candiolo state: TO country: Italy name: Filippo Montemurro role: CONTACT name: Valentina Casalone role: CONTACT lat: 44.95858 lon: 7.59812 facility: IRCCS Sacro Cuore Don Calabria status: RECRUITING city: Negrar state: VR country: Italy name: Stefania Gori role: CONTACT lat: 45.52918 lon: 10.93899 facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale status: NOT_YET_RECRUITING city: Napoli country: Italy name: Vincenzo Quagliariello role: CONTACT lat: 40.85216 lon: 14.26811 facility: Fondazione IRCCS Policlinico San Matteo, Pavia status: RECRUITING city: Pavia country: Italy name: Riccardo Caccialanza role: CONTACT name: Paolo Pedrazzoli role: CONTACT lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06337006 id: SÜKAEK 2023/14/1 briefTitle: Laryngeal Mask Airway Failure in Pediatric Patients overallStatus: RECRUITING date: 2023-09-15 date: 2024-04-15 date: 2024-05-15 date: 2024-03-29 date: 2024-03-29 name: Samsun University class: OTHER briefSummary: There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified after tracheal intubation, there are no objective data to define the misplacement of LMAs, which are increasingly used especially in short surgical procedures.

The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data. conditions: Airway Management studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Placement of the laryngeal mask airway measure: Evaluation of the success of placement of the laryngeal mask airway sex: ALL minimumAge: 2 Years maximumAge: 12 Years stdAges: CHILD facility: Samsun University status: RECRUITING city: Samsun state: Canik zip: 55090 country: Turkey name: OZGUR KOMURCU, 1 role: CONTACT phone: 90 505 5273180 email: zgrkom@gmail.com name: Hatice SELCUK KUSDERCİ role: PRINCIPAL_INVESTIGATOR lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06336993 id: liuxianguiji briefTitle: Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-16 date: 2023-12-15 date: 2024-03-29 date: 2024-03-29 name: Zhejiang Provincial Tongde Hospital class: OTHER briefSummary: The aim of this randomized controlled trial was to explore the clinical efficacy and safety of HXTL in the treatment of NSLBP based on TCM principles and to compare the clinical outcomes of different syndromes of NSLBP with celecoxib.In this study, 80 patients with NSLBP were recruited and randomly grouped to use TCM compound and celeoxib respectively for intervention. The pain status and lumbar function use scale of patients were scored before intervention, 1 week, 2 weeks and 3 weeks after intervention, and the adverse reactions of patients after medication were recorded, and the clinical efficacy of the two groups of patients was compared finally. conditions: Low Back Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 71 type: ACTUAL name: herbal compound name: Celecoxib measure: Visual Analogue Scale measure: Oswestry disability index measure: Japanese Orthopaedic Association Scores measure: the adverse reactions of digestive or other system sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongde Hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06336980 id: 31021 briefTitle: Creating Welcoming Faith Communities for People With Serious Mental Illnesses overallStatus: RECRUITING date: 2024-01-22 date: 2025-12 date: 2025-12 date: 2024-03-29 date: 2024-03-29 name: Temple University class: OTHER name: National Institute on Disability, Independent Living, and Rehabilitation Research briefSummary: The goal of this intervention study is to test a behavioral intervention to increase inclusionary practices toward individuals with serious mental illness in faith communities. The main questions it aims to answer are:

1. To determine if the behavior-based intervention leads to an increase in inclusionary practices (e.g., conducting outreach with mental health agencies).
2. To determine if the behavior-based intervention is effective in increasing inclusive practices by members and leaders of faith communities.
3. To determine if the intervention leads to a greater understand of mental illness and a decrease in stigmatizing beliefs by congregation members.
4. To determine if the intervention results in individuals with serious mental illness and their family members reporting less discrimination and increased inclusion.

Congregations will be asked to create an inclusion committee that will then work on developing systems and changing congregational practices to become more inclusive. All congregation members will be invited to a half-day training that will provide information on mental illness and inclusion, and will provide tips and strategies when they encounter situations or behaviors that are less familiar to them. All congregation members will be given the opportunity to participate in a survey about congregational practices. conditions: Other studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 700 type: ESTIMATED name: Increasing Inclusionary Practices in Faith Communities measure: Inclusionary practices measure: Indicators of Welcome measure: Mental Health Knowledge Questionnaire measure: Social Distance Scale measure: Community Attitudes Toward the Mentally Ill measure: Reported and Intended Behavior Scale measure: Sense of Belonging Scale measure: University of California Los Angeles Loneliness Scale measure: Lerman Quality of Life Interview sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Temple Univeristy status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19121 country: United States name: Crystal Slanzi, PhD role: CONTACT email: crystal.slanzi@temple.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06336967 id: 855282 briefTitle: Testing a Wellness App for First Responders, Military Personnel and Veterans overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-09-01 date: 2026-01-01 date: 2024-03-29 date: 2024-04-08 name: University of Pennsylvania class: OTHER name: Nlyten Corp briefSummary: The purpose of the research study is to trial a smart phone application, the GUIDE App, to better understand its impact on social connectedness, personal growth and mental health/wellness among first responders, soldiers, and veterans. The research team will also investigate workplace metrics (e.g., engagement and burnout), implementation outcomes and technical merit. The investigators plan to run a three-armed randomized waitlist pilot feasibility trial with up to 150 participants. conditions: Mental Health Wellness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: GUIDE measure: PERMA-Profiler Overall Wellbeing Score measure: Patient Health Questionnaire for depression symptoms (PHQ-8) measure: Generalized Anxiety Disorder (GAD-7) measure: WHO Well-being Index (WHO-5) measure: Personal Wellbeing Score (PWS) measure: Difficulties in Emotion Regulation Scale Short Form (DERS-SF) measure: Positive Emotion (Positive emotion subscale of the PERMA-Profiler) measure: Social Connectedness (Engagement and Relationship subscales of PERMA-Profiler) measure: Social Connectedness (Number of posts/comments in the app) measure: Personal Growth (Meaning and Accomplishment subscales of the PERMA-Profiler) measure: Personal Growth (Total GUIDE lessons and courses completed) measure: Utrecht Work Engagement Scale (UWES-17) measure: Maslach Burnout Inventory (MBI) measure: Job Retention (Employment status) measure: Feasibility of Intervention Measure (FIM) measure: Acceptability of Intervention Measure (AIM) measure: Intervention Appropriateness Measure (IAM) measure: System Usability Scale (SUS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19146 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06336954 id: MA-NSCLC-#-037 briefTitle: Adibelimab, Famitinib and Chemotherapy for Advanced NSCLC After PD-1 Inhibitor Failure overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-07-31 date: 2026-12-31 date: 2024-03-29 date: 2024-03-29 name: Second Affiliated Hospital of Xi'an Jiaotong University class: OTHER briefSummary: This prospective, single-arm trial explores the efficacy of Adibelimab monoclonal antibody combined with Famitinib and chemotherapy in treating locally advanced or metastatic NSCLC patients with negative driver genes who have progressed after PD-1 monoclonal antibody and chemotherapy treatment. The study focuses on assessing progression-free survival (PFS) in 40 participants. Key objectives include evaluating PFS and understanding the progression patterns post-first-line immunotherapy, with an interest in whether switching from PD-1 to PD-L1 inhibitors can overcome immune resistance. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Adibelimab measure: Progression-free survival time (PFS) measure: Objective Response Rate measure: Duration of Response measure: Overall Survival measure: Treatment-Related Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336941 id: 32822 briefTitle: "Ultra-High Frequency intraOral UltraSonography of the TONgue" (HOUSTON) acronym: HOUSTON overallStatus: RECRUITING date: 2018-06-07 date: 2025-12-31 date: 2030-12-31 date: 2024-03-29 date: 2024-03-29 name: University of Pisa class: OTHER briefSummary: Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.

In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions. conditions: Oral Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 400 type: ESTIMATED name: Ultrasound measure: Depth of invasion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Università di Pisa status: RECRUITING city: Pisa zip: 56126 country: Italy name: Rossana Izzetti, DS, PhD role: CONTACT phone: +39050993037 email: rossana.izzetti@unipi.it lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06336928 id: 1B-23-6 id: NCI-2024-01332 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 1B-23-6 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-04-01 date: 2030-04-01 date: 2024-03-29 date: 2024-03-29 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer. conditions: Breast Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 490 type: ESTIMATED name: Non-Interventional Study measure: Assess the sensitivity and specificity of LBx as a screening method for breast cancer sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Keck Medicine of USC Koreatown city: Los Angeles state: California zip: 90020 country: United States name: Bomi Choi role: CONTACT phone: 323-865-0451 email: Bomi.Choi@med.usc.edu name: Anastasia Martynova, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Los Angeles General Medical Center city: Los Angeles state: California zip: 90033 country: United States name: Kimberly Arieli, RN role: CONTACT phone: 323-865-0451 email: Kimberly.Arieli@med.usc.edu name: Anastasia Martynova, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: USC / Norris Comprehensive Cancer Center city: Los Angeles state: California zip: 90033 country: United States name: Kimberly Arieli, RN role: CONTACT phone: 323-865-0451 email: Kimberly.Arieli@med.usc.edu name: Anastasia Martynova, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: USC Norris Oncology/Hematology-Newport Beach city: Newport Beach state: California zip: 92663 country: United States name: Kristy Massopust role: CONTACT phone: 949-474-5733 email: Massopust_K@med.usc.edu name: Anastasia Martynova, MD role: PRINCIPAL_INVESTIGATOR lat: 33.61891 lon: -117.92895 hasResults: False

 nctId: NCT06336915 id: 121.NUR.2022.D briefTitle: Physician-Nurse Dyad Rounding: A Collaborative Approach to Improve Unit-Level Metrics overallStatus: RECRUITING date: 2023-01-03 date: 2024-12-30 date: 2024-12-30 date: 2024-03-29 date: 2024-03-29 name: Methodist Health System class: OTHER briefSummary: The project will be implemented on one unit at a time until the co-rounding process has been implemented on each Medical-Surgical unit. This study will involve the geo-localized hospitalist on the designated unit and the nursing staff involved in clinical patient care conditions: Wellness, Psychological studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Physician-Nurse Dyad Rounding measure: Difference in percentage of discharged patients before 1400 (Mon-Fri) after project implementation compared to before implementation measure: Difference in Top Box Patient Satisfaction Scores and Doctor Domain measure: Difference in LOS of private hospitalist patients after project implementation compared to before implementation measure: Difference in collaboration and build positive relationships scores after project implementation compared to before implementation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Institute at Methodist Health System status: RECRUITING city: Dallas state: Texas zip: 75203 country: United States name: Colette N Ndjom, MS role: CONTACT phone: 410-947-4681 phoneExt: 74681 email: ColetteNgoNdjom@mhd.com name: Loretta W Bedell, MPH role: CONTACT phone: 214-947-4680 phoneExt: 74680 email: lorettabedell@mhd.com name: Lauren Hoffman, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Methodist Dallas Medical Center status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75203 country: United States name: Colette N Ndjom, MS role: CONTACT phone: 214-947-4681 email: mhsirb@mhd.com name: Loretta W Bedell, MPH role: CONTACT phone: 217-947-4680 email: mhsirb@mhd.com name: Lauren Hoffman, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06336902 id: 3C-23-11 id: NCI-2024-01368 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 3C-23-11 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-29 date: 2024-03-29 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer. conditions: Metastatic Colorectal Adenocarcinoma conditions: Stage IV Colorectal Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Balstilimab name: Biospecimen Collection name: Botensilimab name: Computed Tomography name: Dietary Intervention name: Magnetic Resonance Imaging name: Vitamin C measure: Proportion of patients who adhere to the fast mimicking diet measure: Incidence of adverse events (AEs) measure: Overall response rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Los Angeles General Medical Center city: Los Angeles state: California zip: 90033 country: United States name: Charlean Ketchens, RN role: CONTACT phone: 323-865-0451 email: Charlean.Ketchens@med.usc.edu name: Rabia Rehman role: CONTACT phone: 323-865-0451 email: Rabia.Rehman@med.usc.edu name: Diana Hanna, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: USC / Norris Comprehensive Cancer Center city: Los Angeles state: California zip: 90033 country: United States name: Charlean Ketchens, RN role: CONTACT phone: 323-865-0451 email: Charlean.Ketchens@med.usc.edu name: Rabia Rehman role: CONTACT phone: 323-865-0451 email: Rabia.Rehman@med.usc.edu name: Diana Hanna, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06336889 id: 092.TRA.2018.D briefTitle: Pelvic Angioembolization: A Prospective Multi-Institutional Study (Data From All Campuses Will be Used) overallStatus: RECRUITING date: 2017-10-26 date: 2024-10 date: 2024-10 date: 2024-03-29 date: 2024-03-29 name: Methodist Health System class: OTHER briefSummary: The investigator's propose a multicenter prospective observational study to investigate the use of embolization in patients with negative angiogram and to ascertain the optimal level of treatment when the angiogram is positive; non-selective vs. selective embolization. conditions: Pelvic Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Pelvic Angioembolization measure: Mortality outcome measure: transfusion requirements measure: thromboembolic events measure: Patient demographics(age, sex) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Dallas Medical Center status: RECRUITING city: Dallas state: Texas zip: 75201 country: United States name: Jennifer Burris, MD role: CONTACT phone: 214-947-1280 email: clinicalresearch@mhd.com lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06336876 id: 080.EDU.2019.R briefTitle: Perceived Coping, Meaning, and Joy at Work overallStatus: RECRUITING date: 2020-06-30 date: 2024-12 date: 2024-12 date: 2024-03-29 date: 2024-03-29 name: Methodist Health System class: OTHER briefSummary: The aim of this study is to assess and describe employee characteristics associated with perceived horizontal inter-collegial workplace uncivil behavior within nursing services, and identify any relationships with meaning and joy in work (MJW), and assess job satisfaction. conditions: Undefined studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 84 type: ESTIMATED name: Survey measure: Workplace Incivil Behavior measure: Meaning, Joy in Work measure: Occupational Coping Self-Efficacy measure: Demographic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Richardson Medical Center status: RECRUITING city: Richardson state: Texas zip: 75082 country: United States name: Maxine Adegbola, RN role: CONTACT phone: 214-876-9767 email: maxineadegbola@mhd.com name: Maxine Adegbola, RN role: PRINCIPAL_INVESTIGATOR name: David Irvan, RN role: SUB_INVESTIGATOR name: Terri Daugherty, RN role: SUB_INVESTIGATOR name: Joanna Bender, RN role: SUB_INVESTIGATOR name: Tabitha Moore, RN role: SUB_INVESTIGATOR name: Sharon Blackerby, RN role: SUB_INVESTIGATOR name: Katherine Hartdegen, RN role: SUB_INVESTIGATOR name: Melissa Miller, RN role: SUB_INVESTIGATOR name: Shannon Jackson, RN role: SUB_INVESTIGATOR name: Obed Thomas, RN role: SUB_INVESTIGATOR lat: 32.94818 lon: -96.72972 hasResults: False

 nctId: NCT06336863 id: STU-2023-1151 briefTitle: Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-08 date: 2026-12 date: 2024-03-29 date: 2024-04-05 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients." conditions: Kidney Transplant Immunosuppression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Allosure and TruGraf name: Immunosuppression Taper measure: Incidence of acute kidney graft rejection measure: Incidence of facilitation to Belatacept monotherapy measure: Patient Survival after Immunosuppression Wean measure: Kidney Graft Failure after Immunosuppression Wean measure: Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean measure: Incidence of Proteinuria after Immunosuppression Wean measure: Incidence of de-novo donor specific antibodies (dnDSA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas Southwestern Medical Center city: Dallas state: Texas zip: 75390 country: United States name: David Wojciechowski, DO role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-06 uploadDate: 2024-03-28T09:25 filename: Prot_SAP_000.pdf size: 293395 hasResults: False

 nctId: NCT06336850 id: 069.GID.2020.D briefTitle: Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement overallStatus: RECRUITING date: 2020-12-23 date: 2025-01-01 date: 2025-01-01 date: 2024-03-29 date: 2024-03-29 name: Methodist Health System class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies. conditions: Liver Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement measure: Portal Pressure Gradient Measurements from Hepatic and Portal Veins measure: Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension measure: Clinical significance between portal pressure gradient measurement and portal hypertension sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Dallas Medical Center status: RECRUITING city: Dallas state: Texas zip: 75203 country: United States name: Prashant Kedia, MD role: CONTACT lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06336837 id: 24-3T/48 briefTitle: False Positive Peripheral Blood Culture in Children With Leukaemia: A Prevalence Study overallStatus: RECRUITING date: 2024-03-15 date: 2024-06-01 date: 2024-12-01 date: 2024-03-29 date: 2024-04-01 name: Ege University class: OTHER briefSummary: Chemotherapy, the main treatment for childhood leukemia, has side effects on healthy cells. One of the most important of these side effects is the risk of infection due to neutropenia. In clinics, blood culture is the gold standard for the detection of possible infection risk (bacteremia, fungemia, etc.). During the diagnosis and treatment process in children with leukemia, a large number of peripheral or catheter blood cultures are performed. When the culture results are positive, it is accepted that the infection has grown. In some cases, a positive peripheral blood culture result may not be clinically significant. An agent belonging to the skin flora of the patient or the healthcare professional taking the field culture may also cause the blood culture result to be positive. This is called contamination or false positive blood culture. Contaminated cultures may cause prolonged hospitalization, additional medical interventions, unnecessary initiation of antibiotic treatment and related antibiotic resistance, toxicity due to additional drugs and an increase in hospital costs. The peripheral blood culture contamination rate, which is accepted as a quality indicator in some countries, should be below 3%.

In this context, this study aimed to determine the prevalence of false positive peripheral blood cultures by examining the peripheral blood culture results obtained during routine follow-ups from children hospitalized with leukemia in the pediatric hematology clinic. The data will be collected retrospectively covering three years before March 2024 when the ethics committee approval was obtained. Since the relevant clinic cares for approximately 25 new children diagnosed with leukemia annually, the study sample is planned as 75 cases. conditions: Nurse's Role conditions: Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 75 type: ESTIMATED measure: blood culture contamination rate sex: ALL minimumAge: 0 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ege University status: RECRUITING city: İzmir zip: 35100 country: Turkey name: Seda ARDAHAN SEVGILI, PhD role: CONTACT phone: 00905544318390 email: sedardahan@gmail.com name: Figen YARDIMCI, PhD role: CONTACT email: figenyardimci@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06336824 id: EVOS 1.2 dated 25/10/2023 briefTitle: Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia acronym: EVOS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-03-29 date: 2024-04-05 name: Clinical Research Centre, Malaysia class: OTHER briefSummary: The Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus aureus Bacteraemia (EVOS) study is a multicentre, randomized, open-label, parallel group, phase 3, non-inferiority trial of early intravenous to oral antibiotic switch in comparison with standard intravenous antibiotic regime among patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). The study is based on the hypothesis that an early switch from IV to oral antimicrobial therapy is non-inferior and safe compared to conventional minimum 14-day course of IV therapy in patients with low-risk uncomplicated SAB. conditions: Staphylococcus Aureus Bacteremia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 290 type: ESTIMATED name: Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid name: IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline measure: Rate of SAB-relapse measure: Number of days of hospitalization measure: Rate of all-cause mortality measure: Rate of complications related to IV therapy measure: Rate of Clostridium difficile diarrhoea measure: Rate of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Sultanah Aminah city: Johor Bahru state: Johor zip: 80100 country: Malaysia name: Wei Xuan Tuang role: CONTACT email: weixuan0706@gmail.com lat: 1.4655 lon: 103.7578 facility: Hospital Sultanah Bahiyah city: Alor Setar state: Kedah zip: 05460 country: Malaysia name: Sharifah Baizura Syed Alwi role: CONTACT email: baizura1973@hotmail.my lat: 6.12104 lon: 100.36014 facility: Hospital Sultan Abdul Halim city: Sungai Petani state: Kedah zip: 08000 country: Malaysia name: Noralfazita An role: CONTACT email: noralfazitaa@moh.gov.my lat: 5.647 lon: 100.48772 facility: Hospital Tuanku Ja'afar city: Seremban state: Negeri Sembilan zip: 70300 country: Malaysia name: Tiang Koi Ng role: CONTACT email: tiangkoi79@yahoo.com lat: 2.7297 lon: 101.9381 facility: Hospital Pulau Pinang city: George Town state: Penang zip: 10450 country: Malaysia name: Chuan Huan Chuah role: CONTACT email: chchuah7@yahoo.com lat: 5.41123 lon: 100.33543 facility: Hospital Seberang Jaya city: Seberang Jaya state: Penang zip: 13700 country: Malaysia name: Peng Peng Ang role: CONTACT email: angpp2209@gmail.com lat: 5.39085 lon: 100.41044 facility: Hospital Raja Permaisuri Bainun city: Ipoh state: Perak zip: 30450 country: Malaysia name: Steven Lim role: CONTACT email: stevenlimcl@gmail.com lat: 4.5841 lon: 101.0829 facility: Hospital Ampang city: Ampang state: Selangor zip: 68000 country: Malaysia name: Suraya Hanim Abdullah Hashim role: CONTACT email: surayahanim.abdullahhashim@gmail.com facility: Hospital Sultan Idris Shah Serdang city: Kajang state: Selangor zip: 43000 country: Malaysia name: Kah Chuan Lim role: CONTACT email: ck7902@gmail.com lat: 2.99424 lon: 101.78875 facility: Hospital Tengku Ampuan Rahimah city: Klang state: Selangor zip: 41200 country: Malaysia name: Azureen Azmel role: CONTACT email: aazmel@gmail.com lat: 3.03333 lon: 101.45 facility: Hospital Selayang city: Selayang Baru Utara state: Selangor zip: 68100 country: Malaysia name: Anuradha P. Radhakrisnan role: CONTACT email: anurapr70@gmail.com lat: 3.2549 lon: 101.6668 facility: Hospital Melaka city: Melaka zip: 75400 country: Malaysia name: Wee Fu Gan role: CONTACT email: ganweefu@gmail.com lat: 2.196 lon: 102.2405 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-25 uploadDate: 2024-03-28T09:13 filename: Prot_SAP_001.pdf size: 749936 hasResults: False

 nctId: NCT06336811 id: DEU active-pasive VR briefTitle: Virtual Reality Distraction During Phlebotomy in Children acronym: activeVR overallStatus: COMPLETED date: 2023-05-30 date: 2023-12-30 date: 2023-12-30 date: 2024-03-29 date: 2024-03-29 name: Dokuz Eylul University class: OTHER briefSummary: This randomized controlled study was conducted to evaluate the effect of distraction methods using virtual reality on the emotional appearance, pain, fear, and anxiety associated with the procedure during phlebotomy in children aged 6-12 in a private blood collection unit. conditions: Pain, Acute conditions: Child, Only conditions: Anxiety and Fear studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Before blood collection, the "Emotional Appreance Scale for Children" was evaluated by a non-researcher nurse. Pediatric patients between the ages of 6 and 12, from whom blood would be collected, were distributed to groups according to the randomization scheme. whoMasked: INVESTIGATOR count: 150 type: ACTUAL name: passive virtual reality distraction name: active virtual reality distraction measure: procedure related pain measure: anxiety measure: fear measure: emotional apperance sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Gülçin Özalp Gerçeker city: İzmir zip: 35100 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06336798 id: STUDY00005871 id: K23HL166775 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL166775 briefTitle: Bioenergetic Effect of Pioglitazone in CLD-PH overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-08 date: 2028-08 date: 2024-03-29 date: 2024-04-01 name: Emory University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is:

• Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD.

Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo). conditions: Pulmonary Hypertension conditions: Pulmonary Hypertension Due to Lung Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Pioglitazone 30mg name: Placebo name: Labs measure: Change in Mitochondrial metabolism parameters: Spare respiratory capacity measure: Change in Mitochondrial metabolism parameters: Maximal respiration measure: Change in Mitochondrial metabolism parameters: Basal respiration measure: Number of hypoglycemia incidences measure: Number of participants with leg edema measure: Change in BNP levels measure: Change in Six minute walk distance (6MWT) measure: Change in Borg dyspnea score measure: Change in NYHA/WHO Functional Classification measure: Change in University of California San Diego Shortness of Breath Questionnaire score measure: Change in emPHasis-10 Questionnaire score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336785 id: 04-2023-HIT-K&S briefTitle: Kiss and Smile HIT overallStatus: RECRUITING date: 2023-11-02 date: 2024-11-30 date: 2025-11-30 date: 2024-03-29 date: 2024-04-01 name: Erevna Innovations Inc. class: OTHER briefSummary: The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler treatments.

The "Kiss and Smile HIT" considers lip volume, lip framing and expression to improve patients appearance. This trial will assess the effectiveness of the Kiss and Smile HIT algorithm in treating patients with different kiss and smile related issues (e.g. volume loss, lips lack proper framing, lack of a confident smile due to issues with expression). conditions: Aesthetic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Restylane line of dermal fillers and Dysport neuromodulator measure: Global Aesthetic Improvement Scale (GAIS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erevna Innovations Inc. status: RECRUITING city: Montréal state: Quebec zip: H3R3A1 country: Canada name: Andreas Nikolis, MD role: CONTACT phone: 514-488-0163 email: research@vicpark.com lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06336772 id: 10-2023-GAL-SHYP briefTitle: Restylane Shaype Versus Juvederm Volux for Chin Augmentation overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-23 date: 2024-10-31 date: 2024-11-01 date: 2024-03-29 date: 2024-04-01 name: Erevna Innovations Inc. class: OTHER briefSummary: This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin conditions: Chin Retrusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Restylane Shaype name: Juvéderm Volux measure: Statistically significant group differences in the average three-dimensional volumetric increase since baseline measure: Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale) measure: Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale) measure: Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erevna Innovations Inc. city: Montréal state: Quebec zip: H3R3A1 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06336759 id: 2021-10-GAL-JWL briefTitle: Safety and Efficacy of Fillers for Contouring the Jawline overallStatus: COMPLETED date: 2021-11-11 date: 2022-12-14 date: 2023-11-10 date: 2024-03-29 date: 2024-04-01 name: Erevna Innovations Inc. class: OTHER briefSummary: The study aims to evaluate the safety and efficacy of two hyaluronic acid products, Restylane Lyft and Defyne, for contouring the jawline and chin, addressing concerns about contour deficits in patients seeking aesthetic treatments. conditions: Jawline Contour Deficit studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Restylane Defyne name: Restylane Lyft measure: Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS) measure: Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale measure: Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS) measure: Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erevna Innovations Inc. city: Montréal state: Quebec zip: H3R3A1 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06336746 id: RHenningsson briefTitle: Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-03-31 date: 2024-03-29 date: 2024-04-17 name: Karlstad Central Hospital class: OTHER briefSummary: The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery. The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent.

The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions.

In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioning

During surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery. conditions: Heart Failure, Systolic conditions: Robotic Surgery studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Esophageal Doppler measure: Change of Stroke Volume during Trendelenburg position and pneumoperitoneum. measure: % Change of Systemic Vascular Resistance;PulsePressureVariation; Peak Velocity; Stroke Volume Variation and FlowTimeCorrected measure: % change in regional brain saturation rSO2 during Trendelenburg position and pneumooperitoneum. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dpt of Anesthesiology&Intensive Care; Central Hospital of Karlstad city: Karlstad state: Värmland zip: 65230 country: Sweden name: Ragnar N Henningsson, Associate Professor role: CONTACT phone: +461083317434 email: ragnar.henningsson@regionvarmland.se lat: 59.3793 lon: 13.50357 hasResults: False

 nctId: NCT06336733 id: APHP220828 briefTitle: Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy acronym: KIN-ATTACK-FMF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03-03 date: 2026-09-15 date: 2024-03-29 date: 2024-03-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of

* on demand anakinra treatment (100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine.
* compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment. conditions: FMF studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: ANAKINRA measure: Mean number of FMF-attacks per month at 6 months of treatment. measure: Cumulative days of FMF attack treatment measure: AIDAI (Auto-inflammatory Diseases activity index) score measure: Number of painful days and severity of FMF attacks occurring between randomization and M6 measure: Quality of life score measured by EuroQOL questionnaire (EQ-5D5L) measure: Number of local cutaneous reactions at 6 months (erythema and oedema involving the injection sites) in the anakinra arm measure: Proportion of Adverse events sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Médecine interne Hopital Tenon city: Paris zip: 75020 country: France name: Léa SAVEY role: CONTACT phone: 00 33 1 56 01 60 77 email: lea.savey@aphp.fr name: Sophie Georgin-Lavialle, MD,PHD role: CONTACT phone: 0 33 1 56 01 74 31 email: sophie.georgin-lavialle@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06336720 id: HMI-SA-PoNS-STK001 briefTitle: PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study overallStatus: RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-08-30 date: 2024-03-29 date: 2024-04-29 name: Helius Medical Inc class: INDUSTRY briefSummary: Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors.

Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization.

Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up. conditions: Chronic Stroke Survivors studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Portable Neuromodulation Stimulator (PoNS) measure: Primary safety endpoints sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brooks Rehabilitation status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States name: Mark Bowden, PhD. PT role: CONTACT phone: 904-345-6626 email: Mark.Bowden@Brooksrehab.org lat: 30.33218 lon: -81.65565 facility: Shepherd Center status: RECRUITING city: Atlanta state: Georgia zip: 30309 country: United States name: Cathy Furbish, PT, DPT, CCRP role: CONTACT phone: 404-350-7591 email: cathy.furbish@shepherd.org lat: 33.749 lon: -84.38798 facility: Neurology Center of New England, P.C. status: RECRUITING city: Foxboro state: Massachusetts zip: 02035 country: United States name: Rachel O'Donnell role: CONTACT phone: 781-551-5812 phoneExt: 101 email: rodonnell@myneurodr.com name: MD role: CONTACT lat: 42.06538 lon: -71.24783 facility: Rehabologym Corp status: RECRUITING city: Tarrytown state: New York zip: 10591 country: United States name: Avrielle Peltz, MA OTR/L role: CONTACT phone: 914-603-8600 email: avrielle.peltz@rehabologym.com lat: 41.07621 lon: -73.85875 hasResults: False

 nctId: NCT06336707 id: HS-20089-103 briefTitle: HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2026-04-08 date: 2028-04-08 date: 2024-03-29 date: 2024-03-29 name: Hansoh BioMedical R&D Company class: INDUSTRY briefSummary: HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6.

This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1048 type: ESTIMATED name: HS-20089 name: Adebrelimab name: Bevacizumab name: Cisplatin / carboplatin measure: Maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20089 in combination therapy measure: Incidence and severity of adverse events (AEs) measure: Observed maximum plasma concentration (Cmax) of HS-20089 measure: Time to reach maximum plasma concentration (Tmax) of HS-20089 following the first dose measure: Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20089 measure: Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089 measure: Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measure: Duration of response (DoR) assessed by investigators according to RECIST 1.1 measure: Disease control rate (DCR) assessed by investigators according to RECIST 1.1 measure: Progression-free survival (PFS) assessed by investigators according to RECIST 1.1 measure: Overall survival (OS) measure: Percentage of participants with antibodies to HS-20089 in serum sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336694 id: SYSUFAH2021-025 briefTitle: A Deep Learning Radiomics Model for Predicting Occult Peritoneal Metastases of Pancreatic Adenocarcinoma overallStatus: COMPLETED date: 2021-01-01 date: 2022-10-31 date: 2023-07-30 date: 2024-03-29 date: 2024-03-29 name: First Affiliated Hospital, Sun Yat-Sen University class: OTHER briefSummary: Occult peritoneal metastases (OPM) in patients with pancreatic ductal adenocarcinoma (PDAC) are frequently overlooked during imaging. We aimed to develop and validate a CT-based deep learning-based radiomics (DLR) model with clinical-radiological characteristics to identify OPM in patients with PDAC before treatment. conditions: Pancreatic Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 302 type: ACTUAL name: surgery or diagnostic staging laparoscopy measure: diagnosed with peritoneal metastases sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shi Siya city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06336681 id: #12966 briefTitle: Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB) acronym: IMT_EIB overallStatus: RECRUITING date: 2022-02-10 date: 2025-08 date: 2025-08 date: 2024-03-29 date: 2024-03-29 name: Indiana University class: OTHER briefSummary: Due to the lack of studies examining the impact of inspiratory muscle training (IMT) on the severity of exercise-induced bronchoconstriction (EIB) and exercise performance, the specific aim of this study is to assess the efficacy of flow-resistive IMT on EIB severity and symptoms, short-acting beta-2-agonist medication use, operating lung volumes, respiratory and limb locomotor muscle deoxygenation during constant-load cycling exercise, exertional dyspnea, and cycling time-trial performance. conditions: Exercise Induced Bronchospasm conditions: Exercise Induced Asthma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: PrO2Fit Device measure: Exercise-Induced Bronchoconstriction (EIB) Severity measure: Maximum Inspiratory Pressure and Sustained Maximum Inspiratory Pressure measure: 16-km Cycling Time-Trial Time to Completion measure: 16-km Cycling Time-Trial Power Output measure: Constant Load Performance measure: Perception of Breathing Intensity and Unpleasantness and Leg Fatigue measure: Deoxygenation of the respiratory and limb locomotor muscles by near-infrared spectroscopy measure: Femoral blood flow (FBF) of the limb locomotor muscles by ultrasound measure: Lung Volumes sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: School of Public Health-Bloomington status: RECRUITING city: Bloomington state: Indiana zip: 47405 country: United States name: Tim Mickleborough, Ph.D. role: CONTACT phone: 812-855-0753 email: tmickleb@indiana.edu lat: 39.16533 lon: -86.52639 hasResults: False

 nctId: NCT06336668 id: REB23-1283 briefTitle: Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-28 date: 2026-02-28 date: 2024-03-29 date: 2024-04-01 name: University of Calgary class: OTHER briefSummary: Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives.

The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks. conditions: Feeding; Difficult, Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective randomized-controlled crossover trial comparing 2 different HMFs and 2 intestinal rSO2S periods in random order: 6 hours while on B-HMF and 6 hours on H-HMF with at least 6 hours washing period primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Randomizing the participants to either Bovine-HMF or Human Milk based-HMF will mask the Investigator whoMasked: INVESTIGATOR count: 18 type: ESTIMATED name: Human milk-based HMF measure: Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy measure: Changes in SMA doppler peak flow velocity (PSV) measure: Changes in SMA doppler end-diastolic velocity (EDV) measure: Changes in SMA doppler Porcelout's resistance index (RI) sex: ALL maximumAge: 30 Weeks stdAges: CHILD hasResults: False

 nctId: NCT06336655 id: 153309 briefTitle: Physiology of Unloading VA ECMO Trial overallStatus: RECRUITING date: 2024-04-15 date: 2028-02-01 date: 2029-02-01 date: 2024-03-29 date: 2024-04-25 name: University of Utah class: OTHER name: University of Minnesota briefSummary: The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for non-postoperative cardiogenic shock (CS). The main aims of the study are:

1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO
2. To determine the effects on myocardial function of adding LV unloading to ECMO
3. To test the effects on myocardial recovery of adding LV unloading to VA ECMO

Participants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups. conditions: Cardiogenic Shock studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: IABP measure: Change in pulmonary capillary wedge pressure measure: Change in pulmonary artery diastolic pressure measure: Change in left ventricular end diastolic diameter measure: Change in N-terminal pro b-type natriuretic peptide measure: Hemodynamic stability measure: Global cardiovascular function measure: Difference in partial pressure of carbon dioxide (pCO2) measure: Lactate measure: Cardiac BIN1 measure: Troponin I measure: Tumor necrosis factor alpha measure: Ejection fraction percentage measure: Interferon gamma measure: Limb ischemia measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah status: RECRUITING city: Salt Lake City state: Utah zip: 84132 country: United States name: Joseph E. Tonna, MD, FAAEM role: CONTACT phone: 801-587-9373 email: joseph.tonna@hsc.utah.edu lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06336642 id: 2023-0933 id: NCI-2024-02452 type: OTHER domain: NCI-CTRP Clinical Trials Registry briefTitle: Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2030-03-31 date: 2032-03-31 date: 2024-03-29 date: 2024-03-29 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer. conditions: Dyspnea studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: SPOT-ON Early Start name: SPOT-ON Delayed Start measure: Primary Outcome Measure: 1.Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: David Hui, MD role: CONTACT phone: 713-792-6258 email: dhui@mdanderson.org lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06336629 id: WIN2023 briefTitle: A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-15 date: 2024-10 date: 2024-10 date: 2024-03-29 date: 2024-03-29 name: Sun Pharmaceutical Industries Limited class: INDUSTRY briefSummary: Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice. conditions: Acne Vulgaris studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Winlevi (clascoterone) 1% & Duac gel measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16. measure: Percent of total lesion reduction at week 16 compared to baseline measure: Percent of inflammatory lesion reduction at week 16 compared to baseline measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline. measure: Tolerability measures of erythema based on 5-point severity scale measure: Tolerability measures of dryness based on 5-point severity scale measure: Tolerability measures of peeling based on 5-point severity scale measure: Assessment of skin oiliness based on 5-point severity scale measure: Tolerability measures of burning/stinging based on 6-point severity scale measure: Tolerability measures of pruritus based on 6-point severity scale sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Skin Sciences, PLLC city: Louisville state: Kentucky zip: 40217 country: United States lat: 38.25424 lon: -85.75941 hasResults: False

 nctId: NCT06336616 id: 31164 briefTitle: Getting Out of the House: Using Behavioral Activation to Increase Community Participation overallStatus: RECRUITING date: 2024-02-15 date: 2026-08 date: 2026-12 date: 2024-03-29 date: 2024-04-10 name: Temple University class: OTHER name: National Institute on Disability, Independent Living, and Rehabilitation Research briefSummary: The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness.

The overall objective of this study is to increase engagement in meaningful activities and community participation. The objectives of the project are as follows:

1. To determine if the intervention leads to increases the frequency and variety of activities.
2. To determine if the intervention leads to increases in community mobility.
3. To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention.
4. To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life).

Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period.

For data collection, participants will also be asked to:

1. Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period;
2. Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time, at three separate times (e.g., baseline, after the intervention, and at the end of the maintenance period); and
3. Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation.

The study will enroll 52 participants split into 4 cohorts of 13. The study will use a multiple baseline design and, as such, all participants will receive the intervention and there is no control group. conditions: Major Depressive Disorder conditions: Schizo Affective Disorder conditions: Schizophrenia conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 52 type: ESTIMATED name: Behavior Activation measure: Activity Logs measure: Participation Checklist measure: Behavior Activation for Depression Scale measure: Temple University Community Participation Measure measure: Community Mobility (Global Positioning System; GPS) measure: Community Mobility (Global Positioning System; GPS) measure: Lerman Quality of Life Interview measure: New General Self-Efficacy Scale (adapted to participation) measure: Recovery Assessment Scale (RAS) measure: Activity Assessment Scale measure: Capabilities and Opportunities for Participation Questionnaire measure: Self-Control and Self-Management Scale measure: Habit Strength Scale measure: University of California Los Angeles Loneliness Scale measure: Lehman Quality of LIfe (QOL) Interview Social Relations sub scale measure: Hopkins Symptoms Checklist measure: The Life Engagement Test measure: The University of Rhode Island Change Assessment Measure (URICA) measure: Reward Probability Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Temple University status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19120 country: United States name: Crystal Slanzi role: CONTACT lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06336603 id: WIN2022 briefTitle: A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-15 date: 2024-09 date: 2024-09 date: 2024-03-29 date: 2024-03-29 name: Sun Pharmaceutical Industries Limited class: INDUSTRY briefSummary: Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Adapalene 0.3% gel in combination to emulate real life practice. conditions: Acne Vulgaris studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Winlevi (clascoterone) 1% & Adapalene 0.3% gel measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16. measure: Percent of total lesion reduction at week 16 compared to baseline measure: Percent of inflammatory lesion reduction at week 16 compared to baseline measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline measure: Tolerability measures of erythema based on 5-point severity scale measure: Tolerability measures of dryness based on 5-point severity scale measure: Tolerability measures of peeling based on 5-point severity scale measure: Assessment of skin oiliness based on 5-point severity scale measure: Tolerability measures of burning/stinging based on 6-point severity scale measure: Tolerability measures of pruritus based on 6-point severity scale sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Skin Sciences, PLLC city: Louisville state: Kentucky zip: 40217 country: United States lat: 38.25424 lon: -85.75941 hasResults: False

 nctId: NCT06336590 id: Pro2024000249 briefTitle: Student Exercise and Sleep Timing Study - Part 2 acronym: SiESTa 2 overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2026-12-01 date: 2026-12-16 date: 2024-03-29 date: 2024-03-29 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality.

Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration.

Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger).

Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity. conditions: Sleep conditions: Mood conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 62 type: ESTIMATED name: Morning Exercise measure: Sleep Quality measure: Mood measure: Stress measure: Productivity sex: ALL minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT facility: College Avenue Gym city: New Brunswick state: New Jersey zip: 08901 country: United States lat: 40.48622 lon: -74.45182 facility: Cook/Douglass Rec Center city: New Brunswick state: New Jersey zip: 08901 country: United States name: Assistant Director of Operations role: CONTACT phone: 848-932-8063 email: samantha.plum@rutgers.edu lat: 40.48622 lon: -74.45182 facility: Rutgers Fitness Center city: New Brunswick state: New Jersey zip: 08901 country: United States lat: 40.48622 lon: -74.45182 facility: Rutgers Sleep Lab city: New Brunswick state: New Jersey zip: 08901 country: United States lat: 40.48622 lon: -74.45182 facility: Livingston Rec Center city: Piscataway state: New Jersey zip: 08854 country: United States name: Assistant Director of Operations role: CONTACT phone: 848-932-8063 email: samantha.plum@rutgers.edu lat: 40.49927 lon: -74.39904 facility: Werblin Rec Center city: Piscataway state: New Jersey zip: 08854 country: United States name: Assistant Director of Operations role: CONTACT phone: 848-932-8063 email: samantha.plum@rutgers.edu lat: 40.49927 lon: -74.39904 hasResults: False

 nctId: NCT06336577 id: 2024/0003 briefTitle: Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France acronym: ARBT21 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-29 name: Centre Hospitalier Sud Francilien class: OTHER briefSummary: The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France. conditions: Down Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 250 type: ESTIMATED name: lower respiratory tract disease measure: distribution of lower respiratory tract diseases sex: ALL minimumAge: 1 Day maximumAge: 17 Years stdAges: CHILD facility: Centre Hospitalier Sud Francilien city: Corbeil-Essonnes zip: 91106 country: France name: Yousra MESBAHI role: CONTACT phone: 0161697760 email: yousra.mesbahi@chsf.fr lat: 48.60603 lon: 2.48757 hasResults: False

 nctId: NCT06336564 id: 71168623.6.0000.5544 briefTitle: Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2026-12 date: 2024-03-28 date: 2024-03-28 name: Centro de Atenção ao Assoalho Pélvico class: OTHER briefSummary: Genitourinary Syndrome fo Menopause (GSM) is made up of a set of changes in the region of the vulva, vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue, which leads to a reduction in blood supply, disorders in collagen metabolism and skin elasticity. The standard treatment for urinary incontinence during menopause is pelvic floor muscle training, associated or not with local hormone replacement therapy. Although low cost and easy to access, it is associated with low patient's adherence. Physical methods such as laser and radiofrequency in non-ablative, ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis. It is hypothesized that menopausal women, who present symptoms of GSM, may benefit from this new, minimally invasive resource (microablative radiofrequency). This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM. A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic, clinical data and symptoms, following the routine and standard of the service. To evaluate the treatment, the following will be used: voiding diary, pad test, vaginal cytology, histopathology, Female Sexual Function Index (FSFI), Short-Form Health Survey - SF-36 Questionnaire, King's Health Questionnaire, evolution of symptoms (dryness, pain during sexual activity, vaginal laxity, itching, burning sensation and pain in the vaginal introitus) and level of patient's satisfaction. Patients will be randomized into: group 1 or control group, which will perform pelvic floor muscle training, PFMT, with supervision (three times) and at home twice a day, and group 2 or test group, which will perform the same PFMT protocol associated with vaginal microablative radiofrequency. 10% lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vagina/vaginal introitus, with an interval of 30 to 40 days. The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM. conditions: Menopause conditions: Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Pelvic floor muscle training name: Microablative Radiofrequency measure: Resolution or improvement of episodes of urinary loss assessed by pad test measure: Resolution or improvement of episodes of urinary loss assessed by urinary diary measure: Number of patients with tolerability related to treatment assessed by Likert Scale. measure: Number of patients with adverse effects related to treatment assessed by histopathology. measure: Resolution or improvement of episodes of urinary loss assessed by questionnaire. measure: Recovery of vaginal health assessed by Vaginal Index Maturation measure: Recovery of vaginal health assessed by vaginal pH measure: Improvement of Sexual Function assessed by Female Sexual Function Index measure: Improvement of quality of life assessed by Short-Form Health Survey (SF-36) measure: Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire. measure: Degree of patient satisfaction using a five-point Likert scale. measure: Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS) sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Atenção ao Assoalho Pelvico city: Salvador state: Ba zip: 40.290-000 country: Brazil lat: -12.97111 lon: -38.51083 hasResults: False

 nctId: NCT06336551 id: UniversityAmsterdam briefTitle: Acceptance and Commitment Therapy for Insomnia overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-26 date: 2026-01-26 date: 2024-03-28 date: 2024-03-29 name: University of Amsterdam class: OTHER briefSummary: Insomnia is a common sleep problem that impacts both physical and mental health. Acceptance and Commitment Therapy for Insomnia (ACT-I) is proposed as a promising new treatment for insomnia. However, its effectiveness without overlapping behavioral components of the current standard treatment, cognitive behavioral therapy, remains largely unknown.

The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia, compared to a waitlist control group. The second goal is to explore the potential working mechanisms of ACT-I, using network intervention analysis.

Adults with insomnia will be randomized to an ACT-I or waitlist group. Both the ACT-I treatment and waiting period span 7 weeks. Assessments take place at baseline (pre), after 4 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the ACT-I group.

The main questions this RCT aims to answer are:

* Is ACT-I superior to a waitlist control group in improving insomnia severity (primary outcome) in addition to sleep diary measures, anxiety, depression, general mental health, and sleep-related quality of life (secondary outcomes)?
* How do networks of insomnia symptoms or potential treatment processes (i.e., psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and sleep-related safety behaviors) develop during and following ACT-I? conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Acceptance and Commitment Therapy for insomnia (ACT-I) measure: Insomnia severity measure: Insomnia severity measure: Insomnia severity measure: Insomnia severity measure: General well-being measure: General well-being measure: General well-being measure: General well-being measure: Sleep-related quality of life measure: Sleep-related quality of life measure: Sleep-related quality of life measure: Sleep-related quality of life measure: Anxiety symptoms measure: Anxiety symptoms measure: Anxiety symptoms measure: Anxiety symptoms measure: Depression symptoms measure: Depression symptoms measure: Depression symptoms measure: Depression symptoms measure: Sleep diary: total sleep time measure: Sleep diary: total sleep time measure: Sleep diary: total sleep time measure: Sleep diary: total sleep time measure: Sleep diary: sleep onset latency measure: Sleep diary: sleep onset latency measure: Sleep diary: sleep onset latency measure: Sleep diary: sleep onset latency measure: Sleep diary: wake after sleep onset measure: Sleep diary: wake after sleep onset measure: Sleep diary: wake after sleep onset measure: Sleep diary: wake after sleep onset measure: Sleep diary: sleep efficiency measure: Sleep diary: sleep efficiency measure: Sleep diary: sleep efficiency measure: Sleep diary: sleep efficiency measure: Psychological flexibility measure: Psychological flexibility measure: Psychological flexibility measure: Psychological flexibility measure: Psychological inflexibility measure: Psychological inflexibility measure: Psychological inflexibility measure: Psychological inflexibility measure: Sleep-related arousal measure: Sleep-related arousal measure: Sleep-related arousal measure: Sleep-related arousal measure: Dysfunctional sleep-related cognitions measure: Dysfunctional sleep-related cognitions measure: Dysfunctional sleep-related cognitions measure: Dysfunctional sleep-related cognitions measure: Sleep-related safety behaviors measure: Sleep-related safety behaviors measure: Sleep-related safety behaviors measure: Sleep-related safety behaviors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Amsterdam city: Amsterdam state: Noord-Holland zip: 1018 WS country: Netherlands name: Mathilde I Looman, MSc role: CONTACT phone: (0)20 525 6810 phoneExt: +31 email: m.i.looman@uva.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06336538 id: CASE1124 briefTitle: Abbreviated MBCT for Depression in Older African American/Black Breast Cancer Survivors overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-01-31 date: 2025-01-31 date: 2024-03-28 date: 2024-03-29 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression. conditions: Breast Cancer conditions: Breast Cancer Female conditions: Breast Cancer Stage I conditions: Breast Cancer Stage II conditions: Breast Cancer Stage III conditions: Mild Depression conditions: Moderate Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Investigator will first conduct focus groups with older (≥65 years old) African American/Black (AA/B) breast cancer survivors (BCS) with elevated depressive symptoms. They will collect participant perspectives on barriers and facilitators to participation in MBI clinical trials, as well as how to adapt this intervention, called Mindfulness-Based Cognitive Therapy-Brief (MBCT-Brief), to increase cultural relevancy for older AA/B BCS with elevated depressive symptoms. They will then conduct a single arm clinical trial that incorporates the results of the qualitative data analysis to establish feasibility and acceptability of MBCT-Brief. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 31 type: ESTIMATED name: MBCT measure: Mean participant attendance rate measure: Acceptability rate using CSQ(Client Satisfaction Questionnaire-8) measure: Change in fear of recurrence as assessed using FCRI(Fear of Cancer Recurrence Inventory) scores measure: Change in trait mindfulness as assessed using FFMQ-15(Five Facet of Mindfulness Scale Short Form) scores measure: Change in Quality of life as assessed using ICS-2(Impact of Cancer Scale version 2) scores measure: Change in depressive symptoms as assessed using PROMIS-D(Patient Reported Outcomes Measurement Information System-Depression) scores sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: Cleveland Clinic Department of Wellness and Preventive Medicine city: Cleveland state: Ohio zip: 44106 country: United States name: Jacob Hill, ND role: CONTACT lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06336525 id: 2023P001895 id: R01HL164462 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL164462 briefTitle: Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-01-31 date: 2027-01-31 date: 2024-03-28 date: 2024-04-22 name: Brigham and Women's Hospital class: OTHER name: University of Alabama at Birmingham name: Emory University name: University of Pennsylvania name: University of Massachusetts, Worcester name: The University of Texas Health Science Center at San Antonio name: Beth Israel Deaconess Medical Center name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health. conditions: Sleep Apnea conditions: Insomnia conditions: Sleep Deprivation conditions: Sleep Disorders, Circadian Rhythm conditions: Sleepiness, Excessive Daytime conditions: Fatigue studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 3680 type: ESTIMATED measure: Oxygen desaturation index measure: Insomnia Severity Index measure: Sleep Duration measure: Sleep Duration Regularity measure: Sleep Timing measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment Short Form 8a measure: Restless Legs Syndrome (RLS) measure: Chronotype measure: Sleep Timing Regularity measure: Global Sleep Quality measure: Oxygen desaturation index, 3% sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06336512 id: RC.28.1.2024 briefTitle: Trimester Sequential Estimation of Serum Zonulin as a Predictor of Gestational Diabetes Mellitus overallStatus: COMPLETED date: 2023-01-15 date: 2023-07-01 date: 2023-10-01 date: 2024-03-28 date: 2024-03-28 name: Benha University class: OTHER briefSummary: Gestational diabetes mellitus (GDM) is the development of glucose intolerance (GI) during pregnancy in a previously normoglycemic (NG) woman and associated with insulin resistance (IR). GDM is the most prevalent metabolic disorder during pregnancy and became a major public health problem for being usually diagnosed and detected after 24 gestational weeks (GW), while its complications can occur much earlier and this may explain its burden on maternal and fetal welfare. Human zonulin is a surrogate marker of intestinal permeability and can be utilized as biomarker for intestinal barrier function. Zonulin-mediated increase in intestinal permeability plays a role in the pathogenesis of insulin resistance, obesity, DM and metabolic syndrome. The increasing global prevalence of GDM with its associated risk of poor pregnancy and long-term risks for the mother and the offspring may lead to the production of new generation of diabetics. conditions: Gestational Diabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Newly Pregnant Women with singleton fetus primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ACTUAL name: ELISA measure: Estimation of Gestational DM sex: FEMALE minimumAge: 22 Years maximumAge: 50 Years stdAges: ADULT facility: Benha university city: Banhā state: El- Qalyobia zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False

 nctId: NCT06336499 id: TREC2023-KY107 briefTitle: Risk Stratification of Orbital Tumors Based on MRl and Artificial Intelligence overallStatus: COMPLETED date: 2012-01-01 date: 2022-10-31 date: 2023-12-31 date: 2024-03-28 date: 2024-03-29 name: Beijing Tongren Hospital class: OTHER briefSummary: Orbital tumors can be categorized into benign and malignant tumors, and there are significant variations in their biological behavior, treatment, and prognosis. This study aims to enhance the accurate diagnosis and risk stratification of orbital tumors using artificial intelligence (AI) technology and multiparameter magnetic resonance imaging (MRI) data. It further explores the intrinsic relationship between MRI and the differential diagnosis of benign and malignant orbital tumors, as well as the pathological subtypes of malignant tumors and Ki-67 expression levels. This research aims to aid in guiding personalized diagnosis and treatment decision-making for patients with orbital tumors while promoting the practical application and incorporation of AI technology. conditions: Orbital Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 600 type: ACTUAL name: Multi-parametric MRI and image analysis by deep learning or machine learning algorithms measure: The area under the curve of Receiver Operating Characteristic of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and levels of Ki-67 expression in malignant ones. measure: The area under the Precision-Recall curve of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. measure: Sensitivity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. measure: Specificity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. measure: Accuracy of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336486 id: BalikesirU-FTR-BG-01 briefTitle: the Effectiveness of Intermittent Pneumatic Compression on Neuropathic Pain in Patients With Diabetic Polyneuropathy overallStatus: COMPLETED date: 2018-12-04 date: 2020-02-01 date: 2020-02-01 date: 2024-03-28 date: 2024-04-01 name: Busra Gunes class: OTHER briefSummary: In this study,the effectiveness of intermittent pneumatic compression therapy on neuropathic pain and quality of life in patients with neuropathic pain due to type 2 diabetes was investigated conditions: Diabetic Neuropathic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two groups with a conventional therapy control group primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: intermittent pneumatic compression +pregabalin group name: pregabalin group measure: The Leeds assessment of neuropathic symptoms and signs(LANSS) measure: Pain quality rating scale(PQAS) measure: Visual Analog Scale(VAS) measure: 36-Item Short Form Health Survey(SF-36) sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Balıkesir University city: Balıkesir state: Merkez zip: 10050 country: Turkey lat: 39.64917 lon: 27.88611 hasResults: False

 nctId: NCT06336473 id: 2023-A02097-38 briefTitle: Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome acronym: SEDSKIN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-07-31 date: 2024-03-28 date: 2024-03-28 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS). conditions: Ehlers-Danlos Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-center study performed on biopsied skin samples primaryPurpose: BASIC_SCIENCE masking: NONE count: 28 type: ESTIMATED name: skin biopsy measure: Young's modulus quantification measure: Collagen fibril diameter measurement measure: Collagen fibril D-period length measurement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Maussins-Nollet city: Paris zip: 75019 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06336460 id: 2023-537 briefTitle: PENG vs. FIC Blocks in Hip Fractures in the ED overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-03-28 date: 2024-03-28 name: Orange Park Medical Center class: OTHER briefSummary: This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture. conditions: Hip Fractures conditions: Nerve Block conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The research associate/outcome assessor will not have access to group assignment and will therefore be blinded to the type of block. Although the patient, their caregiver(s), and the clinician caring for the patient will not be directly informed of the group assignment, a note will be logged in the clinical record by the physician placing the block indicating the details of the block after this procedure has been completed. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Pericapsular Nerve Group (PENG) Block name: Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures measure: Numeric pain score at 30 minutes measure: Numeric pain score at 60 minutes measure: Cumulative Morphine Milligram Equivalents in 24 hours after enrollment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336447 id: STU00220295 briefTitle: VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain overallStatus: RECRUITING date: 2024-01-12 date: 2026-12-31 date: 2027-02-28 date: 2024-03-28 date: 2024-03-28 name: Northwestern University class: OTHER briefSummary: This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain.

The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures. conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trail. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessor will be blinded to study randomization whoMasked: OUTCOMES_ASSESSOR count: 62 type: ESTIMATED name: Experimental: Group #1: Virtual Reality Headset name: Group 2 No Virtual Reality Headset measure: Procedural related pain measure: Procedure related satisfaction measure: Post procedure anxiety measure: Mean reduction in pain 1 month after procedure measure: Midazolam administered measure: Fentanyl administered sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern Medicine Pain Center status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Paul Fitzgerald role: CONTACT phone: 312-695-1064 email: p-fitzgerald2@northwestern.edu name: Jason Ross, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06336434 id: IMPAACT 2040 briefTitle: CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-09-24 date: 2026-12-24 date: 2026-12-24 date: 2024-03-28 date: 2024-03-28 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants. conditions: HIV-1-infection conditions: Pregnancy conditions: Postpartum studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: CAB LA 600mg name: RPV LA 900mg name: CAB LA 400mg name: RPV LA 600mg measure: PK trough of CAB LA measured in plasma in pregnancy and postpartum measure: Percentage of adults with at least one Grade 3 or higher adverse event in pregnancy and through 18 weeks postpartum measure: Percentage of adults with at least one serious adverse event in pregnancy and through 18 weeks postpartum measure: PK trough measured in plasma in pregnancy and postpartum measure: Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery measure: Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery using the standardized FDA snapshot algorithm measure: Percentage of adults with virologic escape (single measurement of greater than or equal to 200 copies/mL) from study entry through pregnancy and through 18 weeks postpartum measure: Percentage of adults with confirmed virologic failure through 18 weeks postpartum measure: Number of adults with HIV-1 resistance to CAB and/or RPV using IAS-USA in participants who experience confirmed virologic failure, assessed at entry and time of failure measure: Number of infants with HIV-1 infection measure: Percentage of infants at least one Grade 3 or higher adverse event through 18 weeks post-birth measure: Percentage of infants at least one serious adverse event through 18 weeks post-birth measure: Percentage of infants with a congenital anomaly consistent with the Metropolitan Atlanta Congenital Defects Program (MACDP) definition of defect measure: Percentage of deaths among infants measure: Percentage of adults with a spontaneous abortion (less than 20 weeks gestation) measure: Percentage of adults with a fetal demise/stillbirth (greater than or equal to 20 weeks gestation) measure: Percentage of neonatal deaths (within 28 days of life) among infants measure: Percentage of infants born small for gestational age (SGA) at < 10th percentile measure: Percentage of infants born with low birth weight < 2500 g measure: Percentage of infants born preterm < 37 weeks gestation measure: Percentage of adult-infant participant pairs with any adverse pregnancy outcome of spontaneous abortion, fetal demise/stillbirth, neonatal death, SGA, or preterm delivery measure: CAB and RPV plasma concentrations in infants exposed to CAB LA + RPV LA during pregnancy and via chest/breastfeeding measure: Percentage of adults who discontinued injections prior to receiving the full course of injections due to intolerability of injection measure: Frequency of CAB LA + RPV LA injections received measure: Percentage of adults willing to continue CAB LA + RPV LA postpartum and/or in future pregnancies sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 4601, University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program city: La Jolla state: California zip: 92093-0672 country: United States name: Megan Loughran, BA role: CONTACT phone: 858-534-9218 email: meloughran@health.ucsd.edu lat: 32.84727 lon: -117.2742 facility: Site 5048, University of Southern California LA city: Los Angeles state: California zip: 90033 country: United States name: Lourdes Topete role: CONTACT phone: 323-865-1585 email: ltopete@usc.edu lat: 34.05223 lon: -118.24368 facility: Site 5092, Johns Hopkins University, Baltimore city: Baltimore state: Maryland zip: 21287 country: United States name: Amanda Haines role: CONTACT phone: 443-287-8950 email: ahaines8@jhmi.edu lat: 39.29038 lon: -76.61219 facility: Site 5013, Jacobi Medical Center Bronx city: Bronx state: New York zip: 10461 country: United States name: Marlene Burey, NP role: CONTACT phone: 718-918-4783 email: marlene.burey@nychhc.org lat: 40.84985 lon: -73.86641 facility: Site 8051 - Wits RHI Shandukani Research Centre city: Johannesburg zip: 2001 country: South Africa name: Rorisang Komane, BNS role: CONTACT phone: +27-72-933-4002 email: rkomane@wrhi.ac.za lat: -26.20227 lon: 28.04363 facility: Site 8052, Soweto city: Johannesburg country: South Africa name: Ntatule Ndiweni role: CONTACT phone: +27-11-989-9748 email: ndiwenih@phru.co.za lat: -26.20227 lon: 28.04363 facility: Site 8950, FAMCRU CRS city: Parow zip: 7505 country: South Africa name: Jeanne de Jager, MSc role: CONTACT phone: +27-21-938-4290 email: jeannes@sun.ac.za lat: -33.89723 lon: 18.59992 facility: Site 30300, Umlazi Clinical Research Site city: Umlazi zip: 4066 country: South Africa name: Zukiswa Godlwana role: CONTACT phone: +27-31-2601998 email: zukiswa.godlwana@caprisa.org lat: -29.96572 lon: 30.88639 hasResults: False

 nctId: NCT06336421 id: Şuletuvanç briefTitle: The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous overallStatus: COMPLETED date: 2022-11-01 date: 2023-06-15 date: 2024-03-22 date: 2024-03-28 date: 2024-03-28 name: Ataturk University class: OTHER briefSummary: Purpose: To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean section.The research was conducted in a randomized controlled experimental design.The population of the research consisted of primiparous pregnant women with a caesarean section indication in the Ataturk University Health Research and Application Center Gynecology Clinic Operating Room. conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: statistics expert whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Virtual Reality measure: Personal Information Form measure: State Anxiety Scale measure: Pregnant follow-up form sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Ayse Aydin city: Yakutiye state: Erzurum zip: 25000 country: Turkey lat: 39.89821 lon: 41.26916 hasResults: False

 nctId: NCT06336408 id: B2023-370R briefTitle: The SLEEP-CARE Study overallStatus: RECRUITING date: 2024-02-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-28 date: 2024-03-28 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Sleep disorder is common in ICU patients, such as reduced sleep time, fragmentation, and abnormal sleep rhythm. In 2023, American Thoracic Society released a research statement on sleep and circadian disruption(SCD) in ICU, which considered SCD is an important potential target for improving critical illness outcomes. Although polysomnography(PSG) is the gold standard of sleep measurement, subjective sleep evaluation tools are still used in most clinical studies related to sleep in ICU. This makes the sleep quality of ICU patients overestimated and difficult to reflect their true sleep conditions. And the answers to how and which outcomes different levels of sleep deprivation affect patient outcomes are still unclear and need to be further explored. conditions: Sleep Disturbance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: Compound outcome index measure: LOS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University status: RECRUITING city: Shanghai country: China name: Jingjing Li, Master role: CONTACT phone: 13512106878 email: li.jingjing@zs-hospital.sh.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06336395 id: 2019/00888 briefTitle: Ma-Spore ALL 2020 Study overallStatus: RECRUITING date: 2020-03-04 date: 2030-03 date: 2030-03 date: 2024-03-28 date: 2024-03-28 name: National University Hospital, Singapore class: OTHER briefSummary: The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy. conditions: B Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: Prednisolone name: Dexamethasone name: Vincristine name: Methotrexate name: L-Asparaginase name: Pegylated asparaginase name: Erwinase name: Dasatinib name: Imatinib name: Cyclophosphamide name: Cytarabine name: Mercaptopurine name: Thioguanine name: Rituximab name: Doxorubicin name: Fludarabine measure: Overall survival (OS) measure: Event free survival (EFS) measure: Cumulative incidence (CI) of relapse for all treated cohorts measure: Cumulative incidence (CI) of therapy-related mortality (TRM) for all treated subjects sex: ALL maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Subang Jaya Medical Centre status: RECRUITING city: Kuala Lumpur zip: 47500 country: Malaysia name: Hai Peng Lin role: CONTACT phone: +603 56391621 email: flslhp@gmail.com name: Lee Lee Chan, MBBS role: SUB_INVESTIGATOR lat: 3.1412 lon: 101.68653 facility: University Malaya Medical Centre status: RECRUITING city: Kuala Lumpur zip: 59100 country: Malaysia name: Hany Arrifin, MBBS role: CONTACT phone: +603 79492065 email: hany@ummc.edu.my lat: 3.1412 lon: 101.68653 facility: KK Women's and Children's Hospital status: RECRUITING city: Singapore zip: 229899 country: Singapore name: Ah Moy Tan, MBBS role: CONTACT phone: +65 63941039 email: tan.ah.moy01@singhealth.com.sg lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06336382 id: 23-0874 id: 1R21MH135148 type: NIH link: https://reporter.nih.gov/quickSearch/1R21MH135148 briefTitle: Tau Biomarkers in Late-onset Psychosis (LOP) overallStatus: RECRUITING date: 2024-02-16 date: 2026-12-31 date: 2027-06-30 date: 2024-03-28 date: 2024-03-28 name: Jeremy Koppel class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing. conditions: Late Onset Schizophrenia conditions: Delusional Disorder (Late Onset) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 16 type: ESTIMATED name: Tau PET imaging scan measure: Quantification of neurofibrillary tangle pathology in subjects via PET [18F]PI-2620 radiotracer uptake. measure: Measurement of peripheral soluble tau pathology with tau plasma immunoassays. measure: Evaluation of sensorimotor gating integrity and it's association to tau PET ligand uptake. sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: The Feinstein Institutes for Medical Research status: RECRUITING city: Manhasset state: New York zip: 11030 country: United States name: Erica Christen, MS role: CONTACT phone: 516-562-3492 email: EChriste@northwell.edu name: Michelle Gong, AS role: CONTACT phone: 516-562-3492 email: MGong@northwell.edu lat: 40.79788 lon: -73.69957 hasResults: False

 nctId: NCT06336369 id: 1713/2023 briefTitle: Brown Adipose Tissue Activity in Gilbert's Syndrome overallStatus: RECRUITING date: 2024-03-06 date: 2027-01-15 date: 2027-01-15 date: 2024-03-28 date: 2024-03-28 name: Medical University of Vienna class: OTHER name: University of Vienna name: Griffith University briefSummary: The goal of this case-control study is to investigate energy metabolism and brown adipose tissue (BAT) activity in individuals with Gilbert's syndrome (GS) and controls. The main focus of the study is to analyze:

1. the link between bilirubin metabolism and metabolic health.
2. energy metabolism and body composition in individuals with Gilbert's syndrome and control subjects
3. brown adipose tissue activity in Gilbert's syndrome and healthy controls.

Participants will undergo the following investigations:

1. cold exposure
2. PET-CT imaging with 18-F-FDG
3. MRI imaging of liver, abdominal fat and muscle
4. blood sampling
5. indirect calorimetry
6. bioelectrical impedance analysis
7. infrared thermography

Researchers will compare individuals with GS and control subjects in terms of metabolic health, body composition and BAT activity. conditions: Gilbert Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: analyzing brown adipose tissue, body composition and metabolic health measure: cold-induced brown adipose tissue (BAT) activation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Florian Kiefer, MD, PhD role: CONTACT phone: +43140400 phoneExt: 43120 email: florian.kiefer@meduniwien.ac.at lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06336356 id: D6970C00011 briefTitle: A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2024-11-05 date: 2024-11-05 date: 2024-03-28 date: 2024-03-28 name: AstraZeneca class: INDUSTRY briefSummary: The main purpose of this study is to assess the serum free cortisol response after ACTH stimulation test at baseline and at Week 8 in participants with uncontrolled hypertension. conditions: Uncontrolled Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: Baxdrostat name: Placebo measure: Individual Cortisol Level measure: Number of Participants with Abnormal Stimulated Cortisol sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336343 id: STUDY-23-01698 briefTitle: Bimekizumab in Plaque Psoriasis overallStatus: RECRUITING date: 2024-03 date: 2025-10-31 date: 2025-10-31 date: 2024-03-28 date: 2024-03-28 name: Icahn School of Medicine at Mount Sinai class: OTHER name: UCB Pharma name: Psoriasis Treatment Center of Central New Jersey briefSummary: The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies. Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins (specifically, interleukins 17a and 17F), which are known to increase inflammation. This study will look at the effectiveness of bimekizumab in psoriasis patients that have failed previous therapies that target interleukin IL-17A or 23. conditions: Plaque Psoriasis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Bimekizumab measure: Body Surface Area (BSA) of < 1 measure: Psoriasis and Severity Index Score (PASI) of < 1 measure: Physician Global Assessment (PGA) of < 1 measure: Psoriasis and Severity Index Score (PASI) of < 2 measure: Physician Global Assessment (PGA) of < 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey status: RECRUITING city: East Windsor state: New Jersey zip: 08520 country: United States name: Elise Nelson role: CONTACT phone: 609-443-4500 name: Jerry Bagel role: PRINCIPAL_INVESTIGATOR lat: 40.268 lon: -74.54043 facility: Icahn School of Medicine at Mount Sinai status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Giselle Singer role: CONTACT phone: 212-241-3288 name: Mark Lebwohl role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06336330 id: D1699R00050 briefTitle: Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany acronym: EvolutionHF-DE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-09-30 date: 2026-09-30 date: 2024-03-28 date: 2024-03-28 name: AstraZeneca class: INDUSTRY briefSummary: Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). Dapagliflozin was recently granted approval for heart failure by the European Commission, regardless of ejection fraction and whether the patient has diabetes. Real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, HF symptoms and their impact on physical limitation, HRQoL and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in Germany. conditions: Heart Diseases conditions: Cardiovascular Diseases conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Time to discontinuation of dapagliflozin measure: Reasons for discontinuation of dapagliflozin measure: Dose changes of dapagliflozin measure: Number of patients with dapagliflozin treatment interruptions measure: Treatment switches from dapagliflozin to other SGLT2i measure: Time to other heart failure treatment discontinuation measure: Number of other heart failure treatment initiation measure: Number of other heart failure treatment dosage changes measure: Number of other heart failure treatment discontinuation measure: Number of glucose lowering medication initiation measure: Number of glucose lowering medication dosage changes measure: Number of glucose lowering medication discontinuation measure: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score measure: Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire measure: Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score measure: The absolute change from baseline in occurrence of depressions in patients initiated on dapagliflozin for HF as captured by the Patient Health Questionnaire-9 (PHQ-9) measure: Healthcare resource utilisation - Number of hospitalisations since dapagliflozin initiation measure: Healthcare resource utilisation - Length of HF-related hospital stay since dapagliflozin initiation sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336317 id: ELIMINATE-2024 briefTitle: Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE acronym: ELIMINATE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-12 date: 2027-12 date: 2024-03-28 date: 2024-03-28 name: Region Örebro County class: OTHER name: The Swedish Heart and Lung Association name: Örebro University, Sweden name: University of Cambridge briefSummary: The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are:

Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo. conditions: Acute Myocardial Infarction conditions: Cardiovascular Diseases conditions: Inflammatory Response studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Influenza vaccine name: Placebo measure: The right coronary artery measure: The whole coronary tree measure: Ascending aorta measure: Interleukin 1 beta (IL-1β) measure: Tumor necrosis factor alpha (TNF-α) measure: Interleukin-2 receptor (IL-2r) measure: Interleukin Interleukin-6 (IL-6 ) measure: Ferritin measure: Troponin-I measure: N-terminal pro-B-type natriuretic peptide measure: Explorative endpoints measure: Explorative endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336304 id: NXTPMCF-01 briefTitle: NXT Post-Market Clinical Follow-up overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: Laborie Medical Technologies Inc. class: INDUSTRY briefSummary: NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations conditions: Urinary Incontinence conditions: Urinary Obstruction conditions: Urinary Bladder, Overactive conditions: Urinary Bladder, Neurogenic conditions: Urinary Incontinence, Urge studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED measure: Assess NXT system performance measure: Assess NXT system safety measure: Assess NXT system performance sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336291 id: PH-L19TNFLOM-01/23 briefTitle: A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence acronym: GLIOSTELLA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-03-28 date: 2024-03-28 name: Philogen S.p.A. class: INDUSTRY briefSummary: The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence conditions: Glioblastoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: L19TNF name: L19TNF name: L19TNF name: Lomustine name: Lomustine measure: Adverse Events measure: Serious Adverse Events measure: Unacceptable Toxicity measure: DILI assessment measure: Survival measure: Overall Survival measure: Progression Free Survival measure: Objective Response Rate measure: Disease Control Rate measure: Duration of Response measure: Time to reach maximum drug concentration [Tmax] measure: Terminal half-life [t1/2] measure: Area under the drug concentration-time curve, extrapolated to infinity [AUC] measure: Maximum drug concentration [Cmax] measure: Human anti-fusion protein antibodies (HAFA) levels against L19TNF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336278 id: 19/03/2024 briefTitle: Relationship Between Central Sensitization and Kinesiophobia in Knee Osteoarthritis overallStatus: COMPLETED date: 2022-10-01 date: 2023-10-01 date: 2023-12-01 date: 2024-03-28 date: 2024-04-22 name: Selda Sarıkaya class: OTHER briefSummary: Objective: The knee joint is one of most common locations in OA. In recent years, it has been accepted that there are different pain phenotypes and patient subgroups in knee OA and that central sensitization (CS) mechanisms are at the forefront in some patients. It is also known that fear of movement, known as kinesiophobia, develops in patients with chronic pain. The aim of this study is to investigate CS and kinesiophobia in patients with knee OA, their relationships with each other, and their effects on pain intensity, functional status, pain catastrophizing and depression.

Materials and Methods: Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms. conditions: Knee Osteoarthritis conditions: Central Sensitisation conditions: Kinesiophobia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 84 type: ACTUAL name: Pressure Algometer measure: Pain Pressure Treshold measure: Central Sensitization measure: Kinesiophobia measure: Pain Catastrophizing measure: Depression measure: Visuel Analog Scala measure: Western Ontario and McMaster Universitesies Osteoarthritis Index sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zonguldak Bulent Ecevit Universitiy city: Zonguldak zip: 67100 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False

 nctId: NCT06336265 id: Diaphragm ultrasound briefTitle: Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High-flow Nasal Cannula Oxygen Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: Xingui Dai class: OTHER briefSummary: Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. Throughout the procedure, a panel of experts assessed whether the patient needed endotracheal intubation; If yes, the study was terminated; if no, high-flow nasal cannula oxygen therapy was continued, and observation and evaluation were continued until the end point of the study (12 hours after treatment). If patients or their family members do not want to continue to participate in the study during the study, they will be considered as withdrawal. If patients suffer from sudden malignant arrhythmia or cardiac arrest during the study, resulting in death or transfer to other hospitals or other departments during the study, patients will be excluded. Data from dropped and excluded patients were not included in the final statistical analysis. After the data of 269 patients were collected, the study was concluded, and the results and conclusions were derived by statistical analysis. conditions: Hypoxic Respiratory Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 269 type: ESTIMATED name: Diaphragm ultrasound measure: Thickness and thickening fraction of Diaphragm measure: Diaphragmatic excursion measure: Respiratory rate measure: Incidence of tracheal intubation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336252 id: F-23059441 briefTitle: Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients acronym: SENS4ME overallStatus: RECRUITING date: 2024-04 date: 2025-12-20 date: 2026-06-20 date: 2024-03-28 date: 2024-03-28 name: Bispebjerg Hospital class: OTHER name: AAL name: Innovationsfonden briefSummary: Primary Objective To investigate if patients hospitalised for older adults with a decreased level of physical function, either related to a chronic condition e.g., COPD, Congestive heart failure, renal failure; infections; frailty and tendency of falling; orthopaedic surgery - after hip fracture will increase their time spent out of bed during hospitalisation and 3 months after discharge through visual feedback and motivational intervention about physical activities from a new mobile technology.

Hypothesis Patients hospitalised for medical disease will increase their physical activity level during hospitalisation and 3 months after discharge through visual feedback and motivational intervention from a new mobile technology. conditions: COPD conditions: Heart Failure conditions: Parkinson Disease conditions: Arthritis conditions: Old Age; Cachexia conditions: Stroke Sequelae studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1/1 allocation primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Primary outcome (accelerometer data) blinded for the investigator and assesor. whoMasked: OUTCOMES_ASSESSOR count: 162 type: ESTIMATED name: Digital nudging intervention target to change behavior measure: Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes) measure: Readmission within 90 days measure: Length of stay (days) measure: Time spent lying down, sitting, standing, and walking measured in minutes related to the total accelerometer wear time (minutes) measure: Time spent out of bed in hospital in minutes related to the total accelerometer wear time (minutes) measure: Time spent out of bed after discharge in minutes related to the total accelerometer wear time (minutes) measure: Quality of life (EQ5D-5L) measure: - In-hospital fall incidents sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Christian Dall status: RECRUITING city: Copenhagen zip: 2400 country: Denmark name: Christian H Dall, PhD role: CONTACT phone: 00 45 28604402 email: christian.have.dall@regionh.dk name: Morten T Kristensen, Professor role: CONTACT phone: 0045 38635000 email: morten.tange.kristensen@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06336239 id: KS2023097 briefTitle: PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study acronym: PLACARD overallStatus: RECRUITING date: 2023-12-21 date: 2024-06-30 date: 2024-12-30 date: 2024-03-28 date: 2024-04-12 name: Beijing Anzhen Hospital class: OTHER briefSummary: The association between Cardiovascular Disease (CVD) and Chronic Kidney Disease (CKD) is well established. Traditional risk factors for CVD and CKD are similar, with type 2 diabetes mellitus (T2DM) being the most prevalent risk factor. However, CKD is underdiagnosed and undertreated in patients with CVD. Further understanding of the combination of CKD in CVD patients is important to formulate prevention and treatment strategies for CVD patients and high-risk groups, reduce adverse events in CVD patients, and prevent progression of CKD to End Stage Renal Disease (ESRD). conditions: Cardiovascular Disease conditions: Type 2 Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 3000 type: ESTIMATED measure: The prevalence of albuminuria measure: Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria measure: The prevalence of microalbuminuria and macroalbuminuria measure: To evaluate the related influence factors of albuminuria and the treatment patterns of CKD patients and non-CKD patients in cardiology departments; measure: Evaluate the management of patients with type 2 diabetes mellitus and cardiovascular disease across different levels of cardiology departments in hospitals. measure: Exploratory Objective sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Sixth Hospital status: RECRUITING city: Beijing state: Beijing country: China name: Lei Dong role: CONTACT lat: 39.9075 lon: 116.39723 facility: Fangshan District First Hospital status: COMPLETED city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: COMPLETED city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Chinese PLA Army Characteristic Medical Center status: COMPLETED city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: Haidong City Second People's Hospital status: NOT_YET_RECRUITING city: Haidong state: Gansu country: China name: Haiyan Xu role: CONTACT facility: The First Affiliated Hospital of Sun Yat-sen University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China name: Chen Liu role: CONTACT lat: 23.11667 lon: 113.25 facility: First Hospital of Hebei Medical University status: RECRUITING city: Shijia Zhuang state: Hebei country: China name: Le Wang role: CONTACT phone: 18633889597 email: coronary2012@163.com lat: 34.17775 lon: 109.84894 facility: Ruyang County People's Hospita status: RECRUITING city: Luoyang state: Henan zip: 471201 country: China name: Yanna Song role: CONTACT name: Litao Wu role: PRINCIPAL_INVESTIGATOR lat: 34.68361 lon: 112.45361 facility: Luoyang Sixth People's Hospita status: COMPLETED city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: Yongcheng People's Hospital status: COMPLETED city: Yongcheng state: Henan country: China facility: The First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Zhengzhou state: Henan country: China name: Zhanying Han role: CONTACT lat: 34.75778 lon: 113.64861 facility: Zhangjiagang Sixth People's Hospital status: COMPLETED city: Zhangjiagang state: Jiangsu country: China lat: 31.865 lon: 120.53889 facility: Shenyang Ninth People's Hospital status: RECRUITING city: Shenyang state: Liaoning country: China name: Peng Gao role: CONTACT phone: 18940223349 email: 35095369@qq.com lat: 41.79222 lon: 123.43278 facility: Shenyang Tenth People's Hospital status: ACTIVE_NOT_RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: Jining First People's Hospital status: NOT_YET_RECRUITING city: Jining state: Shandong country: China name: Changjie Ren role: CONTACT lat: 35.405 lon: 116.58139 facility: Tai'an First People's Hospital status: COMPLETED city: Tai'an state: Shandong country: China lat: 36.18528 lon: 117.12 facility: Weihai Central Hospital status: NOT_YET_RECRUITING city: Weihai state: Shandong country: China name: Yufeng Wang role: CONTACT lat: 37.50914 lon: 122.11356 facility: Jing'an District Central Hospital of Shanghai status: COMPLETED city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine status: NOT_YET_RECRUITING city: Shanghai state: Shanghai country: China name: Xin Chen, Phd role: CONTACT email: heartmedi@163.com name: Xin Chen, Phd role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Zhongshan Hospital Fudan University Qingpu Branch status: RECRUITING city: Shanghai state: Shanghai country: China name: Zilong Wang role: CONTACT phone: 18116016189 email: qy1499@126.com lat: 31.22222 lon: 121.45806 facility: Qinyuan County People's Hospital status: COMPLETED city: Changzhi state: Shanxi country: China lat: 35.20889 lon: 111.73861 facility: Shanxi Bethune Hospital status: RECRUITING city: Taiyuan state: Shanxi country: China name: Yue Song role: CONTACT phone: 13657218603 email: song_yu_e@163.com lat: 37.86944 lon: 112.56028 facility: The First Affiliated Hospital of Xi'an Jiaotong University status: NOT_YET_RECRUITING city: XI Ail state: Shanxi country: China name: Zuyi Yuan role: CONTACT lat: 44.9 lon: 122.8 facility: The Fifth People's Hospital of Sichuan Province status: NOT_YET_RECRUITING city: Chendu state: Sichuan country: China name: Xiaojuan Zhang role: CONTACT facility: West China Hospital of Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Yong Peng role: CONTACT lat: 30.66667 lon: 104.06667 facility: The First Affiliated Hospital of Xinjiang Medical University status: NOT_YET_RECRUITING city: Ürümqi state: Xinjiang country: China name: Xiang Ma role: CONTACT lat: 43.80096 lon: 87.60046 facility: Taizhou Central Hospital status: RECRUITING city: Taizhou state: Zhejiang country: China name: Haipeng Cai role: CONTACT phone: 13867622455 email: 1917483306@qq.com lat: 32.49069 lon: 119.90812 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-26 uploadDate: 2024-02-29T04:49 filename: Prot_000.pdf size: 711941 hasResults: False

 nctId: NCT06336226 id: BB AVF one stage vs two stage briefTitle: Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-05 date: 2024-03-28 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques . conditions: Arterio-venous Fistula studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Brachio basilic arterio venous fistula one stage versus two stage measure: Comparative study between one stage brachio basilic arterio venous fistula versus two stage sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336213 id: 20240306 briefTitle: Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients overallStatus: RECRUITING date: 2024-02-19 date: 2024-11-01 date: 2024-12-15 date: 2024-03-28 date: 2024-03-28 name: Petrovsky National Research Centre of Surgery class: OTHER briefSummary: According to the literature, presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units, but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery. Previous study carried out in Petrovsky NRCS related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis. conditions: Aortic Aneurysm and Dissection conditions: Cardiac Valve Disease conditions: Thoracic Aortic Aneurysm conditions: Thoracic Aortic Dissection studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Ampicillin-sulbactam measure: Infectious complications rate measure: Total amount of complicated patients measure: Mortality measure: Length of hospital stay measure: Length of ICU stay measure: Multiorgan failure sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Petrovsky Research National Centre of Surgery (Petrovsky NRCS) status: RECRUITING city: Moscow zip: 119991 country: Russian Federation name: Artem Gubko, Ph.D. role: CONTACT phone: +79684241490 email: gubko@artvig.ru name: Denis Guskov, Ph.D role: SUB_INVESTIGATOR name: Boris Akselrod, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06336200 id: Karabuk-006 briefTitle: Knee Osteoarthritis and Kinesiophobia overallStatus: RECRUITING date: 2024-01-01 date: 2024-04-30 date: 2024-05-30 date: 2024-03-28 date: 2024-04-05 name: Karabuk University class: OTHER briefSummary: Kinesiophobia after total knee arthroplasty is an important parameter affecting recovery. However, the relationship between kinesiophobia and the factors it may cause is not clear. Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after total knee arthroplasty. conditions: Knee Osteoarthritis conditions: Kinesiophobia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 56 type: ESTIMATED measure: Kinesiophobia measure: Severity of pain measure: Functional mobility measure: Proprioception measure: Fear of falling sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Pursaklar Public Hospital status: RECRUITING city: Ankara country: Turkey name: Musa Gunes, Msc role: CONTACT phone: 0 (370) 418 9081 email: musagunes@karabuk.edu.tr name: Fidan Yılmaz, Msc role: PRINCIPAL_INVESTIGATOR name: Emime Emirmahmutoğlu, Bachelors role: PRINCIPAL_INVESTIGATOR name: Buğrahan Şahin, MD role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06336187 id: UPO 2020 02 briefTitle: European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study) acronym: EASE overallStatus: RECRUITING date: 2018-06-01 date: 2024-12 date: 2030-12 date: 2024-03-28 date: 2024-04-10 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER name: Università degli Studi del Piemonte Orientale "Amedeo Avogadro" briefSummary: The goal of this observational, prospective, multi-national clinical study is to assess overall survival of patients who are diagnosed with incidental, histologically (biopsy) confirmed, \<4 cm Renal Cell Carcinoma (RCC) and are managed conservatively with active surveillance.

The primary endpoint is overall survival. The Secondary endpoints are tumor growth rate, progression rate, cancer-specific survival, progression-free survival, identification of clinical and pathological variables and molecular and genetic markers that correlate with growth rate and progression.

The main question it aims to answer is: patients with RCC (less than 4 cm) diagnosis can be managed with active surveillance instead treated with invasive curative procedure? For all participants a percutaneous biopsy of the renal mass will be arranged in all cases to histologically confirm the diagnosis of RCC (unless a diagnostic biopsy has been acquired in the previous 6 months). As a minimum, two samples will be used for diagnostic purposes while remaining core(s) will be preserved for molecular studies.

Then, all patients will be under active surveillance, which is defined as the initial monitoring of tumor size by serial abdominal imaging (US, CT, or MRI) Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter. A follow-up visit will also be carried out at the time of progression when it occurs. Follow-up visits will include medical history and physical examination (optional), and assessment of concurrent medications, blood and urine collection and storage if participating in translational activities, cross-sectional abdominal and chest imaging exams.

Follow-up percutaneous biopsies of the renal tumor are not mandatory, but can be performed when considered clinically important. conditions: Renal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: active surveillance name: molecular investigation measure: Overall Survival measure: Disease progression measure: Molecular pattern sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Alessandro Volpe, MD role: CONTACT lat: 45.44694 lon: 8.62118 hasResults: False

 nctId: NCT06336174 id: Anhui-SIA-cohort briefTitle: Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study overallStatus: RECRUITING date: 2022-11-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-28 date: 2024-04-02 name: Anhui Medical University class: OTHER briefSummary: The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients. conditions: Intracranial Atherosclerosis conditions: Cognitive Impairment conditions: Cerebrovascular Event studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin name: Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin measure: The changes in Memory measure: Occurrence of ischemic cerebrovascular events measure: MoCA (Montreal Cognitive Assessment) measure: MMSE (Mini Mental State Examination) measure: DST (Digital Span Test; Forward and Backward) measure: The Stroop Color Test measure: CTT (Color Trail Test) measure: CDT (Clock drawing test) measure: VFT (Verbal Fluency Test) measure: HAMD (Hamilton Depression Scale) measure: HAMA (Hamilton Anxiety Scale) measure: MRI measure- resting state MRI images measure: MRI measures-structural phase MRI images measure: MRI measures-3D pCASL images measure: Ultrasound measures-MCA-PI (middle cerebral artery-pulsatility index) measure: Ultrasound measures-IMT (intima-media thickness) measure: Blood Metabolomics measures-CRP (C-reactive protiein) measure: Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein) measure: Blood Metabolomics measures-miRNA/microRNA sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Medical University status: RECRUITING city: Hefei state: Anhui zip: 230032 country: China name: Qiang Wei, PhD role: CONTACT phone: +8618788836237 email: qiangwei_914@126.com lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06336161 id: ESPB versus CEI briefTitle: Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-03-28 date: 2024-03-28 name: Al-Azhar University class: OTHER briefSummary: Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.

The methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Fentanyl measure: Measurement of Post-operative Pain sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT facility: Al-Azhar University hospitals city: Cairo country: Egypt name: Mohamed Khalil, Resident role: CONTACT phone: +201001297071 email: khalil.mohamed24mkh@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06336148 id: ACTM-838-01 briefTitle: A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-07 date: 2024-03-28 date: 2024-03-28 name: Actym Therapeutics, Inc. class: INDUSTRY briefSummary: This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an Open label Single dose study. primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 35 type: ESTIMATED name: ACTM-838 measure: Incidence and severity of adverse events and serious adverse events - Part 1a and Part 1b measure: Proportion of participants experiencing dose limiting toxicities - Part 1a and 1b measure: Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) - Part 1a and Part 1b measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1b measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1b measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1b measure: Progression free survival (PFS) - Part 1b measure: Change in tumor markers - Part 1b measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1b measure: Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a measure: Progression free survival (PFS) - Part 1a measure: Change in tumor markers - Part 1a measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a measure: Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200 city: Westmead state: New South Wales zip: 2145 country: Australia name: Mark Wong, Dr role: CONTACT phone: +61 2 9845 5200 email: mark.wong@sydney.edu.au lat: -33.80383 lon: 150.98768 facility: Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202 city: Bedford Park state: South Australia zip: 5042 country: Australia name: Ganessan Kichenadasse, Dr role: CONTACT phone: +61 491 670 039 email: clinicaltrials@socru.org.au lat: -35.03333 lon: 138.56667 facility: Alfred Hospital, 55 Commercial Road, Site No: 201 city: Melbourne state: Victoria zip: 3004 country: Australia name: Andrew Haydon, Dr role: CONTACT phone: +61 3 9076 3129 email: andrew.haydon@monash.edu.au lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06336135 id: 23-001 briefTitle: Reduction in Symptoms After Laser Therapy With Acorn aHFS overallStatus: ENROLLING_BY_INVITATION date: 2024-03-25 date: 2025-03 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: Acorn Biolabs Inc. class: INDUSTRY briefSummary: This study evaluates the severity and duration of symptoms experienced after laser therapy comparing four post-procedure topical products. Each product is applied to an individual region of interest (5 cm diameter) on the back or décolleté according to randomization code after laser therapy. The subject, blind to the product applied to each of 4 regions of interest, assesses eight symptoms daily for 14 days. Photography is performed daily. conditions: Skin Aging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: autologous hair follicle derived secretome measure: Reduction in severity and duration of symptoms sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Rejuuv Medi Spa city: Markham state: Ontario zip: L3R0M3 country: Canada lat: 43.86682 lon: -79.2663 hasResults: False

 nctId: NCT06336122 id: 83904_1 id: R01DK135885-01 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK135885-01 briefTitle: OASIS: Peer Support for T2DM in Appalachia (Peer Participant) acronym: OASIS overallStatus: RECRUITING date: 2024-02-21 date: 2025-12-31 date: 2026-03-31 date: 2024-03-28 date: 2024-04-08 name: University of Kentucky class: OTHER name: Department of Health and Human Services name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are:

Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management?

If effective, which facets of the peer model are most effective? Peer coaches will Undergo peer coach training.

Reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting.

Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 76 type: ESTIMATED name: Peer Coach Training - Weekly name: Peer Coach Training - Biweekly measure: Number of participants with change in A1c measure: Diabetes Empowerment measure: Quality of Life Index measure: Social Support measure: Depression Scale measure: Problem Areas in Diabetes measure: Diabetes Self-Management measure: Acts of Daily Living measure: Social Network Scale sex: ALL minimumAge: 55 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barren River Area Development District status: RECRUITING city: Bowling Green state: Kentucky zip: 42101 country: United States name: Michelle Hines role: CONTACT phone: 270-306-4036 email: michelle@bradd.org lat: 36.99032 lon: -86.4436 facility: UK HealthCare status: RECRUITING city: Hazard state: Kentucky zip: 41701 country: United States name: Kay Douthitt, MD role: CONTACT email: key.douthitt@uky.edu lat: 37.24954 lon: -83.19323 hasResults: False

 nctId: NCT06336109 id: N-20220063-3 briefTitle: Fragmented Sleep, Pain, and Biomechanics overallStatus: RECRUITING date: 2024-01-26 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-04-03 name: Aalborg University class: OTHER briefSummary: This interventional study aims to test the effects of sleep disruption on pain sensitivity and biomechanics in healthy individuals during experimental knee and shoulder pain. The main question the study aims to answer is:

1) Does sleep fragmentation increase experimental knee and shoulder pain and what are the underlying mechanisms?

Participants will receive two injections a) Hypertonic saline (painful) in the knee and b) hypertonic saline (painful) in the upper arm. conditions: Pain conditions: Healthy conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Hypertonic saline knee and shoulder injection measure: Knee Pain intensity (NRS 0-10) measure: Shoulder Pain intensity (NRS 0-10) measure: Pain sensitivity measure: The Pittsburgh Sleep Quality Index score measure: The Pain catastrophizing Scale score measure: The Hospital Anxiety and Depression Scale score measure: The Knee injury and Osteoarthritis Outcome Score measure: Rapid Assessment of Physical Activity score measure: Pain distribution by number of pixels marked on a body chart measure: Video-based motion capture measure: Quality of sleep (NRS 0-100) measure: Level of rest (NRS 0-100) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Aalborg University status: RECRUITING city: Aalborg state: Nordjylland zip: 9000 country: Denmark name: Kristian K Petersen, Dr. Med role: CONTACT phone: (+45) 31697510 email: kkp@hst.aau.dk name: Emma Hertel, M. Sc. role: CONTACT phone: (+45) 60887473 email: eh@hst.aau.dk lat: 57.048 lon: 9.9187 hasResults: False

 nctId: NCT06336096 id: VX23-548-017 briefTitle: A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine overallStatus: RECRUITING date: 2024-03-28 date: 2024-10 date: 2024-10 date: 2024-03-28 date: 2024-04-26 name: Vertex Pharmaceuticals Incorporated class: INDUSTRY briefSummary: The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, in healthy participants. conditions: Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 72 type: ESTIMATED name: Suzetrigine name: Suzetrigine measure: Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ measure: Part B: Cmax of SUZ measure: Part B: AUC0-tlast of SUZ measure: Part B: AUC0-inf of SUZ measure: Part A: Cmax of SUZ Metabolite measure: Part A: AUC0-tlast of SUZ Metabolite measure: Part A: AUC0-inf of SUZ Metabolite measure: Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Part B: Cmax of SUZ Metabolite measure: Part B: AUC0-tlast of SUZ Metabolite measure: Part B: AUC0-inf of SUZ Metabolite measure: Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs measure: Part C: Cmax of SUZ and its Metabolite measure: Part C: AUC0-tlast of SUZ and its Metabolite measure: Part C: AUC0-inf of SUZ and its Metabolite measure: Part C: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion - Tempe status: RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 hasResults: False

 nctId: NCT06336083 id: RC31/23/0618 briefTitle: Familial Form of Carotid Web: a Doppler Ultrasound Study acronym: Family-WEB overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-03-28 date: 2024-04-11 name: University Hospital, Toulouse class: OTHER briefSummary: There is no evidence of familial forms of carotid web. The aim of this study is to determine the prevalence of carotid web among relatives of patient with carotid web using carotid doppler ultrasound. conditions: Carotid Web studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 90 type: ESTIMATED name: Doppler ultrasound measure: Evaluation of the prevalence of carotid web by doppler ultrasound in first-degree relatives of patients with carotid web. measure: Description of the clinical characteristics of relatives with carotid web and their index case. measure: Description of the morphological characteristics of relatives with carotid web and their index case. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Toulouse, Purpan city: Toulouse zip: 31059 country: France name: Louis FONTAINE, MD role: CONTACT phone: 05 61 77 93 67 phoneExt: +33 email: fontaine.l@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06336070 id: 2024-FIS-3251696 id: CIACIF/2022/368 type: OTHER_GRANT domain: Regional Ministry of Education, Universities and Employment - Generalitat Valenciana briefTitle: Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study acronym: POWER Health overallStatus: RECRUITING date: 2024-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-28 date: 2024-04-04 name: University of Valencia class: OTHER name: Generalitat Valenciana briefSummary: POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations. conditions: Breast Cancer Female conditions: Cardiometabolic Syndrome conditions: Metabolism Disorder, Lipid conditions: Autonomic Dysfunction conditions: Cardiovascular Diseases in Old Age studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: HIIT program (8 weeks) name: MPI program (8 weeks) measure: Fat oxidation during incremental test measure: Detrended Fluctuation Analysis measure: Weight measure: Height measure: Calf, waist and hip circumferences. measure: Lean mass measure: Fat-free mass measure: Visceral adipose tissue measure: Bone Mass measure: Fat mass measure: Blood Pressure measure: Oxygen Saturation measure: Sarcopenia measure: Physical activity and sedentariness measure: Lactate measure: Rating Perceived Exertion measure: Visual Analogue Scale of Pain measure: Cadence measure: Mechanical Power measure: Muscle Power 5STS measure: Basal metabolic rate measure: Respiratory exheange ratio at rest measure: Fat oxidation at rest measure: Carbohydrate oxidation at rest measure: Carbohydrate oxidation during incremental test measure: Energy expenditure during incremental test measure: FATmax intensity measure: VO2peak measure: Sample Entropy measure: SD1/SD2 ratio measure: The root mean square of successive differences between normal heartbeats (RMSSD) sex: FEMALE minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Activity and Sport Sciences status: RECRUITING city: Valencia state: Comunidad Valenciana zip: 46010 country: Spain name: Cristina Blasco Lafarga, PhD role: CONTACT phone: 64372 phoneExt: 9638 email: m.cristina.blasco@uv.es name: Jordi Monferrer-Marín, Predoctoral student role: SUB_INVESTIGATOR name: Ainoa Roldán, PhD role: SUB_INVESTIGATOR name: Jørn Wulff Helge, PhD role: SUB_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06336057 id: RC31/23/0408 briefTitle: Mentalizating in Adults Suffering From Narcolepsy Type 1. acronym: NARCOMENTAL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: University Hospital, Toulouse class: OTHER briefSummary: The main objective is to examine the potential mentalization impairments affecting a population suffering from narcolepsy type 1. Indeed, the hypothesis of this research is that mentalization could be impaired in narcoleptic patients. conditions: Narcolepsy Type 1 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Mentalization measure: Comparison of mentalization abilities, in a population of patients with NT1 versus a control group. measure: Comparison and description of mentalization abilities in a population of patients versus controls. measure: Better characterization of the clinical impression of an altered subjective experience of the difficulties the patients are going through. measure: Determination of the existence of a correlation between the time of appearance of the first symptoms and the initiation of treatment and the level of mentalization in NT1 patients, or not. measure: Determination of the existence of a correlation between the age at the first symptoms of NT1 patients and mentalization abilities, or not. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet city: Toulouse zip: 31059 country: France name: Rachel DEBS, Dr role: CONTACT phone: 05 61 77 94 88 email: debs.r@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06336044 id: Taufiller/22 briefTitle: Pre-marketing Clinical Trial to Evaluate the Safety and Efficacy of the Filler of Hyaluronic Acid Recombinant Collagen overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2025-01 date: 2024-03-28 date: 2024-03-28 name: Taumedika s.r.l. class: INDUSTRY name: Nextrasearch S.r.l.s. briefSummary: Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 20 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events conditions: Wrinkle conditions: Scar conditions: Laxity; Skin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 20 patients will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Karisma measure: Safety: no adverse events measure: Efficacy: change of wrinkles and scars measure: Efficacy: change of wrinkles and scars measure: Efficacy: change of wrinkles and scars measure: Efficacy: change of wrinkles and scars measure: Duration of the efficacy sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06336031 id: 30002163 briefTitle: Impact of Blood Phobia on Fainting Susceptibility overallStatus: RECRUITING date: 2024-03-30 date: 2024-12 date: 2025-02 date: 2024-03-28 date: 2024-04-17 name: Simon Fraser University class: OTHER briefSummary: The primary purpose of this study is to characterize cardiovascular autonomic function to emotional stimuli (blood-injection-injury phobia \[needle phobia\]) during an orthostatic (upright) challenge in individuals with and without known needle phobia. It is well established that emotional stress can produce hypotensive (low blood pressure) reactions. Interestingly, these hypotensive reactions to venipuncture (even with minimal blood drawn), insulin injections, finger sticks for blood sugar monitoring, dental care, and vaccinations can affect up to a quarter of adults and appear to be uniquely associated with blood-injection-injury phobia rather than other phobias. These hypotensive reactions can ultimately lead to a vasovagal syncope (fainting) response, and lead to increased avoidance of medical and dental procedures as a result of this phobia. Ultimately, this has severe implications on public health and places additional strain on the Canadian healthcare system. Currently, there is limited understanding surrounding the initiation of this response. Additionally, a comprehensive profile of cardiovascular autonomic function during exposure to provoking stimuli during orthostatic stress has not been captured in the literature. We will test individuals with and without blood-injection-injury phobia using our standard approach while exposing them to emotional stimuli. conditions: Syncope, Vasovagal conditions: Blood, Injection, Injury Type Phobia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: blood-injection-injury (BII) phobia stimuli name: neutral stimuli measure: Orthostatic Tolerance sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Simon Fraser University status: RECRUITING city: Burnaby state: British Columbia zip: V5A 1S6 country: Canada name: Vera E Lucci, PhD role: CONTACT phone: 7787828560 email: vlucci@sfu.ca name: Victoria E Claydon, PhD role: PRINCIPAL_INVESTIGATOR lat: 49.26636 lon: -122.95263 hasResults: False

 nctId: NCT06336018 id: NN7535-7703 id: U1111-1289-2466 type: OTHER domain: World Health Organization (WHO) briefTitle: A Research Study on Etavopivat in Participants With and Without Liver Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2025-07-04 date: 2025-07-04 date: 2024-03-28 date: 2024-03-28 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days. conditions: Liver Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Etavopivat measure: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat) measure: Maximum observed etavopivat plasma concentration after a single dose (Cmax, etavopivat) measure: Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration after a single dose (AUC0-last, etavopivat) measure: Time to maximum observed etavopivat plasma concentration after a single dose (tmax, etavopivat) measure: Terminal half-life for etavopivat after a single dose (t1/2, etavopivat) measure: Apparent plasma clearance of etavopivat after a single dose (CL/Fetavopivat) measure: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values (Vz/Fetavopivat) measure: Number of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orlando Clinical Research Center city: Orlando state: Florida zip: 32806 country: United States lat: 28.53834 lon: -81.37924 facility: Amer. Rrsch Corp-TX Liver Inst city: San Antonio state: Texas zip: 78215 country: United States lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06336005 id: NN6022-7683 briefTitle: A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People overallStatus: RECRUITING date: 2024-03-28 date: 2024-10-17 date: 2024-10-17 date: 2024-03-28 date: 2024-04-15 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.

The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.

Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.

The study will last for about 10 months in total. conditions: Healthy Volunteers conditions: Cardiometabolic Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: NNC6022-0001 name: Placebo (NNC6022-0001) measure: Number of treatment emergent adverse events (TEAE) measure: AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose measure: AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose measure: Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose measure: IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON - location Groningen status: RECRUITING city: Groningen zip: 9728 NZ country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06335992 id: Dnr 2022-00831-01 briefTitle: Tissue Regeneration in Patients With Chronic Obstructive Pulmonary Disease After an Exercise Intervention. acronym: T-Rex overallStatus: RECRUITING date: 2022-09-01 date: 2025-02-28 date: 2025-04-30 date: 2024-03-28 date: 2024-03-28 name: Uppsala University class: OTHER name: Lund University briefSummary: The main objective of this project is to identify mechanisms for lung regeneration in patients with COPD induced by exercise training. The hypothesis is that adjusted exercise training improves disease outcome in these patients by decrease remodelling processes linked to oxidative stress, inflammatory and/or immunological pathways in the lung. Along the way, the investigator also expect to identify (or validate) biomarkers mirroring systemic processes such as reduced inflammation and ameliorating the epithelial barrier in these patients. These events may additionally act as potential targets for interventions.

Objectives (i) Evaluate biomarkers for regenerative processes, matrix turnover, stem cell activity and inflammatory patterns in lung tissue biopsies, blood- and urine samples correlated to vital lung parameters and physical capacity, before and after attending an exercise-training program.

(ii) Study the effects of exercise training on the pulmonary ventilation/perfusion ratio and quality of life.

(iii) Evaluate the relation between pathophysiology in the lung evaluated by CT scan, and systemic response measured by muscle biopsies and biomarkers in blood/urine.

(iv) Investigate in vitro cell behaviour and remodelling/regenerative processes altered in COPD patients upon exercise training (aim 1). conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Exercise regime measure: Pulmonary Function measure: Physical capacity measure: Inflammation markers measure: Level of emphysema measure: Maximal physical capacity ( Wmax) measure: COPD Assessment Test (CAT) sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lund University status: RECRUITING city: Lund country: Sweden name: Gunilla Westergren Thorsson, Phd role: CONTACT phone: +4646222 00 00 email: gunilla.westergren-thorsson@med.lu.se name: Caroline Ms Larsson, Phd role: CONTACT phone: +46736673026 email: caroline.larsson@med.lu.se lat: 55.70584 lon: 13.19321 facility: Uppsala University status: RECRUITING city: Uppsala country: Sweden name: Margareta Mrs Emtner, Phd role: CONTACT phone: +46737594481 email: margareta.emtner@medsci.uu.se name: Christer Mr Janson, Phd role: CONTACT phone: +46186114115 email: christer.janson@medsci.uu.se lat: 59.85882 lon: 17.63889 hasResults: False

 nctId: NCT06335979 id: CPIT565B12101 id: 2023-510025-14-00 type: OTHER domain: EU CT briefTitle: An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). overallStatus: NOT_YET_RECRUITING date: 2024-12-16 date: 2028-08-23 date: 2028-08-23 date: 2024-03-28 date: 2024-04-11 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE conditions: Systemic Lupus Erythematosus, SLE studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: PIT565 measure: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) measure: Maximum Observed Blood Concentrations (Cmax) measure: Time to Reach Maximum Blood Concentrations (Tmax) measure: Presence/absence of Anti-drug Antibodies sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335966 id: STUDY00025975 briefTitle: BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy acronym: BEST-RPP overallStatus: RECRUITING date: 2024-01-25 date: 2025-01-30 date: 2025-01-30 date: 2024-03-28 date: 2024-03-28 name: OHSU Knight Cancer Institute class: OTHER name: Kuni Foundation name: Oregon Health and Science University briefSummary: Recent advancements in swallowable esophageal cell-collection devices (SECD) offer a safe, minimally invasive, accurate, and low-cost alternative to esophageal screening without the need for an upper endoscopy. The BEST-RPP study aims to evaluate the acceptability and feasibility of using this novel approach to screen for Barrett's Esophagus (BE) and Esophageal Carcinoma (EAC) in rural primary care clinic settings in Oregon. conditions: Esophageal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Screening with swallowable esophageal cell-collection devices (SECD) measure: Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD measure: Feasibility of the use of SECD: Number of providers who indicate willingness to be trained and train clinic staff measure: Feasibility of the use of SECD: Number of referrals measure: Feasibility of the use of SECD: Number enrolled measure: Patient acceptability: Number of interested patients who schedule an appointment to be screened measure: Patient acceptability: Number of patients who come to their appointments measure: Patient acceptability: Number of patients interested in being screened via SECD at other care centers measure: Access: time to full diagnostic work up for patients with positive SECD results sex: MALE minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHSU Knight Cancer Institute status: RECRUITING city: Portland state: Oregon zip: 97239 country: United States name: Laura Ferrara, MA role: CONTACT phone: 541-399-1139 name: Fouad Otaki, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06335953 id: IRB00418404 id: U54AG063546 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG063546 briefTitle: ALIGN: Aligning Medications With What Matters Most (Demonstration) overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-04 date: 2025-04 date: 2024-03-28 date: 2024-04-22 name: Johns Hopkins University class: OTHER name: National Institute on Aging (NIA) briefSummary: The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with dementia (PLWD) and the person's care partners.

The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP.

The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months. conditions: Polypharmacy conditions: Alzheimer's Disease and Related Dementias conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 280 type: ESTIMATED name: Pharmacist-led deprescribing intervention measure: Proportion of patients who stop one or more medications measure: Proportion of patients who start one or more new medications measure: Proportion of patients who stop one or more potentially inappropriate medication (PIM) measure: Total number of medications measure: Shared decision-making as assessed by CollaboRATE sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Johns Hopkins Bayview Medical Center city: Baltimore state: Maryland zip: 21224 country: United States name: Ariel Green, MD, MPH, PhD role: CONTACT phone: 410-550-6733 email: ariel@jhmi.edu lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06335940 id: 38RC23.0376 briefTitle: Admission for Respiratory Disease And VIdeo Regulation System acronym: ARAVIS-PED overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-07-31 date: 2024-10-18 date: 2024-03-28 date: 2024-04-02 name: University Hospital, Grenoble class: OTHER briefSummary: Pediatric dyspnea is a major health problem, accounting for up to 27% of admissions to emergency departments in winter. It is estimated that a significant number (13%) of patients presenting to emergency departments are outpatients, at a time when emergency departments are having to cope with an ever-increasing flow of patients.

Proper referral of patients calling the SAMU Centre-15 takes on its full meaning in this context, but regulating paediatric calls is more difficult. Indeed, the regulating doctor is most often in contact with the parents, who describe what they see and pass on their concerns, and it is difficult to have direct contact with patients who are often very young. Obtaining objective criteria such as saturation and respiratory rate is also a real challenge.

To overcome the complexity of medical regulation, a number of tools and aids have been developed, including visio or video-regulation (regulation via the camera on the caller's smartphone).

This device has been evaluated in a number of situations, enabling it to take its place in the daily practice of many doctors, but there is very little data concerning pediatric visio-regulation, particularly with regard to dyspnea.

To the best of the investigator knowledge, there is no prospective study looking at the impact of Video-Regulation on the outcome of patients requiring the advice of SAMU Centre-15 for pediatric dyspnea. conditions: Pediatric Respiratory Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 588 type: ESTIMATED name: Videoregulation measure: To determine in children under 10 years of age for whom a call to the SAMU38 for dyspnea is made, whether the use of Visio-Regulation reduces the percentage of emergency room admissions compared with standard telephone medical regulation. measure: Evaluate whether the use of video-regulation has an impact on the dispatcher's referral decision between ambulatory medicine and the emergency department. measure: Determine whether the use of video-regulation leads to an increase in call time with the regulating doctor measure: Evaluate parents' satisfaction with videoregulation compared with a standard call measure: Evaluate the number of rescue vectors (fire brigade, private ambulance) triggered but whose decision will ultimately be to "leave on the spot" after the rescue worker's assessment. measure: Evaluate whether the increased use of video-regulation is not associated with a higher rate of hospitalization in a conventional ward or intensive care unit sex: ALL maximumAge: 10 Years stdAges: CHILD hasResults: False

 nctId: NCT06335927 id: GWK2023-001 briefTitle: HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC overallStatus: RECRUITING date: 2023-05-11 date: 2025-05-10 date: 2026-05-10 date: 2024-03-28 date: 2024-03-28 name: Fudan University class: OTHER briefSummary: This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma.

The study plans to enroll approximately 45 participants. All enrolled participants will receive continuous treatment: HAIC-Gemox: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles, Cadonilimab(6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W) until the investigator determines that there is no longer any clinical benefit (based on comprehensive assessment including RECIST v1.1 imaging evaluation and clinical condition), intolerable toxicity, initiation of new anti-tumor therapy, or meeting other criteria for treatment discontinuation, whichever occurs first. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: HAIC-GEMOX+Cadonilimab+Regorafenib measure: Objective Response Rate (ORR) measure: Hepatic Objective Response Rate (hORR) measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Time to Response (TTR) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Safety and tolerability sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Li Tan role: CONTACT phone: +8615800680751 lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06335914 id: dualPET-mPC id: CAPCR: 23-5595 type: OTHER domain: University Health Network briefTitle: Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-03-04 date: 2029-09-04 date: 2024-03-28 date: 2024-03-28 name: University Health Network, Toronto class: OTHER briefSummary: This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future. conditions: Advanced Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Ga 68 PSMA-11 PET name: 18F-DCFPyL PET name: FDG PET measure: Proportion of patients with high volume mCSPC having PSMA avid disease measure: Proportion of patients with PSMA-/FDG+ discordant lesions sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Princess Margaret Cancer Centre city: Toronto state: Ontario zip: M5G 2M9 country: Canada name: Di (Maria) Jiang, M.D. role: CONTACT phone: 416-946-4501 phoneExt: 4807 email: di.jiang@uhn.ca name: Di (Maria) Jiang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06335901 id: xx20190901 briefTitle: Clinical Characteristics and Outcomes of Coronary Heart Disease overallStatus: COMPLETED date: 2020-02-01 date: 2022-01-31 date: 2022-04-30 date: 2024-03-28 date: 2024-03-29 name: Xinjiang Medical University class: OTHER briefSummary: This study evaluated and compared the prognostic value of different Baseline data and clinical variables to develop a risk ractor ediction model in patients with CHD. conditions: Coronary Heart Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20000 type: ACTUAL name: Drug:Standard therapy measure: Death （All-cause mortality、Cardiac mortality ） measure: Major adverse cardiovascular events sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xinjiang Medical University city: Ürümqi state: Xinjiang zip: 630000 country: China lat: 43.80096 lon: 87.60046 hasResults: False

 nctId: NCT06335888 id: CRAFT briefTitle: A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis acronym: CRAFT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-05 date: 2029-05 date: 2024-03-28 date: 2024-04-05 name: Insel Gruppe AG, University Hospital Bern class: OTHER name: Paul Scherrer Institut, Center for Proton Therapy briefSummary: The goal of this open-label clinical trial is to evaluate the efficacy of AzaFol-PET/CT in the diagnosis of GCA (giant cell arteritis), to compare AzaFol- with 2-\[18F\]FDG-PET/CT, and to assess the safety and tolerability of AzaFol in subjects with suspicion of GCA.

Participants will undergo AzaFol-PET/CT imaging at a single timepoint. conditions: Giant Cell Arteritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Cross-over, randomized, open label, single-centre primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: AzaFol name: FDG measure: Specificity of the GCA-diagnosis at the patient level measure: Lesion detection rate (visual analysis) measure: Lesion detection rate (semiquantitative analysis) measure: Sensitivity of the GCA-diagnosis at the patient level sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rheumatology and Immunology, University Hospital Bern, Inselspital city: Bern zip: 3010 country: Switzerland name: Britta Maurer role: CONTACT lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06335875 id: HUM00227568 briefTitle: Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones acronym: BIPO overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-03-28 date: 2024-03-28 name: University of Michigan class: OTHER briefSummary: Small exploratory open-label pilot study to assess supplementation of a ketone ester (Juvenescence) combined with a 'ketogenic-mimicking diet' as a potential therapy for persons with bipolar disorder. conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Ketone Ester Beverage name: Low Glycemic Index Diet measure: Change in blood beta-hydroxybutyrate level measure: Change in blood glucose lability measure: Change in neural network stability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Domino's Farms city: Ann Arbor state: Michigan zip: 48105 country: United States lat: 42.27756 lon: -83.74088 facility: University Hospital city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06335862 id: NL.84862.041.23 briefTitle: Primary Posterior Tracheopexy Prevents Tracheal Collapse acronym: PORTRAIT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-09-30 date: 2027-03-31 date: 2024-03-28 date: 2024-03-28 name: UMC Utrecht class: OTHER name: For Wis(h)dom Foundation name: Erasmus Medical Center name: Great Ormond Street Hospital for Children NHS Foundation Trust name: Karolinska University Hospital briefSummary: Introduction: Children born with a blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), need to undergo surgical correction in the first week of life. OA is often accompanied by a weakened windpipe (trachea), known as tracheomalacia (TM). TM entails that the windpipe collapses during expiration. Severe TM can cause respiratory symptoms, including frequent respiratory tract infections and blue spells, that can potentially lead to life-threatening events. In some patients, major secondary surgical treatment may be indicated. This surgical procedure involves widening the trachea (using sutures) to prevent collapse, known as secondary posterior tracheopexy (SPT). Prior to performing this SPT, complications and negative consequences of TM may have already occurred. This may be prevented by performing this procedure during the primary OA correction, called a primary posterior tracheopexy (PPT). The aim of this trial is to determine if a PPT can decrease - or prevent - tracheal collapse in newborns with OA and TM, compared to a wait-and-see policy (no-PPT).

Methods: This is an international multicentre double-blind randomised controlled trial. Seventy eight children with OA type C will be included. Patients will be included after written parental informed consent. Half of the patients will be randomly allocated to the PPT-group and half to the no-PPT-group. The degree and location of TM are evaluated through preoperative, intraoperative and two postoperative videoscopic examinations of the trachea (tracheobronchoscopy). Whether TM symptoms occur is assessed during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages.

Risks and burden: Since OA correction with PPT (more recently implemented in centres of expertise) and without PPT (wait-and-see policy) are both accepted and safe treatment options, participating in the trial does not pose an increased risk or burden with regards to the treatment. Performing tracheobronchoscopies may pose a potential burden. However, a tracheobronchoscopy is a routine diagnostic procedure commonly used to safely assess the trachea. Complications of a tracheobronchoscopy are rare. Also, many of the tracheobronchoscopies are routinely performed as part of standard care for these patients, regardless of the trial. conditions: Oesophageal Atresia With Tracheo-Oesophageal Fistula conditions: Tracheomalacia conditions: Oesophageal Atresia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized 1:1 into either the intervention group (PPT-group) or the wait-and-see group (no-PPT). Since the sutures of the PPT remain in place (in the PPT-group), the participants are allocated to one arm for the duration of the study. After the PPT was or was not performed, the participants will follow the same follow-up schedule. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: All participants, parents/caregivers, investigators and treating healthcare personnel, except for the surgical team performing the OA correction, will be blinded to which study arm the participant is assigned. None of the data gathered is affected by the unblinded surgical team since the primary and key secondary outcome measures are evaluated based on pseudonymised video footage. Furthermore, this video footage is assessed by otolaryngologists who are blinded to the patient and study arm. Moreover, the follow-up and documentation of the secondary endpoints are typically performed by the paediatrician and speech- and language therapists (not the paediatric surgeon or otolaryngologist). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 78 type: ESTIMATED name: Randomisation between the PPT- and no-PPT-group name: Primary Posterior Tracheopexy name: Preoperative tracheobronchoscopy name: Intraoperative tracheobronchoscopy name: Postoperative tracheobronchoscopy through the endotracheal tube during extubation name: Postoperative tracheobronchoscopy after 2-6 months measure: Difference in degree of TM between the PPT-group and no-PPT-group during intraoperative tracheobronchoscopy measure: Key secondary outcome: Difference in degree of TM between the PPT-group and no-PPT-group during postoperative tracheobronchoscopy measure: Difference in symptoms between the PPT-group and no-PPT-group measure: Degree of preoperative TM compared to postoperative TM sex: ALL minimumAge: 34 Weeks stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335849 id: LYB004-CT-AUS-101 briefTitle: A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-05 date: 2024-03-28 date: 2024-03-28 name: Guangzhou Patronus Biotech Co., Ltd. class: INDUSTRY name: Yantai Patronus Biotech Co., Ltd. briefSummary: This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years. conditions: Herpes Zoster studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: LYB004 25µg name: LYB004 50µg name: SHINGRIX measure: Evaluate the reactogenicity of LYB004 vaccine measure: Evaluate the safety and reactogenicity of LYB004 vaccine measure: Evaluate the safety of LYB004 vaccine measure: Evaluate the safety and tolerability in laboratory tests of LYB004 vaccine measure: Evaluate the SAEs and AESIs of LYB004 vaccine measure: Observe the humoral immunity of LYB004 vaccine measure: Observe the cellular immunity of LYB004 vaccine measure: Observe the persistence of humoral immunity of LYB004 vaccine measure: Observe the persistence of cellular immunity of LYB004 vaccine sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nucleus Network Pty Ltd city: Melbourne state: Victoria zip: 3004 country: Australia name: Katherine Gunn role: CONTACT phone: (07) 3707 2781 email: k.gunn@nucleusnetwork.com.au name: Kristof Boot role: CONTACT phone: (07) 3707 2780 email: k.boot@nucleusnetwork.com.au name: Christina Chang, M.D. role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06335836 id: 2024-SR-127 id: 2024-SR-127 type: OTHER domain: Ethics Committee of Nanjing Medical University briefTitle: The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD) overallStatus: RECRUITING date: 2024-03-01 date: 2028-12-30 date: 2028-12-30 date: 2024-03-28 date: 2024-03-28 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD

1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD;
2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation;
3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions;
4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients. conditions: Social Isolation conditions: SCD conditions: Subjective Cognitive Decline conditions: MCI conditions: Mild Cognitive Impairment conditions: AD conditions: Alzheimer Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 209 type: ESTIMATED name: social isolation measure: Incidence of Mild Cognitive Impairment (MCI) measure: Incidence of Alzheimer's disease (AD) measure: AVLT-H measure: MoCA measure: WMS-RLM measure: WDS measure: VFT measure: BNT measure: LSNS-6 measure: UCLA measure: GDS measure: PSQI measure: DTC measure: fMRI measure: tau measure: Aβ measure: APOE genotyping measure: TMT-A, TMT-B sex: ALL minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: China, Jiangsu zip: 210000 country: China name: Zhu Yi role: CONTACT phone: +86 137 0516 4030 email: ZhuYi1981@njmu.edu.cn name: Shi Chunxu role: CONTACT phone: +8618625175592 email: scx_0212@outlook.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06335823 id: STUDY20231621 briefTitle: Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2025-08-01 date: 2024-03-28 date: 2024-03-28 name: Jean Marino class: OTHER briefSummary: Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement. conditions: IUD Insertion Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Transcutaneous electrical nerve stimulation (TENS) name: Placebo Transcutaneous electrical nerve stimulation (TENS) measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University Hospitals city: Cleveland state: Ohio zip: 44106 country: United States name: Jean M Marino, APRN-CNP role: CONTACT phone: 440-720-3250 email: Jean.Marino@UHhospitals.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06335810 id: 23-10026599 id: R01DK135949-01 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK135949-01 briefTitle: Reducing Obesity Using Social Ties Program acronym: ROBUST overallStatus: RECRUITING date: 2024-04-05 date: 2026-03 date: 2026-03 date: 2024-03-28 date: 2024-04-17 name: Weill Medical College of Cornell University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: This trial aims to test the feasibility and acceptability of addressing interpersonal barriers to weight-related behavior change. Specifically, the study will test if, by including up to two friends, family members, or co-workers in a lifestyle intervention for weight loss, the person enrolled in the study loses more weight than someone whose friends, family members, or co-workers were not invited to participate. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: Social Network Intervention name: Individual Lifestyle Intervention name: Social Network Member measure: Number of participants who have attended at least 75 percent of the behavioral coaching sessions measure: Number of intervention participants who have at least one social network member engage in the study measure: Number of participants and social network members combined who complete the final study assessment measure: Change in positive communication and problem solving as measured by the McMaster Family Assessment Device (FAD) Questionnaire measure: Change in weight related social norms measure: Change in median Fitbit wear time in minutes measure: Change in total caloric amounts on three-day food record measure: Change in median number of days that the Fitbit is worn sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Urology status: RECRUITING city: Brooklyn state: New York zip: 11217 country: United States name: Jesabely Solano, BS role: CONTACT phone: 646-962-9209 email: jes4037@med.cornell.edu lat: 40.6501 lon: -73.94958 facility: Weill Cornell Internal Medicine Associates status: RECRUITING city: New York state: New York zip: 10021 country: United States name: Jesabely Solano, BS role: CONTACT phone: 646-962-9209 email: jes4037@med.cornell.edu lat: 40.71427 lon: -74.00597 facility: Weill Cornell Primary Care at Lower Manhattan status: RECRUITING city: New York state: New York zip: 10038 country: United States name: Jesabely Solano, BS role: CONTACT phone: 646-962-9209 email: jes4037@med.cornell.edu lat: 40.71427 lon: -74.00597 facility: Weill Cornell Urology status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Jesabely Solano, BS role: CONTACT phone: 646-962-9209 email: jes4037@med.cornell.edu lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06335797 id: IRB00110733 briefTitle: Optimization of Postoperative Bowel Habits overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: Wake Forest University Health Sciences class: OTHER briefSummary: Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 88 type: ESTIMATED name: Senna Tab name: Dulcolax Suppositories measure: Time in hours to first bowel movement comparison between the two arms measure: Change in Overall Satisfaction (TSQM) Scores measure: Visual Analog Scale (VAS) Pain Scores measure: Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores measure: Bristol Stool Form Scale (BSFS) Scores sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Christina M Mezes, MD role: CONTACT phone: 336-713-4098 email: cmezes@wakehealth.edu name: Sachin N Vyas, MS, PhD role: CONTACT phone: 336.713.4098 email: svyas@wakehealth.edu lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06335784 id: 2023-00456 briefTitle: Mental Imagery and Targeted Memory Reactivation in Insomnia overallStatus: RECRUITING date: 2024-04-22 date: 2027-05-31 date: 2027-08-31 date: 2024-03-28 date: 2024-04-23 name: University Hospital, Geneva class: OTHER name: University of Geneva, Switzerland briefSummary: In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID).

Patients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session/week) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night.

Clinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure).

At the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment ("rocking bed") in which they will be cradled for one night.

The investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition. conditions: Insomnia Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Imagery Rescripting (IR) name: Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep name: Sleep Hygiene name: Sleep Hygiene + Odor name: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention measure: Insomnia Severity Index (ISI) measure: Pittsburgh sleep quality index (PSQI) measure: Total Sleep Time (TST) measure: Wake After Sleep Onset (WASO) measure: Beck Depression Inventory II (BDI-II) measure: State Trait Anxiety Inventory (STAI) measure: Sleep efficiency (SE) measure: Micro-arousals measure: Temperament and Character Inventory measure: Pre-sleep Arousal Scale (PSAS) measure: Arousal Predisposition Scale (APS) measure: Digit Span Task measure: Psychomotor Vigilance Task (PVT) measure: Declarative word paired-associate learning task measure: Attachment Style Questionnaire (ASQ) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Center for Sleep Medicine status: RECRUITING city: Geneva country: Switzerland name: Lampros Perogamvros role: CONTACT phone: +41223729946 email: Lampros.Perogamvros@hcuge.ch name: Lampros Perogamvros role: PRINCIPAL_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False

 nctId: NCT06335771 id: 2098077 id: R01DK131188 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK131188 briefTitle: Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity acronym: ATM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-03 date: 2028-03 date: 2024-03-28 date: 2024-03-28 name: Bettina Mittendorfer class: OTHER name: National Institutes of Health (NIH) name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.

Both groups will have:

* screening visit
* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans)
* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss. conditions: Obesity conditions: Nonalcoholic Fatty Liver conditions: Diabetes Type 2 conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Dietary consultation weight loss intervention measure: Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure. measure: 24-hour plasma glucose concentration measure: Macrophage isolation in adipose tissue biopsy measure: Macrophage isolation in skeletal muscle tissue sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Missouri School of Medicine city: Columbia state: Missouri zip: 65212 country: United States name: Bettina Mittendorfer role: CONTACT phone: 573-822-9377 email: b.mittendorfer@missouri.edu lat: 38.95171 lon: -92.33407 hasResults: False

 nctId: NCT06335758 id: EXC-039-2023-CLR briefTitle: Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication. acronym: RegStud overallStatus: RECRUITING date: 2024-01-15 date: 2025-12-31 date: 2026-01-31 date: 2024-03-28 date: 2024-03-28 name: Dosentrx Ltd. class: INDUSTRY name: US Oncology Research briefSummary: The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.

The study will evaluate and monitor use of ReX in respect of:

* treatment duration
* adverse events
* patient adherence and compliance
* engagement with ReX via patient-reported outcomes

Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen. conditions: Any Solid Oral Medication studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Use of ReX to dispense and monitor solid oral medication therapy. measure: Treatment duration measure: Patient satisfaction measure: Adverse events measure: Patient adherence measure: Patient compliance measure: Patient engagement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHC status: RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States name: Zachary Beck role: CONTACT lat: 39.12713 lon: -84.51435 hasResults: False

 nctId: NCT06335745 id: 24-066 briefTitle: PediCARE Health Equity Intervention in High-Risk Neuroblastoma overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-04-01 date: 2030-04-01 date: 2024-03-28 date: 2024-03-28 name: Dana-Farber Cancer Institute class: OTHER briefSummary: This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.

The names of the intervention groups in this research study are:

* Usual supportive care
* PediCARE + usual supportive care conditions: Neuroblastoma conditions: High-risk Neuroblastoma conditions: Pediatric Cancer conditions: Disparities conditions: Financial Stress conditions: Poverty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 130 type: ESTIMATED name: PediCARE Intervention measure: Change in Kessler-6 Psychological Distress Scale Score measure: Proportion of Enrolled Participants (Feasibility) measure: Change in Mean Household Material Hardship (HMH) Score sex: ALL minimumAge: 0 Years maximumAge: 17 Years stdAges: CHILD facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: Dana Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06335732 id: P.T.REC/012/004394 briefTitle: Prevalenc Of Lumbosacral Radiculopathy Among Physiotherapists Of Pediatric Rehabilitation OF PEDIATRIC REHABILITATION overallStatus: COMPLETED date: 2022-12-05 date: 2023-06-08 date: 2023-08-22 date: 2024-03-28 date: 2024-03-28 name: Kerolous Ishak Shehata class: OTHER briefSummary: Determine the prevalence of lumbosacral radiculopathy among pediatric physiotherapists in the ministry of health in Cairo, Egypt. conditions: Prevalence, Lumbosacral Radiculopathy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 200 type: ACTUAL name: Cross section study; single group related measurement design. measure: The Roland-Morris disability scale (RMS) measure: Straight Leg Raising (SLR) sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: Kerolous Ishak Shehata city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06335719 id: IRB #22-926 briefTitle: Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome overallStatus: RECRUITING date: 2023-03-01 date: 2025-03 date: 2025-06 date: 2024-03-28 date: 2024-03-28 name: The Cleveland Clinic class: OTHER briefSummary: A research study to find out if brief intraoperative electrical stimulation therapy improves nerve regeneration and smile outcomes following two-stage cross face nerve graft facial reanimation surgery. conditions: Facial Paralysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will undergo all the standard steps of the facial reanimation procedures. The difference in care is 2/3 participants may receive the brief electrical stimulation therapy.

Other 1/3 of study participants will undergo the surgery as they normally would if they had not chosen to participate. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is a randomized, controlled, double-blinded (patient and evaluator) prospective study. Plan is to enroll up to 30 patients, with a minimum of 20 completing full follow-up. Randomization 2:1 treatment to control due to previous peripheral nerve research demonstrating intraoperative stimulation accelerates axonal regeneration whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: BES name: Standard of Care surgery measure: To evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology. measure: To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Foundation status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Hana Rosen, MD role: CONTACT phone: 216-444-7018 email: rosenh@ccf.org name: John O'Neill, BS role: CONTACT phone: 4405062611 email: oneillj2@ccf.org name: Patrick Byrne, MD role: PRINCIPAL_INVESTIGATOR name: Michael Fritz, MD role: SUB_INVESTIGATOR name: Brandon Hopkins, MD role: SUB_INVESTIGATOR name: Peter Ciolek, MD role: SUB_INVESTIGATOR name: Dane Genther, MD role: SUB_INVESTIGATOR name: Stephen Hadford, MD role: SUB_INVESTIGATOR name: Peng Ding, MD role: SUB_INVESTIGATOR name: Derek Vos, BS role: SUB_INVESTIGATOR lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06335706 id: 0596/66 briefTitle: The Influence of Fit of Underpants Worn on Semen Quality overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-28 date: 2024-03-28 name: Chulalongkorn University class: OTHER briefSummary: The goal of this observational study is to investigate the impact of underpants fit among Thai males attending the Infertility Clinic, whether alone or with their spouses. The main questions it aims to answer are:

* Assessing the effect of underpants fit on basic semen parameters and sperm DNA integrity.
* Determining the prevalence of preferred type of underpants worn by Thai males.

The participants will need to provide informed consent, complete a questionnaire consisting of 28 questions, and provide a semen sample. conditions: Infertility, Male conditions: Semen Analysis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED name: Fit of underpants worn measure: Semen Volume measure: Total sperm count measure: Sperm concentration measure: Sperm motility measure: Sperm morphology measure: Sperm DNA integrity measure: Preferred type of underpants sex: MALE minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06335693 id: CHHHospital briefTitle: Adjuvant Hypofractionated Radiotherapy for Prostate Cancer overallStatus: RECRUITING date: 2024-03-28 date: 2026-02-28 date: 2027-02-28 date: 2024-03-28 date: 2024-03-28 name: Changhai Hospital class: OTHER briefSummary: Hypofractionated radiation therapy is a new type of radiotherapy which has been shown to play a larger role in the treatment of prostate cancer. The aims of the trial were to evaluate the safety and feasibility of adjuvant hypofractionated radiotherapy following radical prostatectomy for prostate cancer. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Radiotherapy measure: Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events measure: progression-free survival (PFS) measure: medical expenses measure: quality of life(QoL) measure: overall survival (OS) measure: prostate cancer-specific survival (CSS) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Naval Medical University status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Huojun Zhang, PhD role: CONTACT phone: 021-31162222 email: huojunzh@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06335680 id: 21-001493 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-28 date: 2024-03-28 name: [Redacted] hasResults: False

 nctId: NCT06335667 id: 4565 id: UCI 23-72 type: OTHER domain: UCI CFCCC briefTitle: mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer Objectives overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2030-04 date: 2024-03-28 date: 2024-03-28 name: University of California, Irvine class: OTHER briefSummary: This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC). conditions: Urothelial Bladder Cancer conditions: Muscle-Invasive Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: mpMRI + Diagnostic TURBT measure: Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT. measure: Progression free survival (PFS) with mpMRI compared to diagnostic TURBT measure: Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy measure: Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI). measure: Incidence of adverse events with mpMRI versus diagnostic TURBT. measure: Patient Quality of Life with mpMRI versus diagnostic TURBT. measure: Incidence of repeat TURBT. measure: Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chao Family Comprehensive Cancer Center University of California, Irvine city: Orange state: California zip: 92868 country: United States name: Nataliya Mar, MD role: CONTACT phone: 877-827-8839 email: ucstudy@uci.edu lat: 33.78779 lon: -117.85311 hasResults: False

 nctId: NCT06335654 id: 24K056-001 briefTitle: Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-04-18 name: The First Hospital of Jilin University class: OTHER briefSummary: Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. However, with the increasing number of endoscopic resection, the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to distinguish neoplastic from non-neoplastic during colonoscopy. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC can demonstrate the atypical of gland structure and cells after staining and display the super-amplified surface microvessels of the lesion under the EC-NBI mode. However, the judgment of endocytoscopic images needs a lot of experience to improve the diagnostic accuracy. Moreover, endoscopists have certain subjective judgments and errors in endocytoscopic diagnosis. There is an artificial intelligence system which has been developed to identify colorectal neoplasms. However, there is still a lack of prospective clinical verification based on Chinese population. In the study, the investigators performed a prospective clinical study to determine the diagnostic accuracy of artificial intelligence system. conditions: Colorectal Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 350 type: ESTIMATED name: artificial intelligence system measure: sensitivity measure: specificity measure: accuracy measure: positive predictive value measure: negative predictive value measure: high confidence diagnosis rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: First hospital of Jilin University status: RECRUITING city: Changchun state: Jilin zip: 130021 country: China lat: 43.88 lon: 125.32278 hasResults: False

 nctId: NCT06335641 id: COOLHD24-CAN briefTitle: Head COOLing in iscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety stuDy acronym: COOLHEAD-2-CAN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-03-28 date: 2024-03-28 name: University of Calgary class: OTHER briefSummary: This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures. conditions: Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: External active conductive head cooling measure: Adherence to the intervention. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335628 id: RCT: CTG-VCMX briefTitle: Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2029-04 date: 2024-03-28 date: 2024-03-28 name: University of Bern class: OTHER briefSummary: The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed. conditions: Connective Tissue Graft conditions: Volume Collagen Matrix Xenograft studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 38 type: ESTIMATED name: Geistlich Fibro-Gide® measure: Volumetric dimensional changes measure: Clinical: PPD measure: Clinical BoP measure: Clinical: Suppuration measure: Clinical: Mucosa measure: Clinical: ktw measure: Clinical: Mobility measure: Clinical: Thickness measure: Clinical: Contributing factors measure: Patient-reported satisfaction measure: Patient-reported esthetics measure: Patient-reported discomfort measure: Patient-reported pain measure: Prosthetics Survival measure: Prosthetics Sucess measure: Prosthetics Complications measure: Prosthetics PES-WES measure: Prosthetics: Occlusal measure: Prosthetics: Interproximal measure: Radiographics BL measure: Radiographics PP measure: Radiographics distance measure: Radiographics Contacts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bern city: Bern zip: 3010 country: Switzerland name: Martin Schimmel, Prof. role: CONTACT phone: +41316840630 email: martin.schimmel@unibe.ch name: Manrique Fonseca, Dr. med. dent. role: PRINCIPAL_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06335615 id: FMG-5790_2023 briefTitle: A Brief Acceptance Intervention for Stress to Improve Students' Well-Being overallStatus: COMPLETED date: 2023-11-27 date: 2023-12-19 date: 2023-12-19 date: 2024-03-28 date: 2024-03-28 name: VU University of Amsterdam class: OTHER briefSummary: The goal of this randomized controlled trial is to test a brief psychological intervention that focusses on acceptance of stress in a student population. The main questions it aims to answer are:

* Does this brief acceptance intervention increase the well-being of students in the short term?
* By which mechanisms does this effect occur?
* What are moderating factors of this effect?

Half of the participants follow a one-hour intervention, which includes

* psychoeducation and metaphors about stress and how acceptance can help to deal with it
* experiential exercises
* mindfulness meditation
* mindfulness homework practice

Students that receive the intervention will be compared to students that merely received psychoeducation about stress and acceptance to see if the intervention lead to larger increases in well-being. conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 116 type: ACTUAL name: Brief Acceptance Intervention name: Psychoeducation measure: Psychological Well-Being measure: State Anxiety measure: Study Stress measure: Interoceptive awareness measure: Psychological Flexibility sex: ALL minimumAge: 17 Years maximumAge: 29 Years stdAges: CHILD stdAges: ADULT facility: University of Amsterdam city: Amsterdam state: Noord-Holland zip: 1018 WS country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06335602 id: 202301283A3 briefTitle: TCM for Post-operative Edema overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-09-30 date: 2025-12-31 date: 2024-03-28 date: 2024-03-28 name: Chang Gung Memorial Hospital class: OTHER briefSummary: There are loads of research on knee surgery, including surgical methods, rehabilitation strategies, and complication prevention. Whether it is general surgery or endoscopic surgery, there may be postoperative joint swelling, which may last for several weeks depending on the patient's condition. Therefore, reducing swelling as soon as possible is important in post-operative treatment. Swelling of the knee joint may increase soft tissue tension, causing pain and discomfort, and affecting the range of motion and functional recovery of the joint. It may also affect wound healing and increase the risk of complications such as infection and thrombosis. Most clinical research related to traditional Chinese medicine focuses on reducing pain, and little attention is paid to reducing swelling, relatively. Nevertheless most relevant literatures discuss total knee replacement surgery.

Cruciate ligament surgery is very common in sports medicine orthopedics. It is expected that ordinary patients get function recovery quickly after surgery, and athletes can return to play as soon as possible. This study is a prospective study, with partially double-blinded, randomized controlled study design. The investigators are aiming to TCM intervention for knee swelling after cruciate ligament surgery, and evaluation of postoperative swelling and functional improvement. TCM intervention methods are laser acupuncture and external application of herbal medicine. conditions: Anterior Cruciate Ligament Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: LASER acupuncture measure: Leg girth measurement measure: VAS measure: WOMAC measure: Tegner score sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06335589 id: CDX 24-002 briefTitle: Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2026-12-31 date: 2026-12-31 date: 2024-03-28 date: 2024-03-28 name: VA Office of Research and Development class: FED briefSummary: Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment). conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Massed PTSD treatment (e.g., cognitive processing therapy \[CPT\] or prolonged exposure \[PE\] therapy delivered at least 3 times per week) will be compared to CPT \& PE delivered as usual, which is usually once per week. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Clinical interviewers who assess primary outcomes will not be informed of participant's randomization assignment. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: EBP-Massed name: EBP-TAU measure: Treatment completion measure: Acceptability of Intervention (AIM) measure: Client Satisfaction Questionnaire-8 (CSQ-8) measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score measure: Session attendance measure: Patient Health Questionnaire-9 (PHQ-9) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Brief Inventory of Psychosocial Functioning (BIPF) measure: Brief Inventory of Psychosocial Functioning (BIPF) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Durham VA Medical Center, Durham, NC city: Durham state: North Carolina zip: 27705-3875 country: United States name: Stephanie Y Wells, PhD MS BA role: CONTACT phone: 919-286-0411 phoneExt: 134053 email: stephanie.wells2@va.gov name: Laurel B Koss, MS OTR role: CONTACT phone: (919) 286-0411 phoneExt: 775648 email: laurel.koss@va.gov name: Stephanie Y Wells, PhD MS BA role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06335576 id: ZSGCproteomics briefTitle: Establishment of Serum Proteomics Subtypes of Gastric Cancer and Its Clinical Application overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2026-10-31 date: 2026-12-31 date: 2024-03-28 date: 2024-03-28 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: This study is a prospective, single-center, observational study aimed at detecting the status of serum protein profiles at key time points in gastric cancer patients receiving neoadjuvant therapy for advanced disease, and constructing a serum protein model for evaluating the efficacy of neoadjuvant therapy for gastric cancer. Subjects will receive neoadjuvant therapy (treatment regimen determined by the primary physician, limited to systemic therapy, with options including immune checkpoint inhibitor-based regimens and non-immune checkpoint inhibitor-based regimens). After four cycles of treatment, the efficacy will be assessed. Patients eligible for R0 resection will undergo D2 radical surgery regardless of tumor regression, while those ineligible for R0 resection will enter the palliative treatment phase (Note: Subjects are all patients who require neoadjuvant therapy even if they do not participate in this clinical study). Patients will receive regular follow-up evaluations for metastasis/recurrence and survival until tumor recurrence/progression or the last known date of patient survival (Note: Regular follow-up in this study follows the frequency of routine clinical follow-ups). The primary endpoint is progression-free survival (PFS), and the secondary endpoint is pathological response rate (based on Becker tumor regression grading, with residual tumor less than 50% considered effective preoperative treatment).

Peripheral venous blood samples will be collected before the start of neoadjuvant therapy (blood sampling point 1 - baseline) and before surgery after neoadjuvant therapy (blood sampling point 2 - post-treatment). Approximately 3 ml of blood will be collected each time, and about 1.5 ml of serum will be obtained after processing. Serum protein profiling will be conducted to assess the expression of protein profiles at these treatment time points. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 89 type: ESTIMATED name: This study is a single-arm and observational study with no intervention. measure: C-index measure: Sensitivity and specificity of model sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335563 id: STAR009 briefTitle: Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules overallStatus: RECRUITING date: 2024-03-14 date: 2024-12-01 date: 2024-12-01 date: 2024-03-28 date: 2024-04-12 name: Shanghai Pulmonary Hospital, Shanghai, China class: OTHER briefSummary: This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules. conditions: Pulmonary Nodule studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: AR glasses-assisted puncture localizing group versus CT-guided conventional pulmonary nodule puncture localizing group primaryPurpose: TREATMENT masking: NONE maskingDescription: no masking count: 166 type: ESTIMATED name: AR glasses-assisted pulmonary nodule puncture localization name: CT-guided pulmonary nodule puncture localization measure: Accuracy of puncture localization of pulmonary nodules measure: Success rate of puncture localization of pulmonary nodules measure: Adjust the number of needle punctures measure: Operating time measure: Radiation dose sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Pulmonary Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Shenghao Huang role: CONTACT email: huangshplus5@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06335550 id: 2021/2680 briefTitle: Surgical and Patient Reported Outcomes in Robotic Mastectomy overallStatus: COMPLETED date: 2022-11-24 date: 2023-12-31 date: 2024-03-01 date: 2024-03-28 date: 2024-03-28 name: Changi General Hospital class: OTHER briefSummary: Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.

In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.

To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.

The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 29 type: ACTUAL name: Robotic mastectomy measure: Surgical Outcomes - Operative parameters measure: Surgical Outcomes - Length of stay (days) measure: Surgical Outcomes- 30-days morbidity/complications measure: Oncologic outcomes measure: Learning curve sex: FEMALE minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changi General Hospital city: Singapore zip: 529889 country: Singapore lat: 1.28967 lon: 103.85007 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-07-05 uploadDate: 2024-03-08T05:13 filename: Prot_SAP_000.pdf size: 785756 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-05-03 uploadDate: 2024-03-08T05:19 filename: ICF_001.pdf size: 704077 hasResults: False

 nctId: NCT06335537 id: 2405 briefTitle: Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2026-02 date: 2024-03-28 date: 2024-04-24 name: University of California, Irvine class: OTHER briefSummary: The incidence of kidney stone disease continues to rise globally. Although the treatment of kidney stone disease has dramatically improved in recent years, surgical management remains invasive and expensive. Patients who develop kidney stones are at high risk of recurrence during their lifetime; therefore, prevention of stones should be a primary focus. Low levels of citrate and acidic urine are risk factors for the formation of kidney stones such as calcium oxalate and uric acid, respectively. Calcium oxalate stones are the predominant stone composition in the United States, accounting for over 2/3rds of stones. Citrate is a key inhibitor of calcium oxalate crystal formation and thus increasing it in the urine of a calcium oxalate stone former is quite beneficial. Uric acid stones account for approximately 10 percent of all stone types. These stones form primarily due to an acidic urinary environment which is a prerequisite for crystal formation. Common medications for stone formers include potassium citrate which help to make the urine more alkaline. Although effective, these medications have side effects and may prove to be too expensive (upwards of $450/month). Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary citrate levels and alkalinizing the urine. Investigators hypothesize that twice a day oral baking soda in a liquid medium (e.g., water, orange juice, soda, etc.) can be an effective, and inexpensive alternative to urocit K with regard to alkalinizing the urine and raising urinary citrate levels. conditions: Uric Acid Stones studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The following study will be a randomized cross-over trial evaluating the effects of baking soda and Urocit-K on 24-hour urinary parameters in hypocitrituric calcium oxalate and uric acid stone formers. All participants that consent to participate in the study will undergo the same tests.

Participants will begin a 2-week washout period of Urocit-K as their standard of care. After completion of the washout period subjects will be randomized to take either Urocit-K or Baking Soda for 4 weeks. After participants undergo a secondary 2-week washout period, then they are assigned to medication not taken in the first study period for 4 weeks. primaryPurpose: TREATMENT masking: NONE maskingDescription: This is an unblinded study. count: 100 type: ESTIMATED name: Potassium citrate name: Sodium bicarbonate measure: Change in 24-hour Urinary pH measure: Change in 24-hour Urinary Citrate measure: Change in Supersaturation of Calcium Oxalate measure: Change in Supersaturation of Uric acid sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Irvine Medical Center city: Orange state: California zip: 92868 country: United States lat: 33.78779 lon: -117.85311 hasResults: False

 nctId: NCT06335524 id: IRB-300012718 briefTitle: Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants acronym: IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-08 date: 2028-08 date: 2024-03-28 date: 2024-03-28 name: University of Alabama at Birmingham class: OTHER briefSummary: This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age. conditions: Child Development conditions: Infant Development conditions: Infant, Premature, Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 188 type: ESTIMATED name: Finger puppet name: Bookworm reading intervention training and routine EDI care. measure: ASQ-3 scores measure: ASQ-3 scores measure: ASQ scores below -2SD measure: ASQ scores below -2SD measure: ASQ scores below -1SD measure: ASQ scores below -1SD measure: ASQ-SE2 scores measure: ASQ-SE2 scores measure: Severe neurodevelopmental impairment measure: Moderate or severe neurodevelopmental impairment measure: Cognitive Composite Score on BSID-IV measure: Language Composite Score on BSID-IV measure: Motor Composite Score on BSID-IV measure: Edinburgh Postnatal Depression Scale measure: MCHAT score sex: ALL minimumAge: 1 Day maximumAge: 17 Weeks stdAges: CHILD hasResults: False

 nctId: NCT06335511 id: 631-2021-OSS-AUSLBO briefTitle: Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study acronym: ARCHIMEDE overallStatus: RECRUITING date: 2022-10-10 date: 2025-02-28 date: 2025-02-28 date: 2024-03-28 date: 2024-03-28 name: Azienda Usl di Bologna class: OTHER_GOV briefSummary: Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis. conditions: Lumbar Spinal Stenosis conditions: Degenerative Lumbar Spinal Stenosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: microsurgical decompression name: decompression and instrumented fusion measure: Short Form 12 measure: Short Form 12 measure: Short Form 12 measure: Short Form 12 measure: Visual Analogue Scale measure: Visual Analogue Scale measure: Visual Analogue Scale measure: Visual Analogue Scale measure: Oswestry Disability Index measure: Oswestry Disability Index measure: Oswestry Disability Index measure: Oswestry Disability Index measure: EuroQol-5D measure: EuroQol-5D measure: EuroQol-5D measure: EuroQol-5D measure: Postural Balance measure: Postural Balance measure: Postural Balance measure: Postural Balance measure: Locomotor performance measure: Locomotor performance measure: Locomotor performance measure: Locomotor performance measure: Spinal mobility measure: Spinal mobility measure: Spinal mobility measure: Spinal mobility measure: Evaluation of costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Ortopedico Rizzolo status: RECRUITING city: Bologna zip: 40136 country: Italy name: Giovanni Barbanti Brodano, Dr. role: CONTACT phone: +390516366971 email: giovanni.barbantibrodano@ior.it lat: 44.49381 lon: 11.33875 facility: IRCCS Istituto delle Scienze Neurologiche di Bologna status: RECRUITING city: Bologna zip: 40139 country: Italy name: Alfredo Conti, Prof. role: CONTACT phone: 3382131017 email: alfredo.conti2@unibo.it lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06335498 id: 130-0008P briefTitle: Further Study of AFGen1 Clinical Performance acronym: CS3 overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-02 date: 2024-04-12 date: 2024-04-19 date: 2024-03-28 date: 2024-04-12 name: TriVirum, Inc. class: INDUSTRY briefSummary: AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish further evidence for the clinical performance of AFGen1 on human participants. conditions: Atrial Fibrillation conditions: Afib conditions: ECG studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: ECG co-measurement name: Periodic ECG triggered measurement measure: Bland-Altman Comparison measure: Qualitative Evaluation measure: Adhesive performance sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1808 49Th St Ct NW city: Gig Harbor state: Washington zip: 98335 country: United States lat: 47.32926 lon: -122.58013 hasResults: False

 nctId: NCT06335485 id: 2020- P123456 briefTitle: Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery overallStatus: COMPLETED date: 2021-04-01 date: 2022-09-29 date: 2022-09-29 date: 2024-03-28 date: 2024-03-28 name: Brigham and Women's Hospital class: OTHER briefSummary: This study investigates a Cognitive Behavioral Therapy (CBT) intervention for women who are undergoing elective surgery. The objective is to provide a toolkit of stress management techniques to decrease pain and opioid use following surgery. conditions: Back Pain conditions: Cognitive Behavioral Therapy conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients are randomized to either the intervention group or general group, for the intervention group patients will be randomly assigned to attend 4 weekly online virtual CBT sessions that will provide information on stress and pain reduction techniques before surgery, and 2 sessions following patient surgery. primaryPurpose: PREVENTION masking: NONE count: 32 type: ACTUAL name: Cognitive Behavioral Therapy measure: Numeric Pain Rating measure: Pain Medication Usage measure: Activity Tracking (Digital Phenotyping) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06335472 id: Three nerves radiofrequency briefTitle: Three Nerves Versus Suprascapular Nerve Radiofrequency Combined With Hydrodissection in Adhesive Capsulitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02-03 date: 2027-03-05 date: 2024-03-28 date: 2024-03-28 name: Assiut University class: OTHER briefSummary: comparison between effect of three nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up. conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Ultrasound-guided effect of three nerves pulsed radiofrequency versus supra-scapular nerve pulsed radiofrequency both combined with hydro-dissection in reducing the intensity of pain in adhesive capsulitis primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: pain control and range of motion in adhesive capsulitis whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: 3 nerves pulsed radiofrequency with hydrodissection name: suprascapular nerve pulsed radiofrequency with hydrodissection measure: The most effective modality on pain management of shoulder adhesive capsulitis using visual analog score. sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut university Hospital city: Assiut country: Egypt name: safaa noaman, assistant lecturer role: CONTACT lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06335459 id: Epidemiology of bunion briefTitle: Epidemiology of Bunion and Risk Factors overallStatus: NOT_YET_RECRUITING date: 2024-07-24 date: 2025-04-05 date: 2025-06-01 date: 2024-03-28 date: 2024-03-28 name: Assiut University class: OTHER briefSummary: Analysis of the collected data to determine:

* Prevalence.
* Risk factors. Radiological and clinical patterns and their association with specific risk factors Of Hallux Valgus conditions: Hallux Valgus and Bunion studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED name: epidemiology measure: History taken and well clinical examination and AP Foot standing position of 2000 randomly case with determination of Hallux Valgus angles knowing if It's Hallux Valgus or not calculating The prevalence sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335446 id: 011040- AT validation phase id: PG/16/10/32016 type: OTHER_GRANT domain: British Heart Foundation briefTitle: Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation overallStatus: COMPLETED date: 2016-10 date: 2019-10 date: 2019-10 date: 2024-03-28 date: 2024-03-28 name: Barts & The London NHS Trust class: OTHER briefSummary: Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence is increasing partly due to the aging population and it has been referred to as a growing epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of palpitations and increasing the risk of stroke, heart failure and death. Percutaneous catheter ablation is a safe treatment option in symptomatic patients with AF. The success rate of these procedures have improved with time due to our better understanding of AF, development of new techniques and technology, and greater physician experience. However, the success rate of these procedures still only remains around 70%. This is secondary to our limited ability to find the areas that drive AF.

STAR mapping is a novel mapping system that has been developed with a view of better identifying the sites that drive AF through taking into account the mechanisms of AF we have so far demonstrated. To validate this mapping system we aim to use it in patients with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can be readily identified with the existing mapping systems used in clinical practice. We will demonstrate that the STAR mapping algorithm can effectively map AT. conditions: Atrial Tachycardia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: Novel mapping algorithm measure: STAR maps compared to conventional maps sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barts Heart Centre city: London zip: EC1A 7BE country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06335433 id: RM_30_06_22b briefTitle: Isometric Handgrip Training Frequency and Blood Pressure in People With Hypertension overallStatus: RECRUITING date: 2024-03-20 date: 2026-03 date: 2026-03 date: 2024-03-28 date: 2024-03-28 name: Swansea University class: OTHER briefSummary: Hypertension is the most important cause of cardiovascular disease (CVD), stroke, and premature death (WHO, 2021). It is estimated by The World Health Organisation in 2021 that 1.4 billion individuals across the globe have high blood pressure, with only 14% of people actively managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Physical activity is one possible strategy: in previous research, several different types of physical activity have been shown to have beneficial effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of physical activity (150 mins of moderate intensity physical activity per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort, exertion, and physical discomfort (Korkiakangas et al 2009). Thus, there is a need to identify alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021, Toohey et al, 2018).

Low intensity isometric hand grip exercise training (IET) has been shown to result in large decreases in resting blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IET has almost universally involved performing 4 x 2 IET holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). There are very few studies that have investigated the effect of changing different protocol parameters on changes in blood pressure and vascular health, and the minimal effective dose of IET is unknown. Defining the minimal effective dose of different types of exercise may help overcome key barriers to exercise by lowering the required time commitment, reducing perceived effort/exertion, and promoting more positive affective responses. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IET will reduce the efficacy for improving blood pressure.

Therefore, the primary objective of this study is to determine if reducing the frequency of isometric handgrip training from four times a week to two times a week will affect the improvements in resting blood pressure and vascular health in people with hypertension. A secondary objective is to investigate the acute affective and perceptual responses to sessions of IET and the effect of training on these acute affective/perceptual responses. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled trial primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Exercise Training (Isometric Handgrip Exercise) measure: Office measured supine and seated systolic, diastolic and mean arterial pressure measure: Office measured central systolic, diastolic and mean arterial pressure measure: 24-h mean ambulatory systolic, diastolic, and mean arterial pressure measure: Daytime ambulatory systolic, diastolic, and mean arterial pressure measure: Sleeping ambulatory systolic, diastolic and mean arterial pressure measure: Carotid-Femoral Pulse Wave Velocity measure: Affective Valence (Feeling Scale) measure: Ratings of perceived exertion sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Swansea University status: RECRUITING city: Swansea state: Wales zip: SA18EN country: United Kingdom name: Richard Metcalfe, PhD role: CONTACT phone: 01792205678 phoneExt: 4779 email: r.s.metcalfe@swansea.ac.uk lat: 51.62079 lon: -3.94323 hasResults: False

 nctId: NCT06335420 id: 324-2023-GB briefTitle: Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps acronym: Px7 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-09 date: 2024-03-28 date: 2024-03-28 name: Odense University Hospital class: OTHER name: Karolinska Institutet name: Umeå University name: Uppsala University Hospital name: Sahlgrenska University Hospital, Sweden name: Svendborg Hospital briefSummary: The goal of this prospective randomized double-blinded bi-national study is to test the prophylactic effect of polyacetylenes from carrots on the population of patients who had a resection of high-risk adenomas of the large bowel.

The main question it aims to answer is: Will carrot juice rich in polyacetylenes inhibit neoplastic transformation and growth in high-risk humans?

Participants will have to drink 100 ml of juice daily after the adenoma resection for 1 year and keep a simple diary/calendar.

Researchers will compare the group with ingestion of FaOH/FaDOH rich carrot juice versus the group consuming placebo juice, to see if the polyacetylenes significantly reduces neoplastic transformation and growth in high-risk patients. conditions: Colorectal Cancer Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Carrot juice from Yellowstone carrots cultivars name: Placebo juice measure: Number and size of polyps found at the one-year follow up colonoscopy measure: Polyp number and size in relation to carrot consumption measurement measure: Compliance rate (Juice consumption level) measure: Side effects measure: Acceptability of treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery, Odense University Hospital city: Odense zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06335407 id: AS210006-A08 id: W81XWH-21-2-0026 type: OTHER_GRANT domain: DoDCongressionally Directed Medical Research Program briefTitle: Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-09-30 date: 2025-10-29 date: 2024-03-28 date: 2024-03-28 name: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance class: OTHER name: United States Department of Defense name: Congressionally Directed Medical Research Programs name: VA Connecticut Healthcare System name: BioXcel Therapeutics Inc name: Yale University name: RTI International briefSummary: The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials. conditions: Alcohol Use Disorder (AUD) conditions: Post Traumatic Stress Disorder (PTSD) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Participants will receive 40µg on days 1-2. On days 3 and 4, participants will receive 40µg twice per day. On days 5 and 6 participants will receive 40µg in the morning and 80µg in the evening. If dosing is tolerated, per clinical judgement, participants will begin to receive 80µg twice per day on days 7-28. primaryPurpose: OTHER masking: NONE maskingDescription: no one will be masked count: 10 type: ESTIMATED name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg measure: Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28. measure: Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28. measure: Number and Proportion of Adverse Events measure: Change in PTSD symptoms (measured via the PTSD Checklist for Diagnostic and Statistical Manual (DSM-5) - Posttraumatic Stress Disorder Checklist (PCL-5) from baseline (pre-treatment) through day 28. measure: Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28. measure: Change in compulsive drinking (measured via the Obsessive Compulsive Drinking Scale - OCDS) from baseline (pre-treatment) through day 28. measure: Change in mood (measured by the Differential Emotions Scale - DES-R) from baseline (pre-treatment) through day 28. measure: Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28. measure: Change in affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28. measure: Change in overall functioning (measured by the Veteran's RAND 12-item Health Survey - VR-12) from baseline (pre-treatment) through day 28. measure: Change in cognitive functioning (measured by the Hopkins Verbal Learning Test Revised - HVLT-R) from baseline (pre-treatment) through day 28. measure: Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28. measure: Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28. sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Connecticut Healthcare System city: West Haven state: Connecticut zip: 06516 country: United States name: Jenelle Newcomb, BA role: CONTACT phone: 203-932-5711 phoneExt: 12874 email: jenelle.leblanc@yale.edu name: Ismene Petrakis, MD role: CONTACT phone: (203) 932-5711 phoneExt: 12244 email: ismene.petrakis@yale.edu name: Ismene Petrakis, MD role: PRINCIPAL_INVESTIGATOR name: John Krystal, MD role: SUB_INVESTIGATOR lat: 41.27065 lon: -72.94705 hasResults: False

 nctId: NCT06335394 id: NVD003-CLN01 briefTitle: Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion overallStatus: ACTIVE_NOT_RECRUITING date: 2018-08-02 date: 2022-04-27 date: 2028-05-15 date: 2024-03-28 date: 2024-03-28 name: Novadip Biosciences class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion. conditions: Recalcitrant Lower Limb Nonunion studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 11 type: ACTUAL name: NVD003 measure: Safety - Adverse Events measure: Safety - Abnormalities of vital signs measure: Safety - Abnormalities of vital signs measure: Safety - Abnormalities of physical examination measure: Safety - Abnormalities of physical examination measure: Safety - Abnormalities of physical examination measure: Safety - Abnormalities of laboratories measure: Safety - Abnormalities of laboratories measure: Safety - Abnormalities of laboratories measure: Healing efficacy: plain X-ray measure: Healing efficacy: CT-scan measure: Healing efficacy: average time from Investigational Medicinal Product grafting surgery till first observation of plain X-ray and CT-scan confirmed fracture healing measure: Healing efficacy: investigator assessed clinical healing measure: Healing efficacy: average time from IMP grafting surgery to Investigator assessed clinical healing measure: Grafting Surgery parameters measure: Grafting Surgery parameters measure: Complications: rate of subsequent surgical interventions measure: Quality of Life: pain evaluation measure: Quality of Life: questionnaire EuroQol-5 Dimensions measure: Quality of Life: overall treatment effect measure: General Pre-graft implantation safety: all SAEs, AESI and PRAE measure: All SAEs during the extended safety follow-up period sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Interregional Edith Cavel (CHIREC) - Clinique Ste Anne-St Remi city: Anderlecht zip: 1070 country: Belgium lat: 50.83619 lon: 4.31454 facility: Algemeen Ziekenhuis (AZ) Sint-Jan Brugge - Oostende AV - Campus Sint-Jan city: Brugge zip: 8000 country: Belgium lat: 51.20892 lon: 3.22424 facility: Centre Hospitalier Universitaire CHU/UVC Brugmann (Site Horta) city: Brussel zip: 1020 country: Belgium lat: 50.85045 lon: 4.34878 facility: Grand Hôpital De Charleroi city: Charleroi country: Belgium lat: 50.41136 lon: 4.44448 facility: Ziekenhuis Oost-Limburg (ZOL) city: Genk zip: 3600 country: Belgium lat: 50.965 lon: 5.50082 facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg city: Leuven zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 facility: CHU Ambroise Paré city: Mons zip: 7000 country: Belgium lat: 50.45413 lon: 3.95229 facility: Centre Hospitalier Regional De Namur city: Namur zip: 5000 country: Belgium lat: 50.4669 lon: 4.86746 facility: Centre Hospitalier de Luxembourg city: Luxembourg zip: 1210 country: Luxembourg lat: 49.61167 lon: 6.13 facility: University Hospital Basel city: Basel country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06335381 id: 24-0131 id: 1R01NR021134-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01NR021134-01 briefTitle: MOMs Chat and Care Study acronym: MOMs-CC overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-12-31 date: 2028-06-30 date: 2024-03-28 date: 2024-04-01 name: Northwell Health class: OTHER name: National Institute of Nursing Research (NINR) briefSummary: The purpose of this pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care for high-risk Black birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black birthing people (n = 674) will be recruited and randomized to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities. conditions: Severe Maternal Morbidity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned to one of two groups in parallel for the duration of the study. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The Principal Investigator and Biostatistician will be masked. whoMasked: INVESTIGATOR count: 674 type: ESTIMATED name: Northwell Pregnancy & Peds Chats name: Prenatal Telehealth Visits name: Postpartum Telehealth Visits name: Home Blood Pressure Monitor name: Fitbit measure: Severe maternal morbidity (SMM) measure: Preeclampsia measure: Informational Support measure: Emotional Support measure: Tangible Support measure: Minutes of Physical Activity measure: Barriers to Exercise sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Northwell Health city: Manhasset state: New York zip: 11030 country: United States name: Stephanie L Fitzpatrick, PhD role: CONTACT lat: 40.79788 lon: -73.69957 hasResults: False

 nctId: NCT06335368 id: 201512178RINC briefTitle: Assessment of Nutritional and Growth Status in Rett Syndrome Patients overallStatus: COMPLETED date: 2016-03-09 date: 2016-05-23 date: 2020-10-26 date: 2024-03-28 date: 2024-03-28 name: National Taiwan University Hospital class: OTHER briefSummary: Children with Rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. Past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer from osteoporosis and other problems. Lack of proper nutritional support will seriously affect their growth, development and health. in view of There is a lack of relevant research in China, so the investigators would like to use this research to explore the nutritional, growth and postural status of Rett's disease patients, as the reference direction and goal of dietary adjustment and nutritional support for patients, and establish dietary and nutritional strategies for sick children in Taiwan. conditions: Rett Syndrome conditions: Neurologic Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 70 type: ACTUAL name: Nutrition and Growth Status measure: gender, age , disease history checklist measure: Change in Body height measure: Change in Body weight measure: Change in knee height measure: Change in arms height measure: Change in waist measure: Change in hip circumferences sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06335355 id: SHR-1316-307 briefTitle: A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-10 date: 2030-10 date: 2024-03-28 date: 2024-03-28 name: Shanghai Shengdi Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations conditions: Non-squamous Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 401 type: ESTIMATED name: Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin name: Camrelizumab + Pemetrexed + Carboplatin name: Adebrelimab + Pemetrexed + Carboplatin measure: Investigator-assessed Objective Response Rate (Phase One) measure: Overall Survival (Phase Two) measure: The incidence and severity of Adverse Events (AEs) (Phases One and Two) measure: Duration of Response (DoR) based on Investigator Assessment (Phases One and Two) measure: Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two) measure: Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two) measure: Overall Survival (OS) (Phase One) measure: Objective Response Rate (ORR) based on Investigator Assessment (Phase Two) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Tumor Hospital of Shandong First Medical University city: Jinan state: Shandong zip: 250117 country: China name: Jinming Yu role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06335342 id: IEO 0726 briefTitle: Radiotherapy Treatments for Neoplasms in the Head and Neck Region overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: The aim of this study is the evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of radiotherapy treatments in the head and neck region.

Eligible patients undergoing radiotherapy for primary or secondary neoplasms localized in the head and neck anatomical region. conditions: Head and Neck Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 4050 type: ESTIMATED measure: Overall Survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06335329 id: Pro00133616 briefTitle: Point-of-Care Ultrasound (POCUS) Findings and Impact on Vaping overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-07 date: 2025-07 date: 2024-03-28 date: 2024-04-02 name: Medical University of South Carolina class: OTHER briefSummary: Vaping has emerged as a prominent public health crisis in recent years. In 2023, the National Youth Tobacco Survey found that more than 2.1 million adolescents endorse vaping, with 25% of those endorsing daily use. Many adolescents also perceive vapes as safer than cigarettes, and more acceptable to use both indoors and outdoors compared to cigarettes. Vapes are available in numerous device and delivery systems, with the psychoactive agent commonly including nicotine or cannabis, although these can be of a wide variety of concentrations and formulations. They may be ultra-compact and allow for ease of concealment. In addition, they are produced in a variety of appealing flavorings such as candy, desserts, and fruits. Other constituents include the liquids and aerosolized components of the vaping cartridges, including formaldehyde, acetone, glycerol, propylene glycol, acetaldehyde, and heavy metals. Many of the flavoring concentrates, as well as the vaporized solvents, have not been evaluated for long term safety. One of these additives, vitamin E acetate, present in primarily illicit vaping devices, rose to national attention in 2019 for a suspected link to the dramatic increase in vaping/e-cigarette associated lung injury (EVALI) cases, with over 60 confirmed deaths since that time.

To our knowledge, there are no studies evaluating the lung ultrasound findings of asymptomatic vapers. However, there is data to suggest that vaping can lead to pulmonary toxicity in in-vitro and animal models, including increased inflammatory cytokines, hyperreactivity, and oxidative stress. In addition, studies found the risk of bronchitic symptoms is twice as likely in current adolescent vapers, compared to those who have never vaped before. Given the potential pulmonary toxicity of vaping, as well as the increased percentage of adolescent vaping activity in recent years, investigators aim to evaluate baseline lung ultrasound findings in adolescents who vape. Concurrently, investigators will assess if observing their lung ultrasound findings can alter their attitudes and behaviors towards vaping. Prior adult studies have found that showing patients' their atherosclerosis plaque increased the motivation to quit and cessation rates. Additionally, data in pregnant patients found real-time ultrasound feedback of smoking effects on the fetus lead to near abstinence in light smokers. Given the frequent use of point-of-care ultrasound in the emergency department, investigators hope to assess an innovative intervention for cessation. conditions: Vaping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: All participants will be randomized on a 1:1 ratio to be able to see and discuss their ultrasound results, or remain blinded to them. whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Discussion of point-of-care ultrasound lung findings measure: Lung Ultrasound Findings measure: Behavioral Changes sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29412 country: United States name: Kaitlyn Boggs, MD role: CONTACT lat: 32.77657 lon: -79.93092 hasResults: False

 nctId: NCT06335316 id: wallenburg sym briefTitle: Effect of Stellate Nerve Block in Dysphagia overallStatus: COMPLETED date: 2022-01-01 date: 2023-05-04 date: 2023-05-28 date: 2024-03-28 date: 2024-03-28 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ACTUAL name: Injection name: Lidocaine Hydrochloride name: Comprehensive therapy name: placebo measure: Functional Oral Intake Scale measure: Yale Pharyngeal Residue Severity Rating Scale measure: penetration-aspiration scale measure: The Swallowing Quality of Life Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huimin Hos. city: Pengfu country: Taiwan lat: 24.98333 lon: 121.41667 hasResults: False

 nctId: NCT06335303 id: 1462-0004 id: 2023-508395-11-00 type: OTHER domain: CTIS id: U1111-1302-4283 type: OTHER domain: WHO briefTitle: A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) overallStatus: NOT_YET_RECRUITING date: 2024-06-20 date: 2026-04-30 date: 2026-06-30 date: 2024-03-28 date: 2024-03-28 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.

Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff.

At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Idiopathic Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: BI 1819479 name: Placebo matching BI 1819479 measure: Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year] measure: Absolute change from baseline in FVC at Week 24 [in milliLiter] sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335290 id: IEO 725 briefTitle: Radiotherapy Treatments for the Treatment of Thoracic District Tumors overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of thoracic radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the thoracic anatomical region. conditions: Thoracic Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 13200 type: ESTIMATED measure: Overall survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06335277 id: IEO 0727 briefTitle: Total Body Irradiation Treatments for Patients Treated at European Institute of Oncology overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: Patients eligible undergoing total body irradiation as candidates for bone marrow or peripheral stem cell transplant. conditions: Leukemia conditions: Leukemia, Chronic conditions: Leukemia, Acute conditions: Lymphoma conditions: Aplastic Anemia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Overall Survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06335264 id: 2024-9987 briefTitle: Screening for Heart Failure Using a Multimodal Wearable Device acronym: WEAR-HF overallStatus: RECRUITING date: 2024-01-15 date: 2024-07 date: 2024-12 date: 2024-03-28 date: 2024-03-28 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER name: HOP-Child Technologies Inc briefSummary: The purpose of this study is to find out if there are any patterns in the way people's bodies react to physical activities and their voices when they have heart failure, a disease where the heart cannot function sufficiently. To do this, the investigators will use a smartwatch that can measure multiple signals like the participant's heart rate and movement. Investigators will ask participants with and without heart failure to wear the Watch HOP (from HOP-Child Technologies Inc.) and sensors during physical tasks at their clinic visit at the McGill University Health Centre. Researchers will also record the participants' voices between their visits. The key signals can help find who is at risk for heart failure or develop new ways to monitor and treat it. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: Watch HOP measure: Presence or absence of heart failure measure: left ventricular ejection fraction (LVEF) measure: Natriuretic peptide (NT-proBNP) level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: McGill University Health Centre status: RECRUITING city: Montreal state: Quebec zip: H4A 3J1 country: Canada name: Abhinav Sharma, MD role: CONTACT phone: 514 934-1934 email: dreamcvlab@muhc.mcgill.ca name: Abhinav Sharma, MD role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06335251 id: IEO 0728 briefTitle: Radiotherapy Treatments for Neoplasms of the Limbs overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: In this observational study patients treated at European Institute of Oncology with radiotherapy to limbs will be included conditions: Bone Neoplasms conditions: Bone Metastases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Overall survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06335238 id: IEO 0729 briefTitle: Radiotherapy Treatments for Neoplasms in the Abdominal-pelvic Region overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of abdominal-pelvic region radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the tabdominal-pelvic region. conditions: Abdominal Cancer conditions: Pelvic Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 7700 type: ESTIMATED measure: Overall survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06335225 id: 2023-NHLHCRF-YXHZ-ZRMS-06 briefTitle: Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics overallStatus: RECRUITING date: 2024-03-13 date: 2025-07-31 date: 2025-07-31 date: 2024-03-28 date: 2024-03-28 name: China-Japan Friendship Hospital class: OTHER briefSummary: With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. The medical nutritional treatment of diabetes is recommended as the cornerstone of diabetes treatment by various guidelines. With the development of nutrigenomics, it has been found that genes related to the absorption, metabolism, distribution and excretion of various nutrients are related to diabetes. This study intends to conduct precision nutrition intervention for prediabetic patients based on nutritional genes, and evaluate the effectiveness and safety of these nutritional interventions. conditions: Prediabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Precise nutritional intervention name: Conventional nutritional intervention measure: HbA1c measure: Concentration of fasting plasma glucose measure: Concentration of 2-hour plasma glucose measure: Concentration of fasting insulin measure: Concentration of fasting C peptide measure: Concentration of TC, TG, LDL-C, and HDL-C measure: Concentration of ALT, AST, TBIL measure: Concentration of creatinine measure: BMI measure: Waist hip ratio sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital status: RECRUITING city: Beijing country: China name: Xiao Ma, MD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06335212 id: IRBNET ID 1448963 briefTitle: Peripheral Defocus Profile of Multifocal Minus Contact Lenses overallStatus: COMPLETED date: 2019-06-01 date: 2019-08-01 date: 2019-08-05 date: 2024-03-28 date: 2024-03-28 name: State University of New York College of Optometry class: OTHER briefSummary: Purpose: Numerous studies have proven that emmetropization in young animals including humans is regulated by visual input. It has long been hypothesized that peripheral myopic defocus may act as a stop signal to reduce myopia progression and axial elongation. As such, multifocal soft contact lenses (MFCLs) have been utilized for myopia control in school-aged children, with variable efficacies. One potential explanation is that the actual peripheral myopic defocus an eye experiences during MFCL wear may not be identical to the Add power and not sufficient to reduce myopia progression. Our study investigated and compared the peripheral power profiles of myopic eyes when they were uncorrected and wore single vision contact lenses (SVCLs) and MFCLs of different Add powers.

Methods: Subjects with -1.00 D to -10.00 D of myopia (SE, determined with manifest refraction) were custom fit with both single vision (SV) and MFCLs (+2.00 and +4.00 D Add; provided by Specialeyes) in both eyes. These Specialeyes MFCLs had an aspheric design with a standard total optical zone of 8.0mm. Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor (Grand Seiko Co Ltd) and OPD OPD-Scan III Wavefront Aberrometer (Marco) on the subjects in the following conditions: (1) no CLs, (2) SVCLs, (3) MFCLs (+2.00D Add), and (4) MFCLs (+4.00D Add). Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia. Data in the right eye was used for analysis. conditions: Myopia conditions: Refractive Errors conditions: Contact Lens studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 19 type: ACTUAL name: Single vision and multifocal contact lenses measure: refractive power sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: State University of New York, College of Optometry city: New York state: New York zip: 10036 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06335199 id: H24109 id: 5P2CHD086844-09 type: NIH link: https://reporter.nih.gov/quickSearch/5P2CHD086844-09 briefTitle: tVNS Responsiveness Testing With Pupil Size overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-31 date: 2025-04-30 date: 2024-03-28 date: 2024-04-01 name: Georgia Institute of Technology class: OTHER name: Emory University name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The goal of this study is to learn about the acute pupil response to transcutaneous vagus nerve stimulation (tVNS) in stroke survivors and healthy adults. The main question it aims to answer is whether pupil size response is greater with bilateral tVNS compared to unilateral tVNS. Participants will receive tVNS and sham at the outer ear unilaterally and bilaterally in resting condition. The pupil size of the participants will be recorded during tVNS. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Unilateral tVNS stimulation name: Bilateral tVNS stimulation name: Unilateral Sham stimulation name: Bilateral Sham stimulation measure: Pupil size change sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Human Neuromuscular Physiology Lab city: Atlanta state: Georgia zip: 30318 country: United States name: Minoru Shinohara, Ph.D. role: CONTACT phone: 404-894-1030 email: shinohara@gatech.edu lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06335186 id: Soh-Med-24-03-04MS briefTitle: Predictive and Prognostic Significance of Age,Blood Tests,Comorbidities(ABC) Score,Cologne Watch(C-watch)Score and Rockall Score for Risk of Variceal Re-bleeding Among Cirrhotic Patients overallStatus: RECRUITING date: 2024-02-10 date: 2025-03 date: 2025-03 date: 2024-03-28 date: 2024-03-28 name: Sohag University class: OTHER briefSummary: Introduction

Portal hypertension is a common complication of liver cirrhosis and is often underestimated in clinical diagnosis. The incidence of portal hypertension is approximately 20% to 98% in patients with cirrhosis (Wu et al., 2022). It is the major driver in the transition from the compensated to the 'decompensated' stage of cirrhosis, defined by the presence of clinical complications, including ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, and hepatic encephalopathy (Berzigotti., 2017).

Acute variceal bleeding is one of the most lifethreatening complications of liver cirrhosis. Twenty two percent to sixty one percent of cirrhotic patients receiving primary prophylaxis will develop first variceal bleeding during the first two years of follow up. Furthermore, variceal bleeding is associated with high risk of rebleeding and mortality (Tantai et al., 2019).

Patients with cirrhosis, although much progress has been made in diagnosis and treatment using vasoactive drugs, preventive antibiotics, early endoscopy and interventional radiology, the 6-week mortality rate remains high, ranging from 10 to 20%, mainly due to failure to control bleeding in the first days. Therefore, the prognostic method of patients with acute variceal bleeding is to determine the risk of rebleeding and resistance to standard treatment (accounting for 20-30%) and mortality rate in order to be able to adopt more aggressive treatment measures. The prognosis is very important but also difficult, not only because of the bleeding status but also depending on the severity of the underlying cirrhosis (Huy et al., 2023).

Many risk factors are known to influence the outcome in Upper Gastrointestinal Bleeding (UGIB) setting: Age, comorbidities, presence of shock, endoscopic diagnosis, haemoglobin values at the time of bleeding, stigmata of recent haemorhage and need for blood transfusion have all been described as significant risk factors for rebleeding and death (Monteiro S et al., 2016).

Many risk assessment score systems, including pre-endoscopy and post-endoscopy evaluations, have been developed to predict outcomes such as the need for hospital-based intervention, endoscopic therapy, and admission to an intensive care unit (ICU), rebleeding, and mortality. Some studies showed that these scoring systems distinguish low-risk patients who can potentially be managed as outpatients, allowing more efficient use of resources. Other studies suggested that these score systems distinguish higher-risk patients who might require emergency endoscopy or management in an intensive care unit (Li et al., 2022).

In 1993, the Rockall Scoring system was introduced to predict the mortality after UGIB and was validated for its use to identify the patients at high risk for re-bleed and mortality. Complete Rockall scoring system is based on an initial clinical score at the time of admission which consist of age (score 0-2), presence of shock (0-2), co-morbidities (score 0-3) and post endoscopic diagnosis (score 0-2) with stigmata of recent hemorrhages (score 0-2). Both clinical and post endoscopic scores added together gives a complete Rockall score with maximum score being 11 (Dewan et al., 2018).

In 2020, Laursen S.B. and colleagues conducted a multicenter international study and developed a new prognostic scoring system for UGIB called the ABC score. This scoring system is based on three criteria: age, blood test results, and comorbidities. The score ranges from 0 to 18 points, categorizing the risk into low (≤3 points), moderate (4-7 points), and high (≥8 points) levels. The 30-day mortality rates for high-risk UGIB patients in these three risk groups were 1%, 7%, and 25%, respectively ( Ky et al., 2023)

The new Cologne Watch (C-Watch) score was designed as a pre-endoscopic score for acute variceal and non-variceal UGIB and incorporates laboratory values only (c-reactive protein, white blood cell count, alanine-aminotransferase, thrombocytes, creatinine, and hemoglobin) with a minimum point value of 0 and a maximum point value of 8. Within the validation set, it predicted a composite endpoint consisting of recurrent bleeding, need for intervention (interventional radiology, surgery), or death within 30 days with an area under the receiver-operating characteristics curve (AUROC) of 0. About 38.7% of patients were within the high-risk group, i.e., ≥2 points, reached the composite endpoint, whereas no patient classified as low risk (≤1 point) (Allo et al., 2022). conditions: Upper Gastrointestinal Variceal Bleeding in Cirrhotic Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: upper endoscopy measure: ABC score. measure: Rockall score sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06335173 id: ACU193-201 id: 2023-509807-34-00 type: REGISTRY domain: EU CT Number briefTitle: A Study to Evaluate Efficacy and Safety of Intravenous ACU193 in Participants With Early Alzheimer's Disease (ALTITUDE-AD) acronym: ALTITUDE-AD overallStatus: RECRUITING date: 2024-02-29 date: 2031-01 date: 2031-01 date: 2024-03-28 date: 2024-03-29 name: Acumen Pharmaceuticals class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the efficacy of ACU193 infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2040 type: ESTIMATED name: ACU193 name: Placebo measure: Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score measure: Change from Baseline in ADCS-iADL Score measure: Change from Baseline in ADAS-Cog13 Score measure: Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) measure: Change from Baseline in Mini-Mental State Examination (MMSE) measure: Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) measure: Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score measure: Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) measure: Change from Baseline in Resource Utilization in Dementia (RUD) measure: Change from Baseline in Zarit Burden Interview (ZBI) measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13 measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE measure: Percentage of Participants with No Clinical Progression at One Year measure: Number of Participants with Treatment-Related Adverse Events (TEAEs) measure: Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) measure: Number of Participants who Discontinue or Withdraw due to TEAE measure: Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies measure: Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI) measure: Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) measure: Serum Concentration of ACU193 measure: Concentration of ACU193 in Cerebrospinal Fluid (CSF) measure: CSF Concentrations of ACU193 in a Subset of Participants measure: Correlation Between ACU193 Exposure with Clinical Efficacy Measures measure: Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids measure: Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest measure: Target Engagement Assessed by Measurement of ACU193- Amyloid-β oligomer (AβO) Complex in CSF measure: Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers measure: Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants measure: Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers measure: Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Banner Alzheimer's Institute- Clinical Trials Department status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85006 country: United States lat: 33.44838 lon: -112.07404 facility: IMA Clinical Research - Phoenix status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85012 country: United States lat: 33.44838 lon: -112.07404 facility: The Neurology Center of Southern California - Carlsbad status: NOT_YET_RECRUITING city: Carlsbad state: California zip: 92011-4219 country: United States lat: 33.15809 lon: -117.35059 facility: Neurology Center of North Orange County status: NOT_YET_RECRUITING city: Fullerton state: California zip: 92835 country: United States lat: 33.87029 lon: -117.92534 facility: Irvine Medical Research status: NOT_YET_RECRUITING city: Irvine state: California zip: 92614 country: United States lat: 33.66946 lon: -117.82311 facility: Healthy Brain Research status: NOT_YET_RECRUITING city: Long Beach state: California zip: 90804 country: United States lat: 33.76696 lon: -118.18923 facility: Sharp Mesa Vista Hospital status: NOT_YET_RECRUITING city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 facility: Syrentis Clinical Research status: NOT_YET_RECRUITING city: Santa Ana state: California zip: 92705 country: United States lat: 33.74557 lon: -117.86783 facility: CenExel - California Neuroscience Research Medical Group, Inc (CNR) status: NOT_YET_RECRUITING city: Sherman Oaks state: California zip: 91403-2131 country: United States lat: 34.15112 lon: -118.44925 facility: Alpine Clinical Research Center status: NOT_YET_RECRUITING city: Boulder state: Colorado zip: 80301-1880 country: United States lat: 40.01499 lon: -105.27055 facility: The Mile High Research Center status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80218 country: United States lat: 39.73915 lon: -104.9847 facility: Yale School of Medicine - Alzheimer's Disease Research Unit (ADRU) status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510-3330 country: United States lat: 41.30815 lon: -72.92816 facility: Research Center for Clinical Studies, LLC status: NOT_YET_RECRUITING city: Norwalk state: Connecticut zip: 06851-4903 country: United States lat: 41.1176 lon: -73.4079 facility: Re:Cognition Health - Fairfax status: NOT_YET_RECRUITING city: Washington state: District of Columbia zip: 22031 country: United States lat: 38.89511 lon: -77.03637 facility: JEM Research Institute status: RECRUITING city: Atlantis state: Florida zip: 33462 country: United States name: Clinical Research Coordinator role: CONTACT phone: 561-968-2933 email: research@jemri.net lat: 26.5909 lon: -80.10088 facility: Bradenton Research Center status: NOT_YET_RECRUITING city: Bradenton state: Florida zip: 34205 country: United States lat: 27.49893 lon: -82.57482 facility: Gil Fernandez-Yera, MD, PA status: NOT_YET_RECRUITING city: Coral Gables state: Florida zip: 33135 country: United States lat: 25.72149 lon: -80.26838 facility: Brain Matters Research status: NOT_YET_RECRUITING city: Delray Beach state: Florida zip: 33445 country: United States lat: 26.46146 lon: -80.07282 facility: Coral Clinical Research status: NOT_YET_RECRUITING city: Homestead state: Florida zip: 33032 country: United States lat: 25.46872 lon: -80.47756 facility: K2 Medical Research - Villages status: RECRUITING city: Lady Lake state: Florida zip: 32159 country: United States name: Kylie Webster role: CONTACT phone: 352-565-7524 email: kylie.webster@k2med.com lat: 28.91749 lon: -81.92286 facility: Verus Clinical Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33125 country: United States lat: 25.77427 lon: -80.19366 facility: Finlay Medical Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33126 country: United States lat: 25.77427 lon: -80.19366 facility: Collier Neurologic Specialists (CNS), L.L.C. status: NOT_YET_RECRUITING city: Naples state: Florida zip: 34105-8522 country: United States lat: 26.14234 lon: -81.79596 facility: Ocala Health - Family Care Specialists - Ocala I status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34470 country: United States lat: 29.1872 lon: -82.14009 facility: Progressive Medical Research status: NOT_YET_RECRUITING city: Port Orange state: Florida zip: 32127 country: United States lat: 29.13832 lon: -80.99561 facility: Alzheimer's Research and Treatment Center - Stuart status: NOT_YET_RECRUITING city: Stuart state: Florida zip: 34997 country: United States lat: 27.19755 lon: -80.25283 facility: K2 Medical Research - Tampa status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 facility: Charter Research - Lady Lake status: RECRUITING city: The Villages state: Florida zip: 32162 country: United States name: Brittany Ortiz role: CONTACT phone: 352-775-1000 email: brittany.ortiz@charterresearch.com lat: 28.93408 lon: -81.95994 facility: Alzheimers Research and Treatment Center - Wellington status: NOT_YET_RECRUITING city: Wellington state: Florida zip: 33414 country: United States lat: 26.65868 lon: -80.24144 facility: Conquest Research status: RECRUITING city: Winter Park state: Florida zip: 32789 country: United States name: Elizabeth Schneider role: CONTACT phone: 689-488-9113 email: elizabeth.schneider@ConquestResearch.com lat: 28.6 lon: -81.33924 facility: Charter Research - Winter Park status: NOT_YET_RECRUITING city: Winter Park state: Florida zip: 32792 country: United States lat: 28.6 lon: -81.33924 facility: Columbus Memory Center status: NOT_YET_RECRUITING city: Columbus state: Georgia zip: 31909 country: United States lat: 32.46098 lon: -84.98771 facility: Accel Research- Neurostudies status: NOT_YET_RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: CenExel - iResearch Atlanta status: NOT_YET_RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: CenExel - iResearch Savannah status: NOT_YET_RECRUITING city: Savannah state: Georgia zip: 31405 country: United States lat: 32.08354 lon: -81.09983 facility: Office of Jeffrey S. Ross, MD status: NOT_YET_RECRUITING city: Northbrook state: Illinois zip: 60640 country: United States lat: 42.12753 lon: -87.82895 facility: KU Wichita Center for Clinical Research status: NOT_YET_RECRUITING city: Wichita state: Kansas zip: 67214 country: United States lat: 37.69224 lon: -97.33754 facility: ActivMed Practices and Research status: NOT_YET_RECRUITING city: Methuen state: Massachusetts zip: 03801 country: United States lat: 42.7262 lon: -71.19089 facility: Boston Center for Memory status: NOT_YET_RECRUITING city: Newton state: Massachusetts zip: 02459 country: United States lat: 42.33704 lon: -71.20922 facility: Donald S. Marks, MD. P.C. status: NOT_YET_RECRUITING city: Plymouth state: Massachusetts zip: 02360 country: United States lat: 41.95844 lon: -70.66726 facility: Hattiesburg Clinic - Memory Center status: NOT_YET_RECRUITING city: Hattiesburg state: Mississippi zip: 39401-7246 country: United States lat: 31.32712 lon: -89.29034 facility: Las Vegas Medical Research Center status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89113-2215 country: United States lat: 36.17497 lon: -115.13722 facility: Princeton Psychiatric Center status: NOT_YET_RECRUITING city: Princeton state: New Jersey zip: 08540-2859 country: United States lat: 40.34872 lon: -74.65905 facility: The Cognitive and Research Center of New Jersey status: NOT_YET_RECRUITING city: Springfield state: New Jersey zip: 07081 country: United States lat: 40.70491 lon: -74.31723 facility: CenExel - Advanced Memory Research Institute of NJ status: RECRUITING city: Toms River state: New Jersey zip: 08755 country: United States name: Anna Anna Brocco role: CONTACT phone: 732-341-9500 phoneExt: 3510 email: amri.recruitment@cenexel.com lat: 39.95373 lon: -74.19792 facility: IMA Clinical Research - Albuquerque status: NOT_YET_RECRUITING city: Albuquerque state: New Mexico zip: 87109 country: United States lat: 35.08449 lon: -106.65114 facility: Neurological Associates of Albany status: NOT_YET_RECRUITING city: Albany state: New York zip: 12208 country: United States lat: 42.65258 lon: -73.75623 facility: Neurological Institute of New York status: NOT_YET_RECRUITING city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: SUNY Upstate Medical University - Upstate University Hospital (SUNY Health Science Center) status: NOT_YET_RECRUITING city: Syracuse state: New York zip: 13210-2342 country: United States lat: 43.04812 lon: -76.14742 facility: AMC Research status: NOT_YET_RECRUITING city: Matthews state: North Carolina zip: 28105 country: United States lat: 35.11681 lon: -80.72368 facility: Cleveland Clinic - Lou Ruvo Center for Brain Health (CCLRCBH) status: NOT_YET_RECRUITING city: Lakewood state: Ohio zip: 44107 country: United States lat: 41.48199 lon: -81.79819 facility: Summit Research Network status: NOT_YET_RECRUITING city: Portland state: Oregon zip: 97210 country: United States lat: 45.52345 lon: -122.67621 facility: Abington Neurological Associates status: NOT_YET_RECRUITING city: Abington state: Pennsylvania zip: 19001 country: United States lat: 40.12067 lon: -75.11795 facility: Keystone Clinical Research status: RECRUITING city: Norristown state: Pennsylvania zip: 19462 country: United States name: Cherian Verghese role: CONTACT phone: 610-277-8073 email: CVerghese@flourishresearch.com lat: 40.1215 lon: -75.3399 facility: Rhode Island Mood and Memory status: NOT_YET_RECRUITING city: East Providence state: Rhode Island zip: 02914 country: United States lat: 41.81371 lon: -71.37005 facility: Neurology Clinic. P.C status: NOT_YET_RECRUITING city: Cordova state: Tennessee zip: 38018 country: United States lat: 35.15565 lon: -89.7762 facility: The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group) status: NOT_YET_RECRUITING city: Knoxville state: Tennessee zip: 37920-1511 country: United States lat: 35.96064 lon: -83.92074 facility: Senior Adult Specialty Research status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78757 country: United States lat: 30.26715 lon: -97.74306 facility: Gadolin Research, LLC status: NOT_YET_RECRUITING city: Beaumont state: Texas zip: 77702 country: United States lat: 30.08605 lon: -94.10185 facility: Kerwin Medical Center status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: Okanagan Clinical Trials status: NOT_YET_RECRUITING city: Kelowna state: British Columbia country: Canada lat: 49.88307 lon: -119.48568 facility: Office of Alexandre Henri-Bhargava, MD status: NOT_YET_RECRUITING city: Victoria state: British Columbia country: Canada lat: 48.43294 lon: -123.3693 facility: Parkwood Institute status: NOT_YET_RECRUITING city: London state: Ontario country: Canada lat: 42.98339 lon: -81.23304 facility: Hippocampe d/b/a Ottawa Memory Clinic status: NOT_YET_RECRUITING city: Ottawa state: Ontario country: Canada lat: 45.41117 lon: -75.69812 facility: The Kawartha Regional Memory Clinic (KRMC) status: NOT_YET_RECRUITING city: Peterborough state: Ontario country: Canada lat: 44.30012 lon: -78.31623 facility: Baycrest - The Rotman Research Institute (RRI) status: NOT_YET_RECRUITING city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 facility: Toronto Memory Program (TMP) (Neurology Research Inc.) status: NOT_YET_RECRUITING city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 facility: University Health Network (UHN) - Toronto Western Hospital (TWH) - Krembil Neuroscience Centre (KNC) - Memory Clinic status: NOT_YET_RECRUITING city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 facility: MoCA Research and Innovations status: NOT_YET_RECRUITING city: Greenfield Park state: Quebec country: Canada lat: 45.48649 lon: -73.46223 facility: Amiens university hospital status: NOT_YET_RECRUITING city: Amiens country: France lat: 49.9 lon: 2.3 facility: Chu Pellegrin status: NOT_YET_RECRUITING city: Bordeaux country: France lat: 44.84044 lon: -0.5805 facility: Hopital Neurologique Pierre Wertheimer status: NOT_YET_RECRUITING city: Bron country: France lat: 45.73333 lon: 4.91667 facility: Hôpital de la Timone status: NOT_YET_RECRUITING city: Marseille Cedex 05 country: France lat: 43.29551 lon: 5.38958 facility: Chu Montpellier status: NOT_YET_RECRUITING city: Montpellier country: France lat: 43.61092 lon: 3.87723 facility: Hopital Lariboisiere status: NOT_YET_RECRUITING city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut de la Mémoire et de la Maladie d'Alzheimer -IM2A status: NOT_YET_RECRUITING city: Paris country: France lat: 48.85341 lon: 2.3488 facility: CHU de Rennes, CMRR status: NOT_YET_RECRUITING city: Rennes country: France lat: 48.11198 lon: -1.67429 facility: CHU de NANTES-Hôpital Nord Laennec status: NOT_YET_RECRUITING city: Saint-Herblain country: France lat: 47.21765 lon: -1.64841 facility: Hôpitaux Universitaires de Strasbourg status: NOT_YET_RECRUITING city: Strasbourg country: France lat: 48.58392 lon: 7.74553 facility: Centre de Recherche du Gérontopôle - CHU de Toulouse Hôpital la Grave status: NOT_YET_RECRUITING city: Toulouse country: France lat: 43.60426 lon: 1.44367 facility: Charité - Universitaetsmedizin Berlin status: NOT_YET_RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 facility: Pharmakologisches Studienzentrum Chemnitz GmbH status: NOT_YET_RECRUITING city: Chemnitz country: Germany lat: 50.8357 lon: 12.92922 facility: University Hospital of Cologne status: NOT_YET_RECRUITING city: Cologne country: Germany lat: 50.93333 lon: 6.95 facility: Saarland University Hospital status: NOT_YET_RECRUITING city: Homburg country: Germany lat: 49.32637 lon: 7.33867 facility: Zentralinstitut für seelische Gesundheit status: NOT_YET_RECRUITING city: Mannheim country: Germany lat: 49.4891 lon: 8.46694 facility: Technical University of Munich, School of Medicine and Health, Klinikum rechts der Isar status: NOT_YET_RECRUITING city: Munich country: Germany lat: 48.13743 lon: 11.57549 facility: Rostock University Medical Center status: NOT_YET_RECRUITING city: Rostock country: Germany lat: 54.0887 lon: 12.14049 facility: Praxisgemeinschaft Dr. Springub/Schwarz status: NOT_YET_RECRUITING city: Westerstede country: Germany lat: 53.25682 lon: 7.92737 facility: Fondazione Istituto G. Giglio di Cefalù status: NOT_YET_RECRUITING city: Cefalù country: Italy lat: 38.03856 lon: 14.02285 facility: Policlinico San Martino status: NOT_YET_RECRUITING city: Genova country: Italy lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milano country: Italy lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS San Gerardo dei Tintori status: NOT_YET_RECRUITING city: Monza country: Italy lat: 45.58005 lon: 9.27246 facility: Neurology Clinic status: NOT_YET_RECRUITING city: Perugia country: Italy lat: 43.1122 lon: 12.38878 facility: IRCCS Neuromed status: NOT_YET_RECRUITING city: Pozzilli country: Italy lat: 41.51142 lon: 14.06252 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Sapienza Università di Roma - AOU Policlinico Umberto I status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: SSD Alzheimer's disease and related dementias status: NOT_YET_RECRUITING city: Torino country: Italy lat: 45.07049 lon: 7.68682 facility: A.O. Piafondazione Card. G. Panico status: NOT_YET_RECRUITING city: Tricase country: Italy lat: 39.93018 lon: 18.35421 facility: Centrum Medyczne Neuromed status: NOT_YET_RECRUITING city: Bydgoszcz country: Poland lat: 53.1235 lon: 18.00762 facility: Krakowska Akademia Neurologii Sp. z o.o. status: NOT_YET_RECRUITING city: Krakow country: Poland lat: 50.06143 lon: 19.93658 facility: NZOZ Syntonia status: NOT_YET_RECRUITING city: Pruszcz Gdanski country: Poland lat: 54.26217 lon: 18.63625 facility: RCMed status: NOT_YET_RECRUITING city: Sochaczew country: Poland lat: 52.22944 lon: 20.23838 facility: Centrum Medyczne Senior status: NOT_YET_RECRUITING city: Sopot country: Poland lat: 54.4418 lon: 18.56003 facility: Centrum Medyczne NeuroProtect status: NOT_YET_RECRUITING city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Hospital Universitari General de catalunya status: NOT_YET_RECRUITING city: Sant Cugat Del Vallès state: Barcelona country: Spain lat: 41.47063 lon: 2.08611 facility: Fundacion CITA alzheimer status: NOT_YET_RECRUITING city: San Sebastián state: Gipuzkoa country: Spain lat: 43.31283 lon: -1.97499 facility: Fundacion Neuropolis - Hospital Viamed Montecanal status: NOT_YET_RECRUITING city: Cuarte de Huerva state: Zaragoza country: Spain lat: 41.59466 lon: -0.93268 facility: Fundacio ACE status: NOT_YET_RECRUITING city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Reina Sofia status: NOT_YET_RECRUITING city: Cordoba country: Spain lat: 37.89155 lon: -4.77275 facility: Cae Oroitu status: NOT_YET_RECRUITING city: Getxo country: Spain lat: 43.35689 lon: -3.01146 facility: Hospital Ruber status: NOT_YET_RECRUITING city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Policlínica Gipuzkoa status: NOT_YET_RECRUITING city: San Sebastian country: Spain lat: 43.31283 lon: -1.97499 facility: Hospital Victoria Eugenia status: NOT_YET_RECRUITING city: Sevilla country: Spain lat: 37.38283 lon: -5.97317 facility: Hospital Universitari i Politècnic La Fe status: NOT_YET_RECRUITING city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Re:Cognition Health - Plymouth status: NOT_YET_RECRUITING city: Plymouth state: Devon country: United Kingdom lat: 50.37153 lon: -4.14305 facility: Panthera Biopartners - Enfield status: NOT_YET_RECRUITING city: Enfield Town state: Greater London country: United Kingdom lat: 51.65147 lon: -0.08497 facility: Re:Cognition Health - London status: NOT_YET_RECRUITING city: London state: Greater London country: United Kingdom lat: 51.50853 lon: -0.12574 facility: St. Pancras Clinical Research Ltd. status: NOT_YET_RECRUITING city: London state: Greater London country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Panthera Bio-Partners - Rochdale status: NOT_YET_RECRUITING city: Rochdale state: Greater Manchester country: United Kingdom lat: 53.61766 lon: -2.1552 facility: Re:Cognition Health - Winchester status: NOT_YET_RECRUITING city: Winchester state: Hampshire country: United Kingdom lat: 51.06513 lon: -1.3187 facility: Neuroclin Glasgow status: NOT_YET_RECRUITING city: Motherwell state: Lanarkshire country: United Kingdom lat: 55.78924 lon: -3.99187 facility: Panthera Bio-Partners - Preston status: NOT_YET_RECRUITING city: Preston state: Lancashire country: United Kingdom lat: 53.76282 lon: -2.70452 facility: Re:Cognition Health - Guildford status: NOT_YET_RECRUITING city: Guildford state: Surrey country: United Kingdom lat: 51.23536 lon: -0.57427 facility: Re:Cognition Health - Birmingham status: NOT_YET_RECRUITING city: Birmingham state: West Midlands country: United Kingdom lat: 52.48142 lon: -1.89983 facility: Panthera Biopartners - Sheffield status: NOT_YET_RECRUITING city: Sheffield state: Yorkshire country: United Kingdom lat: 53.38297 lon: -1.4659 facility: Re:Cognition Health - Bristol status: NOT_YET_RECRUITING city: Bristol country: United Kingdom lat: 51.45523 lon: -2.59665 hasResults: False

 nctId: NCT06335160 id: Mebendazole Ulcerative Colitis briefTitle: Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-05 date: 2024-03-28 date: 2024-03-28 name: Tanta University class: OTHER briefSummary: To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Mebendazole measure: change in disease activity measure: change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity measure: Change in Hemoglobin Concentration measure: Change in Erythrocyte sedimentation rate (ESR) measure: Change in Serum albumin measure: Change in Serum Interleukin -6 (IL-6) measure: Change in Serum Nitric oxide (NO) measure: Change in Serum Intra cellular adhesion molecule 1 (ICAM-1) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335147 id: HLX10IIT114 briefTitle: PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-31 date: 2026-01-31 date: 2024-03-28 date: 2024-03-28 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: Evaluate the efficacy and safety of PD1 monoclonal antibody combined with mFOLFOX6 neoadjuvant therapy for advanced resectable metastatic colon cancer with enriched pro-inflammatory pan macrophage subpopulations conditions: Metastatic Colon Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: Serplulimab, mFOLFOX6 measure: pathologic complete response（pCR） measure: Objective response rate (ORR) measure: 2-year overall survival rate measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335134 id: SCW0502-1016 briefTitle: A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin overallStatus: RECRUITING date: 2023-07-14 date: 2024-01-08 date: 2024-03-31 date: 2024-03-28 date: 2024-03-28 name: Hangzhou Sciwind Biosciences Co., Ltd. class: INDUSTRY briefSummary: This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: XW003 injection name: Metformin name: Warfarin name: Rosuvastatin name: Digoxin measure: Pharmacokinetics of metformin: AUC0-inf measure: Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf measure: Pharmacokinetics of rosuvastatin: AUC0-inf measure: Pharmacokinetics of digoxin: AUC0-inf sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: West China Second University Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Qin Yu role: CONTACT phone: 02885503960 lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06335121 id: 21120602 id: 1R01MH134264 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH134264 briefTitle: Implementation of PrEP Care Among Women in Family Planning Clinics overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-12 date: 2027-06 date: 2024-03-28 date: 2024-03-28 name: Rush University Medical Center class: OTHER name: National Institute of Mental Health (NIMH) name: University of Illinois at Chicago name: Planned Parenthood of Illinois briefSummary: This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers. conditions: PrEP Uptake conditions: HIV conditions: Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 250 type: ESTIMATED name: POWER Up strategies - measure: PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP. measure: Receipt of PrEP refills among Black women accessing FP services at 6 months. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06335108 id: SenoEx_TLA_Maligne briefTitle: Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 ) overallStatus: RECRUITING date: 2022-12-05 date: 2024-12-01 date: 2024-12-01 date: 2024-03-28 date: 2024-03-28 name: University Hospital Tuebingen class: OTHER briefSummary: The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery. conditions: Breast Carcinoma conditions: Breast Carcinoma in Situ studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: General Anaesthesia name: Local tumescent anaesthesia measure: Postoperative Pain measure: HRQoL/ Quality of life measure: Postoperative pain medication requirements measure: Complications measure: Length of hospital stay measure: Duration of surgery measure: Drainage delivery rate measure: Follow-up surgery for R1 situation measure: Preoperative fear of surgery and anaesthesia measure: Costs measure: Satisfaction of the surgeon with the course of the operation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Women's Hospital status: RECRUITING city: Tübingen zip: 72076 country: Germany name: Bettina Böer, Dr. role: CONTACT phone: +49 7071 29 82211 email: Bettina.Boeer@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06335095 id: a319 briefTitle: Gait Analysis and Degenerative Spine overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2026-09 date: 2024-03-28 date: 2024-03-28 name: Universidade Nova de Lisboa class: OTHER briefSummary: The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:

* What are the biomechanical variables affected by the disease
* How they evolve with disease progression and treatment conditions: Spinal Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Kinematic sensors measure: Change from baseline in gait parameter - speed (m/s) - at 3 months measure: Change from baseline in gait parameter - speed (m/s) - at 6 months measure: Change from baseline in gait parameter - speed (m/s) - at 12 months measure: Change from baseline in gait parameter - step length (m) - at 3 months measure: Change from baseline in gait parameter - step length (m) - at 6 months measure: Change from baseline in gait parameter - step length (m) - at 12 months measure: Change from baseline in gait parameter - step width (m) - at 3 months measure: Change from baseline in gait parameter - step width (m) - at 6 months measure: Change from baseline in gait parameter - step width (m) - at 12 months measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335082 id: DISRUPT-AF briefTitle: A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF acronym: DISRUPT-AF overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-11-30 date: 2027-01-30 date: 2024-03-28 date: 2024-04-11 name: Heart Rhythm Clinical and Research Solutions, LLC class: OTHER name: Boston Scientific Corporation briefSummary: The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF). conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 900 type: ESTIMATED name: Pulsed Field Ablation measure: Long term effectiveness measure: Long-term safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arrhythmia Institute at Grandview city: Birmingham state: Alabama zip: 35243 country: United States name: Anil Rajendra, MD role: CONTACT phone: 205-971-7578 email: arajendra@alcardio.com name: Susan Thorington role: CONTACT phone: 205-971-7578 email: susan.thorington@grandviewhealth.com name: Anil Rajendra, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: Community Memorial Health Systems city: Ventura state: California zip: 93003 country: United States name: Jonathan Dukes, MD role: CONTACT phone: 805-653-0101 email: jonathan_dukes@mac.com name: Jennifer Freeland role: CONTACT phone: 805-948-8278 email: jfreeland@cmhshealth.org name: Jonathan Dukes, MD role: PRINCIPAL_INVESTIGATOR lat: 34.27834 lon: -119.29317 facility: Endeavor Health (Northshore) city: Glenview state: Illinois zip: 60026 country: United States name: Mark Metzl, MD role: CONTACT phone: 847-570-2640 email: mmetzl@northshore.org name: Marisa Durante role: CONTACT phone: 847-687-8527 email: mdurante@northshore.org name: Mark Metzl, MD role: PRINCIPAL_INVESTIGATOR lat: 42.06975 lon: -87.78784 facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Jorge Romero, MD role: CONTACT phone: 617-732-5241 email: jeromero@bwh.harvard.edu name: Fernando Moreno role: CONTACT phone: 617-732-5241 email: fmoreno2@bwh.harvard.edu name: Jorge Romero, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Cardiovascular Associates of Delaware Valley city: Haddon Heights state: New Jersey zip: 08035 country: United States name: George Mark, MD role: CONTACT phone: 856-546-3003 email: gmark4@yahoo.com name: Erin Siderio role: CONTACT phone: 856-582-2000 phoneExt: 5207 email: esiderio@hearthousenj.com name: George Mark, MD role: PRINCIPAL_INVESTIGATOR lat: 39.87734 lon: -75.06462 facility: Texas Cardiac Arrhythmia Research Foundation (St. Davids) city: Austin state: Texas zip: 78705 country: United States name: Andrea Natale, MD role: CONTACT phone: 512-522-9410 email: tcarfan@gmail.com name: Deb Cardinal, RN role: CONTACT phone: 512-431-4868 email: dscardinal@austinheartbeat.com name: Andrea Natale, MD role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 hasResults: False

 nctId: NCT06335069 id: 2023-508066-15-00 briefTitle: 18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-03-28 date: 2024-03-28 name: Maastricht University Medical Center class: OTHER briefSummary: The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients. conditions: Breast Cancer conditions: Breast Neoplasms conditions: Breast Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-group, single-center pilot study primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ESTIMATED name: 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI measure: To investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a radioactive PET tracer in patients with ER+ breast cancer. measure: To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center+ city: Maastricht zip: 5800 country: Netherlands name: Thiemo JA van Nijnatten, MD, PhD role: CONTACT email: thiemo.nijnatten@mumc.nl lat: 50.84833 lon: 5.68889 hasResults: False

 nctId: NCT06335056 id: IRBAM-21-0702 id: 1R15HD108765-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R15HD108765-01A1 briefTitle: Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools acronym: ProudMe overallStatus: ENROLLING_BY_INVITATION date: 2024-02-19 date: 2025-12 date: 2026-04 date: 2024-03-28 date: 2024-03-28 name: Louisiana State University and A&M College class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: Pennington Biomedical Research Center name: Texas A&M University name: University of Nevada, Las Vegas briefSummary: This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost. conditions: Treatment (ProudMe) conditions: Waitlist Control studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions. primaryPurpose: PREVENTION masking: NONE count: 480 type: ESTIMATED name: ProudMe name: Waitlist Control measure: Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers measure: Screen time measure: Food environment measure: Body mass index z score measure: Waist circumference measure: Activity self-efficacy measure: Self-monitoring measure: Social support measure: School Wellness Policy measure: Cafeteria Nutrition sex: ALL minimumAge: 10 Years maximumAge: 15 Years stdAges: CHILD facility: LSU Pedagogical Kinesiology Lab city: Baton Rouge state: Louisiana zip: 70803 country: United States lat: 30.45075 lon: -91.15455 hasResults: False

 nctId: NCT06335043 id: 119245 briefTitle: Personalized Pharmacotherapy Using Pharmacogenetics in Veterans acronym: PGx overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-04-01 date: 2024-03-28 date: 2024-03-28 name: Lawson Health Research Institute class: OTHER briefSummary: This study is an observational clinical trial aimed at to evaluate the use of pharmacogenetic testing (PGx) for mental health treatment in members and Veterans of the CAF and RCMP patient population as well as the attitudes of both St. Joseph's OSI Clinic Psychiatrists and patients towards PGx. Both OSI Clinic Psychiatrists participants and patient participants will be administered a brief demographic survey in addition to a survey examining their views on, and current knowledge of PGx. Patient participants will have an opportunity to opt-in to or opt-out of receiving PGx. For patient participants who opt-in to PGx (PGx-guided treatment group), a report summarizing the PGx results will be sent to each patient participants' respective OSI Clinic Psychiatrist, alongside a questionnaire that captures the OSI Clinic Psychiatrist participant's treatment planning and changes to treatment planning. Where applicable, past treatment data from patient participants acquired at the St. Joseph's OSI Clinic will be used to identify the number of prior medication changes. Patient participants who opt-out of PGx but continue to receive pharmacologic care at the St. Joseph's OSI Clinic will act as a standard care comparator treatment group. Patient participant's outcomes including PTSD, depression and anxiety severity, and medication-related side effects, will be assessed until the patient participant is discharged from the OSI Clinic or after 24 weeks, whichever comes first. All patient participants, regardless of their study treatment group, will have their symptomatology collected via standard care data collection protocol (Client Reported Outcomes Monitoring Information System (CROMIS) and electronic medical records (EMR)); a self-report assessing the presence of side effects will be completed via Lawson REDCap. OSI Clinic Psychiatrist participants and patient participants will be asked to complete a virtual exit interview at the end of their participation. conditions: Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 155 type: ESTIMATED name: Pharmacogenetics Testing measure: PHQ-9 - Patient Health Questionnaire 9 measure: GAD-7 - General Anxiety Disorder-7 measure: PCL-5 - Posttraumatic Stress Disorder Checklist - 5 measure: OQ-45 - Outcome Questionnaire 45 measure: Pharmacological Side Effect Measure measure: Electronic Medical Record Extraction Measure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06335030 id: 2.1_AUT-SP2_001_Tancredi briefTitle: Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism overallStatus: RECRUITING date: 2021-03-29 date: 2024-01-30 date: 2024-11-30 date: 2024-03-28 date: 2024-03-28 name: IRCCS Fondazione Stella Maris class: OTHER name: Ospedale Borgo Trento - Verona name: Università degli Studi di Trento briefSummary: Brief Summary: Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as Autism Spectrum Disorder (ASD) , both on an individual level, both on family and social ones .

Children (2-6 years) diagnosed with ASD according to Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM5) criteria were enrolled in an observational, cross-sectional and multicentric study conducted by three different Italian clinical centers. Regarding this sample, principal aims of the study are to describe characteristics of food selectivity, to evaluate its correlation with ASD symptoms, with cognitive and adaptive functioning of ASD preschoolers, to describe its impact on parental stress. conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Child Oral and Motor Proficiency Scale (ChOMPS) measure: Brief Autism Mealtime Behavior Inventory (BAMBI) measure: Sensory Profile 2 (SP2) measure: Child Behavior Checklist (CBCL) measure: Parenting Stress Index (PSI) measure: Observation of child meal-time measure: Food Diary measure: Gastrointestinal severity symptom index (GSSI) measure: Mac Arthur measure: Autism Quotient (AQ) measure: Autism Diagnostic Observation Schedule-2 (ADOS-2) measure: Vineland-II scales (VABS II) sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: IRCCS Stella Maris status: RECRUITING city: Pisa state: PI zip: 56128 country: Italy name: Raffaella Tancredi role: CONTACT phone: +39050886292 email: raffaella.tancredi@fsm.unipi.it name: Roberta Nencioli role: CONTACT phone: +39050886347 email: roberta.nencioli@fsm.unipi.it lat: 43.70853 lon: 10.4036 facility: Università degli Studi di Trento-Laboratorio di Osservazione, Diagnosi e Formazione status: TERMINATED city: Rovereto zip: 38068 country: Italy lat: 45.8904 lon: 11.04053 facility: Azienda Ospedaliera Borgo Trento status: TERMINATED city: Verona zip: 37126 country: Italy lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06335017 id: 294-2024-HFH briefTitle: Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous overallStatus: RECRUITING date: 2024-04-10 date: 2024-12 date: 2024-12 date: 2024-03-28 date: 2024-04-12 name: Holy Family Hospital, Nazareth, Israel class: OTHER briefSummary: The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in multiparous women.

The main question it aims to answer are:

Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline.

In the control group, the catheter will be inserted into cervical canal without ingestion of castor oil. conditions: Induction of Labor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 216 type: ESTIMATED name: Induction of labor measure: time to delivery measure: balloon expulsion time measure: Bishop score at catheter expulsion measure: Number of women that will have non-vertex presentation after removal of the catheter measure: Duration of active phase measure: Duration of second stage measure: Mode of delivery measure: Indications for cesarean or vacuum deliveries measure: Number of patients that will have intrapartum fever ≥ 38 °C measure: Number of patients that will require use of intrapartum use of antibiotic treatment measure: Number of Participants with that will develop clinical signs of chorioamnionitis. measure: Number of Participants with that will develop 3rd and 4th degrees perineal lacerations. measure: Number of Participants with develop postpartum hemorrhage. measure: Number of Participants with need blood transfusion. measure: Number of women that will have side effects related to castor oil use measure: Oxytocin dosage measure: Number of participants with Umbilical Cord prolapse. measure: Number of neonates that will have Apgar score (range 0 to 10) <7. measure: number of women with cord artery pH <7.1 measure: Neonatal birthweight measure: Number of neonates with Neonatal fever ≥ 38 °C measure: The number of neonates that will develop neonatal sepsis. measure: The number of neonates that will require antibiotic treatment. measure: number of neonates with any neonatal complications measure: The number of neonates that will Admit to neonatal intensive care unit (NICU) measure: Length of stay in NICU. measure: Number of neonatal death measure: Maternal hemoglobin level after delivery. measure: Number of participants that will require postpartum hysterectomy. measure: Number of participants that will require postpartum laparotomy. measure: Number of women that will develop postpartum complications measure: The length of stay from birth to discharge home. measure: Maternal satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Holy Family hospital, Nazareth status: RECRUITING city: Nazareth country: Israel name: Wiaam Khatib, MD role: CONTACT phone: 0549192433 email: wiaam.khatib.95@gmail.com name: Raed Salim, MD role: CONTACT email: r.salim@hfhosp.org name: Wiaam Khatib, MD role: PRINCIPAL_INVESTIGATOR lat: 32.69925 lon: 35.30483 hasResults: False

 nctId: NCT06335004 id: 926 briefTitle: Evaluation of Brain Waste Clearance Pathways Using Magnetic Resonance Imaging in Pediatric Patients With White Matter Diseases overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-01 date: 2024-12-31 date: 2025-02-28 date: 2024-03-28 date: 2024-03-28 name: IRCCS Eugenio Medea class: OTHER briefSummary: The dilation of perivascular spaces can be the result of various etiopathogenetic processes. White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies. Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. Dilation of PVS can be associated with changes in white matter and microhemorrhages. We want to study these etiopathogenetic phenomena by implementing specific MRI methods. conditions: Glymphatic System conditions: White Matter Disease conditions: Pediatric Disorder conditions: Perivascular Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Magnetic resonance imaging measure: Extent of white matter lesions measure: Number of perivascular spaces measure: Volume of parasagittal dural space sex: ALL minimumAge: 9 Months maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Institute IRCCS Eugenio Medea city: Bosisio Parini state: Lecco zip: 23842 country: Italy lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06334991 id: QUILT-106 briefTitle: Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-30 date: 2027-03-30 date: 2024-03-28 date: 2024-03-28 name: ImmunityBio, Inc. class: INDUSTRY briefSummary: Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL). conditions: Non-Hodgkin Lymphoma Refractory/ Relapsed studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study is open label, for Refractory/ Relapsed Non-Hodgkin Lymphoma. Up to 10 subjects will receive at least 1 dose of study drug. The initial 3 subjects will receive study drug in a staggered fashion, with a 7 day interval between each subject to evaluate any toxicities. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: CD19 t-haNK measure: Overall safety evaluation in combining CD19 t haNK as a single agent with rituximab measure: Incidence of treatment-emergent AEs (TEAEs) and serious AEs (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 5.0.Clinically important changes in safety laboratory tests and vital signs. measure: Best tumor response in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334978 id: 1-2024 briefTitle: The Effectiveness of Osteopathic Treatment in Cervical Whiplash. overallStatus: COMPLETED date: 2021-01-13 date: 2022-07-10 date: 2022-08-10 date: 2024-03-28 date: 2024-03-28 name: Hospital San Juan de Dios del Aljarafe de Sevilla class: OTHER name: Hospital Universitario Virgen Macarena name: University of Seville briefSummary: Introduction. Whiplash is common after road traffic accidents and affects millions of people worldwide; 50% develop chronic symptoms and 15% have their ability to work compromised. The aim of this study was to evaluate an osteopathic intervention in whiplash and determine whether pain, mobility and quality of life improve with respect to conventional treatment.

Methodology. A randomised, controlled clinical trial between 13/01/2021_10/08/2022 conducted at Hospital San Juan de Dios del Aljarafe. The control group followed the hospital's protocol, and the experimental group also received an osteopathic intervention. Statistical analysis: Statistical Package for the Social Sciences (SPSS-vs27.0); intra-subject comparison: Student's t-test for dependent samples, Wilcoxon's test; inter-group comparisons: Student's t-test for independent samples, Mann-Whitney U, chi-squared. conditions: Whiplash Injury of Cervical Spine conditions: Osteopathia conditions: Quality of Life conditions: Chronic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Randomised controlled clinical trial primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: The study was blinded: patients were unaware of the group to which they had been assigned. Patient evaluations at the start and end were performed by a physiotherapist different to the one performing the intervention, who was also unaware of the patient assignment. The same person performed all therapies for both the control and intervention groups and was unaware of the pre-intervention measurements. The statistician who analysed the data was also unaware of the group to which each patient belonged. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ACTUAL name: Osteopathic intervention measure: Cervical Pain measure: Quality of life in Whiplash Disability measure: Functionality-Neck Disability Index measure: Number of sites measure: Number of analgesics measure: Measuring mobility using inclinometry measure: Measurement of pressure pain using algometry sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: María Victoria RUIZ ROMERO city: Bollullos de la Mitación state: Sevilla zip: 41110 country: Spain lat: 37.34014 lon: -6.13719 hasResults: False

 nctId: NCT06334965 id: APHP230279 briefTitle: Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort acronym: OPERANDI-HCC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-11 date: 2029-09 date: 2024-03-28 date: 2024-03-28 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI.

Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic and follow-up PET-MRI, in patients with HCC treated with TARE. conditions: Hepatocellular Carcinoma conditions: Radioembolization studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 180 type: ESTIMATED name: Simultaneous 18F-Choline PET-MRI measure: Clinical response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beaujon hospital city: Clichy country: France name: Mohamed BOUATTOUR role: CONTACT lat: 48.90018 lon: 2.30952 facility: CHU Nantes city: Nantes country: France name: Yann TOUCHEFEU role: CONTACT lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06334952 id: RCAPHM23_0074 id: ID-RCB type: OTHER domain: 2023-A02482-43 briefTitle: Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic acronym: GALVANI GS-3 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-31 date: 2027-04-30 date: 2024-03-28 date: 2024-03-28 name: Assistance Publique Hopitaux De Marseille class: OTHER name: CRMBM-CEMEREM name: Institut National de la Santé Et de la Recherche Médicale, France - LTSI name: Neuroelectrics Corporation briefSummary: The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are:

* Changes in quality of life
* Percent of newly reported side effects after the stimulation period
* Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total). conditions: Epilepsy conditions: Drug Resistant Epilepsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: transcranial direct current stimulation measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference. measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction) measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction) measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction) measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction) measure: Evaluate the number of seizure-free patients measure: Evaluate the number of seizure-free patients measure: Evaluate the number of seizure-free patients measure: Evaluate the number of seizure-free patients measure: Quality of life after stimulation sessions with the baseline period measure: Quality of life after stimulation sessions with the baseline period measure: Quality of life after stimulation sessions with the baseline period measure: Quality of life after stimulation sessions with the baseline period measure: Evaluation of the change in seizure severity measure: Evaluation of the change in seizure severity measure: Evaluation of the change in seizure severity measure: Evaluation of the change in seizure severity measure: Changes in psychiatric comorbidities measure: Changes in psychiatric comorbidities measure: Changes in psychiatric comorbidities measure: Changes in psychiatric comorbidities measure: Safety assessment and possible side effects measure: Safety assessment and possible side effects measure: Safety assessment and possible side effects measure: Safety assessment and possible side effects measure: Compare brain functional connectivity before and after tDCS treatment measure: Evaluation of the impact of tDCS on interictal epileptic spikes (IESs) measure: Evaluation of the impact of tDCS on interictal epileptic spikes measure: Evaluation of the impact of tDCS on interictal epileptic spikes measure: Evaluation of the impact of tDCS on interictal epileptic spikes measure: Evaluation of the impact of tDCS on interictal epileptic spikes sex: ALL minimumAge: 9 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques city: Bordeaux zip: 33000 country: France name: Jerome Aupy role: CONTACT email: Jerome.aupy@chu-bordeaux.fr lat: 44.84044 lon: -0.5805 facility: Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon city: Bron zip: 69677 country: France name: Sylvain Rheims role: CONTACT email: Sylvain.rheims@chu-lyon.fr lat: 45.73333 lon: 4.91667 facility: Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille city: Lille zip: 59037 country: France name: Philippe Derambure role: CONTACT email: Philippe.Derambure@chru-lille.fr lat: 50.63297 lon: 3.05858 facility: Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone city: Marseille zip: 13005 country: France name: Fabrice Bartolomei role: CONTACT email: Fabrice.bartolomei@ap-hm.fr lat: 43.29551 lon: 5.38958 facility: Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne city: Paris zip: 75014 country: France name: Martine Gavaret role: CONTACT email: m.gavaret@ghu-paris.fr lat: 48.85341 lon: 2.3488 facility: Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou city: Rennes zip: 35033 country: France name: Anca Nica role: CONTACT email: Anca.nica@chu-rennes.fr lat: 48.11198 lon: -1.67429 facility: Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet city: Toulouse zip: 31059 country: France name: Luc Valton role: CONTACT email: valton.l@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06334939 id: KSH.2023-32 briefTitle: Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries overallStatus: RECRUITING date: 2024-01-01 date: 2024-05-01 date: 2024-05-30 date: 2024-03-28 date: 2024-03-28 name: Ahmet Yuksek class: OTHER_GOV briefSummary: Emergence agitation; generally refers to a situation that may occur after a surgical intervention or anesthesia. This situation describes the irritability and agitation of the patient during the recovery process and the period of recovery from anesthesia. Recovery agitation may occur when the patient begins to recover and is usually a short-term condition. It resolves spontaneously. However, in some cases, this agitation may be more pronounced and disturbing. This may affect the patient\&amp;#39;s condition and relaxation. Rapid recovery from anesthesia in the clinic is also a risk factor for agitation.

When the literature is examined, there are not enough studies on Bis suppression ratio and its relationship with recovery agitation is not yet known enough. For this purpose, our study aimed to question this relationship. conditions: Emergence Agitation conditions: Anesthesia Recovery conditions: Bispectral Index Monitor studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Bispectal index Monitoring measure: Relationship between BIS SR value and Emergence Agitation measure: Relationship between average and lowest BIS values and Emergence agitation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli City Hospital status: RECRUITING city: Kocaeli state: Izmıt zip: 41100 country: Turkey name: Mehmet Yilmaz, Associate Proffessor role: CONTACT phone: 505-217-4432 email: drmyilmaz33@gmail.com name: Ahmet Yuksek, Md role: PRINCIPAL_INVESTIGATOR lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06334926 id: EK 18-002-VK briefTitle: BMI and Lymph Node Count in Colorectal Cancer overallStatus: COMPLETED date: 2017-12-01 date: 2020-03-31 date: 2020-03-31 date: 2024-03-28 date: 2024-03-28 name: Klinikum Floridsdorf class: OTHER name: Medical University of Vienna name: Klinik Favoriten name: Salzkammergut Klinikum Vöcklabruck briefSummary: Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.

Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS. conditions: The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long Term studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1192 type: ACTUAL name: no intervention, retrospective data analysis measure: overall survival sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinik Floridsdorf city: Wien zip: 1210 country: Austria lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06334913 id: IRAS 332286 briefTitle: A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-04-01 date: 2029-04-01 date: 2024-03-28 date: 2024-03-28 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER briefSummary: The investigators will assess the use of a smart phone app to monitor patient reported outcomes and record biometric data in patients with myeloproliferative neoplasms. conditions: Myeloproliferative Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Patient reported outcomes - Myeloproliferative Neoplasm-10 Total Symptom Score measure: Healthcare adherence measure: Biometric data analysis - activity index measure: Biometric data analysis - sleep score measure: Biometric data analysis - heart rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334900 id: 69HCL24_0297 briefTitle: Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia acronym: Ata-GAD overallStatus: RECRUITING date: 2023-10-01 date: 2024-01-01 date: 2024-06-30 date: 2024-03-28 date: 2024-03-28 name: Hospices Civils de Lyon class: OTHER briefSummary: Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic encephalitis (LE) and temporal lobe epilepsy. These syndromes all seem to result from a reduced transmission of GABA. These neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. When finding high levels of GAD65-Ab in the serum, a cerebrospinal fluid (CSF) sample should be taken to look for oligoclonal IgG bands and intrathecal GAD-Ab production to prove an auto-immune cause for the various neurological symptoms. conditions: GAD-receptor Antibodies-associated Encephalitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: GAD patients measure: GAD Patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est status: RECRUITING city: Bron zip: 69677 country: France name: Jérôme Honnorat, professor role: CONTACT phone: +33 4 72 35 78 06 email: jerome.honnorat@chu-lyon.fr lat: 45.73333 lon: 4.91667 hasResults: False

 nctId: NCT06334887 id: PID2021-124409OB-I00_O3 briefTitle: esTOCma, an App Used by Teachers: an RCT overallStatus: RECRUITING date: 2024-02-26 date: 2024-05-31 date: 2024-05-31 date: 2024-03-28 date: 2024-04-01 name: University of Valencia class: OTHER name: Ministry of Science and Innovation briefSummary: The aim of the present study is to assess the efficacy of a mobile application called esTOCma in promoting mental health literacy, reducing stigmatizing attitudes related to the Obsessive-Compulsive Disorder (OCD) and improving teachers' confidence in dealing with students that might have OCD. A parallel, randomized controlled trial with two conditions (experimental and control group) will be carried out in a sample of teachers that work in primary and secondary education. Pre-post changes will be assessed. Experimental group will use the app until they finish it (within a set period of 10 days), whereas control group will do nothing for 10 days. Primarily, it is expected that after the use of the app, participants will show an improvement in OCD-related literacy, stigmatizing attitudes, desired social distance and their comfort, confidence and perceived ability in teaching and handling students with OCD. Secondarily, the investigators hypothesize that experimental group might show a reduction in obsessive-compulsive symptoms. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A parallel randomized controlled trial (RCT) with two arms: experimental group (use of esTOCma) and control group (untreated) will be carried out.

As participants enroll in the study, those that meet the inclusion criteria will be randomized into experimental or control group and into contamination or aggressive vignette (see Outcome Measures). Everyone will complete the baseline measures (T1). Then, those assigned to experimental group will use the app esTOCma until they finish it (they will be given a 10-days deadline), whereas control group will do nothing for 10 days. After that, all the participants will complete again the assessment instruments (T2). primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Use of esTOCma measure: Change in general OCD literacy measure: Change in OCD literacy associated with a vignette measure: Change in stigmatizing attitudes related to OCD associated with a vignette measure: Change in comfort in addressing OCD measure: Change in desired social distance measure: Change in obsessive-compulsive symptoms sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Valencia/ Universitat de València status: RECRUITING city: Valencia zip: 46010 country: Spain name: Gemma Garcia-Soriano, PhD role: CONTACT lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06334874 id: REC-FPFUE-32/2023 briefTitle: Study of the Efficacy and Safety of Antioxidants Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients. overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-08-01 date: 2024-03-28 date: 2024-04-12 name: Future University in Egypt class: OTHER briefSummary: Community acquired pneumonia (CAP) is one of the most common and morbid conditions encountered in clinical practice, which causes serious morbidity worldwide. In CAP, oxidative stress is linked to inflammation, demonstrated by increased production of interleukin (IL)-6 and tumor necrosis factor (TNF)-α, which attract inflammatory cells and increase oxidant production by these cells. Attenuation of oxidative stress via antioxidants would be expected to result in reduced pulmonary damage. Antioxidants have been found to be effective in alleviating lung injury and protecting against damage of other organs. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Astaxanthin Oral Capsule name: Placebo measure: change in IL-6 after treatment in the ASX group compared with those in the control group. measure: change in IL-10 after treatment in the ASX group compared with those in the control group. measure: change in tumor necrosis alpha after treatment in the ASX group compared with those in the control group. measure: difference in CURB 65 scores after treatment in the ASX group compared with the control group. measure: o Adverse drug reactions related to ASX as increase bowel movement, stomach pain and increase PT and APTT will be assessed. measure: Length of hospital and ICU stay. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elmatarya Teaching Hospital status: RECRUITING city: Cairo zip: 4650201 country: Egypt name: fatma makram role: CONTACT phone: 01015000329 email: fatma.aboelhassan@fue.edu.eg name: eman elmokadam role: CONTACT email: Eman.abdellatif@fue.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06334861 id: 5001 briefTitle: Multidisciplinary Hospital-Territory Vaccine Center: a Model for Achieving the Herpes Zoster Vaccine Coverage acronym: CeVOT-Her-Zo overallStatus: RECRUITING date: 2022-06-23 date: 2024-05-15 date: 2024-06-30 date: 2024-03-28 date: 2024-03-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The National Vaccination Program, updated by the Ministry of Health in 2021, provides a new vaccination opportunity for frail patients against Herpes zoster virus (HZ). The new treatment option, on the other hand, is designed by combining VZV-specific antigen (gE) with an adjuvant system (AS01B) to induce antigen-specific cellular and humoral immune responses in individuals with preexisting immunity to VZV. Efficacy, assessed in people given two doses 2 months apart, is around 97% in those aged 50 years and 91% in those over 70 years. In the studies conducted, HZ-related hospitalizations were significantly reduced. The vaccine schedule calls for the administration of two doses 2 months apart. The current HZ Vaccination Program implemented at the regional level recommends its active and free offer in people from 18 years of age with congenital and/or acquired immunodepression, through a collaborative relationship involving, on the one hand, multispecialist and multiprofessional medical staff and, on the other hand, citizens called to play a role that is no longer passive but the subject of empowerment by consciously making their own health choices. The collaboration with ASL Roma1, in this sense, acquires value as guarantor of the supply of the adjuvanted recombinant anti-HZ vaccine and of the appropriate reporting of vaccination coverage, which to date is still far from the targets set by the PNPV'17-'19 in adults at risk for disease.

The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients' compliance with the proposed vaccination, the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting. conditions: Herpes Zoster studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 48 type: ESTIMATED name: Herpes Zoster adjuvanted recombinant vaccine measure: Compliance to vaccination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli - UCSC status: RECRUITING city: Roma state: RM zip: 00168 country: Italy name: Patrizia Laurenti, MD PHD role: CONTACT email: patrizia.laurenti@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06334848 id: TOT versus mini sling briefTitle: Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-09 date: 2024-03-28 date: 2024-03-28 name: Ain Shams University class: OTHER briefSummary: To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence. conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: transobturator tape measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function sex: FEMALE maximumAge: 60 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06334835 id: 1/23 OSS SDN briefTitle: Long Non-coding RNAs and Their Role on Epigenome as Diagnostic Markers in Childhood Acute Lymphoblastic Leukemia of T Cells. overallStatus: RECRUITING date: 2023-04-30 date: 2023-12-31 date: 2026-05-31 date: 2024-03-28 date: 2024-04-03 name: IRCCS SYNLAB SDN class: OTHER name: Fondazione Santobono Pausilipon briefSummary: Long non-coding RNAs (lncRNAs) are a class of biomarkers of crescent interest in the hematologic and oncologic field.

They do not encode proteins and can alter gene expression by acting on different steps of regulation, including DNA methylation and chromatin structure. Recent data identified recurrent somatic alterations in genes involved in DNA methylation and post-translational histone modifications in T-ALL, suggesting that epigenetic homeostasis is critically required in restraining tumor development in the T-cell lineage. Further, recent studies showed that the expression levels of specific lncRNAs correlate with the prognosis of patients with Acute Lymphoblastic Leukemia of T-cells (T-ALL). The objectives of this research project are to identify T-ALL-specific lncRNAs to be used as new diagnostic and prognostic biomarkers of disease and to explore their role on chromatin reorganization and transcriptional regulation that may lead to the onset and progression of T-ALL. conditions: Acute Lymphoblastic Leukemia, Pediatric studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: lncRNA signature analyses measure: Evaluation of the expression of selected lncRNAs in pediatric T-ALL patients and cellular models of T-ALL sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Irccs Synlab Sdn status: RECRUITING city: Naples zip: 80143 country: Italy name: Giovanni Smaldone, PhD role: CONTACT phone: 3398768331 email: giovanni.smaldone@synlab.it lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06334822 id: HFT-2024-01 briefTitle: Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK. acronym: HF-TRACK overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-04-30 date: 2024-03-28 date: 2024-03-28 name: Heartfelt Technologies class: INDUSTRY briefSummary: The objective of our research is to evaluate the effectiveness of an innovative medical device designed to measure foot and lower leg sizes in detecting early indications of deteriorating heart failure. This health condition frequently causes leg swelling and breathing difficulties due to fluid accumulation. Early detection of these symptoms is vital for effective management, potentially preventing the need for hospitalization.

Fluid retention in the lower legs and lungs, manifesting as swollen ankles and shortness of breath, is a common sign of progressing heart failure. Often, a slight increase in body weight is the first warning of fluid accumulation, occurring before noticeable swelling or breathing issues arise. Early identification of these fluid accumulation signs is critical for timely intervention, which can avert the necessity for hospital admittance. Patients are usually encouraged to monitor their weight, check for swelling in the ankles, observe their breathing, and consult with their healthcare provider or heart failure specialist at the first sign of these symptoms. In many cases, patients can report these symptoms in time for their healthcare team to adjust their treatment accordingly. Diuretics, or water pills, are often prescribed to help eliminate excess fluid, effectively preventing hospital admissions when used promptly.

The Heartfelt device may provide a useful solution for individuals who find it challenging to consistently monitor these indicators and their weight. It is designed to detect early warning signs seamlessly without imposing additional tasks on the patient's daily routine. The device, intended to complement rather than replace self-monitoring practices, is user-friendly and operates by scanning the feet for any size changes, positioned conveniently by the bedroom floor. This capability allows healthcare professionals to make informed decisions swiftly about patient care, potentially adjusting treatments to avoid further health complications. The device captures images of the feet only, ensuring privacy.

This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for patients facing heart failure challenges. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This 6-month study involves up to 210 patients using the Heartfelt device at home. It is a crossover trial with a 21-day break between two 69-day periods to prevent overlap effects. Patients will either receive standard care or standard care plus Heartfelt alerts. The Heartfelt group is further divided into three 23-day sub-studies to test different alert systems.

Another 60 patients will have monthly measurements taken at the pharmacy without being part of the main randomisation. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Only outcomes assessors will be blinded. whoMasked: OUTCOMES_ASSESSOR count: 270 type: ESTIMATED name: Heartfelt Device installed name: Standard care name: Questionnaires name: Heartfelt Device in pharmacy name: Heartfelt device alerting system measure: All-Cause Mortality Rate. measure: Heart Failure Hospitalisation Incidence. measure: Device-Related Complication Rate. measure: Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices measure: Hospital Admission Duration measure: Cause of Hospitalization measure: Date of Changes in HF Medication Post-Discharge measure: Changes in dosage of HF Medication Post-Discharge measure: Cause of Death measure: Date of Death measure: Loss of Independence measure: Hospitalisation Admission Route measure: Scheduling of Care Events measure: Setting of Care Events measure: Timestamp of Health Alerts Generated by the Heartfelt Device measure: Frequency of Health Alerts Generated by the Heartfelt Device measure: Foot volume measure: Peripheral oedema grading measure: Weight sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr R Raut & Partnership (General Practice) city: Hull state: East Riding Of Yorkshire zip: HU7 5DD country: United Kingdom name: Rajeev Raut, MD role: CONTACT phone: +441482 835880 email: HF-TRACK@hftech.org name: Rajeev Raut, MD role: PRINCIPAL_INVESTIGATOR lat: 53.7446 lon: -0.33525 hasResults: False

 nctId: NCT06334809 id: 028FPO22 briefTitle: INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations acronym: INSIDE overallStatus: RECRUITING date: 2023-03-09 date: 2026-12-31 date: 2027-12-31 date: 2024-03-28 date: 2024-03-28 name: Fondazione del Piemonte per l'Oncologia class: OTHER briefSummary: 400 patients will be enrolled and divided into 3 cohorts: Cohort A: patients with high risk localized prostate cancer (PC) defined as \>cT3 or PSA \> 20 ng/mL or presence of ECE or SVI at mpMRI;

Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC);

Cohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Number, type and frequency of DDR and MMR germline/somatic alterations measure: Changes in PSA levels in the 3 cohorts measure: Number of patient-derived preclinical models sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo status: RECRUITING city: Candiolo state: Turin zip: 10060 country: Italy name: Pasquale Rescigno, MD role: CONTACT email: pasquale.rescigno@ircc.it name: Ilaria Buondonno, PhD role: CONTACT phone: +390119933393 email: ilaria.buondonno@ircc.it lat: 44.95858 lon: 7.59812 facility: AOU San Luigi Gonzaga status: RECRUITING city: Orbassano state: Turin zip: 10060 country: Italy name: Francesco Porpiglia, MD role: CONTACT lat: 45.00547 lon: 7.53813 hasResults: False

 nctId: NCT06334796 id: 10476 briefTitle: Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology acronym: AIDEN overallStatus: COMPLETED date: 2023-10-01 date: 2024-01-01 date: 2024-01-01 date: 2024-03-28 date: 2024-03-28 name: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia class: OTHER name: Entelai briefSummary: This study examines the use of an AI-powered virtual assistant for quickly identifying and handling neurological emergencies, particularly in places with limited medical resources. The research aimed to check if this AI tool is safe and accurate enough to move on to more advanced testing stages. In a first-of-its-kind trial, the virtual assistant was tested with patients having urgent neurological issues. Neurologists first reviewed the AI's recommendations using clinical records and then assessed its performance directly with patients. The findings were as follows: neurologists agreed with the AI's decisions nearly all the time, and the AI outperformed earlier versions of Chat GPT in every tested aspect. Patients and doctors found the AI to be highly effective, rating it as excellent or very good in most cases. This suggests the AI could significantly enhance how quickly and accurately neurological emergencies are dealt with, although further trials are needed before it can be widely used. conditions: Stroke conditions: Guillain-Barre Syndrome conditions: Facial Palsy conditions: Migraine conditions: Status Epilepticus conditions: Vertigo Benign Positional conditions: Delirium conditions: Trigeminal Neuralgia conditions: Meningitis conditions: Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The model of this Phase 1 interventional study involves evaluating the diagnostic accuracy and utility of an AI-powered virtual assistant in the triage of emergency neurological conditions. Patients and healthcare professionals interacted with the assistant, providing real-world clinical scenarios to assess its effectiveness. The study's design aimed to demonstrate the assistant's potential to enhance emergency neurological care by comparing its performance with established diagnostic tools and patient outcomes. primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ACTUAL name: Virtual Assistant measure: Diagnostic performance measure: Appropriate medical conduct or recommendation measure: Assessment of Usability and Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fleni city: Buenos Aires zip: 1428 country: Argentina lat: -34.61315 lon: -58.37723 hasResults: False

 nctId: NCT06334783 id: HV-IIT briefTitle: TIL for Patients With Advanced Solid Tumor overallStatus: RECRUITING date: 2023-05-30 date: 2025-12-31 date: 2026-12-31 date: 2024-03-28 date: 2024-03-28 name: Hervor Therapeutics class: INDUSTRY name: Jinling Hospital, China name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences name: Women's Hospital School Of Medicine Zhejiang University briefSummary: Background:

Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to patients.

TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical cancer.

Objective:

To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor.

Eligibility:

Adults aging 18-75 with advanced solid tumor.

Design:

1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
2. Freshly resected patient tumors were dissected by the surgeon.
3. TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded.
4. At last TIL cells will be re-infused into the patients. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Autologous tumor-infiltrating lymphocyte cells measure: Safety of TIL measure: Overall Response Rate (ORR) measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Progression free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center status: RECRUITING city: Shenzhen state: Guangdong country: China name: Xiugui Sheng, PhD role: CONTACT email: hanxiuchen@yeah.net lat: 22.54554 lon: 114.0683 facility: Nanjing Jinling Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Tangfeng Lv, PhD role: CONTACT phone: +86 25 8086 0114 email: bairoushui@163.com lat: 32.06167 lon: 118.77778 facility: Wowen's hospital, School of medicine, Zhejiang University status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang country: China name: Hui Wang, PhD role: CONTACT email: 5198008@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06334770 id: FDASuRecD032136 briefTitle: Influence of Roxolid Implant Material on the Implant Stability Implant Stability acronym: BLX overallStatus: COMPLETED date: 2021-06-15 date: 2022-01-22 date: 2023-12-12 date: 2024-03-28 date: 2024-03-28 name: Ain Shams University class: OTHER briefSummary: Fourteen completely edentulous patients were selected to participate in this study. From the outpatient clinic of Prosthodontic Department, Faculty of Dentistry, Ain Shams University.

After fabrication of complete denture for all patients, patients were randomly divided to:

Group A: Seven patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® implant were inserted opposed by mandibular complete denture.

Group B: Seven patients were rehabilitated with implant retained maxillary overdenture where four conventional acid etched implants were inserted opposed by mandibular complete denture.

After implant placement using surgical guide, smart peg and ostell device were used to measure the primary stability of the implant then cover screw was placed and after six weeks, secondary stability was measured for both groups.

After four months, the second stage started in which exposure of the implant fixtures took place and pick up was carried out.

Patients were recalled frequently for post-insertion inspection and adjustment. conditions: Completely Edentulous Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 18 type: ACTUAL name: Roxolid implants name: Titanium implants measure: measuring primary at time of surgery measure: secondary implant stability after 6 weeks sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry of Dentistry Ainshams Univeristy city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06334757 id: HLX10IIT22 briefTitle: Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure overallStatus: RECRUITING date: 2023-05-08 date: 2024-08-31 date: 2025-06-30 date: 2024-03-28 date: 2024-03-28 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients. conditions: Non-Squamous Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Serplulimab name: Bevacizumab Biosimilar HLX04 name: Pemetrexed name: Carboplatin measure: ORR(Overall Response Rate) measure: PFS(Progression Free Survival) measure: OS(Overall Survival) measure: AE(Adverse Event) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital status: RECRUITING city: Zhengzhou state: Henan zip: 450003 country: China name: zhen he role: CONTACT phone: 13523530961 lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06334744 id: COVAR briefTitle: Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active. overallStatus: COMPLETED date: 2021-11-17 date: 2023-01-08 date: 2023-06-08 date: 2024-03-28 date: 2024-03-29 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER briefSummary: To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine. conditions: Oncologic Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ACTUAL measure: Determination of the change in neutralizing antibodies against SARS-CoV-2 (CLIA method) towards VOCs before the third dose of COVID-19 vaccine and 21 days after the same. measure: Evaluation of the kinetics of neutralizing antibodies and anti-SARS-CoV-2 IgG titer (CLIA method) up to 52 weeks after the third dose of COVID-19 vaccine measure: Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine. measure: Evaluation of the incidence of local and systemic adverse reactions (ARs), directly or indirectly linked to the vaccine, in an observation period up to 4 weeks later the third dose of vaccine. measure: Evaluation of the incidence of "New onset" immune-related adverse events (IRAEs), such as immune-related pruritus, rashes, hypophysitis, hepatitis, pneumonia, diarrhoea, colitis in patients undergoing immunotherapy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs San Matteo Pavia city: Pavia state: PV zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06334731 id: 045.PHA.2021.D briefTitle: Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic overallStatus: RECRUITING date: 2021-07-06 date: 2024-12 date: 2024-12 date: 2024-03-28 date: 2024-03-28 name: Methodist Health System class: OTHER briefSummary: Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED measure: Incidence of third generation cephalosporin-resistant bacteria (3GCRB) measure: Incidence of ESBLPE measure: Incidence of CRB measure: Incidence of other pathogens measure: Incidence of nosocomial infections measure: Incidence of clinical outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Dallas Medical Center status: RECRUITING city: Dallas state: Texas zip: 75203 country: United States name: Matthew Crotty, PharmD role: CONTACT phone: 214-941-2400 email: matthewcrotty@mhd.com name: Matthew Crotty, PharmD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06334718 id: 318417 id: NIHR204382 type: OTHER_GRANT domain: National Institute for Health and Care Research briefTitle: Drone Delivered Defibrillators (The 3D Project). overallStatus: RECRUITING date: 2024-03-29 date: 2024-08-22 date: 2024-10-31 date: 2024-03-28 date: 2024-04-09 name: University of Warwick class: OTHER name: Welsh Ambulance Service NHS Trust briefSummary: The goal of this observational study is to explore the optimisation and integration of a drone-delivered Automated External Defibrillator (AED) system into the pre-hospital response to out-of-hospital cardiac arrest. The study is being conducted by the University of Warwick and Welsh Ambulance Service National Health Service Trust (both in the UK)

There are two separate packages of work. In work package 1 the investigators will interview people who have been involved in emergency (999) calls for cardiac arrest, asking them about their experiences with the call-handler and how they feel they might have responded if they had received an AED that had been delivered by a flying drone.

In work package 2 the investigators will conduct simulated cardiac arrests. The participants in the study will make an emergency (999) call to a trained call-handler and, once the cardiac arrest is identified during the call, a drone will be activated from a distant location and fly up to 2km to the test site and deliver an AED. The investigators will record how long it takes to retrieve and attach the AED, and ask the participants for their views about the interaction with the call-handler, AED and drone. conditions: Cardiac Arrest, Out-Of-Hospital studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 44 type: ESTIMATED name: Interviews and simulation measure: Time away from patient's side (SIMULATION) measure: Barriers and facilitators to drone-delivered AED use (INTERVIEW) measure: Interventions to overcome barriers to drone delivered AED use (INTERVIEW) measure: Hands off CPR time (SIMULATION) measure: Total time from start of 999 call to AED application and first shock (SIMULATION) measure: Total drone flight time (SIMULATION) measure: Time from drone arrival to safe to approach (SIMULATION) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Warwick status: RECRUITING city: Coventry country: United Kingdom name: Christopher M Smith, MBChB, PhD role: CONTACT phone: (+44)2476151083 lat: 52.40656 lon: -1.51217 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-27 uploadDate: 2024-03-11T10:47 filename: Prot_000.pdf size: 1072430 hasResults: False

 nctId: NCT06334705 id: C22-11 id: 2022-A02312- 41 type: REGISTRY domain: IDRCB briefTitle: EGEA4 THE 30 YEAR FOLLOW UP OF THE EGEA STUDY overallStatus: RECRUITING date: 2024-02-15 date: 2027-02-15 date: 2028-02-15 date: 2024-03-28 date: 2024-03-28 name: Institut National de la Santé Et de la Recherche Médicale, France class: OTHER_GOV name: APHP name: CHU LYON name: APHM name: University Hospital, Grenoble name: University Hospital, Montpellier briefSummary: Cardiovascular (CV) diseases affect 523 million people worldwide, and are the leading cause of death, accounting for over 18 million deaths (around 30% of all deaths) every year. CV diseases account for around 45% of all deaths in Europe, or around 140,000 deaths a year in France. Asthma is one of the main non-communicable diseases, with a significant societal and individual burden, particularly in subjects suffering from severe asthma. The prevalence of asthma worldwide has risen rapidly over the past five decades, and now affects 272 million people worldwide, representing a prevalence of around 3.6%.

Asthma is often associated with multimorbidity. Allergic rhinitis, chronic sinusitis, sleep apnea syndrome, gastro-oesophageal reflux disease, obesity and hormonal disorders are among the most common conditions associated with asthma. More recently, other chronic conditions linked to asthma have been suggested, including CV diseases.

Although data from the literature in recent years suggest that asthma is associated with an increased risk of major CV events, the underlying mechanisms remain poorly understood. In particular, it is not known whether asthma and CV disease share common etiological processes, such as anthropometric parameters, lifestyle, social, environmental and/or genetic factors, or whether CV disease is a direct consequence of certain features of asthma, such as systemic inflammation or asthma treatments.

Our study is based on the hypothesis that the risk of CV events is increased in patients with asthma, which is supported by a growing body of scientific data.However, it remains to be determined to what extent this increased risk is a consequence of asthma or is linked to shared risk factors between asthma and CV health.

We hypothesize that asthma, and more specifically adult and moderate-to-severe asthma, are associated with early markers of CV risk. Furthermore, by providing a better understanding of the mechanisms involved in this association, we hypothesize that EGEA_30years may help to disentangle and prioritize actionable levers of life-threatening cardiovascular comorbidities in asthma. conditions: Healthy Volunteer EGEA4 Cohort studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 1000 type: ESTIMATED name: blood test, food collection, hair collection, calcium scan, etc. measure: Framingham score variability between asthmatics and non-asthmatics measure: Aortic pulse wave velocity measure: validated predictive biomarkers of CV disease (NTproBNP, Troponin(I) hs), measure: Soluble ST2 measure: coronary calcium score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire Grenoble Alpes status: RECRUITING city: Grenoble zip: 38043 country: France name: Bruno DEGANO, PhD role: CONTACT email: BDEGANO@chu-grenoble.fr lat: 45.16667 lon: 5.71667 facility: Hopital de la Croix Rousse status: RECRUITING city: Lyon zip: 69317 country: France name: Gilles Mr DEVOUASSOUX, MD role: CONTACT email: gilles.devouassoux@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: APHM status: RECRUITING city: Marseille zip: 13000 country: France name: Pascal CHANEZ, PhD role: CONTACT email: pascal.chanez@univ-amu.fr lat: 43.29551 lon: 5.38958 facility: Hôpital Arnaud De Villeneuve status: RECRUITING city: Montpellier zip: 34295 country: France name: Pascal Mr DEMOLY, PHD role: CONTACT email: pascal.demoly@inserm.fr lat: 43.61092 lon: 3.87723 facility: APHP - Hôpital Bichat Claude Bernard status: RECRUITING city: Paris zip: 75018 country: France name: Camille TAILLE, PHD role: CONTACT email: camille.taille@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06334692 id: BLINDER briefTitle: Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome acronym: BLINDER overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2028-05 date: 2024-03-28 date: 2024-04-11 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: This retrospective study is aimed at evaluating the levels of circulating anti-nephrin autoantibodies in patients with INS, including those with MCD/FSGS and in patients who have experienced relapse of FSGS post-transplant, compared to those of a control group of patients with nephrotic syndrome due to primary membranous nephropathy (MN). conditions: Nephrotic Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa). measure: Levels of circulating anti-nephrin autoantibodies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò city: Ranica state: BG zip: 24020 country: Italy name: Federica Casiraghi, PhD role: CONTACT phone: +3903545351 email: federica.casiraghi@marionegri.it lat: 45.72328 lon: 9.71335 hasResults: False

 nctId: NCT06334679 id: zeynepersoz briefTitle: The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage overallStatus: RECRUITING date: 2024-01-15 date: 2024-11-15 date: 2024-12-15 date: 2024-03-28 date: 2024-03-28 name: Marmara University class: OTHER briefSummary: Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. It has been reported that the incidence of itching is high in burn patients during the maturation stage of wound healing. The literature suggests that in managing the symptom of itching, skin hydration support along with cold application methods can also be used. The integrity of the skin, the duration, frequency, characteristics, areas of itching, and identifying conditions that increase or decrease itching are important for managing itching. This study is planned to be conducted with a randomized controlled design to examine the effect of applying cold gel packs to burn areas of burn patients during the maturation stage on itching. This researcher's hypothesis is that burn patients who applied cold gel packs to burn areas during the maturation phase had lower itching severity (frequency, duration, intensity) than those who did not. conditions: Burns conditions: Pruritus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is a prospective interventional type two-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as clinical routine (liquid petroleum jelly) and cold gel pack, and Group-2 (Control) was designed as clinical routine (liquid petroleum jelly). primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: When cold application studies in the literature are examined, cold gel packs are placed in a sheath and contacted with the skin of the patients. Therefore, due to the nature of the application method to be used, patients and the researcher will not be considered blind. The evaluator will be considered blind in the analysis of the study. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Cold Gel Packet Application measure: Itching severity measure: Itching grade sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kartal Dr.Lütfi Kırdar City Hospital status: RECRUITING city: Istanbul country: Turkey name: Zeynep Ersoz role: CONTACT phone: 05553496718 email: zeynepersoz08@gmail.com name: Gaye Filinte role: CONTACT phone: 5339576333 email: gayetaylan@yahoo.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06334666 id: SI 172/2024 briefTitle: The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-06-01 date: 2024-03-28 date: 2024-03-28 name: Mahidol University class: OTHER briefSummary: The study conducted a health survey among Thai adults in 2022 and found a significant increase in obesity and nonalcoholic fatty liver disease (NAFLD), leading to metabolic-associated steatotic liver disease (MASLD). The prevalence of NAFLD was 19.7%, with higher rates in individuals with metabolic syndrome and diabetes. MASLD is associated with insulin resistance and genetic polymorphisms, particularly the patatin like phospholipase domain containing 3-rs738409 variant. Additionally, physical activity was inversely related to liver disease risk, with higher step counts associated with reduced incidence of NAFLD and liver-related mortality. The study aims to investigate the impact of dietary advice and pedometer use on physical activity levels and health outcomes in MASLD patients over 24 weeks. conditions: Daily Step Count conditions: MASLD conditions: BMI conditions: Metabolic Syndrome conditions: NAFLD conditions: Insulin Resistance conditions: Genetic Polymorphism conditions: Cardiovascular Disease (CVD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 86 type: ESTIMATED name: Encourage using pedometer measure: To compare the changes in hepatic fat accumulation assessed by MRI-PDFF between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior. measure: To compare changes in metabolic parameters between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments. measure: To study the impact of genes on changes in hepatic fat accumulation between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334653 id: H-23069670 briefTitle: Exercise-regulated Organ Crosstalk, Influence of IL-6 acronym: EVEX overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-11-01 date: 2024-11-01 date: 2024-03-28 date: 2024-04-09 name: Helga Ellingsgaard class: OTHER briefSummary: Overall the study investigates organ crosstalk during exercise. More specifically, the study investigates the role of IL-6 in regulating glucose, fatty acid, and amino acid kinetics at whole body level and in skeletal muscle, liver, and brain. Furthermore, the study investigates the uptake and release of extracellular vesicles in skeletal muscle, liver, and brain in reponse to exercise. conditions: Healthy Volunteers Only conditions: Energy Metabolism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: exercise measure: Whole body substrate kinetics. measure: Tissue specific utilization and production of substrates. measure: IL-6 regulation of protein synthesis and degradation. measure: Number of EVs from muscle, liver, and brain. measure: Size of EVs from muscle, liver, and brain. measure: EVs from muscle, liver, and brain. measure: Influence of exercise on EV number. measure: Influence of exercise on EV size measure: Influence of exercise on EV content. measure: Tissue specific proteomic content of EVs. measure: Lactate. measure: Pyruvate. measure: Keto acids. measure: Ketone bodies. measure: Influence of IL-6 on fatty acid oxidation rates. measure: Influence of IL-6 on insulin. measure: Influence of IL-6 on glucagon. measure: Influence of IL-6 on epinephrine. measure: Influence of IL-6 on norepinephrine. measure: IL-6 levels. measure: Influence of IL-6 on substrate usage. measure: Influence of IL-6 on perceived exertion. sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Rigshospitalet city: Copenhagen state: Capital Region zip: 2100 country: Denmark name: Helga Ellingsgaard, PhD role: CONTACT phone: +4535457544 email: helga.ellingsgaard@regionh.dk name: Peter S Plomgaard, MD PhD role: CONTACT phone: +4535457544 email: Peter.Plomgaard@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06334640 id: 37C302 briefTitle: Sleeping Quality and Chronic Ocular Diseases acronym: SONNO-OCU overallStatus: RECRUITING date: 2023-10-17 date: 2024-10-17 date: 2025-10-17 date: 2024-03-28 date: 2024-03-28 name: Istituto Auxologico Italiano class: OTHER briefSummary: To assess the impact of sleep quality on chronic eyes diseases conditions: Sleep Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 186 type: ESTIMATED name: Three questionaires measure: Proportion of sleep disorders in patients and healthy volunteers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milan zip: 20145 country: Italy name: Paolo Milani, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06334627 id: ENREACH briefTitle: Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania acronym: EN-REACH overallStatus: ACTIVE_NOT_RECRUITING date: 2022-05-03 date: 2024-04-15 date: 2024-09-15 date: 2024-03-28 date: 2024-03-28 name: London School of Hygiene and Tropical Medicine class: OTHER name: International Centre for Diarrhoeal Disease Research, Bangladesh name: Golden Community, Nepal name: Muhimbili University of Health and Allied Sciences name: University of Glasgow briefSummary: The goal of this clinical trial is to test the effect of a pre-primary education parent group intervention in children with and without disability in Nepal Bangladesh and Tanzania. The main question it aims to answer are:

* What is the impact of a parent group intervention on primary school readiness in children aged 5-6 years old in three LMICs?
* What is the feasibility and accessibility of a parent group intervention for these children?

Participants will attend parent group sessions every two weeks for a total of 9 sessions. Researchers will compare a control group to see if there are impacts on school readiness and child development. conditions: Child Development conditions: Child Development Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1651 type: ACTUAL name: Pre-Primary Intervention measure: Measuring Early Learning Quality and Outcomes (MELQO Tool) measure: The Pediatric Evaluation of Disability Inventory measure: Washington Group Questionnaire measure: The Wechsler Preschool & Primary Scale of Intelligence measure: Pre-school Register measure: Mental Health Questionnaire measure: Pediatric Quality of Life Inventory (PEDSQL Tool) sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: International Centre for Diarrheal Disease Research, Bangladesh city: Dhaka country: Bangladesh lat: 23.7104 lon: 90.40744 facility: Golden Community city: Lalitpur country: Nepal lat: 27.67658 lon: 85.31417 facility: Muhimbili University of Health and Allied Sciences city: Dar Es Salaam country: Tanzania lat: -6.82349 lon: 39.26951 hasResults: False

 nctId: NCT06334614 id: IIT_iReach briefTitle: iReach: a Rehabilitative Medical Device overallStatus: NOT_YET_RECRUITING date: 2024-12-08 date: 2025-05-08 date: 2025-12-08 date: 2024-03-28 date: 2024-03-28 name: Istituto Italiano di Tecnologia class: OTHER briefSummary: The broad goal of this clinical trial is to demonstrate whether a one-month rehabilitative training with our medical device, iReach, can promote the recovery of spatial and sensorimotor abilities and the cortical reorganization process in children with visual impairment between 3 and 36 months of age. conditions: Blindness conditions: Visual Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participant masking because the clinical trial involves infants whoMasked: PARTICIPANT count: 55 type: ESTIMATED name: iReach measure: Incidence of Device Adverse Events measure: Change in motor skills after training with iReach medical device measure: Perceptual responses to multisensory stimuli measure: Change in motor abilities following the rehabilitation with the iReach medical device measure: Variation in the power of the cortical activity following the rehabilitation with the iReach medical device sex: ALL minimumAge: 3 Months maximumAge: 36 Months stdAges: CHILD hasResults: False

 nctId: NCT06334601 id: 09C333 briefTitle: Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness acronym: Muscle-OSA overallStatus: RECRUITING date: 2023-01-15 date: 2025-12-31 date: 2025-12-31 date: 2024-03-28 date: 2024-03-28 name: Istituto Auxologico Italiano class: OTHER briefSummary: In the framework of pathophysiological trait in obstructive sleep apnea (OSA) patients, a simplified method is proposed to measure upper airway (UA) collapsibility and muscle responsiveness during wakefulness. conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 66 type: ESTIMATED name: Tests of upper airway collapsibility and muscle responsiveness. measure: Upper airway collapsibility measure: Upper airway muscle responsiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano,Ospedale San Luca status: RECRUITING city: Milano zip: 20145 country: Italy name: Elisa Perger, MD role: CONTACT phone: +390261911 phoneExt: 2705 email: e.perger@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06334588 id: APHP240105 id: 2023-A02668-37 type: REGISTRY domain: ID-RCB briefTitle: Understanding the Mechanisms of Autism : an MRI and Social Cognition Study acronym: ECLAT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-04 date: 2031-04 date: 2024-03-28 date: 2024-03-28 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 160 type: ESTIMATED name: MRI name: Eye-tracking name: Clinical Scales name: Research of genetic anomalies measure: Rest cerebral blood flow (CBF) measure: Measurements of white matter microstructure - fractional anisotropy measure: Measurements of white matter microstructure - mean diffusivity measure: Measurements of white matter microstructure - radial diffusivity measure: Measurements of white matter microstructure - axial diffusivity measure: Measurements of resting state functional connectivity measure: Correlation between social perception and multimodal brain imaging measure: Correlation between clinical severity and multimodal brain imaging measure: Imaging abnormalities associated with known genetic mutations measure: Social perception abnormalities associated with known genetic mutations measure: Anatomic changes over time - study of developmental trajectory measure: Social perception changes over time - study of developmental trajectory measure: Brain imaging in young children associated with ASD measure: Early data on social perception sex: ALL minimumAge: 3 Months maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Hôpital Necker Enfants Malades city: Paris zip: 75015 country: France name: Nathalie BODDAERT, MD, PhD role: CONTACT phone: +33 1.71.39.65.30 email: nathalie.boddaert@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06334575 id: 2023-505245-13-00 briefTitle: Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels acronym: 3TR-ICS-COPD overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-12 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: Maria Joyera Rodríguez class: OTHER briefSummary: The 3TR-ICS COPD study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers COPD patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage, not receiving ICS (either naïve or \> 3 months since last usage). The overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ICS treatment in patients with COPD stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 135 type: ESTIMATED name: Budesonide measure: Significant molecular changes in COPD stratified by their blood eosinophil counts. measure: Significant molecular changes in COPD with different airflow limitation severities. sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Philips University of Marburg city: Marburg country: Germany name: Peter Alter role: CONTACT lat: 50.80904 lon: 8.77069 facility: Academisch Ziekenhuis Groningen city: Groningen country: Netherlands name: Marteen van den Berge role: CONTACT lat: 53.21917 lon: 6.56667 facility: Clínic Barcelona city: Barcelona zip: 08036 country: Spain name: Alvar Agustí role: CONTACT lat: 41.38879 lon: 2.15899 facility: Son Espases city: Palma De Mallorca zip: 07120 country: Spain name: Francisco de Borja Cosio role: CONTACT lat: 39.56939 lon: 2.65024 facility: University of Leicester city: Leicester country: United Kingdom name: Christopher Brightling role: CONTACT lat: 52.6386 lon: -1.13169 facility: Imperial College London city: London country: United Kingdom name: Lydia J Finney role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06334562 id: KY-2023-112 briefTitle: The Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-31 date: 2025-08-31 date: 2024-03-28 date: 2024-03-28 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: This study aims to compare the use of sugammadex (domestic) and neostigmine for antagonism after thoracic surgery, and observe the effect of sugammadex (domestic) on neuromuscular blockade antagonism after thoracic surgery, in order to provide a basis for optimizing the use of muscle relaxants and their antagonists during anesthesia. conditions: Neuromuscular Blockade studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: SUGAMMADEX SODIUM 100 Mg in 1 mL name: Neostigmine measure: Muscle relaxation recovery time sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334549 id: LSKY2023-107-01 briefTitle: A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-05 date: 2024-12-05 date: 2024-03-28 date: 2024-03-28 name: Dalian Municipal Central Hospital class: OTHER briefSummary: The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane. conditions: Hypotension Drug-Induced studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 180 type: ESTIMATED name: Ephedrine-P name: Phenylephrine-P name: Norepinephrine-P name: Ephedrine-S name: Phenylephrine-S name: Norepinephrine-S measure: Continual changes in Cerebral Oxygen Saturation measure: Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) measure: Continual changes in heart rate (HR) measure: Continual changes in stroke volume (SV) measure: Continual changes in cardiac output (CO) measure: Continual changes in systemic vascular resistance (SVR) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dalian Municipal Central Hospital status: RECRUITING city: Dalian state: Liaoning zip: 116033 country: China name: Liping Han, M.D. role: CONTACT lat: 38.91222 lon: 121.60222 hasResults: False

 nctId: NCT06334536 id: 0832/66 briefTitle: Multi-country Survey on Violence Against Women Among Medical Staff overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-28 date: 2024-03-28 name: Chulalongkorn University class: OTHER name: Asia and Oceania Federation of Obstetrics and Gynaecology briefSummary: The goal of this observational study is to investigate the knowledge, attitude, and practice (KAP) towards violence against women (VAW) among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries

The main question it aims to answer is:

* the KAP towards VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries
* the KAP towards support service of VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries

Participants will be asked to complete the online self-administrated questionnaire. conditions: Violence Against Women studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED measure: KAP towards VAW measure: KAP towards support service of VAW sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334523 id: Volem briefTitle: Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout acronym: Volem overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-30 date: 2027-12-31 date: 2024-03-28 date: 2024-03-28 name: Centre Hospitalier Intercommunal Creteil class: OTHER briefSummary: The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional ventilation to reduce or even cancel dead space due to respiratory prostheses. This objective is particularly interesting in the smallest preterm infants in which the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L/min at tip of endotracheal tube to purge expired CO2 trapped in the prostheses to have a CO2-free volume of gas available for subsequent insufflation. conditions: Extremely Low Birthweight Infant conditions: Continuous Tracheal Gas Insufflation conditions: Medical Device conditions: Lung Protection conditions: Ventilator-Induced Lung Injury studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: ventilation measure: cumulative duration of non-invasive ventilation periods in living patients measure: The pressure gradient of the ventilation measure: The age at the definitive withdrawal of any ventilatory support (PPS) measure: Definitive weaning age of invasive ventilation measure: Definitive O2 weaning age measure: the death rate measure: The rate of recourse to the HFO measure: The level of pneumothorax measure: The rate of bronchopulmonary dysplasia (BPD) diagnosed measure: Rate of postnatal systemic corticosteroid therapy measure: Duration of exposure to systemic sedatives measure: The cumulative day invasive ventilation measure: Non-programmed extubation rate measure: Rate of secondary blooddstream infection measure: neuroimaging complication measure: Neurodevelopmental monitoring measure: Pulmonary inflammation by cytokine dosage for intubated patients measure: Pulmonary inflammation by cytokine dosage for intubated patients measure: Pulmonary inflammation by cytokine dosage for intubated patients measure: rate of Retinopathy rank >1 measure: severe hypoxemia measure: Additional dose of surfactant sex: ALL minimumAge: 23 Weeks maximumAge: 26 Weeks stdAges: CHILD hasResults: False

 nctId: NCT06334510 id: HL-SJLG-2021-Ⅳ-01 briefTitle: Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations. overallStatus: COMPLETED date: 2021-11-17 date: 2023-01-20 date: 2023-03-28 date: 2024-03-28 date: 2024-03-28 name: Hualan Biological Bacterin Co. Ltd. class: INDUSTRY briefSummary: To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare adverse reaction of 1‰. conditions: GCP studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4900 type: ACTUAL name: One dose of quadrivalent influenza virus split vaccine was administered measure: To evaluate the safety and immunogenicity of Hualan Biovar quadrivalent influenza vaccine in a larger population in the real world, and to observe rare adverse drug reaction (ADR) of 1‰. measure: To explore the consistency of three consecutive batches of commercial vaccines for vaccination in adults aged 18-59 years. sex: ALL minimumAge: 3 Years maximumAge: 74 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kou Zengqiang city: Jinan state: Shandong zip: 250000 country: China lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06334497 id: APH220791 id: 2023-506216-40-00 type: OTHER domain: EU CT briefTitle: Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections acronym: LUCY-1 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-03-28 date: 2024-03-28 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy (in association with valganciclovir) in renal transplant recipients with CMV DNAemia, requiring valganciclovir treatment per investigator's judgment. conditions: Cytomegalovirus Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Letermovir name: Valganciclovir name: Letermovir placebo measure: Virological response to treatment on week-3 measure: Eradication of CMV DNAemia (< 200 IU/ml) before Week-12 measure: Number of days between baseline and first measure of CMV DNAemia < 200 IU/mL measure: Absence of CMV-related symptoms at baseline and each visit measure: Adverse event (AE) occurence measure: Sequencing of whole UL97, UL54, UL56, UL89 and UL51 genes measure: Ganciclovir plasma concentration measure: Letermovir plasma concentration measure: Measure of the CMV specific T-cell immunity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Necker Enfants Malades city: Paris zip: 75015 country: France name: Laurence BUSSIERES, PhD role: CONTACT phone: +33 6 62 08 19 58 email: laurence.bussieres@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06334484 id: 6413 briefTitle: Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics acronym: TiTR_GR1DM overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2025-09-26 date: 2026-03-26 date: 2024-03-28 date: 2024-03-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential in the therapeutical management of subjects with T1DM (1). The Diabetes Complications and Control Trial (DCCT) has showed that intensive insulin treatment was associated with a reduction in the onset of complications related to diabetes. In recent years, treatment of T1DM evolved rapidly because of the significant improvements in the use of technology (2). With the spread of continuous glucose monitoring (CGM) systems, standardized metrics, summarizing time spent within optimal glucose range (time in range - TIR), time below target glucose range (TBR) and time above target glucose range (TAR), have become commonly used metrics in clinical practice (3,4). Furthermore, glucose management indicator (GMI) estimates glycated haemoglobin from the average glucose level of CGM readings for 14 days and coefficient of variation (CV) evaluates the amplitude of glucose excursions.

Advanced hybrid closed loop (AHCL) systems combine insulin pump infusion and real time CGM (rtCGM) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected and can administer automatic corrective boluses in case of hyperglycaemia (6). Different algorithms, as Model Predictive Control (MPC) or Proportional-Integral-Derivative (PID), are used by different systems available on the market and are currently used in clinical practice. Overall, AHCL are associated with improvement of glycated hemoglobin (HbA1c) and TIR opening to the possibility to gain even tighter glycemic control.

The primary objective is therefore to evaluate the glycemic improvement expressed through adjunctive CGM metrics in subjects with T1DM 24 months after starting AHCL therapy conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Advanced hybrid closed loop systems measure: change in time spent in tighter glucose range after 24 months of hybrid closed loop system sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy name: DARIO PITOCCO role: CONTACT phone: +390630155701 email: dario.pitocco@policlinicogemelli.it name: DARIO PITOCCO role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06334471 id: INCS_WGS_B-001 briefTitle: Whole Genome Sequencing in Breast Cancer acronym: WGS SIT overallStatus: RECRUITING date: 2022-08-02 date: 2025-08-02 date: 2030-12-31 date: 2024-03-28 date: 2024-04-03 name: Inocras Korea Inc. class: INDUSTRY briefSummary: This study aims to conduct whole genome sequencing in breast cancer patients to elucidate individual genetic characteristics and their correlation with breast cancer subtypes. The primary objective is to establish new treatment guidelines aligned with the paradigm shift in precision medicine. The study will include both prospective and retrospective cohorts totaling 1200 participants. Prospective participants must provide consent and be eligible for tissue collection, while retrospective participants must have histologically confirmed breast cancer and available tissue samples from Samsung Medical Center Biobank. The study period spans 3 years for subject enrollment and 5 years for follow-up observations, with an expected completion date of December 31, 2030. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1200 type: ESTIMATED name: no intervention needed measure: Establishing individual genetic characteristics of breast cancer patients through WGS measure: Analysis of correlation between whole-genome sequencing results and genetic subtypes of breast cancer sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Yeon Hee Park, MD role: CONTACT name: Yeon Hee Park, MD role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06334458 id: IEO 1910 briefTitle: Epigenomic and Machine Learning Models to Predict Pancreatic Cancer acronym: IMAGene overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-03 date: 2024-02-21 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: The goal of the multicentric and interdisciplinary IMAGene project is to pursue early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups, by developing and validating a comprehensive cancer risk prediction algorithm (CRPA) as a clinical support tool to calculate a personalized risk profile.

The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 170 type: ACTUAL name: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups measure: Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm measure: Identification of one or more abnormal methylation changes present in blood cells of participants with suspicious lesions versus methylation profiles of participants with no identified lesions measure: Validation of igenetic biomarker testing in liquid biopsy followed by radiological exam as early cancer diagnostic tool sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toulouse University Hospital city: Toulouse country: France lat: 43.60426 lon: 1.44367 facility: European Institute of Oncology city: Milan country: Italy lat: 45.46427 lon: 9.18951 facility: Oncological Institute "Prof. Dr. Ion Chiricuta" city: Cluj-Napoca country: Romania lat: 46.76667 lon: 23.6 facility: Catalan Institute of Oncology city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06334445 id: IEO 1874 briefTitle: CARDIOCARE Prospective Clinical Study acronym: CARDIOCARE overallStatus: RECRUITING date: 2023-09-14 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective observational study to refine and validate risk stratification algorithms aimed at identifying elderly patients at higher risk of developing cardiotoxicity (us-ing risk factors and potential blood and stool biomarkers) and at assessing whether integrated patient-oriented behavioral and psychological interventions can mitigate, prevent or delay the onset of cardiotoxicity from chemotherapy. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 736 type: ESTIMATED name: Control group name: Intervention group measure: Evaluation of the onset of cardiotoxicity measure: Intra-patient assessment of major adverse cardiac events (MACEs) measure: Intra-patient assessment of plasma Troponin I measure: Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation measure: Percentage in the two arm of hospital admission measure: Number of Cardiovascular death in the two arms measure: Number of Non-cardiovascular death in the two arms measure: Evaluation of Health Related Quality of Life in the two arms measure: Cost-effectiveness of provided healthcare pathways determined by costs combined with quality-adjusted life-years (QALYs) in the two arms sex: FEMALE minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06334432 id: NUV-1511-01 briefTitle: Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03 date: 2027-03 date: 2027-10 date: 2024-03-28 date: 2024-03-28 name: Nuvation Bio Inc. class: INDUSTRY briefSummary: NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors. conditions: Advanced Solid Tumor conditions: HER2-negative Breast Cancer conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC) conditions: Pancreatic Cancer conditions: Platinum-resistant Ovarian Cancer (PROC) studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 466 type: ESTIMATED name: NUV-1511 measure: Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors measure: Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s)) measure: Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s) measure: Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development measure: Phase 2: Confirm the optimal NUV-1511 target tumor types for further development measure: Phase 1: Explore preliminary efficacy of NUV-1511 measure: Phase 1: Explore preliminary efficacy of NUV-1511 measure: Phase 1: Explore preliminary efficacy of NUV-1511 measure: Characterize the PK profile of NUV-1511 measure: Characterize the PK profile of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity measure: Evaluate drug exposure-response relationship measure: Evaluate drug exposure-response relationship sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology status: RECRUITING city: Irving state: Texas zip: 75038 country: United States name: Naga Koteswari Cheedella role: CONTACT phone: 214-645-4673 email: ncheedella@nextoncology.com lat: 32.81402 lon: -96.94889 facility: START Mountain status: RECRUITING city: Salt Lake City state: Utah zip: 84124 country: United States name: William McKean role: CONTACT phone: 801-581-2121 email: William.McKean@hci.utah.edu lat: 40.76078 lon: -111.89105 facility: NEXT Oncology status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Alex Spira role: CONTACT phone: 210-580-9500 email: aspira@nextoncology.com lat: 38.84622 lon: -77.30637 hasResults: False

 nctId: NCT06334419 id: 2023-0795 briefTitle: Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS) overallStatus: RECRUITING date: 2024-01-29 date: 2024-09-30 date: 2024-09-30 date: 2024-03-28 date: 2024-03-28 name: Craig Erickson class: OTHER name: Healx Limited briefSummary: This is a single dose, placebo-controlled study. Male subjects aged 18 to 40 years (inclusive) with a diagnosis of FXS. Eligible subjects may enroll in this study comprised of two in home and two in clinic visits each 14 days apart, for a total of four visits. Subjects will be given single dose gaboxadol (10 mg) or matched placebo at each of these visits to take orally. Thus, all enrolled subjects will receive placebo at home and in clinic and receive gaboxadol at home and in clinic in a blinded fashion. conditions: Fragile X Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study was designed as a 2-intervention crossover, with all study participants receiving all possible interventions. These are placebo and Gaboxadol. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Quadruple masking (participant, care provider, investigator and outcomes assessor) count: 10 type: ESTIMATED name: Gaboxadol name: Placebo measure: To evaluate target engagement of gaboxadol treatment on high density EEG recordings measure: To investigate the feasibility of home research visits and procedures in adult males with FXS measure: To investigate the feasibility of high density EEG recording at home in adult males with FXS measure: To potentially explore the pharmacokinetics of gaboxadol treatment in single-dose trial design measure: To investigate the effect of gaboxadol treatment on neuropsychological assessments measure: To investigate the effect of gaboxadol treatment on eye tracking assessments measure: To investigate the effect of gaboxadol treatment on clinician-rated measures measure: To determine whether FMRP levels predict treatment response sex: MALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Cincinnati Children's Hospital Medical Center status: RECRUITING city: Cincinnati state: Ohio zip: 45229 country: United States name: Ashley Dapore role: CONTACT phone: 513-517-1580 email: ashley.dapore@cchmc.org name: Hannah J Sachs, MPA role: CONTACT phone: 513-636-2592 email: hannah.sachs@cchmc.org name: Craig A Erickson, MD role: PRINCIPAL_INVESTIGATOR name: Kelli Dominick, MD, PhD role: SUB_INVESTIGATOR name: Meredith Nelson, PhD role: SUB_INVESTIGATOR name: Ernest Pedapati, MD role: SUB_INVESTIGATOR name: Debra Reisinger, PhD role: SUB_INVESTIGATOR name: Lauren Schmitt, PhD role: SUB_INVESTIGATOR lat: 39.12713 lon: -84.51435 hasResults: False

 nctId: NCT06334406 id: 098 DRC 210 ER03 012 briefTitle: Antitumor T Cell Responses in Patients With Bladder Cancer acronym: immunoBLAD overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2026-04-02 date: 2026-04-02 date: 2024-03-28 date: 2024-03-28 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 33 type: ESTIMATED name: Biological samples measure: Tumor antigen specific T-cell responses measure: Monitoring of T cells in the blood measure: Monitoring of immune cell death parameters in the blood measure: Monitoring of immune suppressive cells in the blood measure: Overall survival measure: Progression-free survival measure: Local progression-free survival measure: Transcriptomic analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334393 id: VLA1601-102 briefTitle: Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults overallStatus: RECRUITING date: 2024-03-25 date: 2024-12-31 date: 2025-12-28 date: 2024-03-28 date: 2024-03-28 name: Valneva Austria GmbH class: INDUSTRY briefSummary: This phase 1 clinical trial consists of an initial open-label sentinel run-in (n=25) and a randomized, double-blind, dose-finding (n=125) investigating three antigen dose levels (low, medium and high) of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants (CpG1018®, 3M-052-AF/AP 60-702). VLA1601 will be administered according to a two-dose regimen (i.e., on Day 1 and Day 29).

The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination; and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination. Additionally, safety and immune response of the vaccine candidate will be monitored throughout the trial. conditions: Zika conditions: Zika Virus Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: VLA1601 name: CpG 1018® name: 3M-052-AF measure: Solicited Adverse Events measure: Solicited Adverse Events measure: Neutralizing antibodies against ZIKA virus (ZIKV) measure: Solicited Adverse Events measure: Solicited Adverse Events measure: Unsolicited AEs measure: Unsolicited AEs measure: Vaccine-related unsolicited AEs measure: Vaccine-related unsolicited AEs measure: Any AEs measure: Any AEs measure: any vaccine-related AEs measure: Vaccine-related unsolicited AEs measure: Adverse Events of Special Interest (AESI) measure: Adverse Events of Special Interest (AESI) measure: Vaccine-related Adverse Events of Special Interest (AESI) measure: Vaccine-related Adverse Events of Special Interest (AESI) measure: Serious Adverse Events (SAE) measure: Serious Adverse Events (SAE) measure: Vaccine-related Serious Adverse Events (SAE) measure: Vaccine-related Serious Adverse Events (SAE) measure: ZIKV-specific neutralizing antibodies measure: Seroconversion rate (SCR) measure: Geometric Mean Fold Increase (GMFI) sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Flourish Research status: RECRUITING city: Chicago state: Illinois zip: 60640 country: United States name: Rupal Trivedi, MD role: CONTACT lat: 41.85003 lon: -87.65005 facility: Velocity Clinical Research status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States name: Frederick Raiser, MD role: CONTACT lat: 41.25626 lon: -95.94043 hasResults: False

 nctId: NCT06334380 id: 73688 briefTitle: VR for Surgical Prehabilitation and Rehabilitation acronym: VR-PREP overallStatus: ENROLLING_BY_INVITATION date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-04-25 name: Stanford University class: OTHER briefSummary: This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery. conditions: Breast Cancer conditions: Frailty conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants randomized to one of two arms, VR self-paced modules with live PT guidance and VR without live PT guidance. primaryPurpose: OTHER masking: SINGLE maskingDescription: Blinded assessor will conduct adherence calls. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Virtual Reality Modules Only name: Virtual Reality Modules + Live Physical Therapist Support measure: VR for remote Physical Therapy (PT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford Hospital and Clinics city: Palo Alto state: California zip: 94305 country: United States lat: 37.44188 lon: -122.14302 hasResults: False

 nctId: NCT06334367 id: SWYX:NO.2022-1028 briefTitle: Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2026-03-26 date: 2026-03-26 date: 2024-03-28 date: 2024-03-28 name: Wang Xin class: OTHER_GOV briefSummary: The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition. conditions: GVHD studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: CD25 treatment name: low-dose ATG measure: The incidence of aGVHD measure: The incidence of cGVHD measure: the time of immune reconstitution in haploidentical transplant measure: the time of infection occurrence measure: the time of donor cell engraftment measure: the time of disease relapse measure: the time of death of transplant patient sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University city: Jinan state: Shandong zip: 250021 country: China name: Xin Wang, MD, PHD role: CONTACT phone: 86-531-68778331 email: xinw007@126.com name: Xiaosheng Fang, MD, PHD role: CONTACT phone: 8615168889703 email: fxsh_1010@126.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06334354 id: 23-320 briefTitle: A Study of Changes in Thinking Related to Aging and Cancer in Breast Cancer Survivors (TRAC) acronym: TRAC overallStatus: RECRUITING date: 2024-03-19 date: 2029-03 date: 2029-03 date: 2024-03-28 date: 2024-04-26 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to look at how differences in cognitive (mental) function develop over time in breast cancer survivors compared to volunteers without a history of cancer (healthy volunteers). Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so the researchers can compare the results of neurocognitive testing (which looks at memory, attention, and information processing) on each group of participants. conditions: Breast Cancer Survivors studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 420 type: ESTIMATED name: Assessments name: Assessment (Survivors Only) name: APOE and DNA Isolation measure: examine cognitive effects measure: measure levels of smoking exposure sex: FEMALE minimumAge: 65 Years maximumAge: 80 Years stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (All protocol activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (All Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (All Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center status: RECRUITING city: New York state: New York zip: 10065 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 name: Tim Ahles, PhD role: CONTACT phone: 646-888-0048 name: James Root, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (All Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.70038 lon: -73.59291 hasResults: False

 nctId: NCT06334341 id: R01MD018523-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/R01MD018523-01A1 briefTitle: A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP) acronym: MOST:PrEP overallStatus: ENROLLING_BY_INVITATION date: 2024-02-21 date: 2028-04 date: 2028-04 date: 2024-03-28 date: 2024-03-28 name: Henry Ford Health System class: OTHER name: University of South Florida name: New York University briefSummary: What is known: There are 1.2 million people in the US who meet the indications for PrEP; yet, disparities exist in uptake. For example, only 9% of Black and 16% of Latino individuals, compared to 65% of White individuals, have been prescribed PrEP. At Henry Ford Health (HFH) system, only 10% of eligible patients have been prescribed PrEP. Primary care is an ideal setting for PrEP to be offered as an HIV prevention method since providers see large numbers of patients who are HIV negative, with some who are at increased risk for HIV, and the primary care setting is often the point of entry to the healthcare system. The multiphase optimization strategy (MOST) framework is a novel, innovative way to identify an efficient intervention. What will be done: In this optimization trial, the investigators will test the effectiveness of intervention components, alone and in combination, on new PrEP prescriptions in primary care at HFH. First, feedback will be generated on context-specific (system and individual level) factors for intervention component delivery via focus groups with providers (n=15) and patients eligible for PrEP (n=30). Then, four intervention components will be tested in an optimization trial, with 16 conditions being implemented at 32 clinics. Finally, feedback will be generated on the factors that affected implementation via semi-structured interviews with providers (n=30) and patients (n=30). Participants will be primary care providers (PCPs) and patients eligible for PrEP in Henry Ford Health System. Clinics will be randomized (yes/no) to receive any combination of provider and patient intervention components. Provider intervention components include computer-based simulation training and/or best practice alerts delivered via the electronic health record (EHR). Patient intervention components include HIV risk assessment and/or PrEP informational video - both delivered via the EHR. Primary outcome is the rate of new PrEP prescriptions at the clinic level. Secondary outcomes will include PrEP maintenance, number of HIV tests ordered by a PCP, and number of PCPs trained. Sub analyses will test which factors moderate (e.g., patient sex, race, age, gender, sexual orientation) or mediate (e.g., perceived HIV risk, provider and patient PrEP knowledge) PrEP uptake, focusing on priority populations and disparities in rates of PrEP prescription. Implications: 1) Understanding which intervention components lead to increased PrEP prescriptions will represent an important advance in HIV prevention efforts. 2) Optimizing a multi-level intervention for providers and patients to increase PrEP prescriptions would lead to a new, efficient, evidence-based option. 3) Determining what factors are related to PrEP uptake will help reduce disparities in PrEP initiation among those most in need. 4) Understanding the context specific factors related to intervention component implementation will help identify best methods for replication/adaptation in other healthcare systems. conditions: HIV Seropositivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 1380 type: ESTIMATED name: Computer-based simulation training for providers name: Best Practice Alert name: HIV Risk Assessment name: PrEP Informational Video measure: Clinic-Level PrEP Prescription measure: PrEP Knowledge measure: PrEP awareness measure: PrEP prescribing comfort measure: PrEP prescribing intentions measure: Perceived HIV risk measure: Preferences for patient- provider communication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henry Ford Health city: Detroit state: Michigan zip: 48202 country: United States lat: 42.33143 lon: -83.04575 hasResults: False

 nctId: NCT06334328 id: 2205009237 briefTitle: Virtual Reality-based Mindful Movement Therapy for Seniors overallStatus: COMPLETED date: 2022-08-15 date: 2023-09-30 date: 2024-01-31 date: 2024-03-28 date: 2024-03-28 name: Drexel University class: OTHER briefSummary: The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a virtual reality-based mindful movement therapy (VR-MMT) protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. This study is innovative and high impact as this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach. conditions: Cognitive Decline conditions: Physical Activity conditions: Psychological Wellbeing studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 12 type: ACTUAL name: Virtual reality based mindful movement therapy measure: Treatment adherence measure: Treatment acceptability measure: Treatment satisfaction measure: Qualitative feedback measure: Safety measure: Montreal Cognitive Assessment (MoCA) measure: Trail making test measure: The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) measure: Physical Activity Scale for the Elderly (PASE) measure: Physical Performance Battery (SPPB) measure: General Self-Efficacy Scale measure: Positive Affect and Negative Affect Scale (PANAS) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Drexel Universitsy city: Philadelphia state: Pennsylvania zip: 19102 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06334315 id: 2000037337 id: R01HD111436 type: OTHER_GRANT domain: NIH briefTitle: Oral Contraceptive Pill (OCP) Pharmacogenomics overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2028-05 date: 2024-03-28 date: 2024-03-28 name: Yale University class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how our bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. We also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are:

* Do individuals with the CYP3A7\*1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill?
* Do individuals with the CYP3A7\*1C variant experience higher rates of breakthrough ovulation while taking a desogestrel/ethinyl estradiol combined oral contraceptive pill?
* What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users?

Participants will take a specific formulation of combined oral contraceptive pill (desogestrel/ethinyl estradiol) and undergo the following procedures:

* Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill
* Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill
* Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill
* A transvaginal ultrasound to measure any ovarian follicles (optional procedure) conditions: Contraception conditions: Pharmacogenomic Drug Interaction studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 700 type: ESTIMATED name: Desogestrel / Ethinyl Estradiol Pill measure: Serum etonogestrel concentration measure: Serum ethinyl estradiol concentration measure: Serum estradiol concentration measure: Serum progesterone concentration measure: Modified Hoogland score measure: Positive and Negative Affect Scheduled measure: Sex hormone binding globulin levels measure: Serum albumin concentration sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of Colorado Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Yale city: New Haven state: Connecticut zip: 06520 country: United States lat: 41.30815 lon: -72.92816 hasResults: False

 nctId: NCT06334302 id: RMC0362-23ctil briefTitle: The Effect of Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" With 80% Reduced Sucrose on Glucose Response of People With TID overallStatus: RECRUITING date: 2024-03-25 date: 2024-04-25 date: 2024-04-25 date: 2024-03-28 date: 2024-04-12 name: Rabin Medical Center class: OTHER name: Omega 3 Galilee briefSummary: Omega Galil has developed a novel fatty sweetener that allows the use of up to 80% less sugar (particularly sucrose) and yet achieves a natural sweet flavor, using a novel technology of milling the natural sucrose crystals together with oil and thus creating a micro-suspension of sugar in oil or fat. The suspension increases the surface area of the sugar particles and thus a lower quantity of sugar is required in order to reach an enhanced perception of sweetness at the sweet taste receptors in the mouth. Omega Galil provides fatty food products that use up to 80% less sucrose, while tasting as sweet as regular sugar sweetened foods, with no aftertastes of sugar substitutes, and no chemical modifications or additives.

Postprandial glucose (PPG) excursions in Type 1 Diabetes happen mainly due to a delay in subcutaneous insulin absorption and action, but also among other factors, depend on the meal composition. The glycemic index (GI) ranks foods based on acute glycemic response over a 2-h period of 50 g of available carbohydrates (CHO) of a test food compared with the reference standard glucose. Glycemic Load (GL) is a GI-weighted measure of carbohydrate content, which estimates the impact of carbohydrate intake using the GI while taking into account the amount of carbohydrates that are eaten in a serving. Several studies have demonstrated differences in PPG after consumption of low versus high GI meals, with rapid glucose spikes following high GI meals . Helping people with T1D achieve a diet with a lower glycemic load can improve both their quality of life and their diabetes-associated complications.

The proposed randomized, double blind, cross-over, active control, clinical trial aims to:

1. compare the glycemic response of T1D subjects to 20 grams of the O'Sweet sugar-reduced spread containing 8% sugar and a total of 1.6 grams of sucrose per meal, with their glycemic response to 20 grams of control Nutella spread, containing 56% sugar and a total of 11 grams sucrose per meal.
2. compare the acceptance ("Not sweet enough, just right or too sweet") Labeled Magnitude score of O'Sweet compared to the control spread (Nutella). conditions: Type1diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" name: Active Control-Nutella hazelnut cocoa spread measure: Delta postprandial glucose level measure: Incremental area under the curve (iAUC) measure: Peak postprandial glucose level measure: Time in range (TIR) of 70-180 mg/dl measure: Percentage of subjects who reached the desired glucose target measure: The percentage of time spent above 180 mg/dl measure: The percentage of time spent above 250 mg/dl measure: The percentage of time spent above 350 md/dl measure: Labeled Magnitude Scale (gLMS) sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Schneider Children Medical Center of Israel status: RECRUITING city: Petach-Tikva country: Israel name: Alona Hamou, MSc role: CONTACT phone: 972-545-950-277 email: alonah@clalit.org.il lat: 32.08707 lon: 34.88747 hasResults: False

 nctId: NCT06334289 id: YXLL-KY-2024(017) briefTitle: A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: Qianfoshan Hospital class: OTHER briefSummary: Perioperative neurocognitive impairment (PND) mainly includes acute postoperative delirium (POD) and persistent postoperative cognitive impairment (POCD), which are common postoperative complications in elderly patients. Perioperative neurocognitive impairment (PND) is attracting increasing attention, but its exact mechanism is still unclear. The diagnosis of PND lacks the gold standard, so it is difficult to determine the incidence rate. At present, the diagnosis is mainly conducted through the scale. Therefore, this study aims to explore the correlation between peripheral blood biomarkers and PND in elderly frail patients undergoing gastrointestinal surgery. conditions: Perioperative Neurocognitive Disorders conditions: Frail Elderly studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 338 type: ESTIMATED measure: Postoperative 7-day incidence of PND sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334276 id: DROWN_INHOS briefTitle: Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016 acronym: DROWN_INHOS overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-28 date: 2024-03-28 name: Prehospital Center, Region Zealand class: OTHER briefSummary: This nationwide, registry-based study aims to link Danish Prehospital Drowning Data data with inhospital data to develop a Utstein-style Danish Drowning Registry. This study will report mortality and neurological outcomes 30 days after a drowning incident since 2016. conditions: Drowning conditions: Drowning, Near conditions: Drowning; Asphyxia conditions: Drowning and Nonfatal Submersion conditions: Drowning or Immersion of Unknown Intent conditions: Drowning and Submersion, Undetermined Intent conditions: Drowning and Submersion While in Bath-Tub conditions: Drowning and Submersion While in Natural Water conditions: Drowning and Submersion While in Swimming-Pool studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ESTIMATED name: Drowning measure: 30-day mortality measure: Neurological outcome measure: Hospital length of stay measure: Intensive care unit admission measure: Intensive care unit length of stay measure: Need for mechanical ventilation measure: Duration of mechanical ventilation measure: Survival to hospital discharge sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center city: Næstved state: Region Zealand zip: 4700 country: Denmark lat: 55.22992 lon: 11.76092 hasResults: False

 nctId: NCT06334263 id: 332302 briefTitle: Splenic Embolisation Decisions acronym: SPEED overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-30 date: 2025-09-30 date: 2024-03-27 date: 2024-03-27 name: University Hospital Plymouth NHS Trust class: OTHER briefSummary: The spleen is often injured when the body sustains trauma. This leads to bleeding. The bleeding can be stopped by a big operation cutting open the belly or a small hole in your groin where a blood vessel can be accessed and through which the bleeding can be stopped. We do not know what types of injuries it is best to use this procedure. We do not know why we do not use the smaller technique in some instances. We also do not know exactly which of a number of ways to stop the bleeding could be better. We have a big data set in the trauma and audit research network (TARN) which we would like to use to help answer these questions and design further studies to better answer the questions. Adding a few other pieces of data, we are able to answer key questions into how the spleen will best be treated in trauma. conditions: Trauma conditions: Spleen Injury studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 8000 type: ESTIMATED measure: To determine if service design significantly affects splenic embolisation (SE) rates in AAST grade 2-5 acute traumatic splenic injuries (ATSI) across the 22 Major Trauma Centres (MTCs) in the UK. measure: To determine if variation in treatment affects SE outcomes in ATSI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334250 id: IRAS:327077 briefTitle: Pulsed Field Ablation During Left Atrial Appendage Occlusion: A Randomised Controlled Trial acronym: PLANET-AF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Liverpool Heart and Chest Hospital NHS Foundation Trust class: OTHER briefSummary: Atrial fibrillation (AF) is the most common abnormal heart rhythm. It is also a leading cause of stroke, due to blood clots forming within an area called the 'left atrial appendage'. Usually, blood thinners (anticoagulants) are given to patients to reduce this risk. However, some patients are not able to take these medications due to a high bleeding risk. In this situation, these patients are sometimes offered a 'left atrial appendage occlusion' (LAAO) procedure - this is performed by inserting wires through the veins in the groin into the heart, then deploying a device which blocks the appendage, thus stopping blood clots from forming. There is increasing interest within our professional community of combining this procedure with another, called 'catheter ablation', which is performed to improve the symptoms of AF. This procedure uses similar access to the heart, but is not often performed in the same sitting - and often not performed at all in this patient group as they are felt to be at higher risk of complications due to bleeding or clotting. Pulsed Field Ablation (PFA) is a new technology which significantly improves safety of ablation. In this randomised controlled trial, patients referred for LAAO will be randomised to receive LAAO+PFA (intervention) or LAAO alone (control). Patients will be blinded to treatment received, which allows thorough assessment of the benefit of ablation. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 66 type: ESTIMATED name: Catheter ablation of atrial fibrillation using Pulsed Field Ablation name: Left atrial appendage occlusion measure: Change in quality of lfie measure: Time to atrial fibrillation recurrence measure: Requirement for unplanned further ablation or cardioversion procedures measure: Procedural metrics measure: Procedural safety outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Liverpool Heart and Chest Hospital city: Liverpool state: Merseyside zip: L14 3PE country: United Kingdom name: Mark Mills role: CONTACT phone: +441516001616 email: mark.mills@lhch.nhs.uk lat: 53.41058 lon: -2.97794 hasResults: False

 nctId: NCT06334237 id: Y_113_0009 briefTitle: Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-21 date: 2026-02-21 date: 2024-03-27 date: 2024-03-27 name: Changhua Christian Hospital class: OTHER briefSummary: This research project aims at exploring the psychosomatic factors that influence and moderate the efficacy of holistic care and personalized treatment for migraine patients. It is a prospective longitudinal observational study. The project's goal is to understand how physical, psychological, spiritual, and social factors affect the care and treatment outcomes for migraineurs. The study will include participants aged 18 to 65, who meet the International Headache Society's criteria for migraines. It will utilize a range of methodologies including questionnaires, interviews, and medical records to collect data on various factors like lifestyle, psychological state, and social support. The project will assess the effectiveness of treatments, compliance, and other outcomes such as emotional and sleep conditions. conditions: Migraine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: personalized treatment measure: Migraine attack frequency measure: Migraine attack intensity measure: Migraine attack duration measure: Effectiveness of acute medication measure: Compliance rate of migraine diary measure: Compliance rate of lifestyle modification measure: depression measure: anxiety measure: well-being measure: Pain Resilience sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhua Christian Hospital city: Chang Hua zip: 500 country: Taiwan name: Yen-Yu Chen, MD role: CONTACT phone: +886-4-7238595 email: 107281@cch.org.tw lat: 24.07327 lon: 120.56276 hasResults: False

 nctId: NCT06334224 id: 2242/MODREC/23 briefTitle: Acute Physiological Responses to Twice Daily Blood Flow Restriction Training overallStatus: RECRUITING date: 2023-11-06 date: 2024-09 date: 2024-09 date: 2024-03-27 date: 2024-03-27 name: Defence Medical Rehabilitation Centre, UK class: OTHER_GOV name: University of Bath briefSummary: The Academic Department of Military Rehabilitation (ADMR) is currently conducting a pan-defence, randomised control trial (RCT) investigating the utility of twice daily blood flow restriction training in UK military personnel with persistent knee pain (NCT05719922). Due to logistical confinements, this pan-defence RCT is confined to collecting outcome data pre and post-intervention. Therefore, the acute physiological mechanisms which underpin adaptation will remain unknown.

Consequently, ADMR is undertaking an additional, single centre RCT which will compare the acute physiological responses to low load resistance training with and without the addition of blood flow restriction. Specifically, this study will elucidate the effect of twice daily blood flow restriction training on measures of muscle swelling, muscle damage and inflammation. This data may aid in the optimisation of blood flow restriction exercise prescription within UK Defence Rehabilitation and elsewhere. conditions: Muscle Weakness conditions: Muscle Damage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two arm randomised control trial primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Due to the nature of the intervention, it is not possible to blind participants or outcome assessors to the treatment allocation. There is also no effective sham condition available. This is a common limitation within all blood flow restriction training research. count: 18 type: ESTIMATED name: Low load resistance training with blood flow restriction name: Low load resistance training measure: Maximum isometric voluntary contraction of knee extensor muscles measure: Vastus lateralis muscle thickness measure: Venous blood sampling for markers of exercise induced muscle damage measure: Delayed onset muscle soreness measure: Quadriceps discomfort measure: Discomfort caused by the BFR cuff measure: Rating of perceived exertion measure: Knee joint range of motion measure: Daily wellness questionnaire measure: Venous blood sampling for inflammatory markers sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Defence Medical Rehabilitation Centre status: RECRUITING city: Loughborough zip: LE12 5QW country: United Kingdom name: Kieran M Lunt, MSc role: CONTACT phone: +44(0) 1509 251 500 phoneExt: 3401 email: kieran.lunt103@mod.gov.uk name: Peter Ladlow, PhD role: CONTACT phone: +44(0) 1509 251 500 phoneExt: 3407 email: peter.ladlow100@mod.gov.uk name: Kieran M Lunt, MSc role: PRINCIPAL_INVESTIGATOR lat: 52.76667 lon: -1.2 hasResults: False

 nctId: NCT06334211 id: FP-020C-23-001 briefTitle: Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-09-30 date: 2025-01-31 date: 2024-03-27 date: 2024-04-11 name: Foresee Pharmaceuticals Co., Ltd. class: INDUSTRY name: InClin, Inc. briefSummary: This is a study to Investigate the Safety, Tolerability, and Pharmacokinetics, of Single (including Food Effect) and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FP-020 in Healthy Volunteers primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double-blind (placebo appears the same as active FP-020) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 74 type: ESTIMATED name: FP-020 name: placebo measure: The incidence, severity, and type of Adverse Events (AEs) and Serious Adverse Events (SAEs). measure: Clinically significant abnormalities. measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Cmax measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Tmax measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-24 hours measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0 - last measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-inf measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - λz measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - t1/2 measure: Evaluate the food effect on the PK profile of FP-020 - Cmax measure: Evaluate the food effect on the PK profile of FP-020 - Tmax measure: Evaluate the food effect on the PK profile of FP-020 - AUC measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Cmax measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Tmax measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - 24 measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUCo - last measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - inf measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects λz measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - t1/2 measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RCmax measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RAUC sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Scientia Clinical Research Ltd city: Randwick state: New South Wales zip: 2031 country: Australia name: Christopher Argent, MD role: CONTACT lat: -33.91439 lon: 151.24895 hasResults: False

 nctId: NCT06334198 id: Naldemedine_OIBD id: 2023-507744-36-00 type: CTIS briefTitle: The Effect of Naldemedine on Opioid-induced Bowel Dysfunction overallStatus: RECRUITING date: 2024-03-12 date: 2025-03 date: 2025-03 date: 2024-03-27 date: 2024-03-28 name: Asbjørn Mohr Drewes class: OTHER briefSummary: Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol conditions: Opioid-Induced Bowel Dysfunction conditions: Constipation studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Naldemedine name: Placebo name: Tramadol measure: Total gastrointestinal transit time measure: Colorectal transit time measure: Constipation symptoms measure: Bowel movement frequency measure: Stool consistency measure: Gastrointestinal symptoms measure: Opioid-induced constipation measure: Diagnostic evaluation of opioid-induced constipation measure: Colonic motility patterns measure: Opiate withdrawal symptoms measure: Colon volume measure: Colonic water content measure: Defecation assessment sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Aalborg University Hospital status: RECRUITING city: Aalborg zip: 9000 country: Denmark name: Asbjørn Mohr Drewes role: CONTACT lat: 57.048 lon: 9.9187 hasResults: False

 nctId: NCT06334185 id: pVax briefTitle: Evaluation of Vaccination for Streptococcus Pneumoniae in Adults With an Episode of Invasive Pneumococcal Infection. acronym: pVax overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-07-01 date: 2024-03-27 date: 2024-03-28 name: Azienda Ospedaliera di Lecco class: OTHER name: IRCCS Ospedale San Raffaele briefSummary: Respiratory tract infections are among the leading causes of death worldwide and many of these infections are preventable through vaccination. One of the most important bacteria from an etiological and mortality point of view regarding respiratory and systemic infections is the gram-positive Streptococcus pneumoniae. Four types of vaccines are currently available for this pathogen: three pneumococcal conjugate vaccines (PCV13, PCV15, and PCV20) and one polysaccharide vaccine (PPSV23). In Italy, people over 65 years of age and people suffering from chronic pathologies with effects on the immune system would be advised to be vaccinated with the pneumococcal conjugate vaccine and with the polysaccharide vaccine as a second dose.

However, there are no data available in Italy on vaccination coverage in these population categories and above all the vaccination rates in patients who have a history of an episode of invasive pneumococcal infection are not known. The aim of the study is to measure how many patients are vaccinated for S. pneumoniae after hospitalization for a systemic pneumococcal infection in order to understand patients' awareness of preventing this infection after receiving a first diagnosis. conditions: Invasive Pneumococcal Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 320 type: ESTIMATED measure: Rate of antipneumococcal vaccination in hospitalized patients for invasive pneumococcal infection between 2015 and 2019. measure: Rate of pneumococcal serotype that caused the invasive infection in patients vaccinated prior to the infectious event sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334172 id: H-23071221 briefTitle: The Role of Oxytocin in Regulating Blood Glucose acronym: GLOXY-1 overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-27 date: 2024-04-04 name: University Hospital, Gentofte, Copenhagen class: OTHER briefSummary: Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose. conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: The randomized order of infusions is blinded to both participant and investigator whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Oxytocin name: Placebo measure: Insulin secretion - c-peptide measure: Glucose measure: Insulin measure: Glucagon measure: GIP measure: GLP-1 measure: Lipids measure: Cross-linked C-telopeptide of type I collagen( CTX) measure: Procollagen type I N-terminal propeptide (P1NP) sex: MALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Center for Clinical Metabolic Research, Gentofte Hospital status: RECRUITING city: Hellerup state: Capital Region zip: 2900 country: Denmark name: Filip K Knop, MD, PhD role: CONTACT phone: 004538674266 email: filip.krag.knop.01@regionh.dk lat: 55.73204 lon: 12.57093 hasResults: False

 nctId: NCT06334159 id: PER-ECL-2019-08 briefTitle: Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes overallStatus: RECRUITING date: 2020-11-05 date: 2025-07-20 date: 2027-07-20 date: 2024-03-27 date: 2024-03-27 name: Universitat Internacional de Catalunya class: OTHER briefSummary: The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months. conditions: Bone Resorption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane name: Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane measure: Horizontal Bone Gain measure: Bone Width Gain measure: Horizontal Dimensional Stability measure: Post-surgical complications measure: Patient's satisfaction measure: Histologic examination of the augmented bone at 6 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Georgios Markantonatos status: RECRUITING city: Barcelona state: Sant Cugat Del Vallès zip: 08195 country: Spain name: Georgios Markantonatos, DDS role: CONTACT phone: +34666022568 email: giorgosmark@uic.es name: Cristina Vallès, DDS, MS, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06334146 id: UNLV-2023-62 briefTitle: Tap Dance for Adults With Lower Limb Amputation overallStatus: RECRUITING date: 2024-03-04 date: 2025-05 date: 2025-05 date: 2024-03-27 date: 2024-03-27 name: University of Nevada, Las Vegas class: OTHER briefSummary: The goal of this study is to determine whether it is possible for people with lower limb amputation (LLA) to perform adapted tap dance, whether an adapted tap dance program would be enjoyable, and whether it may improve balance and balance confidence.

There is a lack of research investigating therapeutic interventions for people with lower limb amputation (LLA). Tap dance encourages balance and novel movements of the limbs, while providing auditory feedback from the feet that provide information about the foot's contact with the ground, which may help prosthesis users gain a better ability to understand where their prosthetic foot is in space. As with most forms of dance, tap is usually taught and practiced in a group setting, which encourages community involvement. It has been shown to be safer than many forms of dance due to low impact forces. It also, as a genre, can incorporate canes, chairs and partner work, providing the ability to modify steps/moves when required so that they remain practical, achievable and safe for people with mobility limitations, while still enabling participation. It therefore may be an accessible dance medium to help improve balance, balance confidence, and build community for people with LLA.

Participants will be asked to:

* come to 1 hour dance classes, once per week, for 8 weeks.
* do mobility tests before and after the program
* complete questionnaires before, during and after the program. The total time for participation is approximately 8-10 weeks. conditions: Amputation; Traumatic, Leg, Lower studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Tap dance program measure: Session Adherence measure: Physical Activities Enjoyment Scale (PACES) measure: Change in Timed Up-and-Go test score measure: Change in Four Square Step Test score measure: Change in Berg Balance Scale score measure: Change in Activities-Specific Balance Confidence Scale score measure: Physical Activities Enjoyment Scale (PACES) score - Mid program measure: Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) functional activity restriction subscale score measure: Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) social activity restriction subscale score measure: Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) athletic activity restriction score measure: Use of assistive devices per session measure: Session completion per session sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nevada Las Vegas status: RECRUITING city: Las Vegas state: Nevada zip: 89154 country: United States name: Jenny Kent, PhD role: CONTACT phone: 702-895-5949 email: jenny.kent@unlv.edu lat: 36.17497 lon: -115.13722 hasResults: False

 nctId: NCT06334133 id: TTP399-302 briefTitle: Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes acronym: CATT1 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2026-03 date: 2024-03-27 date: 2024-04-01 name: vTv Therapeutics class: INDUSTRY briefSummary: This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus. conditions: Diabetes Mellitus, Type 1 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Cadisegliatin 800 mg QD name: Cadisegliatin 800 mg BID name: Placebo measure: Change in incidence of Level 2 or Level 3 hypoglycemia measure: To assess the change in HbA1c measure: To assess the effects of treatment on CGM-based metrics for glycemic control measure: To assess the effects of treatment on the incidence of diabetic ketoacidosis measure: To assess the effects of treatment on insulin dosing measure: To assess the effects of treatment on body weight measure: To assess the incidence of adverse events measure: Change in incidence of Level 2 or Level 3 hypoglycemia measure: To assess the change in HbA1c measure: To assess the effects of treatment on CGM-based metrics for glycemic control measure: To assess the incidence of adverse events measure: To assess the effects of treatment on the incidence of diabetic ketoacidosis measure: To assess the effects of treatment on insulin dosing measure: To assess the effects of treatment on body weight measure: High sensitivity C-reactive protein measure: N-terminal pro brain [or B-type] natriuretic peptide measure: Urinary albumin excretion ratio measure: Estimated glomerular filtration rate measure: Gold hypoglycemia awareness score measure: Item 7 of Clarke hypoglycemia awareness scale measure: Snyder's 1-item quality of sleep questionnaire measure: World Health Organization-5 Well-Being Index measure: 8-item Diabetes Distress Scale (participant and partner or family member) measure: Hypoglycemia Confidence Scale for participant and partner or family member measure: 11-item/Short Form Hypoglycemia Fear Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06334120 id: 20654 briefTitle: An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2025-09-30 date: 2026-03-31 date: 2024-03-27 date: 2024-03-27 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.

This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.

To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.

During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.

Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events. conditions: Non-metastatic Castration-resistant Prostate Cancer conditions: Metastatic Hormone-sensitive Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: Darolutamide (Nubeqa, BAY1841788) measure: Number, severity of adverse events (including SAEs) measure: Number, severity of adverse drug reactions (including SADRs) measure: The outcome of (serious) adverse events measure: The outcome of (serious) adverse drug reactions measure: Metastasis-free survival (MFS) measure: Time to symptomatic skeletal event (SSE) measure: Time to prostate-specific antigen (PSA) progression measure: Number of patients with metastasis of castration-resistant prostate cancer (mCRPC) measure: Overall survival measure: Duration of Darolutamide treatment measure: Reasons for ending Darolutamide measure: Dosage and dose modification of Darolutamide sex: MALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Multiple locations city: Multiple Locations country: Korea, Republic of hasResults: False

 nctId: NCT06334107 id: 24AIREA1191995 briefTitle: Mitochondrial DNA Signatures of Poor Aerobic Exercise Trainability in Young Adults Born Preterm overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2025-12-31 date: 2024-03-27 date: 2024-03-27 name: Texas Tech University class: OTHER briefSummary: Young adults born very preterm (32 weeks gestation or earlier) do not respond well to aerobic exercise training, meeting the recommendations set by the Physical Activity Guidelines for Americans, where they do not increase their fitness level (or cardiorespiratory fitness). Thus, they do not receive the health benefits of exercise. Achieving physical fitness through aerobic exercise training is the most cost-effective method for preventing and treating many diseases. Young adults born very preterm also have a higher risk of these conditions. Thus, their inability to respond to increase their fitness is a major problem.

One likely explanation for poor exercise trainability and increased heart disease risk in young adults born very preterm is the effect of the early birth on the major energy producers in all our cells: Mitochondria. During late-stage gestation, mitochondria change from relying on sugar as a major fuel source to fat. Unfortunately, individuals born very preterm miss this transition in fuel source reliance, which causes significant stress and damage to mitochondria. Mitochondria are critical for post-natal organ development; thus, it is thought that preterm birth-induced mitochondrial dysfunction is the underlying cause of poor trainability and high disease risk in young adults born very preterm. Indeed, mitochondrial dysfunction is evident in these individuals.

To date, there is not a way to help young adults born preterm improve their fitness level. One likely target is in the mitochondria: it's DNA. Mitochondrial DNA helps determine how mitochondria function and can be damaged under stress. Our goal in this proposed work is to determine the role of mitochondrial DNA in mitochondrial dysfunction and its link to their poor trainability.

Questions:

1. Are there mitochondrial DNA markers linked to mitochondrial dysfunction and poor exercise trainability in young adults very born preterm?
2. Do mitochondrial DNA in young adults born very preterm respond differently to aerobic exercise training than those born at term?

The investigators expect this work will show mitochondrial DNA changes linked to mitochondrial dysfunction and poor trainability, which can be used for future targets to improve health. This work supports AHA mission by helping to identify a marker in individuals born very preterm linked to their higher heart disease risk and death early in life. conditions: Preterm Birth studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 45 type: ESTIMATED name: Exercise measure: Mitochondrial DNA heteroplasmy measure: Mitochondrial DNA sequence variants measure: Change in maximal aerobic capacity measure: Change in mitochondrial oxidative capacity in peripheral blood mononuclear cells measure: Daily sleep habits sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06334094 id: IRB-23-486 id: IM047-1054 type: OTHER_GRANT domain: Bristol Myers Squibb briefTitle: Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-03-31 date: 2028-05-31 date: 2024-03-27 date: 2024-03-27 name: The University of Texas at Dallas class: OTHER name: Texas Institute for Neurological Disorders briefSummary: The primary objective of this study is to investigate the cognitive benefits of ozanimod in individuals with Multiple Sclerosis (MS). The study aims to understand the neural basis of cognitive improvement in Relapsing-Remitting MS patients under ozanimod treatment using neuroimaging and behavioral techniques to characterize the brain and behavioral changes due to ozanimod treatment. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ozanimod measure: Change in Processing Speed/Symbol-Digit Modality Test (SDMT) Performance measure: Change in Volumetric Blood-Oxygen-Level-Dependent (BOLD) signal as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) measure: Change in Cerebral Blood Flow (CBF) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) measure: Change in Cerebral Metabolic Rate of Oxygen (CMRO2) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) measure: Change in Whole Brain Volume as Measured By Structural Magnetic Resonance Imaging measure: Differences in Diffusion parameters of ozanimod-responders to non-responders as Measured By a Diffusion Kurtosis Resonance Imaging (DKI) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Brain Health city: Dallas state: Texas zip: 75228 country: United States name: Jessica Ma, BS role: CONTACT phone: 972-883-3414 email: jxm180043@utdallas.edu name: Ashley M Campos, MA role: CONTACT email: amc230006@utdallas.edu name: Bart Rypma, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06334081 id: A02040230S briefTitle: Different Surgical Drilling Protocols in Posterior Maxilla overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-29 date: 2023-12-30 date: 2024-06-30 date: 2024-03-27 date: 2024-03-27 name: Mansoura University class: OTHER briefSummary: Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants conditions: Missing Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ACTUAL name: undersized drilling technique name: single drilling technique measure: bone density measurement measure: marginal bone loss sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Heba Elsheikh city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06334068 id: MS.24.03.2725 briefTitle: SHOrt-term Glycemic Control for Reducing Post-SURGical Complications acronym: Surg-ShoGR overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-10 date: 2024-03-27 date: 2024-03-27 name: Mansoura University class: OTHER briefSummary: Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.

There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.

Consequently, we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. conditions: Diabetes conditions: Uncontrolled Diabtetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients in the preoperative anesthesia clinic are divided into one of the following groups:

1. Short-term glycemic control group:

   Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.
2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcome assessors, who will call patients or relatives 30 days after surgery, will be masked for the allocated group. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Short-term glycemic control group name: Standard-of-care group measure: Number of days at home after surgery (DAH-30). measure: Loss of follow-up after surgery measure: Loss of follow up after the clinic preoperative assessment measure: 30-day mortality measure: Length of hospital stay measure: incidence of postoperative complications measure: Quality of Recovery15 (QoR-15) measure: Time to resumption of normal diabetes therapy measure: Incidence of diabetic ketoacidosis or hypoglycemia measure: Incidence of use of intravenous insulin infusion therapy measure: Duration of use of intravenous insulin infusion therapy measure: Change in diabetic management at 30 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moataz Maher Emara city: Mansoura state: Aldakahlia zip: 35516 country: Egypt name: Moataz M Emara, MD, EDAIC role: CONTACT phone: 01064048848 email: mm.emara@mans.edu.eg lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06334055 id: CIP-1091 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-27 date: 2024-03-27 name: [Redacted] hasResults: False

 nctId: NCT06334042 id: GO 23/488 briefTitle: Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit overallStatus: RECRUITING date: 2024-02-01 date: 2024-08-01 date: 2024-09-01 date: 2024-03-27 date: 2024-03-27 name: Oguzhan Kahveci class: OTHER briefSummary: The goal of this observational study is to learn about the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates in critically ill intensive care patients. The investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.

Participants will give a single blood sample (into trace element serum tube) on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit. conditions: Chromium Deficiency conditions: Diabetes Mellitus conditions: Hyperlipidemias conditions: Hypercholesterolemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 350 type: ESTIMATED name: Serum Chromium Level measure: Serum Chromium Level measure: HbA1c measure: Blood Glucose measure: Lipid Profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University status: RECRUITING city: Ankara zip: 06230 country: Turkey name: Oguzhan Kahveci, MD role: CONTACT phone: +903123051207 email: oguzhan.kahveci@hacettepe.edu.tr lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06334029 id: 12.2022 briefTitle: Observational Study of the Structural-functional Connectome in Patients With Epilepsy overallStatus: RECRUITING date: 2023-06-22 date: 2026-11-22 date: 2026-12-31 date: 2024-03-27 date: 2024-03-27 name: IRCCS Eugenio Medea class: OTHER briefSummary: Over the past decade, the concept of the brain as a complex network has extremely influenced the way regarding how the latter is studied (Bartolomei et al., 2017). The structure of both structural and functional networks within the brain has been related to optimal brain functioning (Duma et al., 2022). This evolution of methods and approaches of investigation has directly impacted the study of epilepsy. An early conception of focal epilepsy was that it was related to the activity of the epileptogenic zone, which was identified as the generative element of seizures. However, what was previously considered focal was found to be network alterations at various levels, thus moving from the epileptogenic zone to the concept of the epileptogenic network. Alterations in both the structural and functional network, compared with a healthy control population, have been identified in various forms of epilepsy from focal to idiopathic generalized epilepsy (Lariviere et al., 2022, Zhang et al., 2009). Often the identification and removal of the epileptogenic network, turns out to be the elective therapy in drug-resistant focal epilepsies. The process of diagnosing and defining the epileptogenic network is still debated today. One of the most widely used methods is the implantation of intracranial electrodes for electroencephalographic recording of seizures (Bartolomei et al., 2017). This methodology carries with it several, albeit controlled, risks to the patient. New noninvasive approaches are being developed seeking to integrate information from structural neuroimaging and cortical electrical activity measured by high-density electroencephalography with external electrodes (Duma et al., 2021). These new approaches also include simulative approaches that exploit individualized information such as cortex geometry and patient-specific white matter connections (Courtiol et al. 2020). Thus, starting from a simple structural and diffusion MRI, which is done in routine clinical examinations, multiple localizing hypotheses of the epileptogenic network can be tested using simulative models and then compared with the real EEG signal as validation. Of great relevance is also to understand how the structural-functional connectome relates to cognitive function in patients with epilepsy, who have a high probability of presenting impaired functioning in one or more cognitive domains. conditions: Epilepsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Functional and structural Connectome measure: Identification of regional alteration in the value of functional connectivity measure: Measuring the spread of the epileptogenic network measure: Correlation between the Rey Complex figure test and the regional functional alteration sex: ALL minimumAge: 6 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS E.Medea status: RECRUITING city: Conegliano state: Treviso zip: 31015 country: Italy name: Duma Gian Marco, PhD role: CONTACT phone: +39 0438414248 email: gianmarco.duma@lanostrafamiglia.it lat: 45.88805 lon: 12.30201 hasResults: False

 nctId: NCT06334016 id: I-3597023 id: NCI-2024-01556 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3597023 type: OTHER domain: Roswell Park Cancer Institute id: R01DA057228 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA057228 briefTitle: Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream overallStatus: NOT_YET_RECRUITING date: 2025-03-27 date: 2028-03-01 date: 2028-03-01 date: 2024-03-27 date: 2024-03-27 name: Roswell Park Cancer Institute class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety. conditions: Cannabis Dependence studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Within-subject crossover study primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: Both participants and clinical personnel will be blinded to the nicotine product sequence (active vs. placebo). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Biospecimen Collection name: Cannabis sativa Extract name: Nicotine name: Placebo Administration name: Questionnaire Administration measure: Maximum concentration of THC in plasma (Cmax) measure: Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360) measure: Time to maximum concentration of THC in plasma (Tmax) measure: Incidence of adverse events (AEs) measure: Puffing behaviors measure: Puffing behaviors measure: Short-term drug effects measure: Marijuana Withdrawal Checklist [MWC) measure: Digit Symbol Substitution Task (DSST) measure: Paced Auditory Serial Addition Task (PASET) measure: Tobacco Craving Questionnaire (Short Form) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Danielle M. Smith role: CONTACT phone: 716-845-8403 email: Danielle.Smith@RoswellPark.org name: Danielle M. Smith role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06334003 id: H-23071266 briefTitle: Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology acronym: COMPART overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-12-01 date: 2024-03-27 date: 2024-03-27 name: Rigshospitalet, Denmark class: OTHER name: Herlev Hospital briefSummary: The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women, biological fathers/partners and offspring from pregnancies achieved by frozen embryo transfer (FET), fresh-embryo transfer (fresh ET) and naturally conceived (NC) to investigate maternal cardiometabolic profiles, fetal growth patterns and placental function during pregnancy as well as metabolic and endocrine health in the offspring. Additionally, the aim is to explore genetic and epigenetic patterns in placenta, fetus and parents. As secondary objectives, the investigator group will examine telomere length and minipuberty hormones in children born after FET, fresh-ET and NC. conditions: ART conditions: IVF conditions: Children, Only conditions: Cardiovascular Disease Other studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Offspring body composition measure: Maternal cardiometabolic profile measure: Epigenetic in placenta and cord blood measure: Early markers of reproductive function in FET, fresh-ET and NC children: LH, FSH, SHBG, AMH, androgens, estrogens (SDS) measure: Telomere length in children born after FET, fresh-ET and NC children sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Fertility Clinic, Rigshospitalet, Copenhagen University Hospital city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 facility: Dept. of Paediatric and Adolescent Medicine, Herlev Hospital city: Copenhagen country: Denmark name: Rikke B. Jensen, MD, Ass. Prof role: CONTACT name: Maria L. Vestager, MD, PhD-student role: CONTACT email: maria.linander.vestager.01@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06333990 id: 20220796HU briefTitle: Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-03 date: 2028-03 date: 2024-03-27 date: 2024-03-27 name: Foundation for Advancing Veterans' Health Research class: OTHER name: The University of Texas Health Science Center at San Antonio name: Biomedical Research Institute of New Mexico briefSummary: A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD). conditions: Mild Traumatic Brain Injury studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 146 type: ESTIMATED name: Quetiapine Fumarate name: TAU measure: Neurobehavioral Symptom Inventory measure: World Health Organization Disability Assessment Scale measure: World Health Organization Quality of Life BREF sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333977 id: LG-GQCL001 briefTitle: A Study of LC542019 in Healthy Subjects and Subjects With T2DM overallStatus: COMPLETED date: 2022-03-25 date: 2023-12-14 date: 2023-12-14 date: 2024-03-27 date: 2024-03-27 name: LG Chem class: INDUSTRY briefSummary: to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM). conditions: Healthy conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ACTUAL name: LC542019 name: Placebo measure: Incidence, severity of adverse events measure: Maximum Concentration (Cmax) in Plasma measure: Renal Clearance (CLR) in urine measure: Cardiodynamic evaluation measure: Fasting Plasma Glucose measure: HbA1c sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PPD Development, LP (PPD Clinical Research Unit, Las Vegas) city: Las Vegas state: Nevada zip: 89113 country: United States lat: 36.17497 lon: -115.13722 hasResults: False

 nctId: NCT06333964 id: AST-001P_P301_ASD briefTitle: Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children overallStatus: RECRUITING date: 2023-08-29 date: 2024-09-30 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: Astrogen, Inc. class: INDUSTRY briefSummary: 1. Study purpose: To demonstrate the superiority of AST-001 compared to placebo in improving core symptoms of autism spectrum disorder (ASD) in children with ASD.
2. Background: ASD is a neurodevelopmental disorder characterized by deficits in social communication and social interaction as well as restricted, repetitive patterns of behavior, interests, or activities. There are no approved medicines to treat the core symptom of ASD. Although these drugs and other psychotropic medications are associated with side effects, the use of psychotropic drugs to treat associated psychiatric comorbidities is common. AST-001 is developed to treat the core symptom of ASD.
3. Design: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 clinical trial followed by an Open-Label Extension Treatment Period conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Main study(0\~12 weeks) Experimental: AST-001 Comparator: Placebo of AST-001

Extension study(12\~24 weeks) Experimental: AST-001 Comparator: AST-001 primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: AST-001 name: Placebo of AST-001 measure: K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II) measure: CGI (Clinical Global Impression) measure: SRS-2 (Social Responsiveness Scale-2) measure: K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form) sex: ALL minimumAge: 2 Years maximumAge: 7 Years stdAges: CHILD facility: Soon Chun Hyang University Hospital Cheonan status: RECRUITING city: Cheonan state: Chungcheongnam-do country: Korea, Republic of lat: 36.8065 lon: 127.1522 facility: Hallym University Medical Center status: RECRUITING city: Anyang state: Gyeonggi-do country: Korea, Republic of lat: 37.3925 lon: 126.92694 facility: Samsung Changwon Medical Center status: RECRUITING city: Changwon state: Gyeongsangnam-do country: Korea, Republic of lat: 35.22806 lon: 128.68111 facility: Pusan National University Yangsan Hospital status: RECRUITING city: Yangsan state: Gyeongsangnam-do country: Korea, Republic of lat: 35.34199 lon: 129.03358 facility: Jeonbuk National University Hospital status: RECRUITING city: Jeonju state: Jeollabuk-do country: Korea, Republic of lat: 35.82194 lon: 127.14889 facility: Chungnam National University Hospital status: RECRUITING city: Daejeon country: Korea, Republic of lat: 36.32139 lon: 127.41972 facility: Asan Medical Center status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Hanyang University Seoul Hospital status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Koera University Guro Hospital status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: The Catholic University of Korea, Seoul St. Mary's Hospital status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06333951 id: 20230167 briefTitle: AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) overallStatus: RECRUITING date: 2024-06-03 date: 2026-10-08 date: 2029-10-07 date: 2024-03-27 date: 2024-04-25 name: Amgen class: INDUSTRY briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors. conditions: Thoracic Tumors conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: AMG 193 name: Carboplatin name: Paclitaxel name: Pembrolizumab name: Pemetrexed name: Sotorasib measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT) measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) measure: Number of Participants Experiencing Serious Adverse Events (SAE) measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) measure: Disease Control (DC) per RECIST v1.1 measure: Duration of Response (DOR) per RECIST v1.1 measure: Time to Response (TTR) per RECIST v1.1 measure: Overall Survival (OS) per RECIST v1.1 measure: Progression-free Survival (PFS) per RECIST v1.1 measure: Maximum Plasma Concentration (Cmax) of AMG 193 measure: Time to Maximum Plasma Concentration (tmax) of AMG 193 measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 measure: Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM ) measure: Intracranial Disease Control (IDC) per RANO-BM measure: Intracranial Duration of Response (IDOR) per RANO-BM measure: Time to Intracranial Radiation Therapy per RANO-BM sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope (COH) status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 hasResults: False

 nctId: NCT06333938 id: 01968 briefTitle: Veterans Enhanced Recovery Using Integrative Treatments Around Surgery acronym: VERITAS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2025-06 date: 2024-03-27 date: 2024-03-27 name: Durham VA Medical Center class: FED briefSummary: The study aims to assess the effectiveness of NSS2-Bridge in postoperative pain management in comparison to Battlefield Acupuncture (BFA). conditions: Anesthesia conditions: Surgery conditions: Knee Arthropathy studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Bridge name: BFA measure: Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0 measure: Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate. measure: Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. measure: Fidelity of Treatment among Patients as assessed by a Fidelity Checklist measure: Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. measure: Fidelity of Treatment among Providers as assessed by a Fidelity Checklist measure: Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents. measure: Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333925 id: Pro00114183 briefTitle: Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study acronym: MISO-STIM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-10-31 date: 2026-10-31 date: 2024-03-27 date: 2024-03-27 name: Duke University class: OTHER name: Misophonia Research Fund briefSummary: Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on misophonic distress. This study will examine changes in brain activity during presentation and regulation of misophonic versus distressing sounds. The study team plans to alter activity in a key area of the brain responsible for emotion regulation circuitry over 4 sessions with the goal to test if this intervention helps misophonic distress.

Sixty adult participants with moderate to severe misophonia will be recruited and taught an emotion regulation skill and randomly assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS). The study includes 9-10 visits: the remote screening visit(s), the initial MRI, the four neurostimulation sessions, the follow-up MRI, and two additional remote 1- and 3-month follow-up visits. conditions: Misophonia conditions: Emotion Dysregulation conditions: Sensory Processing Disorder conditions: Auditory Over Responsivity conditions: Anxiety Disorder conditions: Sound Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In regards to the neurostimulation used in the study, there will be two conditions, receiving either active or sham neurostimulation. Both conditions will receive behavioral training in cognitive restructuring (CR; a type of emotion regulation skill). Randomization procedures will match participants on age, gender at birth, and misophonia impairment severity. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: All participants will engage in a behavioral training session (Cognitive Restructuring).

The study team member who will conduct the behavioral session will be kept blind to the type of neurostimulation the participant will receive. Participants will also be kept blinded to what neurostimulation they receive and their perception of what they received will be assessed at follow-up. The intervention provider will also be kept blind to the treatment condition to ensure non-biased administration of the intervention.

Participants will only be told about the type of neurostimulation at the end of the study to protect against different expectations whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: High Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS) name: Sham Repetitive Transcranial Magnetic Stimulation (sham- rTMS) name: Cognitive Restructuring measure: Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and exposure to misophonic versus aversive sounds measure: Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and downregulation of versus exposure to misophonic sounds measure: Differential change in BOLD signal within the Anterior Insular Cortex (AIC) activation when being presented with misophonic versus non-misophonic but aversive sounds measure: Differential change in BOLD signal connectivity between the left Anterior Insular Cortex (AIC) and the right dorsolateral prefrontal cortex (dlPFC) when downregulating versus experiencing distress related to misophonic trigger sounds measure: Change in misophonia impairment and severity using a composite measure: Skin conductance level (scl) measure: Change in Subjective Unites of Distress (SUDS) measure: Changes in self-reported psychopathology measure: Changes in clinician-assessed psychopathology measure: Emotional dysregulation as measured by the Difficulties in Emotion Regulation Scale (DERS) measure: Changes in self-reported cognitive flexibility measure: Changes in self-reported cognitive skills measure: Baseline emotional dysregulation measure: Baseline hyperacusis measure: Baseline Affect Intensity measure: Change in Emotional distress measure: Change in self-reported Emotion regulation measure: Change in Sensory sensitivity measure: Change in Interoceptive Awareness sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Duke University Medical Center city: Durham state: North Carolina zip: 27710 country: United States name: Jessica Choi, MA role: CONTACT phone: 919-684-4432 email: jessica.choi@duke.edu name: Lisalynn D Kelley, BA, CCRP role: CONTACT phone: 919-684-6701 email: lisalynn.kelley@duke.edu name: Andrada D Neacsiu, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06333912 id: ridgesplittingguided briefTitle: Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement overallStatus: COMPLETED date: 2023-08-02 date: 2024-01-29 date: 2024-02-27 date: 2024-03-27 date: 2024-03-27 name: Alexandria University class: OTHER briefSummary: Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency. conditions: Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ACTUAL name: dental implant placement with ridge splitting. measure: Assessing the accuracy of guided surgery measure: the bone-width increase between control and study group. sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Alexandria University, Faculty of dentistry city: Alexandria zip: 21619 country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06333899 id: CONNECT2111 briefTitle: Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-09-01 date: 2034-09-01 date: 2024-03-27 date: 2024-03-27 name: Nationwide Children's Hospital class: OTHER name: Pfizer briefSummary: The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy. conditions: High Grade Glioma conditions: Diffuse Intrinsic Pontine Glioma conditions: Anaplastic Astrocytoma conditions: Infant Type Hemispheric Glioma conditions: Glioblastoma conditions: Glioblastoma Multiforme conditions: WHO Grade III Glioma conditions: WHO Grade IV Glioma conditions: Diffuse Midline Glioma, H3K27-altered studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Feasibility primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Lorlatinib name: Lorlatinib with chemotherapy1 name: Lorlatinib with chemotherapy 2 name: Lorlatinib post Radiation measure: Disease Control Rate measure: Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0 measure: Objective Response Rate (ORR) in HGG measure: Overall Survival (OS) in HGG measure: Progression-Free Survival in HGG sex: ALL minimumAge: 1 Year maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Children's Hospital Colorado city: Aurora state: Colorado zip: 80045 country: United States name: Kathleen Dorris, MD role: CONTACT email: kathleen.dorris@childrenscolorado.org lat: 39.72943 lon: -104.83192 facility: Children's National Medical Center city: Washington state: District of Columbia zip: 20010 country: United States name: Eugene Hwang role: CONTACT email: ehwang@childrensnational.org lat: 38.89511 lon: -77.03637 facility: Ann & Robert H. Lurie Children's Hospital of Chicago city: Chicago state: Illinois zip: 60611 country: United States name: Ashley Plant, MD role: CONTACT email: Aplant@luriechildrens.org lat: 41.85003 lon: -87.65005 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Susan Chi role: CONTACT email: Susan_chi@dfci.harvard.edu lat: 42.35843 lon: -71.05977 facility: Duke University Health System city: Durham state: North Carolina zip: 27708 country: United States name: David Ashley, MD role: CONTACT email: david.ashley@duke.edu lat: 35.99403 lon: -78.89862 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States name: Peter de Blank, MD role: CONTACT email: Peter.deBlank@cchmc.org lat: 39.12713 lon: -84.51435 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43235 country: United States name: Maryam Fouladi, MD, MSc role: CONTACT email: Maryam.fouladi@nationwidechildrens.org lat: 39.96118 lon: -82.99879 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Michael J Fisher, MD role: CONTACT email: fisherm@email.chop.edu lat: 39.95233 lon: -75.16379 facility: Texas Children's Hospital city: Houston state: Texas zip: 77030 country: United States name: Patricia Baxter, MD role: CONTACT email: pabaxter@txch.org lat: 29.76328 lon: -95.36327 facility: Seattle Children's Hospital city: Seattle state: Washington zip: 98105 country: United States name: Sarah Leary role: CONTACT email: sarah.leary@seattlechildrens.org lat: 47.60621 lon: -122.33207 facility: Sydney Children's Hospital city: Randwick state: New South Wales zip: 2031 country: Australia name: David Ziegler, MD role: CONTACT email: d.ziegler@unsw.edu.au lat: -33.91439 lon: 151.24895 facility: Queensland Children's Hospital city: South Brisbane state: Queensland zip: 4101 country: Australia name: Tim Hassall, MD role: CONTACT email: tim.hassall@health.qld.gov.au lat: -27.48034 lon: 153.02049 facility: Perth Children's Hospital city: Perth state: Western Australia zip: 6000 country: Australia name: Nicholas G Gottardo, MBChB role: CONTACT email: nick.gottardo@health.wa.gov.au lat: -31.95224 lon: 115.8614 facility: The Hospital for Sick Children (SickKids) city: Toronto state: Ontario zip: M5G1X8 country: Canada name: Eric Bouffet role: CONTACT email: eric.bouffet@sickkids.ca lat: 43.70011 lon: -79.4163 facility: Montreal Children's Hospital city: Montréal state: Quebec zip: H4A3J1 country: Canada name: Genevieve Legault, MD role: CONTACT email: Genevieve.legault4@mcgill.ca lat: 45.50884 lon: -73.58781 facility: Hopp Children's Cancer Center at NCT Heidelberg (KiTZ) city: Heidelberg state: Baden-Württemberg zip: 69120 country: Germany name: Olaf Witt, MD role: CONTACT email: o.witt@kitz-heidelberg.de lat: 49.40768 lon: 8.69079 facility: Princess Máxima Center city: Utrecht zip: 3720 country: Netherlands name: Jasper van der Lugt role: CONTACT email: J.vanderLugt@prinsesmaximacentrum.nl lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06333886 id: ciusss-nordmtl_ESG briefTitle: Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-18 date: 2028-12-31 date: 2028-12-31 date: 2024-03-27 date: 2024-03-27 name: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal class: OTHER briefSummary: Assessing the sacral nerves is an integral aspect of the evaluation after a spinal cord injury. Being located at the lower end of the spinal cord, the sacral nerves reflect how signals travel through the injured spinal cord. Sacral assessment is therefore essential to determine the level and severity of the spinal cord injury, which helps selecting the proper treatment and predicting recovery (worse when abnormal sacral function. The current assessment relies solely on a manual evaluation, which depends heavily on the physician's experience and does not provide any quantitative value of the dysfunction. The lack of a quantitative method adapted to the clinical setting is a major barrier limiting our knowledge on the impact of sacral function on recovery. We have recently developed an electrophysiological method providing quantitative sacral assessment at bedside after spinal cord injuries. Using this method, we will quantify sacral function in 250 patients with acute spinal cord injuries, and determine its association with recovery 6 months post-injury. We hypothesize that sacral function assessed early within the first 6 weeks after the injury with our method is associated with a better 6-month recovery of motor, sensory, bowel and bladder function. Our objectives are to assess the changes is sacral function during the first 6 months after the injury, and the relationship between early sacral function and 6-month recovery. Sacral function and recovery will be assessed up to 6 months post-injury by the attending physician, in order to measure the electromyographic magnitude of voluntary anal contraction, electromyographic magnitude of anal contraction elicited through sacral reflex testing, and minimal electrical stimulation for which anal sensation is present. The analysis will determine if and how sacral function evolves in time, and if there are specific quantitative criteria of sacral function that physicians can use to determine if patient will have a favorable recovery. conditions: Spinal Cord Injuries conditions: Neurogenic Bowel conditions: Neurogenic Bladder Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: Sacral electromyography measure: Precise assessment and evaluation of neuro-sacral dysfunction measure: Assessment of clinical phenotypes measure: Clinical prognosis assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital du Sacré-Coeur de Montréal city: Montréal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06333873 id: P22-09 briefTitle: Impact of Age-related Macular Degeneration on Daily Living Activitie acronym: AMDAY overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-06 date: 2029-06 date: 2024-03-27 date: 2024-03-27 name: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts class: OTHER briefSummary: The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA) conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study including healthy volunteers and patients with AMD primaryPurpose: OTHER masking: NONE count: 120 type: ESTIMATED name: patient-reported outcome measure: Validity of criteria measure: Validity of content measure: Reproducibility of results sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333860 id: M24-541 briefTitle: A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body) overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2025-03-24 date: 2026-03-31 date: 2024-03-27 date: 2024-03-27 name: AbbVie class: INDUSTRY briefSummary: Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly.

This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participants

Participants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. conditions: Moderate Plaque Psoriasis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 336 type: ESTIMATED name: Risankizumab name: Deucravacitinib measure: Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) measure: Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Almost Clear) with at least 2-grade improvement from Baseline measure: Period B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) in the Intent to Treat Population for non-responders in Period B (ITT_B_NR). measure: Period A: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) measure: Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baseline measure: Period B: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) among participants in the ITT_B_NR Population measure: Period B: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baselineamong participants in the ITT_B_NR Population. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333847 id: K2023-059 briefTitle: Is Multimorbidity a Source of Non-response Bias in Patients With Spinal Pain? - A Pilot Study overallStatus: ENROLLING_BY_INVITATION date: 2023-06-01 date: 2024-04-20 date: 2024-04-20 date: 2024-03-27 date: 2024-03-27 name: Jacob Christiansen Gandløse class: OTHER name: Aalborg Municipality name: Aalborg University name: Aalborg University Hospital briefSummary: The purpose of this study is to investigate whether the number of chronic diseases, the treatment burden resulting from multimorbidity, and health-related quality of life contribute to non-response bias in individuals with chronic back pain. Data is collected from patients at Aalborg University Hospital's Rheumatology Department through electronic means and medical records. The statistical analyses consist of two wave analyses, where we examine differences between patients who respond to invitations to participate in the study based on their response patterns; whether they respond after the first, second, or third invitation. Based on baseline data, a one-way ANOVA is conducted to identify any between-group differences in the aforementioned factors, followed by a repeated measures ANOVA to assess if there are differences between the groups over time. Finally, statistical tests are also performed to examine differences in age and gender distribution between those who complete the questionnaires at baseline compared to those who do not respond to the invitation to participate. conditions: Back Pain conditions: Low Back Pain conditions: Neck Pain conditions: Comorbidities and Coexisting Conditions studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Multimorbidity Treatment Burden Questionnaire (MTBQ). measure: Health-related quality of life (EQ-5D-5L) measure: Brief Pain Inventory - Short form measure: Insomnia Severity Index measure: Patient Health Questionnaire measure: Generalized Anxiety Disorder measure: Work ability score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aalborg University Hospital city: Aalborg zip: 9000 country: Denmark lat: 57.048 lon: 9.9187 hasResults: False

 nctId: NCT06333834 id: Dosis Seriada de Alacramyn briefTitle: Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-08-01 date: 2024-08-30 date: 2024-03-27 date: 2024-03-27 name: Selene Guadalupe Huerta Olvera class: OTHER briefSummary: The clinical study aims to compare the effectiveness of applying two different regimens of scorpion antivenom therapy. In the first regimen (control), the medication is administered to all patients, and depending on the severity of the condition, the dosage varies. In the experimental regimen, an identical dose of scorpion antivenom is administered to patients exhibiting signs and symptoms of scorpion sting intoxication, in addition to pain and other symptoms at the sting site. The primary response variable is the time taken for signs and symptoms to resolve, but differences in complications, adverse effects, venom and antivenom concentration in the blood, and the need for other therapeutic measures are also evaluated. conditions: Centruroides Envenomation studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy in a reduced regimen. The dosing regimen based on response will be one initial intravenous vial in patients with grade III scorpion envenomation, and two initial intravenous vials as the starting dose in patients with grade IV scorpion envenomation, according to the FDA classification of scorpion envenomation. In both scenarios, an additional vial can be administered every 30 minutes if symptoms persist, with no limit on vials. Control Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy according to the traditional regimen proposed in the Mexican Clinical Practice Guideline, where, according to the severity classification of scorpion envenomation, between one and six vials of anti-scorpion venom will be administered, and equal doses can be repeated every 30 minutes if necessary. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: A pharmacist will be responsible for randomizing the patients and preparing the study medication in a blinded manner, so that the treatment is administered by the physician without the care provider or the participant being able to identify it. The pharmacist will keep the randomization results in a sealed envelope that will be opened at the end of the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 121 type: ESTIMATED name: Traditional scorpion antivenom regimen name: Serial dose of scorpion antivenom regimen measure: Time to resolution of signs and symptoms measure: Serum venom concentration measure: Mortality measure: Length of intrahospital stay measure: Serum antivenom concentration sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Servicios Médicos Municipales de San Pedro Tlaquepaque. city: Tlaquepaque state: Jalisco zip: 45560 country: Mexico name: Héctor A González-Ruiz, PhD Student role: CONTACT phone: +52 33 1787 9139 email: andresgonzru@gmail.com name: Selene G Huerta-Olvera, PhD role: CONTACT phone: +52 392 111 0753 email: selene.huerta@academicos.udg.mx lat: 20.64091 lon: -103.29327 hasResults: False

 nctId: NCT06333821 id: BPL-Nim-CC-3003 briefTitle: A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2030-04-01 date: 2030-04-01 date: 2024-03-27 date: 2024-03-27 name: Biotech Pharmaceutical Co., Ltd. class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.

The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival. conditions: Cervical Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a multicenter prospective, randomized, double-blind, placebo-controlled phase III trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: This study is double-blind and will blind both the investigator and the subjects. All participants in the study (including data managers and biostatisticians) will be unaware of treatment assignment (except blind statisticians). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 460 type: ESTIMATED name: Nimotuzumab name: Cisplatin name: External Beam Radiotherapy (EBRT) name: Brachytherapy name: placebo for Nimotuzumab measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR) measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator measure: 3-,5-Year Overall Survival (OS) measure: 3-,5-Year Disease Free Survival(DFS) measure: 3-,5-Year Locoregional Recurrence-Free Survival(LRRFS) measure: 3-,5-Year Distant Metastasis-free Survival (DMFS) measure: Tumor Regression Rate(TRR) measure: Complete Response Rate measure: Complete Response Rate measure: Objective Response Rate measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score measure: Incidence of Treatment-Emergent Adverse Events sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333808 id: GS-US-621-6290 id: 2023-510022-33 type: OTHER domain: European Medicines Agency briefTitle: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy acronym: ARTISTRY-2 overallStatus: RECRUITING date: 2024-03-25 date: 2025-12 date: 2029-12 date: 2024-03-27 date: 2024-04-17 name: Gilead Sciences class: INDUSTRY briefSummary: The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH).

The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH. conditions: HIV-1-infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized in parallel in one of two treatment groups during the Blinded Phase. Participants in both treatment groups will be given the option to continue BIC/LEN FDC treatment during the Open-Label Phase. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 546 type: ESTIMATED name: Bictegravir name: Lenacapavir name: B/F/TAF name: Placebo to match B/F/TAF name: Placebo to match BIC/LEN measure: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm measure: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm measure: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48 measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm measure: Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96 measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48 measure: Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruane Medical and Clinical Research Institute status: RECRUITING city: Los Angeles state: California zip: 90036 country: United States lat: 34.05223 lon: -118.24368 facility: Therafirst Medical Center status: RECRUITING city: Fort Lauderdale state: Florida zip: 33308 country: United States lat: 26.12231 lon: -80.14338 facility: Midway Immunology and Research Center status: RECRUITING city: Fort Pierce state: Florida zip: 34982 country: United States lat: 27.44671 lon: -80.32561 facility: Infectious Disease Specialists of Atlanta status: RECRUITING city: Decatur state: Georgia zip: 30033 country: United States lat: 33.77483 lon: -84.29631 facility: Southhampton Community Healthcare, Inc. status: RECRUITING city: Saint Louis state: Missouri zip: 63139 country: United States lat: 38.62727 lon: -90.19789 facility: South Jersey Infectious Disease status: RECRUITING city: Somers Point state: New Jersey zip: 08244 country: United States lat: 39.31762 lon: -74.5946 facility: The Crofoot research Center, INC. status: RECRUITING city: Houston state: Texas zip: 77098 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06333795 id: 1-10-72-131-23 briefTitle: Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis acronym: FaeMiCue overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-31 date: 2025-12-31 date: 2024-03-27 date: 2024-03-27 name: University of Aarhus class: OTHER briefSummary: This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis. conditions: Diarrhea conditions: Systemic Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will undergo 2 interventions. For the first intervention participants are randomised 1:1 for either Active FMT or placebo For the second intervention, all participants receive active treatment. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The study is blinded throughout the active study period, both the patient and investigator are blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Faecal Microbiota Transplantation (FMT) name: Placebo measure: Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo). measure: Patient-reported treatment outcome on symptoms measure: Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention. measure: Patient-reported outcomes from questionnaires. measure: Patient-reported outcomes from questionnaires. measure: Patient-reported outcomes from questionnaires. measure: Patient-reported overall symptom burden measure: Objective measures from the wireless motility capsule. measure: Objective measures from the wireless motility capsule. measure: Objective measures from the wireless motility capsule. measure: Objective measures from the wireless motility capsule. measure: Objective measures from the low-dose CT scan. measure: Breath Test measure: Faecal microbiota composition measure: Faecal-calprotectin measure: Blood plasma proteomics measure: Blood plasma Fibrosis markers measure: Blood parameters measure: Health-related Quality of life measure: Patient perception of FMT treatment satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital city: Aarhus country: Denmark lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06333782 id: 2023-EU-GEN-01 id: 2023-A02012-43 type: OTHER domain: ANSM briefTitle: Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2025-07-01 date: 2025-07-01 date: 2024-03-27 date: 2024-04-02 name: Bioscience Cosmetics SL class: INDUSTRY name: Eurofins briefSummary: The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy.

The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection).

Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group.

An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection conditions: Vulvar Atrophy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants would be randomized on two groups: Genefill Contour or comparator (Desirial Plus) at a ratio 1:1 primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single blind whoMasked: PARTICIPANT count: 110 type: ESTIMATED name: Experimental- Genefill Contour® name: Marketed comparator - Desirial®Plus measure: Mean of number of occurred ADEs (Adverse device effects) measure: Global Aesthetic Improvement Scale (GAIS) assessment by investigator measure: Global Aesthetic Improvement Scale (GAIS) assessment by participant measure: Patient (Atrophy/Hypotrophy) symptoms measure: Sexual function Assessment, The Female Sexual Function Index (FSFI) measure: Patient´s satisfaction measure: Pain during injection-Visual Analogical Scale (VAS) measure: Adverse Events collection (Global safety during the study period) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cabinet renaissance city: Levallois-Perret state: Paris zip: 92300 country: France name: Massimo Gianfermi, MD role: CONTACT lat: 48.89389 lon: 2.28864 facility: Palais Flore city: Lyon zip: 69006 country: France name: Johanna Gratadour, MD role: CONTACT lat: 45.74848 lon: 4.84669 facility: Medical Center "Tu sie leczy" city: Gdańsk state: Gdansk country: Poland name: Katarzyna Kopacz-Petranyuk, MD role: CONTACT lat: 54.35205 lon: 18.64637 hasResults: False

 nctId: NCT06333769 id: CATIMOR briefTitle: A Phase II Multicenter Clinical Study of Improved Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2026-12-01 date: 2024-03-27 date: 2024-03-27 name: Fujian Cancer Hospital class: OTHER_GOV briefSummary: To explore the complete response (CR) rate of improved short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer conditions: Mid-low Rectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 31 type: ESTIMATED name: Short-course Radiotherapy name: Tislelizumab name: capecitabine name: Oxaliplatin measure: complete response (CR) rate measure: 3y-DFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333756 id: YM110099E briefTitle: Effects of Muscle Strengthening and Fatigue on Activities in Cortex and Muscle acronym: YM110099E overallStatus: COMPLETED date: 2021-05-01 date: 2022-04-30 date: 2022-08-01 date: 2024-03-27 date: 2024-03-27 name: National Yang Ming University class: OTHER briefSummary: We will explored the effect of cross education training on different cortex functional connectivity, cortex and muscle functional connectivity, and maximal voluntary contraction.

Healthy participants receive cross education training of the elbow flexor (12 rep./set, 3sets, 60%MVC, 180°/s, eccentric).Maximal voluntary contraction, electroencephalogram and electromyogram will record during cross education tasks to determine the effects of cross education training on cortical network and muscle functional connectivity conditions: Healthy Adults studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Parallel Assignment primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ACTUAL name: Cross education measure: Corticocortical coherence measure: Corticomuscular coherence measure: Maximal voluntary contraction sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: National Yang-Ming University city: Taipei zip: 112 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06333743 id: ZhuLan briefTitle: Laser Ablation in the Treatment of High-grade Cervical Lesions overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-05 date: 2024-03-27 date: 2024-03-27 name: Peking Union Medical College Hospital class: OTHER name: Obstetrics & Gynecology Hospital of Fudan University briefSummary: Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish to get pregnant in the future. There have been no randomized clinical trials of laser ablation therapy for cervical HSIL in Chinese women. This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL. conditions: High-Grade Squamous Intraepithelial Lesions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 308 type: ESTIMATED name: laser ablation name: LEEP or Conization measure: the rate of HSIL recurrence measure: the satisfaction with the treatment measure: the length of the cervix measure: Psychological state change related to the treatment sex: FEMALE maximumAge: 40 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06333730 id: PMC briefTitle: Comparison of Anesthetic Efficacy of Mental Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Anterior Teeth and Premolars in Symptomatic Irreversible Pulpitis overallStatus: RECRUITING date: 2024-04-01 date: 2024-05-30 date: 2024-06-20 date: 2024-03-27 date: 2024-03-27 name: Prime Foundation class: OTHER briefSummary: Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth.

Study design: This randomized clinical trial study Number of participants: 96 participants which will be randomly divided into two groups: MINB and IANB.

Inclusion criteria: Participants with mandibular premolars or lower anterior experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening, will be included.

Exclusion criteria: Participants with a medical history, allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those taking pain-affecting medication, or those experiencing pain in more than one tooth will be excluded.

Both techniques will use 2% lidocaine and adrenaline 1:80,000. Age, gender, and the efficacy of anesthesia will be recorded in both groups. The chi-square test will be used for comparison. conditions: Symptomatic Irreversible Pulpitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: inferior alveolar nerve block name: mental nerve block measure: COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Peshawar Dental College status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Prof. Dr. Iftikhar Akbar, FCPS, CHIPE role: CONTACT phone: 00923479368676 email: driftikhar156@hotmail.com name: Marghalara Noor, BDS role: CONTACT phone: 00923359631393 email: marghalaranoor96@gmail.com name: Saifa Rashad, BDS role: SUB_INVESTIGATOR lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06333717 id: Dnr 2020-03709 briefTitle: Impact of Whole Grain Rye Bread on Health acronym: FBS overallStatus: COMPLETED date: 2021-03-03 date: 2021-03-03 date: 2021-11-05 date: 2024-03-27 date: 2024-03-27 name: Örebro University, Sweden class: OTHER briefSummary: This randomized controlled trial aims to study how a high intake of a fibre-rich bread affects the composition and functioning of the gut microbiota in healthy subjects, and how this, in turn, impacts on the release of gut peptides, intestinal permeability, stress and cognitive performance. conditions: Healthy Diet studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: double blinding whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 33 type: ACTUAL name: Whole grain bread name: Control bread measure: Microbiota composition baseline vs after intervention using 16S RNA gene sequencing measure: Microbiota composition whole grain rye bread vs control bread using 16S RNA gene sequencing measure: Concentrations of circulatory short-chain fatty acids SCFA measure: Concentrations of faecal SCFA measure: Concentrations of blood glucagon like peptide-1 (GLP-1) measure: Concentrations of blood glucagon like peptide-2 (GLP-2) measure: Concentrations of blood peptide YY (PYY) measure: Concentrations of blood gastric inhibitory polypeptide (GIP) measure: Concentrations of blood neuroactive peptide Y (NPY) measure: Concentrations of blood brain-derived neurotrophic factor (BDNF) measure: Concentrations of blood cytokines measure: Concentrations of blood alkylresorcinols measure: Concentrations of blood lipopolysaccharide-binding protein (LBP) measure: Concentrations of blood soluble CD-14 (sCD-14) measure: Concentrations of sugars in urine measure: Concentrations of saliva cortisol during stress test measure: Concentrations of saliva alpha-amylase during stress test measure: Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale in Irritable Bowel Syndrome (GSRS-IBS) measure: Food habits measured by an electronic food frequency questionnaire Mealq measure: Food habits measured by a Food diary measure: Physical activity measured by the International Physical Activity Questionnaire (IPAQ) measure: Quality of life measured by the Euro Quality of Life questionnaire measure: Perceived stress measured by a Visual analog scale questionnaire measure: Cognitive control using Eriksen flanker task (Flanker task) measure: Working memory performance using a modified N-back task combined with recent-probes item-recognition task (Sternberg task) measure: Electrocardiogram (ECG) using the Biopac system measure: Electrodermal activity (EDA) using the Biopac system sex: ALL minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: Örebro University city: Örebro country: Sweden lat: 59.27412 lon: 15.2066 hasResults: False

 nctId: NCT06333704 id: mRNA-1273-P924 briefTitle: Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection. overallStatus: RECRUITING date: 2023-03-10 date: 2026-12-07 date: 2026-12-07 date: 2024-03-27 date: 2024-03-27 name: ModernaTX, Inc. class: INDUSTRY briefSummary: The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety related information in South-Korean population. conditions: SARS-CoV-2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3300 type: ESTIMATED name: SPIKEVAX Bivalent name: SPIKEVAX X measure: Number of Participants With AEs sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Yonseimin Clinic status: RECRUITING city: Wonju state: Gangwon-do zip: 26428 country: Korea, Republic of lat: 37.35139 lon: 127.94528 facility: Hyundai Clinic status: RECRUITING city: Bucheon state: Gyeonggi-do zip: 14483 country: Korea, Republic of lat: 37.49889 lon: 126.78306 facility: Ma Hak ki Family Medicine Clinic status: RECRUITING city: Bucheon state: Gyeonggi-do zip: 14614 country: Korea, Republic of lat: 37.49889 lon: 126.78306 facility: Nalee Hospital status: RECRUITING city: Gimpo state: Gyeonggi-do zip: 10108 country: Korea, Republic of facility: COA ENT Clinic status: RECRUITING city: Goyang state: Gyeonggi-do zip: 10234 country: Korea, Republic of lat: 37.65639 lon: 126.835 facility: Joon Pediatric Clinic status: RECRUITING city: Gwangmyeong state: Gyeonggi-do zip: 14250 country: Korea, Republic of facility: Janghyeon Medicine Clinic status: RECRUITING city: Siheung state: Gyeonggi-do zip: 14998 country: Korea, Republic of facility: Hanyang Union Rehabilitation Medicine Clinic status: RECRUITING city: Yangju state: Gyeonggi-do zip: 11404 country: Korea, Republic of lat: 37.83311 lon: 127.06169 facility: KimHyungjoo Clinic status: RECRUITING city: Yangju state: Gyeonggi-do zip: 11456 country: Korea, Republic of lat: 37.83311 lon: 127.06169 facility: Kium Children Hospital status: RECRUITING city: Gunsan state: Jeollabuk-do zip: 54072 country: Korea, Republic of lat: 35.97861 lon: 126.71139 facility: Sinsegie ENT Clinic status: TERMINATED city: Busan zip: 48111 country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Jeil Family Medicine Clinic status: WITHDRAWN city: Gwangju zip: 61108 country: Korea, Republic of lat: 35.15472 lon: 126.91556 facility: Bupyeong Yonsei Medical Clinic status: RECRUITING city: Incheon zip: 21405 country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Inha University Hospital status: RECRUITING city: Incheon zip: 22332 country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Woori Medical Clinic status: RECRUITING city: Seoul zip: 01684 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Yonsei Kids Pediatrics Clinic status: RECRUITING city: Seoul zip: 01851 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Star Pediatrics Clinic status: RECRUITING city: Seoul zip: 03912 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Seoul Bon Clinic status: RECRUITING city: Seoul zip: 04032 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Dr Cho's Family Medical Clinic status: RECRUITING city: Seoul zip: 05351 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Songpa Korea Neurosurgical Clinic status: RECRUITING city: Seoul zip: 05769 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: GF Pediatrics Clinic status: RECRUITING city: Seoul zip: 06568 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kim Il Joong Internal Medicine Clinic status: RECRUITING city: Seoul zip: 06727 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: New Yonsei ENT Clinic status: RECRUITING city: Seoul zip: 07327 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Soo Orthopedics Clinic status: TERMINATED city: Seoul zip: 08701 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06333691 id: Aya Mohammed briefTitle: Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin overallStatus: COMPLETED date: 2022-10-01 date: 2024-02-01 date: 2024-02-15 date: 2024-03-27 date: 2024-03-27 name: Minia University class: OTHER briefSummary: Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition. This syndrome is characterized by a sudden increase of the vascular permeability which results in the development of a massive extravascular exudate in the peritoneal cavity, pleural, pericardium causing ascites, pleural and pericardial effusion.

Severe forms are also accompanied by electrolyte disturbances and cardiopulmonary, hepatic, renal, and hemoconcentration associated with increased thromboembolic risk.

This syndrome is avoidable by the judicious use of gonadotropins and careful monitoring of stimulation regimens. conditions: Ovarian Hyperstimulation Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ACTUAL name: Calcium Gluconate measure: the incidence rate of moderate to severe OHSS. sex: FEMALE minimumAge: 23 Years maximumAge: 39 Years stdAges: ADULT facility: Minia University, Faculty of Pharmacy city: Minya country: Egypt lat: 28.10988 lon: 30.7503 hasResults: False

 nctId: NCT06333678 id: 22-321 briefTitle: A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) overallStatus: RECRUITING date: 2024-03-20 date: 2027-03 date: 2027-03 date: 2024-03-27 date: 2024-03-27 name: Memorial Sloan Kettering Cancer Center class: OTHER name: Amgen briefSummary: In this study, the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC). The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab (and not switching to sotorasib). conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase II randomized trial primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: Durvalumab name: Sotorasib measure: Progression-free survival (PFS) measure: Incidence of dose-limiting toxicity (DLT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (All Protocol Activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (All Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (All Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (All Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Narek Shaverdian, MD role: CONTACT phone: 631-212-6323 lat: 40.70038 lon: -73.59291 hasResults: False

 nctId: NCT06333665 id: Wei G briefTitle: PPIO-007 Correlation Analysis of Type II Diabetes Mellitus on Short-term and Long-term Outcomes of Patients With Esophageal Squamous Cell Cancer Undergoing Minimally Invasive Esophagectomy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-20 date: 2024-04-20 date: 2024-05-20 date: 2024-03-27 date: 2024-03-27 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: To date, there is controversy as to whether type II diabetes mellitus is associated with adverse short- and long-term outcomes in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy. At the same time, to the best of our knowledge, the impact of metformin use and glycemic control on short- and long-term outcomes in this patient population is also controversial. Therefore, this study aims to test the hypothesis that diabetes mellitus is associated with reduced survival in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy and that treatment with metformin and/or good glycemic control (HbA1c\<7.0%) is associated with improved survival. conditions: Esophageal Squamous Cell Carcinoma conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 605 type: ACTUAL name: Whether there is type 2 diabetes mellitus before surgery measure: Overall survival measure: Disease-free survival measure: postoperative adverse events measure: perioperative 90-day mortality sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Army Medical Center of the People's Liberation Army city: Chongqing state: Chongqing zip: 400042 country: China lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06333652 id: 22-009239 briefTitle: Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders overallStatus: RECRUITING date: 2024-06-01 date: 2026-12-31 date: 2028-12-31 date: 2024-03-27 date: 2024-04-22 name: Mayo Clinic class: OTHER briefSummary: The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome. conditions: Preeclampsia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: Ravulizumab measure: Alternative Complement Pathway Biomarkers at time of delivery measure: Pregnancy duration measure: Clinical biomarkers of severe features of preeclampsia and HELLP syndrome measure: Hospitalization length in the postpartum period measure: Meningococcal infection after use of ravulizumab sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mayo Clinic Minnesota status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Maria L. Gonzalez Suarez, MD,PhD role: CONTACT phone: 507-284-4083 email: gonzalezsuarez.maria@mayo.edu lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06333639 id: 24Chirortho01 briefTitle: Implementing Virtual Reality in the Operating Room acronym: IRVABO overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-15 date: 2024-10-15 date: 2024-03-27 date: 2024-03-27 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: "Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.

However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.

The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.

The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour." conditions: General Surgery conditions: Orthopedic Procedures studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: orthopaedic surgery name: orthopaedic surgery and fitted with a virtual reality headset measure: To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset. measure: 1. To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on the doses of premedication, compared with the same surgeries without headset. measure: Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU NiICE city: Nice state: Alpes Maritimes zip: 0600 country: France name: GAUCI Marc-Olivier role: CONTACT phone: 04 92 03 69 04 phoneExt: +33 email: gauci.mo@chu-nice.fr lat: 43.70313 lon: 7.26608 hasResults: False

 nctId: NCT06333626 id: 2020281 briefTitle: Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2025-03-31 date: 2024-03-27 date: 2024-03-27 name: The First Affiliated Hospital of Soochow University class: OTHER briefSummary: Nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. Our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric ultrasound. conditions: Nausea and Vomiting, Aspiration, Intraoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: multi-vitamin carbohydrate measure: Gastric antrum area measure: vomiting measure: The pH of vomiting fluid sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06333613 id: CR-6565 briefTitle: Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers overallStatus: RECRUITING date: 2024-03-26 date: 2024-05-20 date: 2024-05-20 date: 2024-03-27 date: 2024-04-24 name: Johnson & Johnson Vision Care, Inc. class: INDUSTRY briefSummary: This is a multi-site, bilateral, dispensing, non-randomized, uncontrolled, unmasked, single arm study to evaluate visual acuity in neophytes. conditions: Visual Acuity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D) measure: Percentage of eyes with slit-lamp findings (Grade 3 or 4) related to study lens wear sex: ALL minimumAge: 13 Years maximumAge: 39 Years stdAges: CHILD stdAges: ADULT facility: Scripps Poway Eyecare & Optometry status: RECRUITING city: San Diego state: California zip: 92131 country: United States lat: 32.71533 lon: -117.15726 facility: Omega Vision Center status: RECRUITING city: Longwood state: Florida zip: 32779 country: United States lat: 28.70305 lon: -81.3384 facility: Maitland Vision Center - North Orlando Ave status: RECRUITING city: Maitland state: Florida zip: 32751 country: United States lat: 28.62778 lon: -81.36312 facility: Kannarr Eye Care status: RECRUITING city: Pittsburg state: Kansas zip: 66762 country: United States lat: 37.41088 lon: -94.70496 facility: Procare Vision Centers status: RECRUITING city: Granville state: Ohio zip: 43023 country: United States lat: 40.06812 lon: -82.5196 hasResults: False

 nctId: NCT06333600 id: Soh-Med-23-07-05 briefTitle: Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss overallStatus: RECRUITING date: 2023-05-20 date: 2024-04-01 date: 2024-05-01 date: 2024-03-27 date: 2024-03-27 name: Sohag University class: OTHER briefSummary: The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases conditions: Dermatology conditions: Female Pattern Baldness studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Topical minoxidil name: Topical Vitamin D name: Saline spray measure: Change of Sinclaire grading of Female pattern hair loss measure: Change of Trichoscopic parameters (Hair dermoscopy) sex: FEMALE minimumAge: 15 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Facult of Medicine, Sohag Uniiversity status: RECRUITING city: Sohag zip: 82515 country: Egypt name: Doaa G Abdelbaset, MSc role: CONTACT phone: 01022330810 phoneExt: 002 email: dodygaber64@yahoo.com name: Doaa G Abdelbaset, Msc role: CONTACT phone: 01014733007 phoneExt: 002 email: dodygaber64@yahoo.com lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06333587 id: IEO 1810 briefTitle: Minimally Invasive Treatments of the Thyroid acronym: MIPA-MITT overallStatus: RECRUITING date: 2022-10-10 date: 2025-12-31 date: 2035-12-31 date: 2024-03-27 date: 2024-03-27 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC) conditions: Papillary Thyroid Microcarcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 270 type: ESTIMATED name: image-guided thermal ablation measure: The proportion of patients with major complications occurring within one month after the date of intervention measure: Percentage of patients with local recurrence at 10 years measure: Percentage of patients with distant metastasis at 10 years measure: Percentage of patients died at 10 years sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Giovanni Mauri role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06333574 id: CDUTCM20240313 briefTitle: Weight Management of Dialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: qinxiu zhang class: OTHER briefSummary: The goal of this clinical trial is to Improve the quality of life in Hemodialysis patient. The main questions it aims to answer are:

* \[Improve the self-compliance of dialysis patients with weight management\]
* \[alleviate the volume load of dialysis patients and reduce cardiovascular complications\] Participants will be divided into two groups based on a weight management regimen： Control group: received routine outpatient management. Specific methods: The dialysis doctor registered the information of the patient\&#39;s weight and blood pressure at the end of dialysis, and informed the patient of the purpose, role and importance of weight management.

Intervention group: On the basis of routine outpatient management, patients or their family members were subjected to remote follow-up management based on wechat, and the follow-up time was 6 months. Specific methods: Same as the control group, the information of weight and blood pressure of the patients was registered at the end of dialysis, and the purpose, role and importance of weight management were informed to the patients. On this basis, a special wechat signal is set up to add patients or patients\&#39; family members as wechat friends and establish a wechat interaction platform with patients. In the interdialysis period, remind patients to weigh themselves through wechat (the time of each weighing is fixed, preferably consistent with the time of weighing in the hemodialysis center), control the weight gain during the interdialysis period not to exceed 4.5% of dry weight, and inform patients again about the purpose, role and importance of weight management. conditions: Hemodialysis conditions: Life Quality conditions: Interdialytic Weight Gain conditions: Cardiovascular Events conditions: Hypertension conditions: Dry Weight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Family weight self-measurement and remote follow-up management based on wechat. name: Routine care measure: Adverse event rate measure: Rate of completion measure: dialysis related symptoms measure: Laboratory index measure: level of Ga measure: level of P measure: level of PTH measure: level of K measure: level of Na measure: level of Cl measure: concentration of albumin and prealbumin measure: Laboratory index of total protein measure: Dialysis efficiency \ dialysis adequacy (KTV) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333561 id: Liver Project 7 briefTitle: HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-30 date: 2024-12-30 date: 2024-03-27 date: 2024-03-27 name: Sun Yat-sen University class: OTHER briefSummary: Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC. conditions: Hepatocellular Carcinoma conditions: Lenvatinib conditions: PD-1 Inhibitor conditions: Hepatic Arterial Infusion Chemotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Hepatic arterial infusion chemotherapy name: Lenvatinib name: Tislelizumab name: Toripalimab name: Sintilimab name: Camrelizumab measure: Overall survival measure: Progression-Free-Survival measure: Objective response rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Qunfang Zhou, Md role: CONTACT phone: 8619868000115 email: zhouqun988509@163.com name: Feng Duan, MD role: CONTACT phone: 8613910984586 email: duanfeng@vip.sina.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06333548 id: KSH_MB_2024_1 briefTitle: Cord Blood Alarin Levels in Term Babies overallStatus: COMPLETED date: 2023-09-18 date: 2023-12-23 date: 2024-01-15 date: 2024-03-27 date: 2024-03-29 name: Konya City Hospital class: OTHER briefSummary: In this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. Thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin. conditions: Birth Weight studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 87 type: ACTUAL name: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM measure: Comparison of cord blood alarin levels of babies in different groups according to birth weight (low-appropriate-large) and babies of mothers diagnosed with gestational diabetes regardless of birth weight. sex: ALL minimumAge: 1 Minute maximumAge: 5 Minutes stdAges: CHILD facility: MELEK city: Konya state: Sıhhiye zip: 06100 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06333535 id: 2022/568 briefTitle: Foot and Abdominal Massage Applied to After Colonoscopy overallStatus: COMPLETED date: 2023-06-01 date: 2024-01-01 date: 2024-02-25 date: 2024-03-27 date: 2024-03-27 name: TC Erciyes University class: OTHER briefSummary: The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale conditions: Abdominal Pain conditions: Distention conditions: Satisfaction, Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 96 type: ACTUAL name: foot massage name: abdominal massage name: foot and abdominal massage measure: abdominal pain measure: Abdominal distension measure: Patient Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University city: Kayseri zip: 38000 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06333522 id: 23-00979 briefTitle: Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-27 date: 2024-03-27 name: NYU Langone Health class: OTHER briefSummary: The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm. conditions: Arthrofibrosis of Knee studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: Losartan measure: Change in range of motion measure: Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06333509 id: CT071-HM-01 briefTitle: Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-06-15 date: 2027-12-31 date: 2024-03-27 date: 2024-03-27 name: CARsgen Therapeutics Co., Ltd. class: INDUSTRY briefSummary: A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia. conditions: Multiple Myeloma conditions: Primary Plasma Cell Leukemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1; Dose escalation followed by dose expansion Phase 2; Single group of each indication will be dosed at the recommended dose level from Phase 1. primaryPurpose: TREATMENT masking: NONE maskingDescription: N/Ap count: 166 type: ESTIMATED name: CT071 measure: Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD). measure: Phase 2: Objective response rate measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes measure: Phase 2: Evaluate additional Safety of CT071. measure: Phase 1 and 2: Assess immunogenicity of CT071 measure: Phase 1 and 2: Evaluate PK profile of CT071 measure: Phase 1 and 2: Evaluate PK profile of CT071 measure: Phase 1 and 2: Evaluate PK profile of CT071 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333496 id: AB20240102H briefTitle: Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-02 date: 2024-03-29 date: 2024-04-08 date: 2024-03-27 date: 2024-04-15 name: Alpine Biotech LLC class: INDUSTRY briefSummary: BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.

PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.

SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints. conditions: Blood Sugar; High conditions: Overweight and Obesity conditions: Fat Burn conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: GLP1 Booster (GB) measure: blood glucose level measure: blood HbA1c level measure: blood insulin level measure: blood GLP1 level measure: blood cholesterol level measure: body weight measure: body fat mass measure: body lean mass measure: body mass index measure: body fat index measure: waist hip ratio measure: Satiety score measure: Resting metabolic rate measure: Blood pressure measure: Heart rate sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alpine Bio city: Salt Lake City state: Utah zip: 84109 country: United States lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06333483 id: AUTO1-SL1 id: 2023-508236-60-00 type: CTIS briefTitle: A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE) acronym: CARLYSE overallStatus: RECRUITING date: 2024-02-02 date: 2024-11 date: 2025-10 date: 2024-03-27 date: 2024-03-27 name: Autolus Limited class: INDUSTRY briefSummary: This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Obecabtagene autoleucel (obe-cel) measure: Dose limiting toxicities measure: Adverse events measure: Remission rate according to Definition of Remission in SLE (DORIS) measure: Response over time according to Definition of Remission in SLE (DORIS) measure: Time to response according to Definition of Remission in SLE (DORIS) measure: Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) measure: Change over time in Physician's global assessment (PGA) measure: Pharmacokinetics (maximum serum concentration [Cmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacokinetics (time to reaching maximum serum concentration [Tmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacokinetics (area under the curve [AUC]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacokinetics (last observed quantifiable concentration [Clast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacokinetics (time to reach last observed quantifiable concentration [Tlast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood measure: Pharmacodynamics: B cell aplasia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University College London Hospitals NHS Foundation Trust status: RECRUITING city: London country: United Kingdom name: Maria Leandro role: CONTACT email: uclh.car-ttrials@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06333470 id: 2024KYPJ025 briefTitle: Liwan Eye Study: the Fourth Follow-up overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-09-30 date: 2024-09-30 date: 2024-03-27 date: 2024-03-28 name: Zhongshan Ophthalmic Center, Sun Yat-sen University class: OTHER briefSummary: Primary angle-closure glaucoma (PACG) is one of the major causes of blindness affecting more than 20 million patients worldwide. The goals of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged 50 years and to develop prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to PACG. conditions: Primary Angle-Closure Glaucoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED name: Primary angle closure diseases measure: The 20-year incidence of primary angle-closure glaucoma (PACG) in Chinese population aged over 50 years measure: The development of prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to primary angle-closure glaucoma (PACG) measure: The 20-year incidence of visual impairment in Chinese population aged over 50 years sex: ALL minimumAge: 70 Years maximumAge: 100 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333457 id: EA4/024/24 briefTitle: Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality acronym: PRE-VR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-01 date: 2025-02-01 date: 2024-03-27 date: 2024-03-27 name: Charite University, Berlin, Germany class: OTHER briefSummary: Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates.